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Appropriateness Criteria

Reference Study Type Patients/Events Study Objective(Purpose of Study) Study Results Study Quality
1. Brown GR, Jones KT. Incidence of breast cancer in a cohort of 5,135 transgender veterans. Breast Cancer Res Treat. 149(1):191-8, 2015 Jan. Observational-Dx 5,135 transgender veterans To examine the incidence of breast cancer in the largest North American sample of transgender (TG) patients studied to date to determine their exposure to cross-sex hormone (CSH), incidence of breast cancer, and to compare results with European studies in transsexual populations. Age-standardized incidences of breast cancer from the general population were used for comparison. Person-years of exposure to known cross-sex hormone (CSH) treatment were calculated. Ten breast cancer cases were confirmed. Seven were in female-to-male patients, two in male to-female patients, and one in a natal male with transvestic fetishism. Average age at diagnosis was 63.8 (SD = 8.2). 52 % received [1 dose of CSH treatment from Veterans Health Administration (VHA) clinicians. All three males presented with late-stage disease were proved fatal. The overall incidence rate was 20.0/100,000 patient-years of VHA treatment (95 % CI 9.6–36.8), irrespective of VA CSH treatment. This rate did not differ from the expected rate in an age-standardized national sample, but exceeded that reported for smaller European studies of transsexual patients that were longer in duration. 4
2. de Blok CJM, Wiepjes CM, Nota NM, et al. Breast cancer risk in transgender people receiving hormone treatment: nationwide cohort study in the Netherlands. BMJ. 365:l1652, 2019 05 14. Observational-Dx 2260 adult trans women / 1229 adult trans men To investigate the incidence and characteristics of breast cancer in transgender people in the Netherlands compared with the general Dutch population. The total person time in this cohort was 33,991 years for trans women and 14,883 years for trans men. In the 2260 trans women in the cohort, 15 cases of invasive breast cancer were identified (median duration of hormone treatment 18 years, range 7-37 years). This was 46-fold higher than in cisgender men (standardised incidence ratio 46.7, 95% confidence interval 27.2 to 75.4) but lower than in cisgender women (0.3, 0.2 to 0.4). Most tumours were of ductal origin and oestrogen and progesterone receptor positive, and 8.3% were human epidermal growth factor 2 (HER2) positive. In 1229 trans men, four cases of invasive breast cancer were identified (median duration of hormone treatment 15 years, range 2-17 years). This was lower than expected compared with cisgender women (standardised incidence ratio 0.2, 95% confidence interval 0.1 to 0.5). 4
3. Gooren LJ, van Trotsenburg MA, Giltay EJ, van Diest PJ. Breast cancer development in transsexual subjects receiving cross-sex hormone treatment. J Sex Med. 10(12):3129-34, 2013 Dec. Observational-Dx 2,307 male-to-female / 795 female-to-male transsexual persons To examine the occurrence of breast cancer in a large cohort of Dutch male and female transsexual persons, also evaluating whether the epidemiology accords with the natal sex or the new sex. Among MtF individuals one case was encountered, as well as a probable but not proven second case. The estimated rate of 4.1 per 100,000 person-years (95% confidence interval [CI]: 0.8-13.0) was lower than expected if these two cases are regarded as female breast cancer, but within expectations if viewed as male breast cancer. In FtM subjects, who were younger and had shorter exposure to cross-sex hormones compared with the MtF group, one breast cancer case occurred. This translated into a rate of 5.9 per 100,000 person-years (95% CI: 0.5-27.4), again lower than expected for female breast cancer but within expected norms for male breast cancer. 4
4. Maglione KD, Margolies L, Jaffer S, et al. Breast cancer in male-to-female transsexuals: use of breast imaging for detection. AJR Am J Roentgenol. 203(6):W735-40, 2014 Dec. Review/Other-Dx 10 To describe two cases of breast cancer in male-to-female transsexuals and to review eight cases previously reported in the literature. No results provided. 4
