| 1. Park SH, Jeong YM, Cho SH, Jung HK, Kim SJ, Ryu HS. Imaging findings of variable axillary mass and axillary lymphadenopathy. [Review]. Ultrasound Med Biol. 40(9):1934-48, 2014 Sep. |
Review/Other-Dx |
N/A |
To describe axillary masses and axillary lymphadenopathies using imaging findings from techniques such as ultrasonography, mammography, computed tomography and magnetic resonance imaging. |
No results listed in abstract. |
4 |
| 2. Ashikaga T, Krag DN, Land SR, et al. Morbidity results from the NSABP B-32 trial comparing sentinel lymph node dissection versus axillary dissection. J Surg Oncol 2010;102:111-8. |
Experimental-Tx |
3983 patients |
The primary objectives of the NSABP B-32 trial are a comparison of survival, regional control and morbidity endpoints between SLND and ALND treatment groups among clinically node negative women with operable invasive breast cancer. |
Shoulder abduction deficits = 10% peaked at one week for the ALND (75%) and SLND (41%) groups. Arm volume differences = 10% at 36 months were evident for the ALND (14%) and SLND (8%) groups. Numbness and tingling peaked at 6 months for the ALND (49%, 23%) and SLND (15%, 10%) groups. Logistic regression correlates of residual morbidity included treatment group, age, handedness, tumor size, systemic chemotherapy and radiation to the axilla. |
1 |
| 3. Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol 2010;11:927-33. |
Experimental-Tx |
5611 women |
To establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects. |
5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1.20 (95% CI 0.96-1.50; p=0.12). 8-year Kaplan-Meier estimates for overall survival were 91.8% (95% CI 90.4-93.3) in group 1 and 90.3% (88.8-91.8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1.05 (95% CI 0.90-1.22; p=0.54). 8-year Kaplan-Meier estimates for disease-free survival were 82.4% (80.5-84.4) in group 1 and 81.5% (79.6-83.4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0.22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye. |
1 |
| 4. Galimberti V, Cole BF, Zurrida S, et al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol 2013;14:297-305. |
Experimental-Tx |
934 patients |
To compare outcomes in patients with SN micrometastases treated with AD, with outcomes in those receiving no further treatment tothe axilla. |
Between April 1, 2001, and Feb 28, 2010, 465 patients were randomly assigned to axillary dissection and 469 to no axillary dissection. After the exclusion of three patients, 464 patients were in the axillary dissection group and 467 patients were in the no axillary dissection group. After a median follow-up of 5.0 (IQR 3.6-7.3) years, we recorded 69 disease-free survival events in the axillary dissection group and 55 events in the no axillary dissection group. Breast-cancer-related events were recorded in 48 patients in the axillary dissection group and 47 in the no axillary dissection group (ten local recurrences in the axillary dissection group and eight in the no axillary dissection group; three and nine contralateral breast cancers; one and five [corrected] regional recurrences; and 34 and 25 distant relapses). Other non-breast cancer events were recorded in 21 patients in the axillary dissection group and eight in the no axillary dissection group (20 and six second non-breast malignancies; and one and two deaths not due to a cancer event). 5-year disease-free survival was 87.8% (95% CI 84.4-91.2) in the group without axillary dissection and 84.4% (80.7-88.1) in the group with axillary dissection (log-rank p=0.16; HR for no axillary dissection vs axillary dissection was 0.78, 95% CI 0.55-1.11, non-inferiority p=0.0042). Patients with reported long-term surgical events (grade 3-4) included one sensory neuropathy (grade 3), three lymphoedema (two grade 3 and one grade 4), and three motor neuropathy (grade 3), all in the group that underwent axillary dissection, and one grade 3 motor neuropathy in the group without axillary dissection. One serious adverse event was reported, a postoperative infection in the axilla in the group with axillary dissection. |
1 |
| 5. Giuliano AE, Ballman KV, McCall L, et al. Effect of Axillary Dissection vs No Axillary Dissection on 10-Year Overall Survival Among Women With Invasive Breast Cancer and Sentinel Node Metastasis: The ACOSOG Z0011 (Alliance) Randomized Clinical Trial. JAMA 2017;318:918-26. |
Experimental-Tx |
891 women |
To determine whether the 10-year overall survival of patients with sentinel lymph node metastases treated with breast-conserving therapy and sentinel lymph node dissection (SLND) alone without axillary lymph node dissection (ALND) is noninferior to that of women treated with axillary dissection. |
Among 891 women who were randomized (median age, 55 years), 856 (96%) completed the trial (446 in the SLND alone group and 445 in the ALND group). At a median follow-up of 9.3 years (interquartile range, 6.93-10.34 years), the 10-year overall survival was 86.3%in the SLND alone group and 83.6%in the ALND group (HR, 0.85 [1-sided 95%CI, 0-1.16]; noninferiority P = .02). The 10-year disease-free survival was 80.2%in the SLND alone group and 78.2%in the ALND group (HR, 0.85 [95%CI, 0.62-1.17]; P = .32). Between year 5 and year 10, 1 regional recurrence was seen in the SLND alone group vs none in the ALND group. Ten-year regional recurrence did not differ significantly between the 2 groups. |
1 |
| 6. The American Society of Breast Surgeons. Performance and Practice Guidelines for Sentinel Lymph Node Biopsy in Breast Cancer Patients. Available at: https://www.breastsurgeons.org/docs/statements/Performance-and-Practice-Guidelines-for-Sentinel-Lymph-Node-Biopsy-in-Breast-Cancer-Patients.pdf. |
Review/Other-Dx |
N/A |
No abstract available. |
No abstract available. |
4 |
| 7. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer. Version 1.2021. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. |
Review/Other-Dx |
N/A |
To provide clinical practice guidelines in breast cancer. |
No results stated in abstract. |
4 |
| 8. Caudle AS, Yang WT, Krishnamurthy S, et al. Improved Axillary Evaluation Following Neoadjuvant Therapy for Patients With Node-Positive Breast Cancer Using Selective Evaluation of Clipped Nodes: Implementation of Targeted Axillary Dissection. J Clin Oncol. 34(10):1072-8, 2016 Apr 01. |
Experimental-Dx |
208 patients |
To determine if pathologic changes in clipped nodes reflect the status of the nodal basin and if targeted axillary dissection (TAD), which includes sentinel lymph node dissection (SLND) and selective localization and removal of clipped nodes, improves the false-negative rate (FNR) compared with SLND alone. |
Of 208 patients enrolled in this study, 191 underwent ALND, with residual disease identified in 120 (63%). The clipped node revealed metastases in 115 patients, resulting in an FNR of 4.2% (95% CI, 1.4 to 9.5) for the clipped node. In patients undergoing SLND and ALND (n = 118), the FNR was 10.1% (95% CI, 4.2 to 19.8), which included seven false-negative events in 69 patients with residual disease. Adding evaluation of the clipped node reduced the FNR to 1.4% (95% CI, 0.03 to 7.3; P = .03). The clipped node was not retrieved as an SLN in 23% (31 of 134) of patients, including six with negative SLNs but metastasis in the clipped node. TAD followed by ALND was performed in 85 patients, with an FNR of 2.0% (1 of 50; 95% CI, 0.05 to 10.7). |
2 |
| 9. Boileau JF, Poirier B, Basik M, et al. Sentinel node biopsy after neoadjuvant chemotherapy in biopsy-proven node-positive breast cancer: the SN FNAC study. J Clin Oncol 2015;33:258-64. |
Experimental-Dx |
153 patients |
To evaluate the accuracy of SNB after NAC in patients presenting with biopsy-proven node-positive breast cancer. |
From March 2009 to December 2012, 153 patients were accrued to the study. The SNB IR was 87.6% (127 of 145; 95% CI, 82.2% to 93.0%), and the FNR was 8.4% (seven of 83; 95% CI, 2.4% to 14.4%). If SN ypN0(i+)s had been considered negative, the FNR would have increased to 13.3% (11 of 83; 95% CI, 6.0% to 20.6%). There was no correlation between size of SN metastases and rate of positive non-SNs. Using this method, 30.3% of patients could potentially avoid CND. |
3 |
| 10. Boughey JC, Ballman KV, Le-Petross HT, et al. Identification and Resection of Clipped Node Decreases the False-negative Rate of Sentinel Lymph Node Surgery in Patients Presenting With Node-positive Breast Cancer (T0-T4, N1-N2) Who Receive Neoadjuvant Chemotherapy: Results From ACOSOG Z1071 (Alliance). Ann Surg. 263(4):802-7, 2016 Apr. |
Experimental-Dx |
203 patients |
To evaluate how often the lymph node containing the clip placed at percutaneous biopsy prior to chemotherapy was found at surgery to be one of the SLNs and how often it was found in the nodes retrieved at ALND. |
A clip was placed at initial node biopsy in 203 patients. In the 170 (83.7%) patients with cN1 disease and at least 2 SLNs resected, clip location was confirmed in 141 cases. In 107 (75.9%) patients where the clipped node was within the SLN specimen, the FNR was 6.8% (confidence interval [CI]: 1.9%-16.5%). In 34 (24.1%) cases where the clipped node was in the ALND specimen, the FNR was 19.0% (CI: 5.4%-41.9%). In cases without a clip placed (n = 355) and in those where clipped node location was not confirmed at surgery (n = 29), the FNR was 13.4% and 14.3%, respectively. |
3 |
| 11. Boughey JC, Suman VJ, Mittendorf EA, et al. Sentinel lymph node surgery after neoadjuvant chemotherapy in patients with node-positive breast cancer: the ACOSOG Z1071 (Alliance) clinical trial. JAMA. 2013;310(14):1455-1461. |
Experimental-Dx |
756 women |
To determine the false-negative rate (FNR) for sentinel lymph node surgery following chemotherapy in women initially presenting with biopsy-proven cN1 breast cancer. |
Seven hundred fifty-six women were enrolled in the study. Of 663 evaluable patients with cN1 disease, 649 underwent chemotherapy followed by both SLN surgery and ALND. An SLN could not be identified in 46 patients (7.1%). Only 1 SLN was excised in 78 patients (12.0%). Of the remaining 525 patients with 2 or more SLNs removed, no cancer was identified in the axillary lymph nodes of 215 patients, yielding a pathological complete nodal response of 41.0% (95% CI, 36.7%-45.3%). In 39 patients, cancer was not identified in the SLNs but was found in lymph nodes obtained with ALND, resulting in an FNR of 12.6% (90% Bayesian credible interval, 9.85%-16.05%). |
3 |
| 12. Kuehn T, Bauerfeind I, Fehm T, et al. Sentinel-lymph-node biopsy in patients with breast cancer before and after neoadjuvant chemotherapy (SENTINA): a prospective, multicentre cohort study. Lancet Oncol 2013;14:609-18. |
Experimental-Dx |
1737 patients |
To evaluate a specifi c algorithm for timing of a standardised sentinel-lymph-node biopsy procedure in patients who undergo neoadjuvant chemotherapy. |
Of 1737 patients who received treatment, 1022 women underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy (arms A and B), with a detection rate of 99·1% (95% CI 98·3–99·6; 1013 of 1022). In patients who converted after neoadjuvant chemotherapy from cN+ to ycN0 (arm C), the detection rate was 80·1% (95% CI 76·6–83·2; 474 of 592) and false-negative rate was 14·2% (95% CI 9·9–19·4; 32 of 226). The false-negative rate was 24·3% (17 of 70) for women who had one node removed and 18·5% (10 of 54) for those who had two sentinel nodes removed (arm C). In patients who had a second sentinel-lymph-node biopsy procedure after neoadjuvant chemotherapy (arm B), the detection rate was 60·8% (95% CI 55·6–65·9; 219 of 360) and the false-negative rate was 51·6% (95% CI 38·7–64·2; 33 of 64). |
3 |
| 13. Mamounas EP, Brown A, Anderson S, et al. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol 2005;23:2694-702. |
Experimental-Dx |
428 patients |
To examine the feasibility and accuracy of this procedure within a randomized trial in patients treated with neoadjuvant chemotherapy. |
Success rate for the identification and removal of a sentinel node was 84.8%. Success rateincreased significantly with the use of radioisotope (87.6% to 88.9%) versus with the use oflymphazurin alone (78.1%, P = .03). There were no significant differences in success rateaccording to clinical tumor size, clinical nodal status, age, or calendar year of randomassignment. Of 343 patients who had SNB and axillary dissection, the sentinel nodes werepositive in 125 patients and were the only positive nodes in 70 patients (56.0%). Of the 218patients with negative sentinel nodes, nonsentinel nodes were positive in 15 (false-negativerate, 10.7%; 15 of 140 patients). There were no significant differences in false-negative rateaccording to clinical patient and tumor characteristics, method of lymphatic mapping, orbreast tumor response to chemotherapy. |
3 |
| 14. Ahn SK, Kim MK, Kim J, et al. Can We Skip Intraoperative Evaluation of Sentinel Lymph Nodes? Nomogram Predicting Involvement of Three or More Axillary Lymph Nodes before Breast Cancer Surgery. Cancer Res. Treat.. 49(4):1088-1096, 2017 Oct. |
Observational-Dx |
1917 patients |
To identify preoperative imaging predictors of >/= 3 ALNs. |
Of the 1,917 patients, 204 (10.6%) had >/= 3 positive nodes. Multivariate analysis showed that involvement of >/= 3 nodes was significantly associated with ultrasonographic and chest computed tomography findings of suspicious ALNs (p < 0.001 each). These two imaging criteria, plus patient age, were used to develop a nomogram calculating the probability of involvement of >/= 3 ALNs. The areas under the receiver operating characteristic curve of the nomogram were 0.852 (95% confidence interval [CI], 0.820 to 0.883) for the training set and 0.896 (95% CI, 0.836 to 0.957) for the validation set. Prospective application of the nomogram showed that 60 of 512 patients (11.7%) had scores above the cut-off. Application of the nomogram reduced operation time and cost, with a very low re-operation rate (1.6%). |
3 |
| 15. An YS, Lee DH, Yoon JK, et al. Diagnostic performance of 18F-FDG PET/CT, ultrasonography and MRI. Detection of axillary lymph node metastasis in breast cancer patients. Nucl Med (Stuttg). 53(3):89-94, 2014. |
Observational-Dx |
215 patients |
To evaluate the diagnostic abilities of 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography(PET/CT) compared with those of ultrasonography and magnetic resonance imaging (MRI) for axillary lymph node staging in breast cancer patients. |
In total, 132 patients (61.4%) had axillary lymph node metastasis. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for the detection of axillary lymph node metastasis were 72.3%, 77.3%, 66.7%, 81.6%, 75.3% for ultrasonography, 67.5%, 78.0%, 65.9%, 79.2%, 74.0% for MRI, and 62.7%, 88.6%, 77.6%, 79.1%, 78.6% for 18F-FDG PET/CT, respectively. There was no significant difference in diagnostic ability among the imaging modalities (i.e., ultrasonography, MRI and 18F-FDG PET/CT). The diagnostic ability of 18F-FDG PET/CT was significantly improved by combination with MRI (p = 0.0002) or ultrasonography (p < 0.0001). The combination of 18F-FDG PET/CT with ultrasonography had a similar diagnostic ability to that of all three modalities combined (18F-FDG PET/CT+ultrasonography+MRI, p = 0.05). |
2 |
| 16. Agliata G, Valeri G, Argalia G, Tarabelli E, Giuseppetti GM. Role of Contrast-Enhanced Sonography in the Evaluation of Axillary Lymph Nodes in Breast Carcinoma: A Monocentric Study. J Ultrasound Med. 36(3):505-511, 2017 Mar. |
Observational-Dx |
50 patients |
To evaluate the diagnostic performance of contrast-enhanced sonography for characterization of the lymph node status (metastatic or not) in patients with breast carcinomas by comparison with sentinel lymph node biopsy. |
The histologic test showed benignity in 22 of 50 sentinel lymph nodes, whereas 28 were metastatic. Among the 22 patients with negative biopsy results,contrast-enhanced sonography showed 18 concordances and 4 false-positives results; among the 28 with positive biopsy results, contrast-enhanced sonographyobtained 100% correct characterizations of the axillary status. The sensitivity, specificity, and accuracy were 100%, 82%, and 92%, respectively. |
3 |
| 17. Ahmed M, Douek M. What is the future of magnetic nanoparticles in the axillary management of breast cancer?. Breast Cancer Res Treat. 143(2):213-8, 2014 Jan. |
Review/Other-Dx |
N/A |
No objective stated in abstract. |
No results listed in abstract. |
4 |
| 18. Chmielewski A, Dufort P, Scaranelo AM. A Computerized System to Assess Axillary Lymph Node Malignancy from Sonographic Images. Ultrasound Med Biol. 41(10):2690-9, 2015 Oct. |
Observational-Dx |
123 women |
To compare the performance of NSD transform features with the performance of features used by Drukker et al. (2013) with an optimized KSVM classifier. |
One hundred five ultrasound images of axillary lymph nodes from patients with breast cancer were evaluated (81 benign and 24 malignant), and each lymph node was manually segmented, delineating both the whole lymph node and internal hilum surfaces. Normalized signed distance transforms were computed from the segmented boundaries of both structures, and each pixel was then assigned coordinates in a 3-D feature space according to the pixel’s intensity, its signed distance to the node boundary and its signed distance to the hilum boundary. Three-dimensional histograms over the feature space were accumulated for each node by summing over all pixels, and the bin counts served as predictor inputs to a support vector machine learning algorithm. Repeated random sampling of 80/25 train/test splits was used to estimate generalization performance and generate receiver operating characteristic curves. The optimal classifier had an area under the receiver operating characteristic curve of 0.95 and sensitivity and specificity of 0.90 and 0.90. Our results indicate the feasibility of axillary nodal staging with computerized analysis. |
2 |
| 19. Spiliopoulos D, Mitsopoulos G, Kaptanis S, Halkias C. Axillary lymph node metastases in adenoid cystic carcinoma of the breast. A rare finding. G Chir. 36(5):209-13, 2015 Sep-Oct. |
Review/Other-Dx |
1 case |
To present a case with presence of axillary lymph node metastases that was successfully treated with no evidence of recurrence one year after the diagnosis and review the literature. |
No results stated in abstract. |
4 |
| 20. Amitai Y, Menes T, Aviram G, Golan O. Do All Women With Abnormal Sonographic Axillary Lymph Nodes Need a Biopsy?. Can Assoc Radiol J. 67(2):173-8, 2016 May. |
Observational-Dx |
171 patients |
To examine clinical and imaging characteristics in correlation with pathological reports of the sonographic guided biopsies toassess the yield of needle biopsy of these nodes. |
Twelve patients (7%) were found to have a malignancy on their axillary lymph node biopsy. Malignancy rates increased with age,and varied with clinical presentation: Axillary mass (8, 26%); history of breast cancer (2, 11%); systemic disease (0%) and breast finding oflow suspicion or incidental abnormal lymph node on screening (1, 1%). Low rates of malignancy were found when the cortex was <6 mm (1,0.8%). The most important imaging finding associated with malignancy was lack of a preserved hilum, in which case almost a third (10, 29%)of the biopsies were malignant. Only 1 of 89 women with a breast finding of low suspicion or an incidental abnormal axillary lymph node wasfound to have malignancy. In this case the lymph node had no hilum. |
3 |
| 21. NCCN Clinical Practice Guidelines in Oncology. Breast Cancer Screening and Diagnosis. Version 1.2020. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf. |
Review/Other-Dx |
N/A |
N/A |
No abstract available. |
4 |
| 22. Moy L, Heller SL, Bailey L, et al. ACR Appropriateness Criteria® Palpable Breast Masses. J Am Coll Radiol 2017;14:S203-S24. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for palpable breast masses. |
No results stated in abstract. |
4 |
| 23. Oliff MC, Birdwell RL, Raza S, Giess CS. The Breast Imager's Approach to Nonmammary Masses at Breast and Axillary US: Imaging Technique, Clues to Origin, and Management. [Review]. Radiographics. 36(1):7-18, 2016 Jan-Feb. |
Review/Other-Dx |
N/A |
To review the anatomy of the chest wall and axilla from the perspective of a breast imager performing US and propose a systematic approach to US of the chest wall and axilla and to describe key imaging features of nonmammary non–lymph node lesions, review the differential diagnosis for such lesions, discuss appropriate patient management, and provide illustrative case examples. |
No results stated in abstract. |
4 |
| 24. Brandt KR, Craig DA, Hoskins TL, et al. Can digital breast tomosynthesis replace conventional diagnostic mammography views for screening recalls without calcifications? A comparison study in a simulated clinical setting. AJR Am J Roentgenol 2013;200:291-8. |
Observational-Dx |
146 women |
To evaluate digital breast tomosynthesis (DBT) as an alternative to conventional diagnostic mammography in the workup of noncalcified findings recalled from screening mammography in a simulated clinical setting that incorporated comparison mammograms and breast ultrasound results. |
Agreement between DBT and diagnostic mammography BI-RADS categories was excellent for readers 1 and 2 (kappa = 0.91 and kappa = 0.84) and good for reader 3 (kappa = 0.68). For readers 1, 2, and 3, sensitivity and specificity of DBT for breast abnormalities were 100%, 100%, and 88% and 94%, 93%, and 89%, respectively. The clinical workup averaged three diagnostic views per abnormality and ultrasound was requested in 49% of the cases. DBT was adequate mammographic evaluation for 93-99% of the findings and ultrasound was requested in 33-55% of the cases. |
2 |
| 25. Gennaro G, Hendrick RE, Toledano A, et al. Combination of one-view digital breast tomosynthesis with one-view digital mammography versus standard two-view digital mammography: per lesion analysis. Eur Radiol. 2013;23(8):2087-2094. |
Observational-Dx |
463 breasts of 250 patients |
To evaluate the clinical value of combining one-view mammography (cranio-caudal, CC) with the complementary view tomosynthesis (mediolateral-oblique, MLO) in comparison to standard two-view mammography (MX) in terms of both lesion detection and characterization. |
The 463 cases (breasts) reviewed included 258 with one to three lesions each, and 205 with no lesions. The 258 cases with lesions included 77 cancers in 68 breasts and 271 benign lesions to give a total of 348 proven lesions. The combination, DBT(MLO)+MX(CC), was superior to MX (CC+MLO) in both lesion detection (LDF) and lesion characterization (LCF) overall and for benign lesions. DBT(MLO)+MX(CC) was non-inferior to two-view MX for malignant lesions. |
2 |
| 26. Waldherr C, Cerny P, Altermatt HJ, et al. Value of one-view breast tomosynthesis versus two-view mammography in diagnostic workup of women with clinical signs and symptoms and in women recalled from screening. AJR Am J Roentgenol 2013;200:226-31. |
Observational-Dx |
144 women |
To compare the diagnostic value of one-view digital breast tomosynthesis versus two-view full-field digital mammography (FFDM) alone, and versus a combined reading of both modalities. |
Eighty-six of the 144 patients were found to have breast cancer. The BI-RADS categories for one-view digital breast tomosynthesis were significantly better than those for two-view FFDM (p < 0.001) and were equal to those of the combined reading in both women admitted for diagnostic workup and women recalled from screening. The sensitivity and negative predictive values of digital breast tomosynthesis were superior to those of FFDM in fatty and dense breasts overall and in women admitted for diagnostic workup and in women recalled from screening. Only 11% of digital breast tomosynthesis examinations required additional imaging, compared with 23% of FFDMs. |
3 |
| 27. Yang TL, Liang HL, Chou CP, Huang JS, Pan HB. The adjunctive digital breast tomosynthesis in diagnosis of breast cancer. Biomed Res Int. 2013;2013:597253. |
Observational-Dx |
59 breasts of 57 patients. |
To compare the diagnostic performance of digital breast tomosynthesis (DBT) and digital mammography (DM) for breast cancers. |
A total of 59 breast cancers were reviewed, including 17 (28.8%) mass lesions, 12 (20.3%) focal asymmetry/density, 6 (10.2%) architecture distortion, 23 (39.0%) calcifications, and 1 (1.7%) intracystic tumor. Combo DBT was perceived to be more informative in 58.8% mass lesions, 83.3% density, 94.4% architecture distortion, and only 11.6% calcifications. As to the forced BIRADS score, 84.4% BIRADS 0 on DM was upgraded to BIRADS 4 or 5 on DBT, whereas only 27.3% BIRADS 4A on DM was upgraded on DBT, as BIRADS 4A lesions were mostly calcifications. A significant P value (<0.001) between the BIRADS category and index lesions was noted |
3 |
| 28. Friedewald SM, Rafferty EA, Rose SL, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA. 311(24):2499-507, 2014 Jun 25. |
Observational-Dx |
454,850 examinations |
To determine if mammography combined with tomosynthesis is associated with better performance of breast screening programs in the United States. |
A total of 454,850 examinations (n=281,187 digital mammography; n=173,663 digital mammography + tomosynthesis) were evaluated. With digital mammography, 29,726 patients were recalled and 5056 biopsies resulted in cancer diagnosis in 1207 patients (n=815 invasive; n=392 in situ). With digital mammography + tomosynthesis, 15,541 patients were recalled and 3285 biopsies resulted in cancer diagnosis in 950 patients (n=707 invasive; n=243 in situ). Model-adjusted rates per 1000 screens were as follows: for recall rate, 107 (95% CI, 89-124) with digital mammography vs 91 (95% CI, 73-108) with digital mammography + tomosynthesis; difference, -16 (95% CI, -18 to -14; P < .001); for biopsies, 18.1 (95% CI, 15.4-20.8) with digital mammography vs 19.3 (95% CI, 16.6-22.1) with digital mammography + tomosynthesis; difference, 1.3 (95% CI, 0.4-2.1; P = .004); for cancer detection, 4.2 (95% CI, 3.8-4.7) with digital mammography vs 5.4 (95% CI, 4.9-6.0) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001); and for invasive cancer detection, 2.9 (95% CI, 2.5-3.2) with digital mammography vs 4.1 (95% CI, 3.7-4.5) with digital mammography + tomosynthesis; difference, 1.2 (95% CI, 0.8-1.6; P < .001). The in situ cancer detection rate was 1.4 (95% CI, 1.2-1.6) per 1000 screens with both methods. Adding tomosynthesis was associated with an increase in the positive predictive value for recall from 4.3% to 6.4% (difference, 2.1%; 95% CI, 1.7%-2.5%; P < .001) and for biopsy from 24.2% to 29.2% (difference, 5.0%; 95% CI, 3.0%-7.0%; P < .001). |
3 |
| 29. Rafferty EA, Rose SL, Miller DP, et al. Effect of age on breast cancer screening using tomosynthesis in combination with digital mammography. Breast Cancer Research & Treatment. 164(3):659-666, 2017 Aug. |
Observational-Dx |
278,908 patients with digital mammography alone and 173,414 patients with digital mammography + tomosynthesis |
To determine the effect of tomosynthesis imaging as a function of age for breast cancer screening. |
Performance parameters were compared for women screened with digital mammography alone (n = 278,908) and digital mammography + tomosynthesis (n = 173,414). Addition of tomosynthesis to digital mammography produced significant reductions in recall rates for all age groups and significant increases in cancer detection rates for women 40-69. Largest recall rate reduction with tomosynthesis was for women 40-49, decreasing from 137 (95% CI 117-156) to 115 (95% CI 95-135); difference, -22 (95% CI -26 to -18; P < .001). Simultaneous increase in invasive cancer detection rate for women 40-49 from 1.6 (95% CI 1.2-1.9) to 2.7 (95% CI 2.2-3.1) with tomosynthesis (difference, 1.1; 95% CI 0.6-1.6; P < .001) was observed. |
3 |
| 30. Bertozzi S, Londero AP, Petri R, Bernardi S. Isolated axillary nodal swelling and cancer of unknown primary. Eur J Gynaecol Oncol. 36(2):131-7, 2015. |
Observational-Dx |
65 patients with isolated axillary lymph node swelling who underwent axillary lymph node excisional biopsy for malignancy suspicion |
To review the prevalence and outcome of patients with isolated axillary nodal swelling suspicious for malignancy affected or not by isolated axillary node metastasis from CUP. |
Histological examination revealed a metastatic infiltration by an occult solid cancer in 16 cases (24%), ten of which were occult breast cancers. Histological patterns and molecular markers allowed in all cases of occult cancer a probable identification of the primary tumor site, while a definitive diagnosis was possible only in the 56.25% of cases (9/16). The prognosis of these patients was very poor with a five-year overall survival of 28%, and thus very similar to patients affected by Stage IV overt breast cancer. |
3 |
| 31. Pentheroudakis G, Lazaridis G, Pavlidis N. Axillary nodal metastases from carcinoma of unknown primary (CUPAx): a systematic review of published evidence. Breast Cancer Res Treat 2010;119:1-11. |
Meta-analysis |
24 retrospective studies (689 patients) |
To systematically review and analyse published data from prospective or retrospective studies of CUPAx patients in order to present available evidence on epidemiology, diagnosis, management and outcome as well as reach appropriate recommendations. |
We systematically reviewed published axillary lymph node metastases from adenocarcinoma or poorly differentiated carcinoma of unknown primary (CUPAx) series and identified 24 retrospective studies enrolling 689 patients from 1975 till 2006. CUPAx affected women at a mean age of 52 years, 66% of whom post-menopausal harbouring low-volume (N1, 48%) or high-volume (52%) nodal disease from ductal adenocarcinoma (83%). Among a total of 446 patients managed with mastectomy, a small breast primary was identified histologically in 321 (72% of cases). Hormone receptor protein expression was observed in 40– 50% of cases, while HER2 overexpression in 31%. CUPAx patients were managed with axillary lymph node dissection coupled to mastectomy (59%), primary breast irradiation (26%) or observation (15%). Observation was associated with high locoregional relapse rates (42%) and risk of metastatic spread. Mastectomy or radiotherapy provided locoregional disease control in 75–85% of cases, while adjuvant systemic therapy was associated with a nonsignificant trend for improved survival in few series. Five-year survival ranged from 59.4 to 88% at a median follow-up of 62 months (mean 5-year survival 72%), with axillary tumour burden being the pivotal prognostic factor. CUPAx is associated with similar presentation, biology and outcome to resected node-positive overt breast cancer and should be treated accordingly. |
Good |
| 32. Fayanju OM, Jeffe DB, Margenthaler JA. Occult primary breast cancer at a comprehensive cancer center. J Surg Res 2013;185:684-9. |
Observational-Tx |
5533 patients |
To describe the management and outcomes of occult primary breast cancer (OPBC) patients treated at our institution, Siteman Cancer Center, a National Cancer Institute (NCI)-designated Comprehensive Cancer Center in St. Louis, Missouri. |
Of 5533 patients reviewed, 7 patients (0.1%) were identified. Median age was 65 years old (range 40–72), and median length of follow-up was 86 months (range 42–124). Four patients underwent modified radical mastectomy (MRM), 1 patient had a lumpectomy and axillary lymph node dissection (ALND), and 2 patients had ALND without breast surgery. Four patients received adjuvant radiation therapy. All 7 patients received chemotherapy. Three patients received endocrine therapy, and 2 patients received anti-HER2 therapy. At last follow-up, all 7 patients were alive with no evidence of disease. |
3 |
| 33. Soundararajan R, Naswa N, Karunanithi S, Walia R, Kumar R, Bal C. Occult breast primary malignancy presenting as isolated axillary lymph node metastasis - early detection of primary site by 18F-FDG PET/CT. Nucl Med Rev Cent East Eur. 19(B):5-7, 2016. |
Review/Other-Dx |
1 case |
To present here a case of 30-year-old female who presented with isolated right axillary lymph node metastasis with no evidence of primary tumor clinically. |
No results stated in abstract. |
4 |
| 34. Buchanan CL, Morris EA, Dorn PL, Borgen PI, Van Zee KJ. Utility of breast magnetic resonance imaging in patients with occult primary breast cancer. Ann Surg Oncol 2005;12:1045-53. |
Observational-Dx |
69 patients with occult primary breast cancer |
To investigate the ability of breast magnetic resonance imaging (MRI) to identify the primary tumor, thereby confirming the diagnosis and broadening treatment options. |
Of 69 patients, 55 had axillary adenopathy without evidence of distant disease (stage II); 14 had stage IV disease. In patients with stage II disease, MRI revealed suspicious lesions in 76% (42 of 55). In 62% (26 of 42), the MRI finding proved to be the occult primary tumor. Of these, 58% (15 of 26) were candidates for breast conservation. MRI did not identify the primary tumor in 25 women; 12 underwent mastectomy. Cancer was found in 33% (4 of 12) of these. Thirteen patients were treated with primary breast irradiation; three were lost to follow-up, one developed distant disease, and nine were without evidence of disease with a median follow-up of 4.5 years. In women with stage IV disease, MRI identified the primary tumor in 5 of 9 patients with regional adenopathy and 2 of 5 patients with distant disease (overall 50%; 7 of 14). MRI identified the primary tumor in women with both mammographically dense (19 of 44; 43%) and less dense (10 of 20; 50%) breasts. |
2 |
| 35. Olson JA, Jr., Morris EA, Van Zee KJ, Linehan DC, Borgen PI. Magnetic resonance imaging facilitates breast conservation for occult breast cancer. Ann Surg Oncol 2000;7:411-5. |
Observational-Dx |
40 women with metastatic axillary adenocarcinoma |
To examine the ability of breast MRI to detect occult breast cancer and to facilitate breast conservation therapy. |
MRI identified the primary breast lesion in 28 of 40 women (70%). Of these 28 patients, 11 had MRM, 11 had lumpectomy/axillary lymph node dissection (ALND)/radiotherapy (XRT), 2 had ALND/XRT alone, and 4 had no local treatment secondary to stage IV disease. Two women initially treated with lumpectomy/ALND subsequently had mastectomy for positive margins. Of the women with positive MRI who had breast surgery, 21 of 22 (95%) had tumor within the surgical specimen. Twelve women had negative MRI of the breast. Five of these 12 underwent MRM, of whom 4 had no tumor in the mastectomy specimen. The remaining 7 patients had ALND and whole breast radiation (ALND/XRT) (n = 5), or were observed (n = 2). Overall, 18 of 34 women surgically treated had MRM, while 16 (47%) preserved their breast. Tumor yield for patients having breast surgery was 81%. |
1 |
| 36. Fernandez Canedo MI, Blazquez Sanchez N, Valdes Solis P, de Troya Martin M. Axillary Silicone Granulomas in Patients With Melanoma. Actas Dermosifiliogr. 107(4):e23-6, 2016 May. |
Review/Other-Dx |
2 cases |
To describe 2 cases of women with breast implants who developed palpable subcutaneous lesions in the axillary region during follow-up of melanoma. |
No results stated in abstract. |
4 |
| 37. Lee SH, Yi A, Jang MJ, Chang JM, Cho N, Moon WK. Supplemental Screening Breast US in Women with Negative Mammographic Findings: Effect of Routine Axillary Scanning. Radiology. 286(3):830-837, 2018 03. |
Observational-Dx |
8664 asymptomatic women 40 years or older with dense breasts and negative results for cancer at mammography |
To evaluate the effect of routine axillary scanning when supplemental screening breast ultrasonography (US) is performed in women with negative mammographic findings. |
The frequency of positive axillary findings was 3.5 per 1000 (14 of 4009) baseline screening US examinations and 2.2 per 1000 (19 of 8835) subsequent screening US examinations. Of the 33 women with 33 positive axillary findings, 11 had positive breast findings; none were diagnosed with breast cancer. The remaining 22 women showed positive findings only in the axilla. The axillary findings revealed no malignancy at biopsy (n = 12) or during 22–54-month follow-up (n = 21) (95% CI: 0%, 10.6%). Without routine axillary scanning, the AIR of screening US decreased from 15.2% (610 of 4009 examinations) to 15.0% (602 of 4009 examinations) at baseline US and from 8.1% (714 of 8835 examinations) to 7.9% (700 of 8835 examinations) at subsequent US examinations, and the PPV for biopsy performed increased from 6.0% (five of 83 examinations) to 6.4% (five of 78 examinations) at baseline US and from 7.6% (13 of 170 examinations) to 7.9% (13 of 164 examinations) at subsequent US examinations, without a change in the CDR. |
3 |
| 38. Riegger C, Koeninger A, Hartung V, et al. Comparison of the diagnostic value of FDG-PET/CT and axillary ultrasound for the detection of lymph node metastases in breast cancer patients. Acta Radiol. 53(10):1092-8, 2012 Dec 01. |
Observational-Dx |
90 patients |
To retrospectively compare the diagnostic value of full-dose, intravenously contrast-enhanced FDG-PET/CT and ultrasound for the detection of lymph node metastases in breast cancer patients. |
The sensitivity, specificity, PPV, NPV, and accuracy of FDG-PET/CT for the detection of axillary lymph node metastases were 54%, 89%, 77%, 74%, and 75%, respectively. For ultrasound it was 38%, 78%, 54%, 65%, and 62%, respectively. FDG-PET/CT was significantly more accurate than ultrasound for the detection of axillary lymph node metastases (P = 0.019). There was no statistically significant difference between the sensitivity of both modalities (P = 0.0578). FDG-PET/CT detected extra-axillary locoregional lymph node metastases in seven patients (8%) that had not been detected by another imaging modality. |
4 |
| 39. de Bresser J, de Vos B, van der Ent F, Hulsewe K. Breast MRI in clinically and mammographically occult breast cancer presenting with an axillary metastasis: a systematic review. Eur J Surg Oncol 2010;36:114-9. |
Review/Other-Dx |
8 retrospective studies |
To give an overview of the value and additional considerations of using breast MRI in occult breast cancer. |
No results stated in abstract. |
4 |
| 40. Muttarak M, Chaiwun B, Peh WC. Role of mammography in diagnosis of axillary abnormalities in women with normal breast examination. Australas Radiol 2004;48:306-10. |
Observational-Dx |
43 patients with palpable unilateral masses |
To determine the cause and imaging characteristics of axillary abnormalities in women who have palpable axillary masses but normal breasts on physical examination, and to determine the usefulness of mammography in detecting occult breast carcinoma. |
Forty of 43 patients had axillary lymphadenopathy while three had lipoma, fibroadenoma and haematoma, respectively. Causes of malignant lymphadenopathy ( n = 22) were metastatic diseases from non-mammary primary malignancy (n = 8), occult ipsilateral breast carcinoma (n = 5), and previous contralateral breast carcinoma (n = 9). Causes of benign lymphadenopathy (n = 18) were reactive nodal hyperplasia (n = 6), collagen vascular diseases (n = 2), and acute bacterial ( n= 2) and tuberculous (n = 8) lymphadenitis. Nodal size was not significantly different between benign and malignant lymph nodes. Benign and malignant nodal margins were variable. Intranodal microcalcifications were found in two cases of breast carcinoma mestastasis. Intranodal macrocalcifications were found in three cases of tuberculous lymphadenitis. Occult primary breast carcinoma was detected on mammograms in four of five patients with axillary lymphadenopathy due to ipsilateral breast carcinoma. Mammographical features of benign and malignant lymphadenopathy may be indistinguishable, but presence of intranodal calcifications is helpful. Mammography is also valuable in depicting occult primary breast carcinoma. |
4 |
| 41. Leibman AJ, Kossoff MB. Mammography in women with axillary lymphadenopathy and normal breasts on physical examination: value in detecting occult breast carcinoma. AJR Am J Roentgenol 1992;159:493-5. |
Review/Other-Dx |
17 patients |
To determine the value of mammography in detecting occult carcinoma in patients with axillary adenopathy and normal breasts on physical examination. |
In 10 of the 17 patients, mammographic findings were abnormal. The mammographic finding of axillary adenopathy in seven patients was inconsequential because the nodes were evident on physical examination. Three patients had abnormal mammographic findings that were potentially significant, including one with a poorly defined mass suggestive of breast carcinoma, one with a subcutaneous nodule, and one with parenchymal breast edema. Two of 17 patients had an occult breast cancer. In only one of the patients was the cancer detected on mammography. The other patient had undergone prior left mastectomy and was thought to have metastases to the right axilla from the contralateral breast. Mammographic findings in this latter patient were normal. |
4 |
| 42. Amin MB, Edge S, Greene F, et al. AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer; 2017. |
Review/Other-Dx |
N/A |
To classify patients with cancer, define prognosis, and determine the best treatment approaches. |
No abstract available. |
4 |
| 43. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 70(1):7-30, 2020 01. |
Review/Other-Dx |
N/A |
Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data. |
Each year, the American Cancer Society estimates the numbers of new cancer cases and deaths that will occur in the United States and compiles the most recent data on population-based cancer occurrence. Incidence data (through 2016) were collected by the Surveillance, Epidemiology, and End Results Program; the National Program of Cancer Registries; and the North American Association of Central Cancer Registries. Mortality data (through 2017) were collected by the National Center for Health Statistics. In 2020, 1,806,590 new cancer cases and 606,520 cancer deaths are projected to occur in the United States. The cancer death rate rose until 1991, then fell continuously through 2017, resulting in an overall decline of 29% that translates into an estimated 2.9 million fewer cancer deaths than would have occurred if peak rates had persisted. This progress is driven by long-term declines in death rates for the 4 leading cancers (lung, colorectal, breast, prostate); however, over the past decade (2008-2017), reductions slowed for female breast and colorectal cancers, and halted for prostate cancer. In contrast, declines accelerated for lung cancer, from 3% annually during 2008 through 2013 to 5% during 2013 through 2017 in men and from 2% to almost 4% in women, spurring the largest ever single-year drop in overall cancer mortality of 2.2% from 2016 to 2017. Yet lung cancer still caused more deaths in 2017 than breast, prostate, colorectal, and brain cancers combined. Recent mortality declines were also dramatic for melanoma of the skin in the wake of US Food and Drug Administration approval of new therapies for metastatic disease, escalating to 7% annually during 2013 through 2017 from 1% during 2006 through 2010 in men and women aged 50 to 64 years and from 2% to 3% in those aged 20 to 49 years; annual declines of 5% to 6% in individuals aged 65 years and older are particularly striking because rates in this age group were increasing prior to 2013. It is also notable that long-term rapid increases in liver cancer mortality have attenuated in women and stabilized in men. In summary, slowing momentum for some cancers amenable to early detection is juxtaposed with notable gains for other common cancers. |
4 |
| 44. James J, Teo M, Ramachandran V, Law M, Stoney D, Cheng M. Performance of CT scan of abdomen and pelvis in detecting asymptomatic synchronous metastasis in breast cancer. Int J Surg. 46:164-169, 2017 Oct. |
Observational-Dx |
586 patients |
To assess the cost effectiveness and usefulness of CTAP in new breast cancers. |
49% (n = 285) of all breast cancer patient underwent staging CTAP which lead to the detection of 4 ASM. (Over all yield of 1%) Overall false positive rate was 15% because of 42 indeterminate results needing further tests. Based merely on approved billing rates this amounted to $ 40733 per single ASM identified. Presence of lymph node metastasis did not increase the chance of positive test result (OR = 1.3; CI:0.13-12.69) |
3 |
| 45. James J, Teo M, Ramachandran V, Law M, Stoney D, Cheng M. A critical review of the chest CT scans performed to detect asymptomatic synchronous metastasis in new and recurrent breast cancers. World J Surg Oncol. 17(1):40, 2019 Feb 23. |
Observational-Dx |
335 cases |
To report our experience with the use of chest CT (CTC). |
Fourteen asymptomatic synchronous distant metastasis (ASM) were detected from 335 CTCs giving an overall yield of 4% (95% CI 1.89–6.47). The overall false-positive rate was 10% due to 35 indeterminate findings that were found not to be metastases after further tests or observation. Even with selective use, CTCs have a low yield of 2% (95% CI -?0.19–4.19) in early breast cancers. Advanced breast cancers have a 9% incidence of ASMs. None of the clinically isolated locoregionally recurrent diseases were associated with detectable distant metastasis in CTC. |
3 |
| 46. Lewin AA, Moy L, Baron P, et al. ACR Appropriateness Criteria R Stage I Breast Cancer: Initial Workup and Surveillance for Local Recurrence and Distant Metastases in Asymptomatic Women. [Review]. Journal of the American College of Radiology. 16(11S):S428-S439, 2019 Nov. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for stage I breast cancer. |
No results stated in abstract. |
4 |
| 47. Cox J, Hancock H, Maier R, et al. Multidetector CT improving surgical outcomes in breast cancer (MISO-BC): A randomised controlled trial. BREAST. 32:217-224, 2017 Apr. |
Experimental-Dx |
291 patients |
To evaluate the utility of multidetector computed tomography to improve pre-operative axillary staging in patients withnewly diagnosed breast cancer |
The proportion of patients undergoing a second operation was similar (CT vs UC: 19.4% vs. 19.7%; CT-UC: -0.3%, 95%CI: = -9.5% to 8.9%, ?2 [1]: p = 1.00). Patients in the two groups were similar before treatment, had similar types and grade of cancer, experienced similar patterns of post-operative complications and reported similar experiences of care. |
1 |
| 48. Paydary K, Seraj SM, Zadeh MZ, et al. The Evolving Role of FDG-PET/CT in the Diagnosis, Staging, and Treatment of Breast Cancer. [Review]. Mol Imaging Biol. 21(1):1-10, 2019 02. |
Review/Other-Dx |
N/A |
To review potential applications of FDG-PET in breast cancer include diagnosis, staging, prognostic assessment, evaluation of response to neoadjuvant chemotherapy (NAC), and recurrence in patients with breast cancer. |
No results stated in abstract. |
4 |
| 49. Peare R, Staff RT, Heys SD. The use of FDG-PET in assessing axillary lymph node status in breast cancer: a systematic review and meta-analysis of the literature. Breast Cancer Res Treat 2010;123:281-90. |
Meta-analysis |
25 studies involving 2,460 patients |
To review and aggregate all studies that measured the performance of FDG-PET in patients with breast cancer, using surgically obtained axillary histology as a reference, in a meta-analysis. |
Sensitivities ranging from 20 to 100% and specificities ranging from 65 to 100% have been reported. An aggregated ROC analysis found an area under the curve of 0.95 (95% CI 0.91-0.97) and a Q* value of 0.89 (95% CI 0.85-0.92) in a total of 25 studies involving 2,460 patients. The AUC and Q* values indicated little difference between the compared study characteristics. |
Good |
| 50. Dialani V, Chadashvili T, Slanetz PJ. Role of imaging in neoadjuvant therapy for breast cancer. [Review]. Ann Surg Oncol. 22(5):1416-24, 2015 May. |
Review/Other-Dx |
N/A |
To review the role of imaging before and after neoadjuvant therapy and discuss the advantages and limitations of currently available modalities, including mammography, ultrasonography, magnetic resonance imaging, and nuclear imaging. |
No results stated in abstract. |
4 |
| 51. Lobbes MB, Prevos R, Smidt M, et al. The role of magnetic resonance imaging in assessing residual disease and pathologic complete response in breast cancer patients receiving neoadjuvant chemotherapy: a systematic review. Insights Imaging. 2013;4(2):163-175. |
Review/Other-Dx |
35 studies |
To assess the role of magnetic resonance imaging (MRI) in evaluating residual disease extent and the ability to detect pathologic complete response (pCR) after neoadjuvant chemotherapy for invasive breast cancer. |
A total of 35 eligible studies were selected. Correlation coefficients of residual tumour size assessed by MRI and pathology were good, with a median value of 0.698. Reported sensitivity, specificity, positive predictive value and negative predictive value for predicting pCR with MRI ranged from 25 to 100 %, 50-97 %, 47-73 % and 71-100 %, respectively. Both overestimation and underestimation were observed. MRI proved more accurate in determining residual disease than physical examination, mammography and ultrasound. Diagnostic accuracy of MRI after neoadjuvant chemotherapy could be influenced by treatment regimen and breast cancer subtype. |
4 |
| 52. Leenders M, Kramer G, Belghazi K, Duvivier K, van den Tol P, Schreurs H. Can We Identify or Exclude Extensive Axillary Nodal Involvement in Breast Cancer Patients Preoperatively? J Oncol 2019;2019:8404035. |
Review/Other-Dx |
N/A |
To evaluate whether the current diagnostic modalities can accurately identify or exclude extensive axillary nodal involvement. |
No results stated in abstract. |
4 |
| 53. Evans DG, Kesavan N, Lim Y, et al. MRI breast screening in high-risk women: cancer detection and survival analysis. Breast Cancer Research & Treatment. 145(3):663-72, 2014 Jun. |
Observational-Dx |
2 prospective studies |
To assess whether introduction of MRI surveillance improves 5- and 10-year survival of high-risk women and determine the accuracy of MRI breast cancer detection compared with mammography-only or no enhanced surveillance and compare size and pathology of cancers detected in women screened with MRI + mammography and mammography only. |
63 cancers were detected in women receiving MRI + mammography and 76 in women receiving mammography only. Sensitivity of MRI + mammography was 93 % with 63 % specificity. Fewer cancers detected on MRI were lymph node positive compared to mammography/no additional screening. There were no differences in 10-year survival between the MRI + mammography and mammography-only groups, but survival was significantly higher in the MRI-screened group (95.3 %) compared to no intensive screening (73.7 %; p = 0.002). |
3 |
| 54. Del Riego J, Diaz-Ruiz MJ, Teixido M, et al. The impact of axillary ultrasound with biopsy in overtreatment of early breast cancer. Eur J Radiol. 98:158-164, 2018 Jan. |
Observational-Dx |
355 pT1 breast cancers |
(a) To compare the axillary tumor burden detected by fine-needle aspiration cytology (FNAC) versus sentinel lymph node biopsy (SLNB). (b) To evaluate the relationship between axillary tumor burden and the number of suspicious lymph nodes detected by axillary ultrasonography (US). (c) To calculate the false-positive and false-negative rates for FNAC in patients fulfilling ACOSOG Z0011 criteria. |
High axillary burden: in entire series 38.5% FNAC+ vs. 5.7% SLNB+ (p<0.0001). In subgroup fulfilling ACOSOG Z0011 criteria: 45.5% vs 6.7%, respectively (p<0.001). 61 positive axillary US. With 1 suspicious node on axillary US: 95.6% had =2 involved nodes (including pN0); with 2 suspicious nodes: 60% had >2 involved nodes. In ACOSOG Z0011 patients, with 1 suspicious node, 93.7% had =2 involved nodes. Of the 37 FNAC in ACOSOG Z0011patients: 54.5% false-positives for high burden; 3.8% false-negatives. |
3 |
| 55. Hieken TJ, Trull BC, Boughey JC, et al. Preoperative axillary imaging with percutaneous lymph node biopsy is valuable in the contemporary management of patients with breast cancer. Surgery 2013;154:831-8; discussion 38-40. |
Observational-Dx |
988 breast cancer patients |
To evaluate whether 18F-FDG-PET/CT and US-guided FNAC are useful for assessment of ALN involvement in breast cancer patients. |
Preoperative axillary ultrasonography (AUS) was performed in 92% and breast/axillary magnetic resonance imaging (MRI) in 51%; 82 (33.5%) of 245 patients with suspicious lymph nodes (LN) were USNB-positive. Regarding nodal status, AUS, MRI, and USNB had negative and positive predictive values of 78%, 76%, 70% and 54%, 58%, 100%, respectively. AUS/MRI visualization of one versus multiple abnormal LNs visualized predicted >2LN+ on final pathology (13.5%/15.1% % vs 30.8%/32.6%, P < .009). Among USNB-LN+ T1/T2 patients, 51.6% had 1-2 LN+ while 60% with multiple and 31% with one AUS-abnormal LN(s) had > 2LN+, P = .001. |
3 |
| 56. Ibrahim-Zada I, Grant CS, Glazebrook KN, Boughey JC. Preoperative axillary ultrasound in breast cancer: safely avoiding frozen section of sentinel lymph nodes in breast-conserving surgery. J Am Coll Surg 2013;217:7-15; discussion 15-6. |
Observational-Dx |
1140 patients |
To determine the frequency and size of macrometastases, and the number of patients with 3 or more positive SLNs, especially in the higher risk ER-negative and premenopausal patients. |
144 (13%) patients were node positive at surgery. Average age, tumor size, histology, ER and PR status were similar comparing 996 SLN negative to 144 (13%) SLN positive patients. Of the SLN positive patients, 25% were premenopausal, 9% were ER negative, and 19% had additional lymph nodes at CALND. Only 19 (2%) patients had SLN metastasis =6 mm, 10 (1%) had metastasis >7 mm, and only 1 patient had =3 positive SLNs. |
2 |
| 57. Verheuvel NC, van den Hoven I, Ooms HW, Voogd AC, Roumen RM. The role of ultrasound-guided lymph node biopsy in axillary staging of invasive breast cancer in the post-ACOSOG Z0011 trial era. Ann Surg Oncol 2015;22:409-15. |
Observational-Dx |
302 node-positive cases were included: 139 and 163 cases in the US and SN groups, respectively. |
To evaluate potential differences in patient and tumor characteristics and survival between axillary node positive patients after ultrasound (US group) or sentinel lymph node procedure (SN group). |
Patients in the US group were older at diagnosis (p < 0.001), more often had palpable nodes (p < 0.001), mastectomy (p < 0.001), larger tumors (p < 0.001), higher tumor grade (p = 0.001), lymphovascular invasion (p = 0.035), a positive Her2Neu (p = 0.006), and a negative hormonal receptor status (p = 0.003). Also, they were more likely to have more lymph nodes with macrometastases (p < 0.001), extranodal extension (p < 0.001), and involvement of level-III-lymph node (p < 0.001). Finally, they showed a worse disease-free survival [hazard ratio (HR) = 2.71; 95 % confidence interval (CI) = 1.49-4.92] and overall survival (HR = 2.67; 95 % CI = 1.48-4.84) than the SN group. |
3 |
| 58. Caudle AS, Kuerer HM, Le-Petross HT, et al. Predicting the extent of nodal disease in early-stage breast cancer. Ann Surg Oncol. 21(11):3440-7, 2014 Oct. |
Observational-Dx |
1108 patients |
To determine if imaging and clinicopathologic features could predict the extent of axillary nodal involvement in breast cancer. |
LND patients had fewer positive nodes (2.2 vs. 4.1; p < 0.0001), smaller metastases (5.3 vs. 13.8 mm; p < 0.0001), and a lower incidence of extranodal extension (24 vs. 53 %; p < 0.0001) than the US group. Even when US identified =2 abnormal nodes, patients were still more likely to have =3 positive nodes (45 %) than SLND patients (19 %; p < 0.001). After adjusting for tumor size, receptor status, and histology, multivariate analysis revealed that metastases identified by US [odds ratio (OR) 4.01; 95 % confidence interval (CI) 2.75-5.84] and lobular histology (OR 1.77; 95 % CI 1.06-2.95) predicted having =3 positive nodes. |
2 |
| 59. Henry-Tillman R, Glover-Collins K, Preston M, et al. The SAVE review: sonographic analysis versus excision for axillary staging in breast cancer. J Am Coll Surg. 220(4):560-7, 2015 Apr. |
Observational-Dx |
95 patients |
To compare the cost-effectiveness of axillary ultrasound-guided core needle biopsy (AUS-CNB) with sentinel lymph node biopsy (SLNB) when evaluating the status of the axilla in operable invasive breast cancer. |
The cohort of 95 patients was divided into 2 groups: clinically positive (CP) (32%) and negative (CN) (68%) axilla. In the CP group, 83% had a suspicious AUS, of which 90% were positive. In the CN group, AUS was suspicious in 70%, with a positive biopsy in 59%. The sensitivity and specificity of AUS-CNB were 90% (95% CI 84.8% to 98.8%) and 100% (95% CI 27% to 59.1%), respectively. Cost estimates comparing AUS-CNB with SLNB demonstrated a cost saving of $236,517 in the CP axilla and $248,490 in the CN axilla, for a total cost savings of $485,007. |
2 |
| 60. Barco I, Chabrera C, Garcia-Fernandez A, et al. Role of axillary ultrasound, magnetic resonance imaging, and ultrasound-guided fine-needle aspiration biopsy in the preoperative triage of breast cancer patients. Clin Transl Oncol. 19(6):704-710, 2017 Jun. |
Observational-Dx |
1505 patients including 1533 axillary US examinations and 1351 axillary MRI studies. |
To establish the role of axillary US and MRI, alone or in combination, associated with ultrasound-guided fine-needle aspiration biopsy (US-FNAB) in the prediction of axillary node involvement. |
For axillary US, Se, Specificity (Sp), Positive Predictive Value (PPV), and NPV were 47.5, 93.6, 82.5, and 73.8%, respectively. For axillary MRI, corresponding values were 29.8, 96.6, 84.9, and 68.4%. When both tests were combined, Sp and PPV slightly improved over individual tests alone. US-FNAB showed a 100% Sp and PPV, with a Se of 80%. |
3 |
| 61. Britton P, Willsher P, Taylor K, et al. Microbubble detection and ultrasound-guided vacuum-assisted biopsy of axillary lymph nodes in patients with breast cancer. Clin Radiol. 72(9):772-779, 2017 Sep. |
Observational-Dx |
139 patients: 36 to Part 1 and 103 to Part 2. |
To assess the feasibility of undertaking microbubble-guided vacuum-assisted biopsy (VAB) of the sentinel lymph node (SLN) and determine its sensitivity in detecting metastases. |
Of the 100 patients in Part 2 included for analysis, 82 (82%) underwent successful biopsy. Sensitivity for detecting metastases was 58.8% (95% confidence interval: 32.9%, 81.6%). The procedure was generally well tolerated; however, VAB interfered adversely with subsequent surgical SLN biopsy with surgeons reporting moderate or severe interference in 48% of patients and an additional 8.3% with complete failure of SLNB. |
3 |
| 62. Houssami N, Ciatto S, Turner RM, Cody HS 3rd, Macaskill P. Preoperative ultrasound-guided needle biopsy of axillary nodes in invasive breast cancer: meta-analysis of its accuracy and utility in staging the axilla. Ann Surg. 254(2):243-51, 2011 Aug. |
Meta-analysis |
31 studies (6166 subjects) |
To establish the effectiveness of UNB in staging the axilla by estimating in meta-analysis: (a) test-related measures, including accuracy and (b) patient-related outcomes, specifically test utility defined in terms of the proportion of women potentially triaged directly to AND, and in whom (unnecessary) SNB could be avoided through systematic use of preoperative UNB. |
Thirty-one studies provided 2874 UNB data from 6166 subjects (median proportion with metastatic nodes 47.2%; IQR 39.5%, 61.2%). Modeled estimates for UNB were: sensitivity 79.6% (95% confidence intervals [CI] 74.1-84.2), specificity 98.3% (95%CI 97.2-99.0), PPV 97.1% (95%CI 95.2-98.3); median UNB insufficiency was 4.1% (IQR0%-10.9%). UNB sensitivity increased with increasing ultrasound sensitivity, and was higher in studies performing UNB for "suspicious" than for "visible" nodes. Specificity was higher in studies of consecutive (vs. selected) subjects, in studies reporting ultrasound data, and in more recent studies. Median proportion of women triaged directly to AND (attributed to UNB) was 19.8% (IQR11.6%-28.1%) or 17.7% (IQR11.6%-27.1%) if restricted to clinically node-negative series. Median proportion of women with metastatic axillary nodes potentially triaged to AND was 55.2% (IQR41.8%-68.2%) and was higher (65.6%; IQR48.9%-69.7%) in the subgroup of studies with median tumor size =21 mm. |
Good |
| 63. Feng Y, Huang R, He Y, et al. Efficacy of physical examination, ultrasound, and ultrasound combined with fine-needle aspiration for axilla staging of primary breast cancer. Breast Cancer Res Treat. 149(3):761-5, 2015 Feb. |
Observational-Dx |
3,781 breast cancer patients |
To compare the efficacy of physical examination (PE), ultrasound (US), and US combined with fine-needle cytology (US-FNAC) in evaluation of node status before sentinel lymph node biopsy (SLNB) for breast cancer patients. |
Abnormal axillary nodes under US were detected in 1,152 cases, among which 821 were proven to have positive nodes by FNAC. The positive FNAC results enabled 11.7% of cN0 patients (373/3,175) to avoid unnecessary SLNB. All 331 cases with abnormal US but negative FNAC results, and the 2,629 cases with normal US underwent SLNB procedure for nodal staging, and metastatic nodes were identified in 745 patients. The sensitivity of PE was 32.2%, with a specificity of 95.5%, a PPV of 83.5%, a NPV of 65%, and an accuracy of 69.3%. The sensitivity, specificity, PPV, NPV, and accuracy of axillary US alone were 58.6, 89.4, 79.6, 75.3, and 76.7%, respectively. Combining axillary US with FNAC resulted in sensitivity, specificity, PPV, NPV, and accuracy of 52.4, 100, 100, 74.8, and 80.3%, respectively. |
3 |
| 64. Galimberti V, Cole BF, Viale G, et al. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol 2018;19:1385-93. |
Experimental-Tx |
931 patients |
To present the analysis of IBCSG 23-01 trial outcomes after a median follow-up of 9·7 years (IQR 7·8–12·7). |
Disease-free survival at 10 years was 76·8% (95% CI 72·5–81·0) in the no axillary dissection group, compared with 74·9% (70·5–79·3) in the axillary dissection group (HR 0·85, 95% CI 0·65–1·11; log-rank p=0·24; p=0·0024 for non-inferiority). Long-term surgical complications included lymphoedema of any grade in 16 (4%) of 453 patients in the no axillary dissection group and 60 (13%) of 447 in the axillary dissection group, sensory neuropathy of any grade in 57 (13%) in the no axillary dissection group versus 85 (19%) in the axillary dissection group, and motor neuropathy of any grade (14 [3%] in the no axillary dissection group vs 40 [9%] in the axillary dissection group). |
1 |
| 65. Donker M, van Tienhoven G, Straver ME, et al. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol 2014;15:1303-10. |
Experimental-Tx |
2402 patients receive axillary lymph node dissection; 2404 receive axillary radiotherapy |
To assess whether axillary radiotherapy provides comparable regional control with fewer side-effects. |
Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1-8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00-0·92) after axillary lymph node dissection versus 1·19% (0·31-2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00-5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years. |
1 |
| 66. Rutgers EJ, Donker M, Poncet C, et al. Abstract GS4-01: Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer patients: 10 year follow up results of the EORTC AMAROS trial (EORTC 10981/22023). Cancer Research 2019;79:GS4-01-GS4-01. |
Experimental-Dx |
1425 patients with a tumor-positive sentinel node biopsy |
To present the 10-year follow up data of the the 5-year analysis of AMAROS trial showing that if locoregional treatment is advised after a tumor-positive axillary sentinel node biopsy (SNB), axillary radiotherapy (ART) is a reasonable alternative for an axillary lymph node dissection (ALND) with less side effects. |
Of the 4806 patients entered, 1425 patients had a tumor-positive SNB: 744 in the ALND-arm and 681 in the ART-arm, 60% with a macrometastasis. Both treatment-arms achieved a median 10-year follow-up and were comparable regarding age, tumor size, grade, tumor type and adjuvant systemic treatment. In the group who had ALND, the 5-year AxR was 0.41% (95%CI: 0.00;0.88) (4/744) and the 10-year AxR was 0.93% (95%CI:0.18;1.68) (7/744). In the group who had ART, the 5-year AxR was 1.04% (95%CI: 0.27;1.81) (7/681) and the 10-year AxR was 1.82% (95%CI: 0.74;2.94) (11/681) (HR 1.71, 95%CI: 0.67;4.39, p = 0.37). Sensitivity analysis, considering deaths and distant recurrences as competing risks, revealed consistent results. There were no significant differences between treatment arms regarding OS (ALND: 84.6% (95%CI: 81.5;87.1), ART: 81.4% (95%CI: 77.9;84.4), HR 1.17, 95%CI: 0.89;1.52, p= 0.26) and DMFS (ALND: 81.7% (95%CI: 78.5;84.4), ART: 78.2% (95%CI: 74.6;81.3), HR 1.18, 95%CI: 0.92;1.50, p=0.19). Cumulative incidence estimates of 10-year LRR are 3.59% (95%CI: 2.12;5.06) (ALND) versus 4.07% (95%CI: 2.49;5.65) (ART) (p= 0.69). More second primaries were observed after ART: 75/681 (21 contralateral breast) as compared to ALND: 57/744 (11 contralateral breast) (p = 0.035). All results are consistent in the per protocol analysis of patients with a tumor-positive SNB. |
3 |
| 67. Park HL, Yoo IR, O JH, Kim H, Kim SH, Kang BJ. Clinical utility of 18F-FDG PET/CT in low 18F-FDG-avidity breast cancer subtypes: comparison with breast US and MRI. Nucl Med Commun. 39(1):35-43, 2018 Jan. |
Observational-Dx |
192 patients including 142 PET scans for staging and 349 PET scans for surveillance. |
To evaluate the diagnostic performance of fluorine-18-fluorodeoxyglucose (F-FDG) PET/CT in initial axillary lymph node (ALN) staging and tumor recurrence in breast cancer subtypes with low F-FDG avidity in comparison with breast ultrasonography (US) and/or MRI. |
For the detection of ALN metastasis, the sensitivity, specificity, and accuracy were calculated to be 51.5, 94.6, and 84.7% for F-FDG PET/CT, 42.4, 90.1, and 79.2% for US, and 51.5, 88.3, and 79.9% for MRI, respectively. PET/CT showed significantly higher specificity than MRI. In the surveillance, the total recurrence rate was 4.3%. There were no cases of recurrence of mucinous or tubular carcinoma. PET/CT showed comparable diagnostic performance for locoregional recurrence compared with US in invasive lobular carcinoma. Distant metastasis developed in five patients (one stage II, four stage III), and all of these were identified by PET/CT alone. |
2 |
| 68. Fujii T, Yajima R, Tatsuki H, Oosone K, Kuwano H. Implication of 18F-Fluorodeoxyglucose Uptake of Affected Axillary Lymph Nodes in Cases with Breast Cancer. Anticancer Res. 36(1):393-7, 2016 Jan. |
Observational-Dx |
179 patients |
To examine whether certain factors, including lymphatic spread and size of metastatic lymph nodes, are associated with FDG avidity in order to evaluate the benefits of a FDG-PET assessment of axillary node metastases. |
The sensitivity, specificity, overall accuracy, and false-negative rates in the diagnosis of axillary lymph node status by FDG-PET were 47.9%, 98.5%, 84.9%, and 52.1%, respectively. The 48 cases with lymph node metastases were divided into two groups based on the presence or not of FDG uptake in the axillary lesions. Clinicopathological features of the primary tumor, including tumor size, standardized uptake value (SUVmax and biomarkers, were not statistically significant factors; only the clinicopathological features of metastatic lymph nodes, including the size of node metastasis, were significantly associated with FDG uptake in the axillary lymph nodes. Among the eight cases of micrometastasis, seven were not detected by FDG-PET. The number of cases with only one affected node was significantly higher in the group without FDG uptake in the axillary lesion. |
3 |
| 69. Liang X, Yu J, Wen B, Xie J, Cai Q, Yang Q. MRI and FDG-PET/CT based assessment of axillary lymph node metastasis in early breast cancer: a meta-analysis. Clin Radiol. 72(4):295-301, 2017 Apr. |
Meta-analysis |
21 studies |
To evaluate the accuracy of magnetic resonance imaging (MRI) and combined 2-[18F]-fluoro-2-deoxy-d-glucose (FDG) positron-emission tomography/computed tomography (PET/CT) for N staging of breast cancer. |
The pooled specificities of MRI and PET/CT were similar at 0.93 (95% confidence interval [CI]: 0.92-0.94) and 0.93 (95% CI: 0.90-0.95), respectively; however, the pooled sensitivity of MRI was (0.82; 95% CI: 0.78-0.85) significantly greater than PET/CT (0.64; 95% CI: 0.59-0.69)]. Further analysis revealed that MRI had a significantly higher diagnostic odds ratio (DOR) value of 51.28 (95% CI: 22.44-117.17) compared to PET/CT at 18.84 (95% CI: 11.71-31.76). |
Good |
| 70. Orsaria P, Chiaravalloti A, Caredda E, et al. Evaluation of the Usefulness of FDG-PET/CT for Nodal Staging of Breast Cancer. Anticancer Res. 38(12):6639-6652, 2018 Dec. |
Observational-Dx |
50 patients |
To assess the value of this non-invasive imaging procedure for axillary staging. |
The sensitivity, specificity, overall accuracy, positive predictive value, and negative predictive value of 18F-FDG PET/CT for axillary LN staging were 87%, 90%, 88%, 93%, and 82%, respectively. Bivariate analyses showed strong interactions of nuclear grade (p=0.05), progesterone receptor expression (p=0.001), Ki-67 index (0.027), and local relapse with the SUV T. A high SUV LN value was significantly correlated with a higher nuclear grade score (p=0.05), oestrogen receptor negativity (p=0.001), progesterone receptor negativity (p=0.014), a high Ki-67 index (>20%; p=0.048), LN metastasis (p<0.001), a basal tumour (p=0.04), and locoregional recurrence (p<0.001). |
2 |
| 71. Koolen BB, van der Leij F, Vogel WV, et al. Accuracy of 18F-FDG PET/CT for primary tumor visualization and staging in T1 breast cancer. Acta Oncol. 53(1):50-7, 2014 Jan. |
Observational-Dx |
62 patients with invasive T1 breast cancer. |
To assess the accuracy of 18F-FDG PET/CT in T1 breast cancer regarding visualization of the primary tumor and the detection of locoregional and distant metastases. |
The primary tumor was visible with PET/CT in 54 (87%) of 62 patients, increasing from 59% (10/17) in tumors = 10 mm to 98% (44/45) in tumors over 10 mm. All triple negative and HER2-positive tumors and 40/48 (83%) ER-positive/HER2-negative tumors were visualized. Sensitivity and specificity of PET/CT in the detection of axillary metastases were 73% and 100%, respectively. PET/CT depicted periclavicular nodes in two patients. Of 12 distant lesions, one was confirmed to be a lung metastasis, three were false positive, and eight were new primary proliferative lesions. |
2 |
| 72. Nakano Y, Noguchi M, Yokoi-Noguchi M, et al. The roles of 18F-FDG-PET/CT and US-guided FNAC in assessment of axillary nodal metastases in breast cancer patients. Breast Cancer. 24(1):121-127, 2017 Jan. |
Observational-Dx |
298 patients |
To evaluate whether 18F-FDG-PET/CT and USguided FNAC are useful for assessment of ALN involvement in breast cancer patients. |
Fifty (85 %) of 59 patients with positive 18F-FDG uptake in the axilla had axillary metastases, but 18F-FDG uptake results were false-positive in 9 (15 %) cases. On the other hand, 29 patients with positive FNAC underwent ALND without the need for SLN biopsy, while the remaining 20 patients with negative FNAC as well as 249 patients with negative US findings underwent SLN biopsy. Subsequently, 68 patients with positive SLN underwent ALND. |
3 |
| 73. Kim JY, Lee SH, Kim S, Kang T, Bae YT. Tumour 18 F-FDG Uptake on preoperative PET/CT may predict axillary lymph node metastasis in ER-positive/HER2-negative and HER2-positive breast cancer subtypes. Eur Radiol. 25(4):1172-81, 2015 Apr. |
Review/Other-Dx |
671 patients with invasive breast cancer. |
To evaluate the association between tumour FDG uptake on preoperative PET/CT and axillary lymph node metastasis (ALNM) according to breast cancer subtype. |
ALNM was present in 187 of 461 ER-positive/HER2-negative, 54 of 97 HER2-positive, and 38 of 113 triple-negative tumours. On multivariate analysis, high tumour SUVmax (=4.25) (P < 0.001), large tumour size (>2 cm) (P = 0.003) and presence of lymphovascular invasion (P < 0.001) were independent variables associated with ALNM. On subset analyses, tumour SUVmax maintained independent significance for predicting ALNM in ER-positive/HER2-negative (adjusted odds ratio: 3.277, P < 0.001) and HER2-positive tumours (adjusted odds ratio: 14.637, P = 0.004). No association was found for triple-negative tumours (P = 0.161). |
4 |
| 74. Jung NY, Kim SH, Kang BJ, Park SY, Chung MH. The value of primary tumor (18)F-FDG uptake on preoperative PET/CT for predicting intratumoral lymphatic invasion and axillary nodal metastasis. Breast Cancer. 23(5):712-7, 2016 Sep. |
Observational-Dx |
428 patients |
To investigate the ability of (18)F-fluorodeoxyglucose positron emission tomography/computed tomography ((18)F-FDG PET/CT) to predict intratumoral lymphatic invasion and axillary LN metastasis. |
The mean SUVmax of primary tumors with lymphatic invasion was higher than that of tumors without lymphatic invasion (5.13 ± 3.49 vs. 3.00 ± 2.47; p < 0.0001). The mean SUVmax of primary tumors with pathologically confirmed axillary LN metastasis was higher than that of tumors without LN metastasis (4.93 ± 3.32 vs. 3.22 ± 2.78; p < 0.0001). The degree of lymphatic invasion correlated strongly with axillary LN metastasis (p = 0.0001). Multiple logistic regression analysis showed that the high SUVmax of the primary tumor (>2.8), the high SUVmax of the axillary LN (>0.72) and the degree of lymphatic invasion were significant predictive factors of the development of axillary LN metastasis. |
3 |
| 75. Catalano OA, Horn GL, Signore A, et al. PET/MR in invasive ductal breast cancer: correlation between imaging markers and histological phenotype. Br J Cancer. 116(7):893-902, 2017 Mar 28. |
Observational-Dx |
21 invasive ductal breast cancer patients. |
To explore the ability of contrast-enhanced breast [18F] FDG positron emission tomography magnetic resonance (PET/MR) to identify the phenotype of breast cancer. |
ER/PR- tumours demonstrated higher Kepmean and SUVmax than ER or PR+ tumours. HER2- tumours displayed higher ADCmean, Kepmean, and SUVmax than HER2+tumours. Only ADCmean discriminated Ki67?14% tumours (lower ADCmean) from Ki67>14% tumours. PET/MR biomarkers correlated with IHC phenotype in 13 out of 21 patients (62%; P=0.001). |
3 |
| 76. Diao W, Tian F, Jia Z. The prognostic value of SUVmax measuring on primary lesion and ALN by 18F-FDG PET or PET/CT in patients with breast cancer. [Review]. Eur J Radiol. 105:1-7, 2018 Aug. |
Meta-analysis |
15 eligible studies with 3574 breast cancer patients. |
To evaluate the prognostic value of maximum standardized uptake values (SUVmax) measured in the primary lesion and axillary lymph nodes (ALN) by pretreatment fluorine-18-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) or positron emission tomography/computed tomography (PET/CT) in patients with breast cancer. |
For EFS, patients with higher primary SUVmax showed a poorer survival prognosis with pooled HR of 1.96 (95% confidence interval (CI) 1.40-2.73). The combined HR of high SUVmax in ALN and ALN-to-primary SUVmax ratio (N/T ratio) were 1.89 (95% CI 0.70-5.07) and 2.06 (95% CI 0.59-7.21), respectively. In analyzing invasive ductal carcinoma (IDC) patients, the pooled HR was 1.91 (95% CI 1.40-2.64). For OS, the pooled HR of SUVmax in primary lesion and ALN were 0.64 (95% CI 0.23-1.84) and 1.09 (95% CI 0.07-16.53), respectively. |
Good |
| 77. Ozgur Aytac H, Colacoglu T, Nihal Nursal G, et al. Predictors determining the status of axilla in breast cancer: Where is PET/CT on that?. J. Balk. Union Oncol.. 20(5):1295-303, 2015 Sep-Oct. |
Observational-Dx |
116 patients |
To demonstrate the role of preoperative FDG-PET/CT imaging on predicting axillary metastasis according to SUVmax of the axilla and prognostic factors influencing this prediction. |
ALN metastasis was present in 62 of 131 T1 (43.7%) and 106 of 142 T2 tumors (74.6%), 20 of 46 (43.5%) ER(-) and 146 of 222 (65.8%) ER(+) tumors, 38 of 71 (53.5%) PgR(-) and 127 of 200 (63.5%) PgR(+) tumors. On multivariate analysis only the tumor size (>2 cm) independently correlated with ALN metastasis (Odds ratio/OR=3.1). None of the other parameters had statistical significance in terms of ALN prediction on FDG-PET/CT. |
3 |
| 78. Fujii T, Yajima R, Tatsuki H, Kuwano H. Prediction of Extracapsular Invasion at Metastatic Sentinel Nodes and Non-sentinel Lymph Nodal Metastases by FDG-PET in Cases with Breast Cancer. Anticancer Res. 36(4):1785-9, 2016 Apr. |
Observational-Dx |
156 patients |
To evaluate the association of FDG uptake with ECI at SLNs and furthermore, evaluate the possibility of FDG-PET assessment of axillary non-SLN metastases. |
Among 35 patients (22.4%) in whom the presence of SLN metastases was diagnosed, 10 cases (28.6%) had FDG uptake in the axillary lesion. The sensitivity, specificity, overall accuracy, and false-negative rates in the diagnosis of SLN status by FDG-PET were 28.6%, 99.2%, 83.3%, and 71.4%, respectively. The false-positive rate of FDG-PET evaluation was 0.8%. The 35 cases with lymph node metastases were divided into two groups based on the presence of FDG uptake in the axillary lesions. Among the 35 cases with SLN metastases, 13 cases (37.1%) had non-SLN metastasis. |
4 |
| 79. van Nijnatten TJA, Ploumen EH, Schipper RJ, et al. Routine use of standard breast MRI compared to axillary ultrasound for differentiating between no, limited and advanced axillary nodal disease in newly diagnosed breast cancer patients. Eur J Radiol. 85(12):2288-2294, 2016 Dec. |
Observational-Dx |
377 cases |
To compare standard breast MRI to dedicated axillary ultrasound (with or without tissue sampling) for differentiating between no, limited and advanced axillary nodal disease in breast cancer patients. |
A total of 377 cases resulted in 81.4% no, 14.4% limited and 4.2% advanced axillary nodal disease at final histopathology. Probability of pN2-3 given cN0 for breast MRI and axillary ultrasound was 0.7-0.9% versus 1.5% and probability of pN2-3 given cN1 was 11.6-15.4% versus 29.0%. When cN1 on breast MRI was observed, PPV to identify positive axillary nodal disease was 50.7% and 59.0%. |
3 |
| 80. Xing H, Song CL, Li WJ. Meta analysis of lymph node metastasis of breast cancer patients: Clinical value of DWI and ADC value. Eur J Radiol. 85(6):1132-7, 2016 Jun. |
Meta-analysis |
13 studies (676 metastatic and 811 non-metastatic lymph nodes) |
To evaluate the diagnostic utility of DWI in the assessment of node metastases and investigate whether the ADC value could be used to discriminate between metastatic and non-metastatic lymph nodes in breast cancer patients. |
(1) The pooled sensitivity, specificity, PPV and NPV of DWI were 0.83, 0.82, 0.83 and 0.85, respectively. The PLR and NLR were 4.95 and 0.23, respectively. The AUC and Q* index were 0.91 and 0.85, respectively. (2) The ADC value of metastatic lymph nodes was lower than non-metastatic lymph nodes (WMD=-0.213, 95% CI -0.349 to -0.076, Z=3.05, P<0.05). (3) Subgroup meta-analysis of the group of b(0800): The pooled sensitivity, specificity, PPV and NPV of DWI were 0.86, 0.86, 0.82 and 0.90, respectively. The PLR and NLR were 6.76 and 0.18, respectively. The AUC and Q* index were 0.93 and 0.87. The ADC value of metastatic lymph nodes was lower than non-metastatic lymph nodes(WMD=-0.267, 95% CI -0.348 to -0.185, Z=6.40, P<0.05). |
Good |
| 81. Abe H, Schmidt RA, Kulkarni K, Sennett CA, Mueller JS, Newstead GM. Axillary lymph nodes suspicious for breast cancer metastasis: sampling with US-guided 14-gauge core-needle biopsy--clinical experience in 100 patients. Radiology 2009;250:41-9. |
Observational-Dx |
100 patients |
To study the clinical usefulness of ultrasonography (US)-guided core-needle biopsy (CNB) of axillary lymph nodes and the US-depicted abnormalities that may be used to predict nodal metastases. |
Nodal metastases were documented at CNB in 64 (64%) of the 100 patients. All 36 patients with negative biopsy results underwent subsequent sentinel lymph node biopsy (SLNB), which yielded negative findings in 32 (89%) patients and revealed metastasis in four (11%). All 44 patients who did not undergo CNB because of negative US results subsequently underwent SLNB, which revealed lymph node metastasis in 12 (27%) patients. Cortical thickening was found in 63 (79%) of the total of 80 metastatic nodes, but only a minority (n = 26 [32%]) of the nodes had an absent fatty hilum. NHBF to the cortex was detected in 52 (65%) metastatic nodes. Both absence of a fatty hilum (metastasis detected in 26 [93%] of 28 nodes) and cortical thickening combined with NHBF (metastasis detected in 52 [81%] of 64 nodes) had a high positive predictive value. No clinically important complications were encountered with the biopsy procedures. |
3 |
| 82. Alvarez S, Anorbe E, Alcorta P, Lopez F, Alonso I, Cortes J. Role of sonography in the diagnosis of axillary lymph node metastases in breast cancer: a systematic review. AJR Am J Roentgenol 2006;186:1342-8. |
Review/Other-Dx |
16 articles |
The purpose of our study was to evaluate the accuracy of sonography and sonographically guided biopsy in the preoperative diagnosis of metastatic invasion of the axilla in patients with breast carcinoma. |
Sixteen articles were selected. In sonography of axillae without palpable nodes, and using lymph node size as the criterion for positivity, sensitivity varied between 48.8% (95% confidence interval, 39.6-58%) and 87.1% (76.1-94.3%) and specificity, between 55.6% (44.7-66.3%) and 97.3% (86.1-99.9%). When lymph node morphology was used as the criterion for positivity, sensitivity ranged from 26.4% (15.3-40.3%) to 75.9% (56.4-89.7%) and specificity, from 88.4% (82.1-93.1%) to 98.1% (90.1-99.9%). The results are different if axillae with palpable nodes are included. The sonographically guided biopsy shows a sensitivity that varies between 30.6% (22.5-39.6%) and 62.9% (49.7-74.8%) and a specificity of 100% (94.8-100%). Many of the summary results obtained after meta-analysis show a heterogeneity that disappears, on occasion, on excluding the studies that use a double gold standard. |
4 |
| 83. Pilewskie M, Jochelson M, Gooch JC, Patil S, Stempel M, Morrow M. Is Preoperative Axillary Imaging Beneficial in Identifying Clinically Node-Negative Patients Requiring Axillary Lymph Node Dissection?. J Am Coll Surg. 222(2):138-45, 2016 Feb. |
Observational-Dx |
425 patients |
To determine if abnormal axillary imaging is predictive of the need for axillary lymph node dissection (ALND) in this population. |
Between August 2010 and December 2013, 3,253 breast cancer patients were treated with BCS and SLN biopsy; 425 patients met Z0011 criteria (cT1-2N0) and had nodal metastasis on SLN biopsy. Clinicopathologic features were median patient age, 58 years; median tumor size, 1.8 cm; 85% ductal histology; and 89% estrogen receptor positive. All women had a mammogram, 242 had axillary US, 172 had MRI. Abnormal LNs were seen on 7%, 25%, and 30% of mammograms, US, and MRIs, respectively. Although abnormal LNs on mammogram or US were associated with a significant increase in ALND and a non-significant trend was seen with MRI, 68% to 73% of women with abnormal axillary imaging did not require ALND. |
1 |
| 84. Lee B, Lim AK, Krell J, et al. The efficacy of axillary ultrasound in the detection of nodal metastasis in breast cancer. AJR Am J Roentgenol 2013;200:W314-20. |
Observational-Dx |
224 patients |
To assess the accuracy and effectiveness of ultrasound examination in detecting axillary nodal involvement in breast cancer patients with the aim of refining our current clinical pathways. |
Two hundred twenty-four cases were included in the analysis, 113 (50.4%) of which had evidence of metastatic nodal involvement at final histology. Of these 113 cases, ultrasound findings for 59 (52.2%) were positive. The overall positive predictive value of ultrasound for detecting metastatic nodal involvement measured 0.81. The negative predictive value was 0.60. The sensitivity was 53.7%; specificity, 85.1%; and accuracy, 67.9%. The ultrasound morphologic lymph node features with the greatest correlation with malignancy were the absence of a hyperechoic hilum (p = 0.003) and increased cortical thickness (p = 0.03). Patients with a metastatic nodal burden density of at least 20% were more likely to have abnormal findings on axillary ultrasound examination (p = 0.009). |
2 |
| 85. Cools-Lartigue J, Sinclair A, Trabulsi N, et al. Preoperative axillary ultrasound and fine-needle aspiration biopsy in the diagnosis of axillary metastases in patients with breast cancer: predictors of accuracy and future implications. Ann Surg Oncol. 20(3):819-27, 2013 Mar. |
Observational-Dx |
235 patients |
To determine the sensitivity, specificity, and accuracy of axillary ultrasound and fine-needle aspiration biopsy (FNAB) in the identification of axillary nodal metastasis in early breast cancer patients. |
Of 235 patients, none demonstrated more than 2 positive sentinel lymph nodes. Ductal carcinoma was present in 68%, estrogen and progesterone receptors were positive in 81 and 64%, respectively, Her-2/neu was positive in 10%, and 36% were axillary node positive. The sensitivity and specificity of ultrasound alone were 55 and 88%, respectively. Predictors of abnormal ultrasound included size of metastasis, estrogen receptor and Her-2 status, tumor grade, and presence of lymphovascular invasion. Addition of FNAB increased the sensitivity and specificity to 69 and 100%. In conjunction with FNAB, the positive and negative predictive values were 100 and 54%, respectively. Ten percent of patients with nodal metastases demonstrated a positive FNAB. Patients with a positive FNAB did not harbor more nodal metastases or a greater proportion of gross extranodal disease compared to patients not subjected to FNAB. |
2 |
| 86. Balasubramanian I, Fleming CA, Corrigan MA, Redmond HP, Kerin MJ, Lowery AJ. Meta-analysis of the diagnostic accuracy of ultrasound-guided fine-needle aspiration and core needle biopsy in diagnosing axillary lymph node metastasis. Br J Surg. 105(10):1244-1253, 2018 09. |
Meta-analysis |
6 studies (1353 patients) |
To review comparative studies examining both preoperative US-FNA and US-CNB of axillary lymph nodes in breast cancer. |
Data on a total of 1353 patients from six studies met the inclusion criteria and were included in the final analysis. US-CNB was superior to US-FNA in diagnosing axillary nodal metastases: sensitivity 88 (95 per cent c.i. 84 to 91) versus 74 (70 to 78) per cent respectively. Both US-CNB and US-FNA had a high specificity of 100 per cent. Reported complication rates were significantly higher for US-CNB compared with US-FNA (7·1 versus 1·3 per cent; P < 0·001). Conversely, the requirement for repeat diagnostic procedures was significantly greater for US-FNA (4·0 versus 0·5 per cent; P < 0·001). |
Good |
| 87. Le-Petross HT, McCall LM, Hunt KK, et al. Axillary Ultrasound Identifies Residual Nodal Disease After Chemotherapy: Results From the American College of Surgeons Oncology Group Z1071 Trial (Alliance). AJR Am J Roentgenol. 210(3):669-676, 2018 Mar. |
Experimental-Dx |
611 patients |
To determine lymph node features on axillary ultrasound (US) images obtained after neoadjuvant chemotherapy that are associated with residual nodal disease in patients with initial biopsy-proven node-positive breast cancer. |
Axillary US images obtained after neoadjuvant chemotherapy and surgical pathologic findings were available for 611 patients. Residual nodal disease was present in 373 patients (61.0%), and 238 (39.0%) had a complete nodal pathologic response. Increased cortical thickness (mean, 3.5 mm for node-positive disease vs 2.5 mm for node-negative disease) was associated with residual nodal disease. Lymph node short-axis and long-axis diameters were significantly associated with pathologic findings. Patients with nodal morphologic type I or II had the lowest rate of residual nodal disease (51 of 91 patients [56.0%] and 138 of 246 patients (56.1%), respectively), whereas those with nodal morphologic type VI had the highest rate (44 of 55 patients [80.0%]) (p = 0.004). The presence of fatty hilum was significantly associated with node-negative disease (p = 0.0013). |
1 |
| 88. Ertan K, Linsler C, di Liberto A, Ong MF, Solomayer E, Endrikat J. Axillary ultrasound for breast cancer staging: an attempt to identify clinical/histopathological factors impacting diagnostic performance. Breast Cancer (Auckl). 7:35-40, 2013. |
Observational-Dx |
172 women |
To assess the diagnostic value of pre-surgery axillary ultrasound for nodal staging in patients with primary breast cancer and to identify clinical/histopathological factors impacting diagnostic performance. |
We enrolled a total of 172 women in the study. Sensitivity of clinical examination plus ultrasound was significantly higher than for clinical examination alone (58% vs. 31.6%). Specificity and positive predictive value were similar while the negative predictive value increased from 63.4% to 73% when additionally applying ultrasound. Sensitivity and specificity of axillary ultrasound were impacted by tumor size (P = 0.2/0.04), suspicious axillary palpation (P , 0.01/,0.01), number of affected lymph nodes (P , 0.01/-) and distant metastases (P = 0.04/,0.01). All other factors had no impact. |
3 |
| 89. Kaur N, Sharma P, Garg A, Tandon A. Accuracy of individual descriptors and grading of nodal involvement by axillary ultrasound in patients of breast cancer. Int J Breast Cancer 2013;2013:930596. |
Observational-Dx |
34 patients |
To assess the accuracy of different descriptors of axillary ultrasound and to formulate a model on grading of axillary involvement. |
Based on the presence of various descriptors, five grades of nodal involvement could be defined. The most accurate descriptors to indicate nodal involvement were loss of hilar fat and hypoechoic internal echoes with specificity of 83% and positive predictive value of 92% each. The combination of descriptors of round shape with loss of hilar fat and hypoechoic internal echos had 100% specificity and positive predictive value. |
3 |
| 90. Elmore LC, Appleton CM, Zhou G, Margenthaler JA. Axillary ultrasound in patients with clinically node-negative breast cancer: which features are predictive of disease?. J Surg Res. 184(1):234-40, 2013 Sep. |
Observational-Dx |
110 women with clinically node-negative breast cancer and suspicious axillary US |
To identify whether certain radiologic characteristics correlate with cytology and final pathology. |
Of the 110 patients, cytology was positive in 71 (68%) and final pathology was positive in 80 (73%). The most common indication for biopsy was lymph node cortex characterized by thickening or eccentric contour (N = 40). Loss of the fatty hilum was described in 17 patients, and 9 patients had lymph nodes with both abnormal cortical and hilar features. Of 43 patients with "suspicious" disease without specific criteria, the most common indication for biopsy was disparity in size of one or more lymph nodes compared with others. Maximum cortical thickness was greater in patients with positive cytology compared with those with negative cytology (7.6 versus 6.2 mm; P = 0.047). Ultrasound characteristics such as lymph node size, cortical morphology, contour, and hilar fat were not individually predictive of final cytology and pathology. |
3 |
| 91. Boland MR, Ni Cearbhaill R, Fitzpatrick K, et al. A Positive Node on Ultrasound-Guided Fine Needle Aspiration Predicts Higher Nodal Burden Than a Positive Sentinel Lymph Node Biopsy in Breast Carcinoma. World J Surg. 40(9):2157-62, 2016 Sep. |
Observational-Dx |
974 patients |
To compare nodal burden in patients with positive USFNAC and a positive SLNB. |
974 patients were eligible for analysis. 439 patients (45 %) had positive USFNAC and 535 (55 %) had a positive SLNB. USFNAC-positive patients were more likely to undergo mastectomy (Chi-square test; p < 0.001), have extra-nodal extension (p < 0.001), be oestrogen receptor negative (p < 0.001) and be HER2 positive (p < 0.001). The median total number of lymph nodes (LNs) excised during AC was higher in the USFNAC group (Mann-Whitney test; 23 vs. 21; p < 0.001). The median total number of involved LNs was 3 (range 1-47) in FNAC-positive patients versus 1 (range 1-37) in SLNB-positive patients (p < 0.001). The median number of involved LNs in level 1 was 3 in FNAC-positive patients versus 1 in SLNB-positive patients (p < 0.001). Within the SLN-positive group, 49 % of the patients had only one involved LN, 28 % had two nodes involved and 23 % had =3. In comparison, within the FNAC-positive group only 13 % of the patients had one involved LN, 12 % had two nodes involved and 74 % had =3. |
3 |
| 92. Senkus E, Kyriakides S, Ohno S, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 26 Suppl 5:v8-30, 2015 Sep. |
Review/Other-Dx |
N/A |
No abstract available. |
No abstract available. |
4 |
| 93. Wahl RL, Siegel BA, Coleman RE, Gatsonis CG. Prospective multicenter study of axillary nodal staging by positron emission tomography in breast cancer: a report of the staging breast cancer with PET Study Group. J Clin Oncol. 2004;22(2):277-285. |
Experimental-Dx |
360 women |
To determine the accuracy of positron emission tomography with fluorine-18-labeled 2-fluoro-2-deoxy-d-glucose (FDG-PET) in detecting axillary nodal metastases in women with primary breast cancer. |
For detecting axillary nodal metastasis, the mean estimated area under the receiver operator curve for the three readers was 0.74 (range, 0.70 to 0.76). If at least one probably or definitely abnormal axillary focus was considered positive, the mean (and range) sensitivity, specificity, and positive and negative predictive values for PET were 61% (54% to 67%), 80% (79% to 81%), 62% (60% to 64%), and 79% (76% to 81%), respectively. False-negative axillae on PET had significantly smaller and fewer tumor-positive lymph nodes (2.7) than true-positive axillae (5.1; P <.005). Semiquantitative analysis of axillary FDG uptake showed that a nodal standardized uptake value (lean body mass) more than 1.8 had a positive predictive value of 90%, but a sensitivity of only 32%. Finding two or more intense foci of tracer uptake in the axilla was highly predictive of axillary metastasis (78% to 83% positive predictive value), albeit insensitive (27%). |
1 |
| 94. Riedl CC, Slobod E, Jochelson M, et al. Retrospective analysis of 18F-FDG PET/CT for staging asymptomatic breast cancer patients younger than 40 years. J Nucl Med. 55(10):1578-83, 2014 Oct. |
Observational-Dx |
134 patients with initial breast cancer stage I to III |
To evaluate the impact of 18F-FDG PET/CT staging in clinical stage I–III breast cancer patients younger than 40 y and compared the rate of upstaging between biologic subgroup categories. |
One hundred thirty-four patients with initial breast cancer stage I to IIIC met inclusion criteria. PET/CT findings led to upstaging to stage III or IV in 28 patients (21%). Unsuspected extra-axillary regional nodes were found in 15 of 134 patients (11%) and distant metastases in 20 of 134 (15%), with 7 of 134 (5%) demonstrating both. PET/CT revealed stage IV disease in 1 of 20 (5%) patients with initial clinical stage I, 2 of 44 (5%) stage IIA, 8 of 47 (17%) stage IIB, 4 of 13 (31%) stage IIIA, 4 of 8 (50%) stage IIIB, and 1 of 2 (50%) stage IIIC. All 20 patients upstaged to stage IV were histologically confirmed. Four synchronous thyroid and 1 rectal malignancies were identified. |
2 |
| 95. Ulaner GA, Castillo R, Goldman DA, et al. (18)F-FDG-PET/CT for systemic staging of newly diagnosed triple-negative breast cancer. Eur J Nucl Med Mol Imaging 2016;43:1937-44. |
Observational-Dx |
232 patients with TNBC |
To assess 18F-FDG-PET/CT for systemic staging of newly diagnosed triple-negative breast cancer (or TNBC). |
A total of 232 patients with TNBC met inclusion criteria. 18F-FDG-PET/CT revealed unsuspected distant metastases in 30 (13%): 0/23 initial stage I, 4/82 (5%) stage IIA, 13/87 (15%) stage IIB, 4/23 (17%) stage IIIA, 8/14 (57%) stage IIIB, and 1/3 (33%) stage IIIC. Twenty six of 30 patients upstaged to IV by 18F-FDG-PET/CT were confirmed by pathology, with the remaining 4 confirmed by follow-up imaging. In addition, 7 unsuspected synchronous malignancies were identified in 6 patients. Initial stage 2B patients who were upstaged to 4 by 18F-FDG-PET/CT had significantly shorter survival compared to initial stage 2B patients who were not (3 year Kaplan Meier estimate 0.33, 95% CI 0.13–0.55 versus 0.97, CI 0.76–0.93, p<.0001). |
2 |
| 96. Lyman GH, Temin S, Edge SB, et al. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 32(13):1365-83, 2014 May 01. |
Review/Other-Dx |
N/A |
To provide evidence-based recommendations to practicing oncologists, surgeons, and radiation therapy clinicians to update the 2005 clinical practice guideline on the use of sentinel node biopsy (SNB) for patients with early-stage breast cancer. |
This guideline update reflects changes in practice since the 2005 guideline. Nine randomized clinical trials (RCTs) met systematic review criteria for clinical questions 1 and 2; 13 cohort studies informed clinical question 3. |
4 |
| 97. Expert Panel on Breast Imaging:, Slanetz PJ, Moy L, et al. ACR Appropriateness Criteria R Monitoring Response to Neoadjuvant Systemic Therapy for Breast Cancer. J. Am. Coll. Radiol.. 14(11S):S462-S475, 2017 Nov. |
Review/Other-Dx |
N/A |
Evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for monitoring response to neoadjuvant systemic therapy for breast cancer. |
No results stated in abstract. |
4 |
| 98. Wecsler JS, Tereffe W, Pedersen RC, et al. Lymph node status in inflammatory breast cancer. Breast Cancer Res Treat 2015;151:113-20. |
Observational-Dx |
761 patients with inflammatory breast cancer |
To investigate the association between lymph node status and overall survival (OS) in individuals with inflammatory breast cancer (IBC). |
Survival analysis was performed using the Kaplan–Meier method. Cox proportional hazard regression was performed to evaluate univariate and multivariate associations between estrogen and progesterone receptor (ER/PR) status, treatment, and OS. Positive nodal status was associated with a significant decrease in OS (p < 0.001). Five-year survival for LN-positive and LN-negative patients was 49 and 66 %, respectively. In node-positive patients, ER or PR positivity was associated with improved OS, (p = 0.025, p = 0.007). In node-positive patients, the combination of surgery and radiation therapy improved OS when compared with surgery alone (p = 0.002). Nearly 80 % of the patients in this study had nodal metastasis. Positive nodal status was found to be an adverse prognostic factor. ER/PR positivity and treatment with surgery and radiation in node-positive patients was found to improve outcomes. Further studies are required to characterize the biology of IBC and guide the optimal treatment of this disease. |
3 |
| 99. An YS, Kang DK, Jung Y, Kim TH. Volume-based metabolic parameter of breast cancer on preoperative 18F-FDG PET/CT could predict axillary lymph node metastasis. Medicine (Baltimore). 96(45):e8557, 2017 Nov. |
Observational-Dx |
173 patients with invasive ductal carcinoma |
To evaluate the association between metabolic parameters on FDG PET/CT and axillary lymph node metastasis (ALNM) in patients with invasive breast cancer. |
Mean age of 173 patients was 49 years. Of 173 patients, 45 (26%) showed ALNM. On univariate analysis, larger tumor size (>2.2cm; P=.002), presence of lymphovascular invasion (P<.001), higher SUVmax (>2.82; P=.038), higher SUVmean (>1.2; P=.027),higher MTV (>2.38; P<.001), and higher TLG (>3.98; P=.007) were associated with a higher probability of ALNM. On multivariateanalysis, presence of lymphovascular invasion (adjusted odds ratio [OR], 11.053; 95% CI, 4.403–27.751; P<.001) and higher MTV(>2.38) (adjusted OR, 2.696; 95% CI, 1.079–6.739; P=.034) maintained independent significance in predicting ALNM. In subgroupanalysis of T2/T3 breast cancer, lymphovascular invasion (adjusted OR, 20.976; 95% CI, 5.431–81.010; P<.001) and higher MTV(>2.38) (adjusted OR, 4.906; 95% CI, 1.616–14.896; P=.005) were independent predictors of ALNM. However in T1 breast cancer,lymphovascular invasion (adjusted OR, 16.096; 95% CI, 2.517–102.939; P=.003) and larger SUV mean (>1.2) (adjusted OR,13.275; 95% CI, 1.233–142.908; P=.033) were independent predictors while MTV was not. |
2 |
| 100. Dunnwald LK, Doot RK, Specht JM, et al. PET tumor metabolism in locally advanced breast cancer patients undergoing neoadjuvant chemotherapy: value of static versus kinetic measures of fluorodeoxyglucose uptake. Clin Cancer Res 2011;17:2400-9. |
Observational-Dx |
75 patients with locally advanced breast cancer |
To compare kinetic parameters to the standardized uptake value (SUV) as predictors of pathologic response, disease-free survival (DFS) and overall survival (OS). |
Tumors that were hormone receptor negative, high grade, highly proliferative, or ofductal histology had higher FDG Ki and SUV values; on average, FDG K1 did not differsystematically by tumor features. Predicting pathologic response in conjunction with estrogenreceptor (ER) and axillary lymph node positivity, kinetic measures (AUC = 0.97) were morerobust predictors compared to SUV (AUC = 0.84, P = 0.005). Changes in K1 and Ki predictedboth DFS and OS, while changes in SUV predicted OS only. In multivariate modeling, onlychanges in K1 remained an independent prognosticator of DFS and OS. |
3 |
| 101. Keam B, Im SA, Koh Y, et al. Early metabolic response using FDG PET/CT and molecular phenotypes of breast cancer treated with neoadjuvant chemotherapy. BMC Cancer 2011;11:452. |
Observational-Dx |
78 stage II or III breast cancer patients |
1) to investigate the predictive value of FDG PET/CT (fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography) for histopathologic response and 2) to explore the results of FDG PET/CT by molecular phenotypes of breast cancer patients who received neoadjuvantchemotherapy. |
The mean pre- and post-chemotherapy standard uptake value (SUV) were 7.5 and 3.9, respectively. Theearly metabolic response provided by FDG PET/CT after one cycle of neoadjuvant chemotherapy was correlatedwith the histopathologic response after completion of neoadjuvant chemotherapy (P = 0.002). Sensitivity andnegative predictive value were 85.7% and 95.1%, respectively. The estrogen receptor negative phenotype had ahigher pre-chemotherapy SUV (8.6 vs. 6.4, P = 0.047) and percent change in SUV (48% vs. 30%, P = 0.038). In triplenegative breast cancer (TNBC), the pre-chemotherapy SUV was higher than in non-TNBC (9.8 vs. 6.4, P = 0.008). |
3 |
| 102. Groheux D, Espie M, Giacchetti S, Hindie E. Performance of FDG PET/CT in the clinical management of breast cancer. [Review]. Radiology. 266(2):388-405, 2013 Feb. |
Review/Other-Dx |
N/A |
To review the role of metabolic imaging with fluorine 18 fluorodeoxyglucose (FDG) in breast cancer. |
FDG PET/CT is very useful for restaging of cancer in patients with documented breast cancer recurrence or in those who are suspected of having breast cancer recurrence and is more efficient than PET alone and conventional imaging methods. FDG PET/CT is also efficient to perform the staging of locally advanced and inflammatory breast cancer. It allows detection of extraaxillary lymph nodes and distant metastases. PET/CT also brings valuable information in the staging of clinical stage IIB and primary operable stage IIIA breast carcinoma. In contrast, the spatial resolution of PET (approximately 5–6 mm) is not sufficient to allow the detection of early axillary node involvement and micrometastases. PET/CT cannot replace staging by using the sentinel node procedure. Also, PET is not recommended for the initial assessment of stage I breast cancer. The metabolic information provided by using PET has been shown to be valuable for the early assessment of response to chemotherapy (at the neoadjuvant and metastasis settings), but this indication remains to be validated. |
4 |
| 103. Cho N, Moon WK, Han W, Park IA, Cho J, Noh DY. Preoperative sonographic classification of axillary lymph nodes in patients with breast cancer: node-to-node correlation with surgical histology and sentinel node biopsy results. AJR Am J Roentgenol 2009;193:1731-7. |
Observational-Dx |
191 breast cancer patients |
To prospectively evaluate the role of axillary lymph node classification by sonography in breast cancer patients by node-to-node correlation with surgical histology and sentinel node biopsy results. |
Of the 191 needle-localized nodes, 41 (21%) had metastases and 150 (79%) did not have metastases. When a cutoff point of a cortical thickness of 2.5 mm was used, sonographic classification showed 85% (35/41) sensitivity, 78% (117/150) specificity, and an area under the curve of 0.861 (95% CI, 0.796–0.926). Of the 54 patients with metastases at sentinel node biopsy or axillary lymph node dissection, 13 (24%) had false-negative results of sonographically guided needle localization. Unsuccessful lymphatic mapping because of absent radiotracer uptake during sentinel node biopsy was found in 4% (7/191), whereas all needle-localized nodes with a cortical thickness of more than 2.5 mm were confirmed as metastases. |
3 |
| 104. Garcia-Ortega MJ, Benito MA, Vahamonde EF, Torres PR, Velasco AB, Paredes MM. Pretreatment axillary ultrasonography and core biopsy in patients with suspected breast cancer: diagnostic accuracy and impact on management. Eur J Radiol. 79(1):64-72, 2011 Jul. |
Observational-Dx |
675 patients (axillary regions) |
To evaluate the diagnostic accuracy of axillary ultrasonography and percutaneous biopsy, both alone and in combination, in detecting axillary metastases in patients with breast cancer and to assess the impact of these techniques on the patients’ management. |
Wee valuated 675 axillary regions and performed 291 core biopsies of axillary lymph nodes in 662patients. In 650 patients, breast cancer was histologically confirmed and in 12 patients malignant tumorsin other locations were confirmed. The sensitivity and specificity of axillary ultrasonography were 63.2%and 88.7%, respectively. The absence of a fatty hilum within the lymph node was the ultrasonographicfinding with the highest positive predictive value for malignancy (93.1%). The sensitivity and specificityof axillary core biopsy were 69.1% and 100%, respectively. Sentinel lymph node biopsy was avoided in33% of initial candidates and immediate breast reconstruction was undertaken in 35.1% of the patientswith mastectomy and negative axillary core biopsy. |
3 |
| 105. Lim GH, Upadhyaya VS, Acosta HA, Lim JMA, Allen JC Jr, Leong LCH. Preoperative predictors of high and low axillary nodal burden in Z0011 eligible breast cancer patients with a positive lymph node needle biopsy result. Eur J Surg Oncol. 44(7):945-950, 2018 07. |
Observational-Dx |
175 patients |
To determine the preoperative factors that could distinguish between low and high axillary nodal burden in Z0011 eligible patients with a needle biopsy proven metastatic node. |
70 (40%) and 105 (60%) patients had low and high nodal burden respectively. The high nodalburden subgroup was more likely to have on ultrasound 3 abnormal lymph nodes (37.14% versus 4.29%)(P < 0.0001) and maximum cortical thickness >4 mm (31.43% versus 10.0%) (P ¼ 0.0036). Multivariateanalysis revealed abnormal lymph nodes 3 to have an odds ratio of 20.72 (95% CI 5.91e72.65)P < 0.0001. |
1 |
| 106. Cancer research campaign (King's/Cambridge) trial for early breast cancer. A detailed update at the tenth year. Cancer Research Campaign Working Party. Lancet 1980;2:55-60. |
Experimental-Dx |
1,665 patients |
To compare the worth of alternative treatments with radical mastectomy in women with primary operable breast cancer. |
Information has been obtained from 1,665 patients eligible for follow-up from 34 NSABP member institutions in Canada and the United States. Results from that trial, at present in its sixth year with patients on study for an average of 36 months, (26 to 62 months), fail to demonstrate an advantage for those who had a radical mastectomy. No significant difference in the treatment failure or survival has as yet been observed in clinically negative node patients who have been randomly managed by conventional radical mastectomy, total mastectomy with postoperative regional radiation or total mastectomy followed by axillary dissection of those patients who subsequently develop positive nodes. Similarly, there presently exists no difference between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy followed by radiation. Of particular interest is the observation that based upon findings from radical mastectomy patients, there may be as many as 40% of patients having a total mastectomy who had histologically positive nodes unremoved, to date only 15% have developed positive nodes requiring an axillary dissection. The persistence of such a difference in incidence would have profound biological significance. The discovery that leaving behind positive axillary nodes has as yet not been influential in enhancing the incidence of distant metastases or the overall proportion of treatment failures and that a disproportionate number of treatment failures in the total mastectomy group occurred in those patients who subsequently required axillary dissection provides reinforcement to the view that positive axillary lymph nodes are not the predecessor of distant tumor spread but are a manifestation of disseminated disease. |
3 |
| 107. Fisher B, Montague E, Redmond C, et al. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer 1977;39:2827-39. |
Experimental-Dx |
2800 patients |
To answer the following question: does a course of radical radiotherapy to the chest wall and regional lymph nodes influence the survival following a simple mastectomy for "early" carcinoma of the breast? |
In the tenth year of follow-up of a multicentre trial of the management of operable breast cancer no significant difference in survival was found between patients treated with simple mastectomy alone (with radiotherapy later if the disease recurred) and those treated with simple mastectomy and routine immediate postoperative radiotherapy. There was a highly significant increased risk of local recurrence in the conservatively treated group, with a hazard ratio of 3.0. The biological and clinical relevance of these results is discussed. |
3 |
| 108. Anderson TL, Glazebrook KN, Murphy BL, Viers LD, Hieken TJ. Cross-sectional imaging to evaluate the extent of regional nodal disease in breast cancer patients undergoing neoadjuvant systemic therapy. Eur J Radiol. 89:163-168, 2017 Apr. |
Observational-Dx |
348 breast cancer patients |
To investigate associations of radiologic nodal staging with pathological N (pN) stage at operation and to explore how this might aid surgical and radiotherapy treatment planning. |
Pre-NST imaging included axillary ultrasound in 338 patients (97%), breast MRI in 305 (88%) and PET/CT or CT in 215 (62%). 213 patients (61%) were biopsy-proven axillary lymph node-positive (LN+) pre-treatment. cT stage was T1 in 9%, T2 in 49%, T3 in 29%, T4 in 12%; median tumor size was 4 cm. Pretreatment rN stage across all the patients was rN0 in 86 (25%), rN1 in 173 (50%), and rN3 in 89 (26%). rN3 disease included level III axillary, supraclavicular and suspicious internal mammary lymph nodes in 47 (53%), 32 (37%) and 45 (52%), respectively. Of patients LN+ at diagnosis, 78 (37%) were rN3. After NST,162 patients (47%) were node-positive at operation with a median (mean) of 3 (5.9 ± 0.4) positive lymph nodes including 128 of 213 (60%) LN+ at diagnosis. Pre-NST rN stage correlated with the likelihood and extent of axillary disease at operation, p = 0.002. Fifty four of 89 rN3 patients (61%) were node-positiveat operation with a median (mean) of 5 (8 ± 1) positive nodes. rN3 patients had larger nodal metastases (median 9 vs 6 mm) and more frequent extranodal extension (61% vs 43%) than rN0/rN1 patients, both p < 0.03. |
2 |
| 109. Candelaria RP, Bassett RL, Symmans WF, et al. Performance of Mid-Treatment Breast Ultrasound and Axillary Ultrasound in Predicting Response to Neoadjuvant Chemotherapy by Breast Cancer Subtype. Oncologist. 22(4):394-401, 2017 04. |
Observational-Dx |
159 patients |
To determine whether mid-treatment ultrasound measurements of index breast tumors and index axillary nodes of different cancer subtypes associate with residual cancer burden (RCB). |
One hundred fifty-nine patients (68 triple negative breast cancer [TNBC], 45 hormone receptor [HR]1/human epidermal growth factor receptor 2 [HER2]2, and 46 HR2/ HER21) were included. Median age at diagnosis was 50 years, range 30–76. Median tumor size was 3.4 cm, range 0.9–10.4. Pathological complete response/RCB-I rates were 36.8% (25/ 68) for TNBC patients, 24.4% (11/45) for HR1/HER22 patients, and 71.7% (33/46) for HR2/HER21 patients. Linear regression analyses demonstrated associations between percent change in tumor ultrasound measurements at mid-treatment with RCB index score in TNBC and HR1/HER22 (p< .05) but not in HR2/HER21 (p > .05) tumors and an association between axillary ultrasound assessment of number of abnormal nodes at mid-treatment with RCB index score across all subtypes (p< .05). |
2 |
| 110. Hennessy BT, Hortobagyi GN, Rouzier R, et al. Outcome after pathologic complete eradication of cytologically proven breast cancer axillary node metastases following primary chemotherapy. J Clin Oncol 2005;23:9304-11. |
Observational-Dx |
403 patients |
To determine long-term outcome in patients achieving pathologic complete remission (pCR) of cytologically proven axillary lymph node (ALN) metastases. |
Of 925 patients treated, 403 patients had cytologically confirmed ALN metastases. Eighty-nine patients (22%) achieved ALN pCR after PCT. Compared with the group without ALN pCR, 5-year OS and RFS were improved in patients achieving ALN pCR (93% [95% CI, 87.5 to 98.5] and 87% [95% CI, 79.7 to 94.3] v 72% [95% CI, 66.5 to 77.5] and 60% [95% CI, 54.1 to 65.9], respectively; P < .0001). Residual primary tumor did not affect outcome of those with ALN pCR. Combination anthracycline/taxane-based PCT resulted in significantly more ALN pCRs, although outcome after ALN pCR was not improved by taxanes. We constructed a nomogram demonstrating that patients who do not benefit from neoadjuvant anthracyclines are unlikely to benefit from subsequent taxanes. |
3 |
| 111. Hunt KK, Yi M, Mittendorf EA, et al. Sentinel lymph node surgery after neoadjuvant chemotherapy is accurate and reduces the need for axillary dissection in breast cancer patients. Ann Surg 2009;250:558-66. |
Observational-Dx |
575 patients |
To evaluate the accuracy of sentinel lymph node (SLN) surgery for patients undergoing neoadjuvant chemotherapy versus patients undergoing surgery first. |
Of the patients, 575 (15.3%) underwent SLN surgery after chemotherapy and 3171 (84.7%) underwent surgery first. Neoadjuvant patients were younger (51 vs. 57 years, P < 0.0001) and had more clinical T2-T3 tumors (87.3% vs. 18.8%, P < 0.0001) at diagnosis. SLN identification rates were 97.4% in the neoadjuvant group and 98.7% in the surgery first group (P = 0.017). False-negative rates were similar between groups (5/84 [5.9%] in neoadjuvant vs. 22/542 [4.1%] in the surgery first group, P = 0.39). Analyzed by presenting T stage, there were fewer positive SLNs in the neoadjuvant group (T1: 12.7% vs. 19.0%, P = 0.2; T2: 20.5% vs. 36.5%, P < 0.0001; T3: 30.4% vs. 51.4%, P = 0.04). Adjusting for clinical stage revealed no differences in local-regional recurrences, disease-free or overall survival between groups. |
3 |
| 112. Fayanju OM, Ren Y, Thomas SM, et al. The Clinical Significance of Breast-only and Node-only Pathologic Complete Response (pCR) After Neoadjuvant Chemotherapy (NACT): A Review of 20,000 Breast Cancer Patients in the National Cancer Data Base (NCDB). Ann Surg 2018;268:591-601. |
Observational-Dx |
5533 patients |
To determine whether the association between overall survival (OS) and response to neoadjuvant chemotherapy (NACT) in breast cancer patients varies with tumor subtype and anatomic extent of pathologic complete response (pCR). |
Of 33,162 identified patients, 20,265 experienced overall pCR (n = 6370, 19.2%), breast-only pCR (n = 494, 1.5%), node-only pCR (n = 1133, 3.4%), no stage change (n = 9641, 29.1%), or upstage (n = 2627, 7.9%). Compared with no stage change, breast-only pCR was associated with improved OS in triple-negative disease [hazard ratio = 0.58, 95% confidence interval (95% CI) = 0.37-0.89], and node-only pCR was associated with improved OS in both triple-negative (hazard ratio = 0.55,95% CI = 0.39-0.76) and HR+/HER2- disease (hazard ratio = 0.54, 95% CI = 0.33-0.89). For patients achieving overall (breast+axilla) pCR, unadjusted 5-year OS was 0.94 (95% CI = 0.93-0.95), with no difference between patients who were cN0 (hazard ratio = 0.95, 95% CI = 0.93-0.96) or cN1 (hazard ratio = 0.94, 95% CI = 0.92-0.96) at diagnosis. |
3 |
| 113. Park J, Chae EY, Cha JH, et al. Comparison of mammography, digital breast tomosynthesis, automated breast ultrasound, magnetic resonance imaging in evaluation of residual tumor after neoadjuvant chemotherapy. Eur J Radiol. 108:261-268, 2018 Nov. |
Observational-Dx |
51 patients |
To compare the accuracy of mammography (MG), digital breast tomosynthesis (DBT), automated breast ultrasound (ABUS) and magnetic resonance imaging (MRI) for the assessment of residual tumor extent in breast cancer after neoadjuvant chemotherapy (NAC). |
MRI size correlated well with pathology (ICC = 0.83), significantly better than MG, DBT and ABUS size (ICC = 0.56, ICC = 0.63 and ICC = 0.55, respectively). The discrepancy between MRI and pathology was statistical different from that of MG and ABUS (p = 0.0231 and 0.0039, respectively), but not different from that of DBT (p = 0.5727). For predicting pCR, MRI and DBT had a better performance compared to MG and US (area under the ROC curve: 0.92, 0.84, 0.72, 0.75, respectively; p = 0.3749 for DBT, p = 0.0972 for MG and p = 0.0596 for ABUS, when MRI being reference). |
3 |
| 114. Cheng X, Li Y, Liu B, Xu Z, Bao L, Wang J. 18F-FDG PET/CT and PET for evaluation of pathological response to neoadjuvant chemotherapy in breast cancer: a meta-analysis. Acta Radiol. 53(6):615-27, 2012 Jul. |
Meta-analysis |
17 studies including 781 subjects |
To determinate the diagnostic performance of 18F-fluorodeoxyglucose position emission tomography/computed tomography (FDG PET/CT) and FDG PET for evaluating response to neoadjuvant chemotherapy in patients with breast cancer. |
Seventeen studies (a total of 781 subjects) met the inclusion criteria. The pooled sensitivity was 0.840 (95% confidence interval [CI] 0.796-0.878). The pooled specificity was 0.713 (95% CI 0.667-0.756). For FDG PET/CT (10 studies included), the pooled sensitivity was 0.847 (95% CI 0.793-0.892), the pooled specificity was 0.661 (95% CI 0.598-0.720). The pooled likelihood ratio (LR+), negative likelihood ratio (LR-), and diagnostic odds ratio (DOR) were 2.835 (95% CI 1.640-4.900), 0.221 (95% CI 0.160-0.305), and 17.628 (95% CI 7.431-41.818). The area under the SROC curve (AUC) was 0.8934. For FDG PET (7 studies included), the pooled sensitivity and specificity were 0.826 (95% CI 0.741-0.892) and 0.789 (95% CI 0.719-0.849). The pooled LR + , LR-, and DOR were 3.601 (95% CI 2.601-4.986), 0.242 (95% CI 0.157-0.374), and 13.641 (95% CI 7.433-25.030). The AUC was 0.8764. |
Inadequate |
| 115. Liu Q, Wang C, Li P, Liu J, Huang G, Song S. The Role of (18)F-FDG PET/CT and MRI in Assessing Pathological Complete Response to Neoadjuvant Chemotherapy in Patients with Breast Cancer: A Systematic Review and Meta-Analysis. [Review]. Biomed Res Int. 2016:3746232, 2016. |
Meta-analysis |
6 studies |
To determine the utilities of 18F-FDG PET/CT and MRI in assessing the pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) in the same cohort of patients with breast cancer. |
A total of 6 studies including 382 pathologically confirmed patients were eligible. The pooled sensitivity and specificity of 18F-FDG PET/CT were 0.86 (95% CI: 0.76–0.93) and 0.72 (95% CI: 0.49–0.87), respectively. Pooled sensitivity and specificity of MRI were 0.65 (95% CI: 0.45–0.80) and 0.88 (95% CI: 0.75–0.95), respectively.Thearea under the SROC curve of 18F-FDG PET/CT and MRI was 0.88 and 0.84, respectively. |
Good |
| 116. Mghanga FP, Lan X, Bakari KH, Li C, Zhang Y. Fluorine-18 fluorodeoxyglucose positron emission tomography-computed tomography in monitoring the response of breast cancer to neoadjuvant chemotherapy: a meta-analysis. Clin Breast Cancer. 13(4):271-9, 2013 Aug. |
Meta-analysis |
15 studies |
To evaluate the diagnostic performance of fluorine-18 fluorodeoxyglucose positron emission tomography (FDG-PET) in monitoring the response of breast cancers to neoadjuvant chemotherapy. |
Fifteen studies with 745 patients were included in the study after meeting the inclusion criteria. The pooled sensitivity and specificity of FDG-PET or PET/CT were 80.5% (95% CI, 75.9%-84.5%) and 78.8% (95% CI, 74.1%-83.0%), respectively, and the positive predictive and negative predictive values were 79.8% and 79.5%, respectively. After 1 and 2 courses of chemotherapy, the pooled sensitivity and false-positive rate were 78.2% (95% CI, 73.8%-82.5%) and 11.2%, respectively; and 82.4% (95% CI, 77.4%-86.1%) and 19.3%, respectively. |
Good |
| 117. Tian F, Shen G, Deng Y, Diao W, Jia Z. The accuracy of 18F-FDG PET/CT in predicting the pathological response to neoadjuvant chemotherapy in patients with breast cancer: a meta-analysis and systematic review. [Review]. Eur Radiol. 27(11):4786-4796, 2017 Nov. |
Meta-analysis |
22 studies |
To evaluate the accuracy of (18)F-FDG PET/CT in predicting the pathological response to neoadjuvant chemotherapy (NAC) in breast cancer (BC) patients. |
The pooled values calculated with a mixed-effects model for the sensitivity, specificity and diagnostic odds ratio with 95% confidence intervals were 81.9% (76.0-86.6%), 79.3% (72.1-85.1%) and 17.35 (10.98-27.42), respectively. |
Good |
| 118. Wang Y, Zhang C, Liu J, Huang G. Is 18F-FDG PET accurate to predict neoadjuvant therapy response in breast cancer? A meta-analysis. Breast Cancer Res Treat. 131(2):357-69, 2012 Jan. |
Meta-analysis |
19 articles |
To provide a systematic overview and quantitative evaluation of the literature on the performance of 18F-FDG PET to predict histopathological response to neoadjuvant therapy in patients with breast cancer. |
Nineteen studies met the inclusion criteria and involved 920 pathologically confirmed patients in total (mean age 49.8 years, all female). Methodological quality was relatively high. To predict histopathological response in primary breast lesions by PET, the pooled sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic odds ratio were 84% (95% CI, 78-88%), 66% (95% CI, 62-70%), 50% (95% CI, 44-55%), 91% (95% CI, 87-94%), and 11.90 (95% CI, 6.33-22.36), respectively. In regional lymph nodes, sensitivity and NPV of PET were 92% (95% CI, 83-97%) and 88% (95% CI, 76-95%), respectively. Subgroup analysis showed that performing a post-therapy (18)F-FDG PET early (after the 1st or 2nd cycle of chemotherapy) was significantly better than later (accuracy 76% vs. 65%, P = 0.001). Furthermore, the best correlation with pathology was yielded by employing a reduction rate (RR) cutoff value of standardized uptake value between 55 and 65%. (18)F-FDG PET is useful to predict neoadjuvant therapy response in breast cancer. However, the relatively low specificity and PPV still call for caution. It is suggested to perform PET in an earlier course of therapy and use RR cutoff value between 55 and 65%, which might potentially identify non-responders early. However, further prospective studies are warranted to assess this regimen and adequately position PET in treatment management. |
Good |
| 119. Jung N, Kim HJ, Jung JH, et al. Restaging the axilla after neo-adjuvant chemotherapy for breast cancer: Predictive factors for residual metastatic lymph node disease with negative imaging findings. Breast J 2019;25:196-201. |
Observational-Dx |
206 patients |
To evaluate predictive factors for residual metastatic axillary lymph node (ALN) disease in patients with negative imaging findings after neo-adjuvant chemotherapy (NAC) for breast cancer. |
Of the 181 and 25 patients with initially node-positive and node-negative disease, 131 (72.4%) and 23 (92.0%), respectively, showed negative imaging findings after NAC. Among these 131 and 23 patients, 53 (40.5%) and two patients (8.7%), respectively, had residual metastatic ALN disease. Low to moderate tumor grade (odds ratio [OR] = 5.2, P = 0.009), positive HR status (OR = 6.6, P = 0.003), and negative HER2 status (OR = 2.6, P = 0.048) were associated with residual metastatic ALN disease. |
3 |
| 120. Wu S, Wang Y, Li J, et al. Subtype-Guided (18)F-FDG PET/CT in Tailoring Axillary Surgery Among Patients with Node-Positive Breast Cancer Treated with Neoadjuvant Chemotherapy: A Feasibility Study. Oncologist 2019. |
Observational-Dx |
133 patients |
To investigate the value of (18)[F]-fluorodeoxyglucose ((18)F-FDG) positron emission tomography/computed tomography (PET/CT) in tailoring axillary surgery by predicting nodal response among patients with node-positive breast cancer after neoadjuvant chemotherapy (NAC). |
With the cutoff value of 2.5 for baseline SUVmax and 78.4% for change in SUVmax, sequential (18)F-FDG PET/CT scans demonstrated a sensitivity of 79.0% and specificity of 71.4% in predicting axillary pathologic complete response with an area under curve (AUC) of 0.75 (95% confidence interval, 0.65-0.84). Explorative subgroup analyses indicated little value for estrogen receptor (ER)-negative, human epidermal growth factor receptor 2 (HER2)-positive patients (AUC, 0.55; sensitivity, 56.5%; specificity, 50.0%). Application of (18)F-FDG PET/CT could spare 19 patients from supplementary ALNDs and reduce one of three false-negative cases in TAD among the remaining patients without ER-negative/HER2-positive subtype. |
2 |
| 121. Steiman J, Soran A, McAuliffe P, et al. Predictive value of axillary nodal imaging by magnetic resonance imaging based on breast cancer subtype after neoadjuvant chemotherapy. J Surg Res. 204(1):237-41, 2016 07. |
Observational-Dx |
135 patients |
To determine residual breast disease after neoadjuvant chemotherapy (NCT) for cancer using MRI. |
A total of 135 patients underwent post-NCT breast MRI. The positive and negative predictive values of MRI are 93% and 26%, respectively. A subset analysis by cancer phenotype demonstrates triple negative cancers have the highest sensitivity (68%) and luminal cancers have the highest positive predictive value (100%). |
2 |
| 122. Javid S, Segara D, Lotfi P, Raza S, Golshan M. Can breast MRI predict axillary lymph node metastasis in women undergoing neoadjuvant chemotherapy. Ann Surg Oncol. 2010;17(7):1841-1846. |
Observational-Dx |
74 women |
To evaluate the predictive value of breast magnetic resonance imaging (MRI) in detecting axillary lymph node metastases prior to initiation of neoadjuvant chemotherapy (NAC) and in detecting residual lymph node metastases after NAC in women found to be node positive prior to NAC. |
Seventy-four women completed NAC and underwent surgery. Sensitivity of MRI in detecting axillary node involvement prior to NAC was 64.7% and specificity was 100%, with positive and negative predictive values of MRI of 100% and 77.8%, respectively. Sensitivity and specificity of MRI to identify residual pathologic axillary lymph node disease following NAC were 85.7% and 89%, respectively, while the positive and negative predictive values were 92% and 80.9%, respectively |
2 |
| 123. Zhou P, Wei Y, Chen G, Guo L, Yan D, Wang Y. Axillary lymph node metastasis detection by magnetic resonance imaging in patients with breast cancer: A meta-analysis. Thorac Cancer. 9(8):989-996, 2018 08. |
Meta-analysis |
26 studies |
To evaluate the diagnostic performance of magnetic resonance imaging (MRI) for the detection of axillary lymph node metastasis in patients with breast cancer. |
The pooled diagnostic sensitivity and specificity of MRI to detect axillary lymph node metastasis in patients with breast cancer were 0.77 (95% confidence interval [CI] 0.75-0.80) and 0.90 (95% CI 0.89-0.91), respectively. The pooled positive and negative likelihood ratios were 7.67 (95% CI 5.09-11.53) and 0.23 (95% CI 0.17-0.32), respectively, by random effect method. The area under the SROC curve was 0.93 for MRI to detect axillary lymph node metastasis in breast cancer patients. |
Good |
| 124. Marinovich ML, Houssami N, Macaskill P, et al. Meta-analysis of magnetic resonance imaging in detecting residual breast cancer after neoadjuvant therapy. [Review]. J Natl Cancer Inst. 105(5):321-33, 2013 Mar 06. |
Meta-analysis |
44 studies including 2050 patients |
To examine MRI accuracy in detecting residual tumor, investigate variables potentially affecting MRI performance, and compare MRI with other tests. |
Forty-four studies (2050 patients) were included. The overall AUC of MRI was 0.88. Accuracy was lower for "standard" pCR definitions (referent category) than "less clearly described" (RDOR = 2.41, 95% confidence interval [CI] = 1.11 to 5.23) or "near-pCR" definitions (RDOR = 2.60, 95% CI = 0.73 to 9.24; P = .03.) Corresponding AUCs were 0.83, 0.90, and 0.91. Specificity was higher when negative MRI was defined as contrast enhancement less than or equal to normal tissue (0.83, 95% CI = 0.64 to 0.93) vs no enhancement (0.54, 95% CI = 0.39 to 0.69; P = .02), with comparable sensitivity (0.83, 95% CI = 0.69 to 0.91; vs 0.87, 95% CI = 0.80 to 0.92; P = .45). MRI had higher accuracy than mammography (P = .02); there was only weak evidence that MRI had higher accuracy than clinical examination (P = .10). No difference in MRI and ultrasound accuracy was found (P = .15). |
Inadequate |
| 125. Hylton NM. Residual Disease after Neoadjuvant Therapy for Breast Cancer: Can MRI Help? Radiology 2018;289:335-36. |
Review/Other-Dx |
N/A |
No abstract available. |
No abstract available. |
4 |
| 126. McGuire KP, Toro-Burguete J, Dang H, et al. MRI staging after neoadjuvant chemotherapy for breast cancer: does tumor biology affect accuracy? Ann Surg Oncol. 2011;18(11):3149-3154. |
Observational-Dx |
203 patients |
To determine the difference between tumor size as estimated by postchemotherapy MRI versus final surgical pathology, and to determine if the accuracy of MRI varies with tumor subtype. |
Two hundred three of 592 patients undergoing surgery after NAC for breast cancer had MRI staging pre and post chemotherapy. All patients had intact tumors prior to the initiation of chemotherapy. Average tumor size by MRI was 4.0 cm pre chemotherapy and 1.2 cm post chemotherapy. The average pathologic tumor size was 1.7 cm (range 0-13 cm). The difference between MRI and pathologic tumor size was greatest in luminal (1.1 cm) and least in triple-negative (TN) and human epidermal growth factor receptor 2 (HER2)-positive tumors (<0.1 cm) (p = 0.015). MRI was a good discriminator for pathologic complete response (pCR) [area under the curve (AUC) 0.777]. Its predictive value for pCR was much greater in TN and estrogen receptor(ER)-/HER2+ than in luminal tumors (73.6 vs. 27.3%) |
3 |
| 127. Straver ME, Loo CE, Rutgers EJ, et al. MRI-model to guide the surgical treatment in breast cancer patients after neoadjuvant chemotherapy. Ann Surg. 2010;251(4):701-707. |
Observational-Dx |
208 patients |
To establish an magnetic resonance imaging (MRI)-based interpretation model to facilitate the selection of breast-conserving surgery (BCS) after neoadjuvant chemotherapy (NAC). |
The accuracy of MRI to detect residual disease was 76% (158/208). The positive and negative predictive value of MRI were 90% (130/144) and 44% (28/64), respectively. In 35 patients (17%), MRI underestimated the tumor size by >20 mm and in 27 patients (13%) this would have lead to incorrect indication of BCS. The features most predictive of indicating feasibility of BCS in tumors <30 mm on preoperative MRI were the largest diameter at the baseline MRI, the reduction in diameter and the tumor subtype based on hormone-, and human epidermal growth factor receptor 2-status (area under the curve: 0.78). |
3 |
| 128. Zhang X, Wang D, Liu Z, et al. The diagnostic accuracy of magnetic resonance imaging in predicting pathologic complete response after neoadjuvant chemotherapy in patients with different molecular subtypes of breast cancer. Quant Imaging Med Surg 2020;10:197-210. |
Observational-Dx |
177 women |
To estimate the diagnostic accuracy of preoperative magnetic resonance imaging (MRI) in predicting pCR in patients with different molecular subtypes of breast cancer and to provide a basis for the selection of surgical methods. |
A total of 177 women with a primary tumor fulfilled the study criteria; 18 of these patients (10.2%) achieved rCR, and 21 (11.9%) achieved a pCR. MRI diagnosis of rCR was significantly correlated with pCR with a Spearman’s correlation coefficient of 0.686 in the entire population. The sensitivity, specificity, accuracy, pCR predictive value (PPV), and non-pCR predictive value (NPV) were estimated to be 66.67%, 97.44%, 93.79%, 77.78%, and 95.60%, respectively. Statistically significant correlations between rCR and pCR were found in Luminal B high Ki67% (P<0.001), HER2-positive (P=0.0035), and triple-negative (P<0.001) subtypes, but not in Luminal A and Luminal B low Ki67% subtypes. On univariate analysis, the tumor characteristics significantly associated with both rCR and pCR were small tumor, lymph node metastasis (LNM) negativity, early clinical stage, high grade, high Ki67% index, and different molecular subtype. On multivariate logistic regression analysis, grade 3 tumors (P=0.013), Ki67% =40% (P<0.000), and stage I tumor (P=0.006) were independently associated with rCR. However, grade 3 tumors (P=0.001), triplenegative breast cancer (TNBC), and clinical stages I and II tumors (P=0.003; P=0.030) were independently associated with the likelihood of attaining a pCR. |
2 |
| 129. Boughey JC, Ballman KV, Hunt KK, et al. Axillary Ultrasound After Neoadjuvant Chemotherapy and Its Impact on Sentinel Lymph Node Surgery: Results From the American College of Surgeons Oncology Group Z1071 Trial (Alliance). J Clin Oncol. 33(30):3386-93, 2015 Oct 20. |
Experimental-Dx |
611 patients |
To determine how the post–neoadjuvant chemotherapy AUS appearance of the lymph nodes affects the FNR of SLN surgeryand to determinehowtheAUSstatus after completion of neoadjuvant chemotherapy correlates with residual disease on final pathology. |
Postchemotherapy AUS images were reviewed for 611 patients. One hundred thirty (71.8%) of 181 AUS-suspicious patients were node positive at surgery compared with 243 (56.5%) of 430 AUS-normal patients (P < .001). Patients with AUS-suspicious nodes had a greater number of positive nodes and greater metastasis size (P < .001). The SLN FNR was not different based on AUS results; however, using a strategy where only patients with normal AUS undergo SLN surgery would potentially reduce the FNR in Z1071 patients with >/= two SLNs removed from 12.6% to 9.8% when preoperative AUS results are considered as part of SLN surgery. |
3 |
| 130. Kelly AM, Dwamena B, Cronin P, Carlos RC. Breast cancer sentinel node identification and classification after neoadjuvant chemotherapy-systematic review and meta analysis. Acad Radiol 2009;16:551-63. |
Meta-analysis |
24 trials (1799 subjects) |
To extend this analysis by conducting an expanded meta-analysis to assess the performance of sentinel node mapping after neoadjuvant chemotherapy that includes trials that have been published since theirs. |
A total of 24 trials of 1799 subjects were reported that met eligibility criteria. All studies identified were published between 2000 and 2007. Lymph node involvement was found in 758 patients (37%) and ranged from 25% to 96% across studies. The proportion of patients who had successful lymph node mapping ranged from 63% to 100%, with 79% of studies reporting a rate of less than 95%. The summary successful identification rate was 0.896 (95% confidence interval [CI] 0.860-0.923) with moderate heterogeneity. The summary FNR was 0.084 (95% CI 0.064-0.109) with no significant heterogeneity. Increasing prevalence of lymph node involvement and same-day mapping and lymph node dissection both significantly reduced the FNR. |
Good |
| 131. Choudhery S, Simmons C, Harper L, Lee CU. Tomosynthesis-Guided Needle Localization of Breast and Axillary Lesions: Our Initial Experience. AJR Am J Roentgenol 2019;212:943-46. |
Review/Other-Dx |
38 lesions |
To review tomosynthesis-guided wire and seed needle localizations of the breast and axilla performed at our institution. |
No results listed in abstract. |
4 |
| 132. Li H, Yao L, Jin P, et al. MRI and PET/CT for evaluation of the pathological response to neoadjuvant chemotherapy in breast cancer: A systematic review and meta-analysis. [Review]. BREAST. 40:106-115, 2018 Aug. |
Meta-analysis |
13 studies |
To estimate the diagnostic accuracy of magnetic resonance imaging (MRI) and positron emission computed tomography (PET/CT) for evaluation of the pathological response to neoadjuvant chemotherapy in breast cancer. |
Thirteen studies involving 575 patients who underwent MRI and 618 who underwent PET/CT were included in our analysis. The pooled sensitivity and specificity of MRI were 0.88 (95% CI: 0.78-0.94) and 0.69 (95% CI: 0.51-0.83), respectively. The corresponding values for PET/CT were 0.77 (95% CI: 0.58-0.90) and 0.78 (95% CI: 0.63-0.88), respectively. The area under the SROC curve for MRI and PET/CT were 0.88 and 0.84, respectively. And the RDOR=1.44 (95% CI, 0.46-4.47P=0.83). |
Good |
| 133. Sheikhbahaei S, Trahan TJ, Xiao J, et al. FDG-PET/CT and MRI for Evaluation of Pathologic Response to Neoadjuvant Chemotherapy in Patients With Breast Cancer: A Meta-Analysis of Diagnostic Accuracy Studies. Oncologist. 21(8):931-9, 2016 08. |
Meta-analysis |
10 studies |
To compare the diagnostic test accuracy of magnetic resonance imaging (MRI) with that of (18)F-fluoro-2-glucose-positron emission tomography/computed tomography (FDG-PET/CT) imaging in assessment of response to neoadjuvant chemotherapy (NAC) in breast cancer. |
A total of 10 studies were included. The pooled estimates of sensitivity and specificity across all included studies were 0.71 and 0.77 for FDG-PET/CT (n = 535) and 0.88 and 0.55 for MRI (n = 492), respectively. Studies were subgrouped according to the time of therapy assessment. In the intra-NAC setting, FDG-PET/CT imaging outperformed MRI with fairly similar pooled sensitivity (0.91 vs. 0.89) and higher specificity (0.69 vs. 0.42). However, MRI appeared to have higher diagnostic accuracy than FDG-PET/CT imaging when performed after the completion of NAC, with significantly higher sensitivity (0.88 vs. 0.57). |
Good |
| 134. Schipper RJ, Moossdorff M, Beets-Tan RGH, Smidt ML, Lobbes MBI. Noninvasive nodal restaging in clinically node positive breast cancer patients after neoadjuvant systemic therapy: a systematic review. [Review]. Eur J Radiol. 84(1):41-47, 2015 Jan. |
Review/Other-Dx |
4 studies (572 patients) |
To provide a systematic review of studies comparing the diagnostic performance of noninvasive techniques and axillary lymph node dissection in the identification of initially node positive patients with pathological complete response of axillary lymph nodes to neoadjuvant systemic therapy. |
Of the 987 abstracts that were considered for inclusion, four were eligible for final analysis, which included a total of 572 patients. The diagnostic performance of clinical examination, axillary ultrasound, breast MRI, whole body (18)F-FDG PET-CT, and a prediction model to identify patients with pathological complete response were investigated. Studies were often limited by small sample size. Furthermore, systemic therapy regimens and definitions of clinical and pathological complete response were variable, refraining further pooling of data. The reported positive predictive value of different techniques to identify patients with axillary pathological complete response after neoadjuvant systemic therapy varied between 40% and 100%. |
4 |
| 135. Buchbender C, Kuemmel S, Hoffmann O, et al. FDG-PET/CT for the early prediction of histopathological complete response to neoadjuvant chemotherapy in breast cancer patients: initial results. Acta Radiol. 53(6):628-36, 2012 Jul. |
Observational-Dx |
26 patients |
To retrospectively test if FDG-PET/CT is able to early differentiate between breast cancer lesions with pathological complete response (pCR) and lesions without pathological complete response (npCR) after two cycles of neoadjuvant chemotherapy (NACT). |
Using evaluation algorithm A the DeltaSUVmax was 13.5 (pCR group) and 3.9 (npCR group) (P = 0.006); the DeltaSUVmax(%) was 79% and 47%, respectively (P = 0.001). On ROC analysis an optimal cut-off DeltaSUVmax(%) of 66% was found. Using evaluation algorithm B the DeltaSUVmax was 17.5 (pCR group) and 4.9 (npCR group) (P = 0.013); the DeltaSUVmax(%) was 89% and 51%, respectively (P = 0.003). On ROC analysis an optimal cut-off DeltaSUVmax(%) of 88% was found. |
3 |
| 136. Kolesnikov-Gauthier H, Vanlemmens L, Baranzelli MC, et al. Predictive value of neoadjuvant chemotherapy failure in breast cancer using FDG-PET after the first course. Breast Cancer Res Treat. 131(2):517-25, 2012 Jan. |
Observational-Dx |
63 patients |
To prospectively evaluate the predictive value of (18)F-fluorodeoxyglucose-positron emission tomography (FDG-PET) to detect the absence of pathological response to preoperative chemotherapy in patients (pts) with breast cancer. |
The mean SUV(max) decrease according to histological response was -52 +/- 21% in case of pCR (Sataloff A) and 25 +/- 34% in other cases (Sataloff B + C + D). Out of the 16 pts with no PET response (SUV decrease less than 15%), only one had a clinical response after the third cycle, and no pCR was observed. The 4-year RFS rate was significantly longer for metabolic responders than for NR (respectively, 85 vs. 44%; P = 0.01). |
3 |
| 137. Kim SY, Cho N, Park IA, et al. Dynamic Contrast-enhanced Breast MRI for Evaluating Residual Tumor Size after Neoadjuvant Chemotherapy. Radiology. 289(2):327-334, 2018 11. |
Observational-Dx |
487 patients |
To investigate the accuracy of dynamic contrast material-enhanced (DCE) breast MRI for determining residual tumor size after neoadjuvant chemotherapy (NAC). |
Compared with tumor size at histopathologic examination, total tumor sizes showed higher agreement at conventional delayed-phase MRI than at early-phase MRI (ICC, 0.76 vs 0.56; P < .001) and comparable agreement at conventional and late delayed-phase MRI (ICC, 0.76 vs 0.74; P = .55). Lobular histologic features and tumor subtype were independently associated with greater size discrepancy (P < .001). Lobular cancers were underestimated in size compared with ductal cancers (mean size discrepancy, -2.8 cm +/- 3.2 vs -0.3 cm +/- 1.8; P = .004). Estrogen receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative cancers were underestimated compared with HER2-positive cancers (-0.8 cm +/- 2.0 vs -0.3 cm +/- 1.7, P = .006) and triple-negative cancers (-0.8 cm +/- 2.0 vs 0.3 cm +/- 1.7, P < .001). |
2 |
| 138. Banys-Paluchowski M, Gruber IV, Hartkopf A, et al. Axillary ultrasound for prediction of response to neoadjuvant therapy in the context of surgical strategies to axillary dissection in primary breast cancer: a systematic review of the current literature. Arch Gynecol Obstet. 301(2):341-353, 2020 02. |
Review/Other-Dx |
N/A |
To perform a systematic review of clinical studies on the use of axillary ultrasound for prediction of response to NAT and ultrasound-guided marking of metastatic nodes for targeted axillary dissection. |
The sensitivity of ultrasound for prediction of residual node metastasis was higher than that of clinical examination and MRI/PET in most studies; specificity ranged in large trials from 37 to 92%. The diagnostic performance of ultrasound after NAT seems to be associated with tumor subtype: the positive predictive value was highest in luminal, the negative in triple-negative tumors. Several trials evaluated the usefulness of ultrasound for targeted axillary dissection. Before NAT, nodes were most commonly marked using ultrasound-guided clip placement, followed by ultrasound-guided placement of a radioactive seed. After chemotherapy, the clip was detected on ultrasound in 72-83% of patients; a comparison of sonographic visibility of different clips is lacking. Detection rate after radioactive seed placement was ca. 97%. |
4 |
| 139. Peppe A, Wilson R, Pope R, Downey K, Rusby J. The use of ultrasound in the clinical re-staging of the axilla after neoadjuvant chemotherapy (NACT). BREAST. 35:104-108, 2017 Oct. |
Observational-Dx |
308 patients |
To evaluate the diagnostic accuracy of aUS post NACT in women who were proven node positive at diagnosis since this change in practice. |
The sensitivity and specificity of aUS was 71% and 88% respectively. The negative predictive value (NPV) was 83%. The false negative rate was 29%. |
3 |
| 140. Helfgott R, Mittlbock M, Miesbauer M, et al. The influence of breast cancer subtypes on axillary ultrasound accuracy: A retrospective single center analysis of 583 women. Eur J Surg Oncol. 45(4):538-543, 2019 04. |
Review/Other-Dx |
583 women |
To determine if unknown biological subtypes influence axillary staging using ultrasound (AUS). |
583 women were included in the study. Sensitivity, Specificity, positive and negative predictive value for AUS were 39%, 96%, 91% and 83%. While sensitivity was significantly lower in Luminal A and B patients (25.0%; 39.8%) as compared to non Luminal breast cancer patients (TN 68.8%; Her2+ 71.4%; p = 0.0032), there were no significant differences between the groups with respect to specificity, PPV and NPV. |
4 |
| 141. Stein RG, Wollschlager D, Kreienberg R, et al. The impact of breast cancer biological subtyping on tumor size assessment by ultrasound and mammography - a retrospective multicenter cohort study of 6543 primary breast cancer patients. BMC Cancer. 16:459, 2016 07 13. |
Observational-Dx |
6543 patients |
To assess the accuracy of tumor size measurement by ultrasound and mammography in a multicentered health services research study. |
Overall, the correlation with histology was 0.61 for mammography and 0.60 for ultrasound. Both correlations were higher in pT2 cancers than in pT1 and pT3. Ultrasound as well as mammography revealed a significantly higher correlation with histology in invasive ductal compared to lobular cancers (p < 0.01). For invasive lobular cancers, the mammography showed better correlation with histology than ultrasound (p = 0.01), whereas there was no such advantage for invasive ductal cancers. Ultrasound was significantly superior for HR negative cancers (p < 0.001). HER2/neu positive cancers were also more precisely assessed by ultrasound (p < 0.001). The size of HER2/neu negative cancers could be more accurately predicted by mammography (p < 0.001). |
3 |
| 142. Nwaogu IY, Yan Y, Appleton CM, Cyr AE, Margenthaler JA. Predictors of false negative axillary ultrasound in breast cancer. J Surg Res. 198(2):351-4, 2015 Oct. |
Observational-Dx |
118 women |
To identify clinicopathologic factors related to false negative axillary ultrasound (AUS) results. |
Of the 118 patients with a normal AUS, 25 (21%) were ultimately found to be node-positive on pathologic assessment after axillary surgery. On bivariate analysis, primary tumor size and lymphovascular invasion (LVI) were found to be significantly different between true- and false-negative AUS. The average tumor size was smaller in the true-negative group compared with that in the false-negative group (16 versus 21 mm [P < 0.01]). The presence of LVI was more likely in the false-negative group (44%) compared with that in the true-negative group (8%, P < 0.0001). No significant difference was noted between groups with regard to patient age, race, body mass index, tumor grade, histologic type, hormone receptor status, and time between AUS and axillary surgery. On multivariate analysis, only the presence of LVI achieved statistical significance (P = 0.0007). |
4 |
| 143. Hieken TJ, Boughey JC, Jones KN, Shah SS, Glazebrook KN. Imaging response and residual metastatic axillary lymph node disease after neoadjuvant chemotherapy for primary breast cancer. Ann Surg Oncol. 20(10):3199-204, 2013 Oct. |
Observational-Dx |
272 patients |
To evaluate post-NAC axillary imaging and surgical pathology to understand how imaging might direct axillary surgery. |
Pre-NAC axillary staging classified patients as AUS negative/no FNA (n = 61), FNA/LN negative (n = 42), and FNA/LN positive (n = 169). Post-NAC axillary imaging included AUS (n = 146), MRI (n = 139), and PET-CT (n = 38). At operation, 128 of 272 patients (47 %) were LN positive: 23.3 % (24 of 103) of cN0 and 61.5 % (104 of 169) of cN1-AUS/FNA-positive patients at presentation. Of the 65 cN1-ypN0 patients, 58.1 % (25 of 43) had an imaging CR by US, 58.6 % (17 of 29) by MRI, and 84.6 % (11 of 13) by PET-CT. The sensitivity of post-NAC axillary imaging in detecting persistent LN metastases for cN1-AUS/FNA-positive patients was 69.8 % for US, 61.0 % for MRI, and 63.2 % for PET-CT. |
3 |
| 144. McGale P, Taylor C, Correa C, et al. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014;383(9935):2127-2135. |
Meta-analysis |
8,135 patients; 22 trials |
To assess the effect of radiotherapy in these women after mastectomy and axillary dissection. |
3786 women had axillary dissection to at least level II and had zero, one to three, or four or more positive nodes. All were in trials in which radiotherapy included the chest wall, supraclavicular or axillary fossa (or both), and internal mammary chain. For 700 women with axillary dissection and no positive nodes, radiotherapy had no significant effect on locoregional recurrence (two-sided significance level [2p]>0.1), overall recurrence (rate ratio [RR], irradiated vs not, 1.06, 95% CI 0.76-1.48, 2p>0.1), or breast cancer mortality (RR 1.18, 95% CI 0.89-1.55, 2p>0.1). For 1314 women with axillary dissection and one to three positive nodes, radiotherapy reduced locoregional recurrence (2p<0.00001), overall recurrence (RR 0.68, 95% CI 0.57-0.82, 2p=0.00006), and breast cancer mortality (RR 0.80, 95% CI 0.67-0.95, 2p=0.01). 1133 of these 1314 women were in trials in which systemic therapy (cyclophosphamide, methotrexate, and fluorouracil, or tamoxifen) was given in both trial groups and, for them, radiotherapy again reduced locoregional recurrence (2p<0.00001), overall recurrence (RR 0.67, 95% CI 0.55-0.82, 2p=0.00009), and breast cancer mortality (RR 0.78, 95% CI 0.64-0.94, 2p=0.01). For 1772 women with axillary dissection and four or more positive nodes, radiotherapy reduced locoregional recurrence (2p<0.00001), overall recurrence (RR 0.79, 95% CI 0.69-0.90, 2p=0.0003), and breast cancer mortality (RR 0.87, 95% CI 0.77-0.99, 2p=0.04). |
Good |
| 145. Nielsen HM, Overgaard M, Grau C, Jensen AR, Overgaard J. Study of failure pattern among high-risk breast cancer patients with or without postmastectomy radiotherapy in addition to adjuvant systemic therapy: long-term results from the Danish Breast Cancer Cooperative Group DBCG 82 b and c randomized studies. J Clin Oncol 2006;24:2268-75. |
Experimental-Tx |
3,083 patients |
To examine the overall disease recurrence pattern among patients randomly assigned to receive treatment with or without RT. |
The 18-year probability of any first breast cancer event was 73% and 59% (P < .001) after no RT and RT, respectively (relative risk [RR], 0.68; 95% CI, 0.63 to 0.75). The 18-year probability of LRR (with or without DM) was 49% and 14% (P < .001) after no RT and RT, respectively (RR, 0.23; 95% CI, 0.19 to 0.27). The 18-year probability of DM subsequent to LRR was 35% and 6% (P < .001) after no RT and RT, respectively (RR, 0.15; 95% CI, 0.11 to 0.20), whereas the probability of any DM was 64% and 53% (P < .001) after no RT versus RT, respectively (RR, 0.78; 95% CI, 0.71 to 0.86). |
1 |
| 146. Wakeam E, Acuna SA, Keshavjee S. Chest Wall Resection for Recurrent Breast Cancer in the Modern Era: A Systematic Review and Meta-analysis. Ann Surg 2018;267:646-55. |
Meta-analysis |
1305 patients (48 retrospective studies) |
To review the literature on chest wall resection for recurrent breast cancer and evaluate overall survival (OS) and quality-of-life (QOL) outcomes. |
Studies consistently reported excellent OS and DFS in properly selected patients. Pooled estimates for 5-year OS in all studies and those from the past 15 years were 40.8% [95% confidence interval (CI) 35.2-46.7) and 43.1% (95% CI 35.8-50.7), whereas pooled 5-year DFS was 27.1% (95% CI 16.6-41.0). Eight studies reported excellent outcomes related to QOL. Mortality was consistently low (<1%) and 30-day pooled morbidity was 20.2% (95% CI 15.3%-26.3%). Study quality varied, and risk of selection bias in included studies was high. |
Inadequate |
| 147. Bouganim N, Tsvetkova E, Clemons M, Amir E. Evolution of sites of recurrence after early breast cancer over the last 20 years: implications for patient care and future research. Breast Cancer Res Treat 2013;139:603-6. |
Meta-analysis |
86,598 patients (53 RCTs) |
To explore changes in the distribution of loco-regional and distant recurrences in clinical trials reported over the last 20 years. To determine the relative impact of adjuvant chemotherapy and endocrine therapy. |
Fifty-three randomized clinical trials with a total of 86,598 patients were included in the analysis. Between 1990 and 2011, the proportion of loco-regional recurrences has decreased from approximately 30 to 15 % (Spearman's ? = -0.40, p < 0.001). There was no interaction between type of surgery (mastectomy vs. lumpectomy), administration of adjuvant radiation therapy and menopausal status and the correlation of loco-regional recurrences and time. Chemotherapy regimen showed a larger negative correlation compared with endocrine therapy ( ? = 0.49 vs. ? = 0.24). Advances in treatment of early breast cancer have differentially reduced the proportion of loco-regional recurrences compared with distant recurrences. In recent trials, loco-regional recurrences account for less than 10-15 % of all recurrences. These falling event rates may affect patient care, especially when deciding on treatments influencing loco-regional control. This change may also impact on the design of clinical trials assessing loco-regional therapy such as surgery and/or local radiation therapy. |
Inadequate |
| 148. Spronk I, Schellevis FG, Burgers JS, de Bock GH, Korevaar JC. Incidence of isolated local breast cancer recurrence and contralateral breast cancer: A systematic review. Breast 2018;39:70-79. |
Review/Other-Dx |
20 articles |
To perform a systematic literature review of the incidence of isolated IBTR and CBC in women diagnosed with early invasive breast cancer. |
Both isolated IBTR and CBC incidence rates steadily increased with the length of follow-up, indicating that IBTR and CBC occur even more than 15 years after diagnosis. The annual incidence rate of isolated IBTR and CBC in women diagnosed with an early invasive breast cancer was 0.6% (range: 0.4-1.1%) and 0.5% (range: 0.2-0.7%), respectively. Analyzed data were lacking information about important risk factors and given treatment with regard to the incidence of recurrence, which hampers the prediction of patient tailored recurrence risks. The presented rates are therefore the best available estimates of isolated IBTR and CBC annual incidence rates based on the current literature. Healthcare professionals could use these rates in their communication with patients diagnosed with early invasive breast cancer. |
4 |
| 149. Pan H, Gray R, Braybrooke J, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. N Engl J Med 2017;377:1836-46. |
Meta-analysis |
62,923 women with ER-positive breast cancer (88 trials) |
To report the influence of various characteristics of the original tumor on the 20-year incidence of breast-cancer outcomes in women with ER-positive, early-stage breast cancer who were scheduled to receive adjuvant endocrine therapy for 5 years and then to stop therapy. |
Breast-cancer recurrences occurred at a steady rate throughout the study period from 5 to 20 years. The risk of distant recurrence was strongly correlated with the original TN status. Among the patients with stage T1 disease, the risk of distant recurrence was 13% with no nodal involvement (T1N0), 20% with one to three nodes involved (T1N1–3), and 34% with four to nine nodes involved (T1N4–9); among those with stage T2 disease, the risks were 19% with T2N0, 26% with T2N1–3, and 41% with T2N4–9. The risk of death from breast cancer was similarly dependent on TN status, but the risk of contralateral breast cancer was not. Given the TN status, the factors of tumor grade (available in 43,590 patients) and Ki-67 status (available in 7692 patients), which are strongly correlated with each other, were of only moderate independent predictive value for distant recurrence, but the status regarding the progesterone receptor (in 54,115 patients) and human epidermal growth factor receptor type 2 (HER2) (in 15,418 patients in trials with no use of trastuzumab) was not predictive. During the study period from 5 to 20 years, the absolute risk of distant recurrence among patients with T1N0 breast cancer was 10% for low-grade disease, 13% for moderate-grade disease, and 17% for high-grade disease; the corresponding risks of any recurrence or a contralateral breast cancer were 17%, 22%, and 26%, respectively. |
Inadequate |
| 150. Stuart-Harris R, Dahlstrom JE, Gupta R, Zhang Y, Craft P, Shadbolt B. Recurrence in early breast cancer: Analysis of data from 3,765 Australian women treated between 1997 and 2015. BREAST. 44:153-159, 2019 Apr. |
Observational-Dx |
3,765 women |
To analyse recurrence in women with EBC from our region from 1997 to 2015. |
Recurrence occurred in 459 (12.2%), predominantly in distant sites (71.7%). In women entered from 2002 onwards, the five and 10 year recurrence rates were significantly lower in the luminal group than the HER2+ and the TN groups. Few recurrences occurred in HER2+ and TN cancers after 36 months. On multivariate analysis the following were associated with a significantly increased risk of recurrence: nodal involvement (p < 0.0001), tumour grade (p < 0.0001), symptomatic presentation (p < 0.0001), presence of LVI (p = 0.001), non-luminal tumour type (p < 0.0001) and tumour size >50 mm (p = 0.02). |
4 |
| 151. Wapnir IL, Price KN, Anderson SJ, et al. Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol 2018;36:1073-79. |
Experimental-Tx |
162 patients |
To investigate the effectiveness of chemotherapy (CT) after local therapy for ILRR. |
From August 2003 to January 2010, 162 patients were enrolled: 58 with ER-negative and 104 withER-positive ILRR. At 9 years of median follow-up, 27 DFS events were observed in the ER-negativegroup and 40 in the ER-positive group. The hazard ratios (HR) of a DFS event were 0.29 (95% CI, 0.13to 0.67; 10-year DFS, 70% v 34%, CT v no CT, respectively) in patients with ER-negative ILRR and1.07 (95% CI, 0.57 to 2.00; 10-year DFS, 50% v 59%, respectively) in patients with ER-positive ILRR(Pinteraction = .013). HRs were 0.29 (95% CI, 0.13 to 0.67) and 0.94 (95% CI, 0.47 to 1.85), respectively,for breast cancer-free interval (Pinteraction = .034) and 0.48 (95% CI, 0.19 to 1.20) and 0.70(95% CI, 0.32 to 1.55), respectively, for overall survival (Pinteraction = .53). Results for the three endpoints were consistent in |
1 |
| 152. Park S, Koo JS, Kim MS, et al. Characteristics and outcomes according to molecular subtypes of breast cancer as classified by a panel of four biomarkers using immunohistochemistry. Breast 2012;21:50-7. |
Observational-Dx |
1006 patients |
To investigate the significance of immunohistochemical molecular subtyping, we evaluated outcomes of subtypes based on estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and Ki-67. |
Using tissue microarrays, 1006 breast cancer patients between November 1999 and August 2005 were categorized into four subtypes: luminal A (ERþ and/or PRþ, HER2-, Ki-67 < 14%), luminal B (ERþ and/or PRþ, HER2-, Ki-67 < 14% or ERþ and/or PRþ, HER2þ), HER2-enriched (ER-, PR-, HER2þ), and triple-negative breast cancer (TNBC) (ER-, PR-, HER2-). Demographics, recurrence patterns, and survival were retrospectively analyzed using uni-/multivariate analyses. Luminal A, luminal B, HER2-enriched, and TNBC accounted for 53.1%, 21.7%, 9.0%, and 16.2% of cases, respectively. Luminal A presented well-differentiation and more co-expression of hormone receptors comparing to luminal B. HER2-enriched showed larger size and higher nodal metastasis. TNBC demonstrated younger age atdiagnosis, larger size, undifferentiation, higher proliferation, and frequent visceral metastases. The peak of recurrence for luminal A was at 36 months postoperatively, while that for HER2-enriched and TNBC peaked at 12 months. The relapse risk of luminal B was mixed. Luminal A showed the best survival, butno difference was observed between the other three subtypes. When matched by nodal status, however, TNBC showed the worst outcomes in node-positive patients. |
4 |
| 153. Clarke M, Collins R, Darby S, et al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;366(9503):2087-2106. |
Meta-analysis |
42,000 patients in 78 randomized studies |
To determine the variations in local treatment that affects the risk of LRR through a meta-analysis of previous studies. |
About three-quarters of the eventual LR risk occurred during the first 5-years. In the comparisons that involved little (<10%) difference in 5-year LR risk there was little difference in 15-year breast cancer mortality. Among the 25,000 women in the comparisons that involved substantial (>10%) differences, however, 5-year LR risks were 7% active vs 26% control (absolute reduction 19%), and 15-year breast cancer mortality risks were 44.6% vs 49.5%. Improved local control may lead to decrease in breast cancer-specific mortality. Avoidance of a LR in a conserved breast (after BCT and radiation) and avoidance of a LR elsewhere (ie, the chest wall or regional nodes) after mastectomy are of comparable relevance to 15 year breast cancer mortality. |
Good |
| 154. Thill M, Jackisch C, Janni W, et al. AGO Recommendations for the Diagnosis and Treatment of Patients with Locally Advanced and Metastatic Breast Cancer: Update 2019. Breast Care (Basel) 2019;14:247-55. |
Review/Other-Dx |
N/A |
No abstract available. |
No abstract available. |
4 |
| 155. Xiao Y, Wang L, Jiang X, She W, He L, Hu G. Diagnostic efficacy of 18F-FDG-PET or PET/CT in breast cancer with suspected recurrence: a systematic review and meta-analysis. [Review]. Nucl Med Commun. 37(11):1180-8, 2016 Nov. |
Meta-analysis |
26 studies and 1752 patients |
To evaluate the overall diagnostic accuracy of fluorine-18 fluorodeoxyglucose (F-FDG)-PET or PET/computed tomography (CT) for the detection of relapse in suspected recurrent breast cancer. |
A total of 26 studies with 1752 patients with suspiciously recurrent breast cancer were included for the analysis; among these, 56.8% because of elevation of tumor markers, in 33.9%, there was suspicion on conventional imaging modalities, and in 9.4%, suggestive clinical symptoms or physical examinations were found. The pooled sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio of F-FDG-PET or PET/CT were 0.90 [95% confidence interval (CI), 0.88-0.90], 0.81 (95% CI, 0.78-0.84), 4.64 (95% CI, 3.50-6.14), 0.12 (95% CI, 0.08-0.16), and 46.52 (95% CI, 29.44-73.51), respectively. In addition, the overall AUC of F-FDG-PET or PET/CT was 0.9358. Meta-regression analysis showed that type of imaging modality (PET over PET/CT) might be a potential source of heterogeneity (P=0.0799). Furthermore, a subgroup analysis indicated that PET/CT appeared to harbor more specificity in the diagnosis of recurrent breast cancer (0.823 vs. 0.796, P=0.035). The increased AUC suggested increased accuracy of PET/CT over PET (0.9477 vs. 0.9111). |
Good |
| 156. Lehman CD, Lee JM, DeMartini WB, et al. Screening MRI in Women With a Personal History of Breast Cancer. Journal of the National Cancer Institute. 108(3), 2016 Mar. |
Observational-Dx |
1521 women |
To compare screening MRI performance in women with personal history versus genetic risk or family history of breast cancer. |
Of 1521 women who underwent screening MRI from July 2004 to November 2011, 915 had PH and 606 had GFH of breast cancer. Overall, MRI sensitivity was 79.4% for all cancers and 88.5% for invasive cancers. False-positive exams were lower in the PH vs GFH groups (12.3% vs 21.6%, P < .001), specificity was higher (94.0% vs 86.0%, P < .001), and sensitivity and cancer detection rate were not statistically different (P > .99). Age (P < .001), prior MRI (P < .001), and clinical indication (P < .001) were individually associated with initial false-positive rate; age and prior MRI remained statistically significant in multivariable modeling (P = .001 and P < .001, respectively). |
3 |
| 157. Wernli KJ, Ichikawa L, Kerlikowske K, et al. Surveillance Breast MRI and Mammography: Comparison in Women with a Personal History of Breast Cancer. Radiology. 292(2):311-318, 2019 08. |
Review/Other-Dx |
13,266 women |
To compare performance of surveillance mammography with breast MRI. |
Breast MRI was associated with younger age at diagnosis, chemotherapy, and higher education and income. Raw performance measures for breast MRI versus mammography were as follows, respectively: cancer detection rates, 10.8 (95% confidence interval [CI]: 6.7, 14.8) versus 8.2 (95% CI: 7.3, 9.2) per 1000 examinations; sensitivity, 61.4% (27 of 44; 95% CI: 46.5%, 76.2%) versus 70.3% (279 of 397; 95% CI: 65.8%, 74.8%); and biopsy rate, 10.1% (253 of 2506; 95% CI: 8.9%, 11.3%) versus 4.0% (1343 of 33 938; 95% CI: 3.7%, 4.2%). In multivariable models, breast MRI was associated with higher biopsy rate (odds ratio [OR], 2.2; 95% CI: 1.9, 2.7; P < .001) and cancer detection rate (OR, 1.7; 95% CI: 1.1, 2.7; P = .03) than mammography alone. However, there were no differences in sensitivity (OR, 1.1; 95% CI: 0.4, 2.9; P = .84) or interval cancer rate (OR, 1.1; 95% CI: 0.6, 2.2; P = .70). |
4 |
| 158. Choi EJ, Choi H, Choi SA, Youk JH. Dynamic contrast-enhanced breast magnetic resonance imaging for the prediction of early and late recurrences in breast cancer. Medicine (Baltimore). 95(48):e5330, 2016 Nov. |
Observational-Dx |
83 recurrent breast cancer patients |
To evaluate dynamic contrast-enhanced breast magnetic resonance imaging (DCE-MRI) features for the prediction of early and late recurrences in patients with breast cancer. |
On breast MRI, prominent ipsilateral whole-breast vascularity was independently associated with early recurrence (hazard ratio [HR], 2.86; 95% confidence intervals [CI], 1.39–5.88) and moderate or marked BPE (HR, 2.08; 95% CI, 1.04–4.18) and rim enhancement (HR, 2.14; 95% CI, 1.00–4.59) were independently associated with late recurrence. Clinico-pathologic variables independently associated with early recurrence included negative estrogen receptor (HR, 0.53; 95% CI, 0.29–0.96), whereas T2 stage (HR, 2.08; 95% CI, 1.04–4.16) and nuclear grade III (HR, 2.54; 95% CI, 1.29–4.98) were associated with late recurrence. |
3 |
| 159. Kolb TM, Lichy J, Newhouse JH. Comparison of the performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology. 225(1):165-75, 2002 Oct. |
Observational-Dx |
221 women |
To (a) determine the performance of screening mammography, ultrasonography (US), and physical examination (PE); (b) analyze the influence of age, hormonal status, and breast density; (c) compare the size and stage of tumors detected with each modality; and (d) determine which modality or combination of modalities optimize cancer detection. |
In 221 women, 246 cancers were found. Sensitivity, specificity, negative and positive predictive values, and accuracy of mammography were 77.6%, 98.8%, 99.8%, 35.8%, and 98.6%, respectively; those of PE, 27.6%, 99.4%, 99.4%, 28.9%, and 98.8%, respectively; and those of US, 75.3%, 96.8%, 99.7%, 20.5%, and 96.6%, respectively. Screening breast US increased the number of women diagnosed with nonpalpable invasive cancers by 42% (30 of 71). Mammographic sensitivity declined significantly with increasing breast density (P <.01) (48% for the densest breasts) and in younger women with dense breasts (P =.02); the effects were independent. Mammography and US together had significantly higher sensitivity (97%) than did mammography and PE together (74%) (P <.001). Tumors detected at mammography and/or US were significantly smaller (P =.01) and of lower stage (P =.01) than those detected at PE. |
4 |
| 160. Berg WA, Zhang Z, Lehrer D, et al. Detection of breast cancer with addition of annual screening ultrasound or a single screening MRI to mammography in women with elevated breast cancer risk. JAMA. 307(13):1394-404, 2012 Apr 04. |
Observational-Dx |
2,662 women |
To determine supplemental cancer detection yield of ultrasound and MRI in women at elevated risk for breast cancer. |
The 2662 patients underwent 7473 mammograms and US, with 110 women having 111 breast cancers detected, of which 33 were detected on mammography only, 32 on US only, 26 on both mammography and US, and 9 on MRI after mammography and US. Eleven were not detected by any imaging modality. Supplemental incidence-screening US identified 3.7 cancers per 1000 women-screens (95% CI 2.1 to 5.8, p<.001). Sensitivity, specificity, and PPV3 for M +US were 57/75 (0.76, 95% CI 0.65 to 0.85), 3987/4739 (0.84, 95% CI 0.83 to 0.85), and 55/339 (0.16, 95% CI 0.12 to 0.21); and for mammography alone 39/75 (0.52, 95% CI 0.40 to 0.64), 4325/4739 (0.91,95% 0.90 to 0.92), and 37/97 (0.38, 95% CI 0.28 to 0.49) (p<.001 all comparisons). Of 612 analyzable MRI participants, 16 (2.6%) had breast cancer diagnosed. Supplemental yield of MRI was 14.7 per 1000 (95% CI 3.5 to 25.9, p=.004). Sensitivity, specificity, and PPV3 for MRI+M+US were 16/16 (1.00, 95% CI 0.79 to 1.00), 390/596 (0.65, 95% CI 0.61 to 0.69), and 15/81 (0.19, 95% CI 0.11 to 0.29); and for M+US 7/16 (0.44, 95% CI 0.20 to 0.70, p=.004), 503/596 (0.84, 95% CI 0.81 to 0.87, p <.001), and 7/38 (0.18, 95% CI 0.08 to 0.34, p= .98) for M+US. Number of screens needed to detect one cancer was 127(95%CI 99 to 167) for mammography; 234(95%CI 173 to 345) for supplemental ultrasound, and 68 (95%CI 39 to 286) for MRI after negative M+US. |
1 |
| 161. Dibble EH, Lourenco AP, Baird GL, Ward RC, Maynard AS, Mainiero MB. Comparison of digital mammography and digital breast tomosynthesis in the detection of architectural distortion. European Radiology. 28(1):3-10, 2018 Jan. |
Observational-Dx |
1888 observations |
To compare interobserver variability (IOV), reader confidence, and sensitivity/specificity in detecting architectural distortion (AD) on digital mammography (DM) versus digital breast tomosynthesis (DBT). |
There were 59 AD patients and 59 controls for 1,888 observations (59 x 2 (cases and controls) x 2 breasts x 2 imaging techniques x 4 readers). For all readers, agreement improved with DBT versus DM (0.61 vs. 0.37). Confidence was higher with DBT, p = .001. DBT achieved higher sensitivity (.59 vs. .32), p < .001; specificity remained high (>.90). DBT achieved higher positive likelihood ratio values, smaller negative likelihood ratio values, and larger ROC values. |
2 |
| 162. Valente SA, Levine GM, Silverstein MJ, et al. Accuracy of predicting axillary lymph node positivity by physical examination, mammography, ultrasonography, and magnetic resonance imaging. Ann Surg Oncol. 19(6):1825-30, 2012 Jun. |
Observational-Dx |
244 women |
To accurately predict axillary nodal involvement by using physical examination and standard breast imaging studies in combination. |
A total of 62 (25%) of 244 women were found to have positive axillary lymph nodes on final histopathologic examination, 42% of whom were able to be identified preoperatively. The sensitivity for predicting axillary metastasis if any one or more examination modalities were suspicious was 56.5%. The specificity for predicting axillary metastasis if any three or more modalities were suspicious was 100%. Of the patients who had all four modalities negative, 14% were ultimately found to have histologically positive nodes at the time of surgery. |
3 |
| 163. Ciatto S, Brancato B, Risso G, et al. Accuracy of fine needle aspiration cytology (FNAC) of axillary lymph nodes as a triage test in breast cancer staging. Breast Cancer Res Treat 2007;103:85-91. |
Observational-Dx |
491 biopsies |
To evaluate the accuracy of ultrasound-guided axillary FNAC in all consecutive clinically T1-2 N0-1 breast cancers that had undergone this test (491 biopsies) |
Sensitivity of node FNAC was 72.6% (67.3-77.9) and specificity was 95.7% (92.5-98.8) for all cases, sensitivity was lower at 64.6% (59.3-70.0) if inadequate cytology was included as a negative result. FNAC sensitivity was highest in women with clinically suspicious nodes [92.5% (88.2-96.7)] and lowest in women with sonographically abnormal and clinically negative nodes [50.0% (41.3-58.7)]. Specificity was high in both groups, 81.2% (54.5-96.0) and 97.2% (94.6-99.9), respectively. The false-negative rate was 15.3% (12.1-18.5), the false-positive rate was 1.4% (0.4-2.5), and the inadequacy rate was 10.8% (8.0-13.5). The likelihood of node FNAC being positive was significantly associated with tumour grade and stage, and the number of nodes involved with metastases. |
2 |
| 164. Deurloo EE, Tanis PJ, Gilhuijs KG, et al. Reduction in the number of sentinel lymph node procedures by preoperative ultrasonography of the axilla in breast cancer. Eur J Cancer 2003;39:1068-73. |
Observational-Dx |
268 axillae |
To investigate whether preoperative axillary ultrasonography and fine-needle aspiration cytology (FNA) can reduce the number of the more time-consuming SLNPs, and to identify a subset of quantitative nodal features to predict metastatic involvement. 268 axillae were ultrasonographically examined. |
In 93 axillae (35%), at least one node was detected with ultrasound. FNA was performed once per axilla on 66 nodes; 37 (56%) contained tumour cells. 31% of all tumour-positive axillae (macro-+micrometastases) was found by ultrasound and FNA (37/121). 41% of all axillae containing macrometastases was found by ultrasound and FNA (36/87). SLNPs were reduced by 14% (37/268). |
3 |
| 165. Sapino A, Cassoni P, Zanon E, et al. Ultrasonographically-guided fine-needle aspiration of axillary lymph nodes: role in breast cancer management. Br J Cancer 2003;88:702-6. |
Observational-Dx |
298 patients |
To evaluate the impact of fine-needle aspiration cytology (FNAC) of ultrasonographically (US) selected axillary LN in the diagnosis of LN metastases and subsequently in the treatment of patients with breast cancer. |
Eighty-five FNAC were informative (49 LN were positive for metastases, 36 were negative). In 49 of 267 patients with invasive breast carcinoma (18%), a preoperative diagnosis of metastatic LN in the axilla could be confirmed. These patients could proceed directly to axillary dissection. In addition, US-guided FNAC presurgically scored 49 out of 88 (55%) metastatic LN. Of all others, with nonsuspicious LN on US (203 cases including 31 DCIS), in which no FNAC examination was performed, 28 invasive carcinomas (16%) turned out to be LN positive on histological examination. |
3 |
| 166. American College of Radiology. ACR Appropriateness Criteria® Radiation Dose Assessment Introduction. Available at: https://www.acr.org/-/media/ACR/Files/Appropriateness-Criteria/RadiationDoseAssessmentIntro.pdf. |
Review/Other-Dx |
N/A |
To provide evidence-based guidelines on exposure of patients to ionizing radiation. |
No abstract available. |
4 |