5. Stone JP, Hartley RL, Temple-Oberle C. Breast cancer in transgender patients: A systematic review. Part 2: Female to Male. [Review]. Eur J Surg Oncol. 44(10):1463-1468, 2018 10. Review/Other-Dx 8 articles To perform a systematic review of the literature and document all reported cases of FtM breast cancer as well as provide research recommendations. Eight articles met inclusion criteria representing 17 transgender men with breast cancer. Median age at diagnosis was 44.5 years. Breast cancer types included: 8 invasive ductal carcinomas, two tubular carcinomas and seven unrecorded. Twelve of the 14 known hormone status tumours were estrogen receptor positive (85.7%), of which nine were also progesterone positive. The most common was breast lump (n = 6) and four patients had local regional or distant disease at presentation. Management was reported for ten patients: six patients underwent mastectomy (60.0%), three radiation (30.0%), and five chemotherapy (50.0%). Breast cancer is present in transgender men and the risk is dependent on top surgery; those with top surgery appear to be lower risk than natal females. 4
6. Joint R, Chen ZE, Cameron S. Breast and reproductive cancers in the transgender population: a systematic review. BJOG: An International Journal of Obstetrics & Gynaecology. 125(12):1505-1512, 2018 Nov. Review/Other-Dx 43 articles To assess breast and reproductive cancer prevalence in the transgender population and to elucidate any associations between gender-affirming hormones and risk of these cancers. The literature search produced 228 articles; 43 were included. The overall evidence quality was very low to low. In transgender women, 20 breast cancer cases, two neovaginal cancer cases, one testicular cancer case and eight prostate cancer cases were reported. In transgender men, 18 breast cancer cases, five ovarian cancer cases, four uterine/cervical cancer cases and one vaginal cancer case were reported. 4
7. Hembree WC, Cohen-Kettenis PT, Gooren L, et al. Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab 2017;102:3869-903. Review/Other-Tx N/A To update the "Endocrine Treatment of Transsexual Persons: An Endocrine Society Clinical Practice Guideline," published by the Endocrine Society in 2009. No results stated in abstract. 4
8. Phillips J, Fein-Zachary VJ, Mehta TS, Littlehale N, Venkataraman S, Slanetz PJ. Breast imaging in the transgender patient. [Review]. AJR Am J Roentgenol. 202(5):1149-56, 2014 May. Review/Other-Dx N/A To review transgender terminology, barriers faced by transgender patients, current breast care screening recommendations, and normal and abnormal imaging findings in this population. N/A 4
9. Kanhai RC, Hage JJ, Mulder JW. Long-term outcome of augmentation mammaplasty in male-to-female transsexuals: a questionnaire survey of 107 patients. Br J Plast Surg. 53(3):209-11, 2000 Apr. Observational-Dx 107 patients To evaluate how well augmentation mammaplasty addresses in the needs of long-term postoperative male-to-female transsexual patients. Eighty patients (75%) indicated satisfaction with the final outcome of the mammaplasty. The median postoperative cup size in this group was B (range of postoperative bra size, 30B-40D). The remaining 27 patients (25%) were unhappy with the results of mammaplasty. The median postoperative cup size in the 18 patients who still felt their breasts to be too small was also B (range of bra size, 30B-48E). The average size of current prostheses in these 18 patients was 261 ml. 4
10. Sonnenblick EB, Shah AD, Goldstein Z, Reisman T. Breast Imaging of Transgender Individuals: A Review. [Review]. Curr. radiol. rep.. 6(1):1, 2018. Review/Other-Dx N/A This review will inform radiologists about the evidence base regarding radiographic imaging for transgender individuals and considerations for providing culturally sensitive care for this population. Transgender individuals are increasingly referred for both screening and diagnostic breast imaging. It is important that the clinic environment is welcoming, the medical staff utilize accepted terminology and patients are able to designate their gender and personal history to ensure appropriate care. Hormone and surgical treatments used for transition by many transgender women and men may change the approach to imaging. 4
11. Weyers S, Villeirs G, Vanherreweghe E, et al. Mammography and breast sonography in transsexual women. Eur J Radiol. 74(3):508-13, 2010 Jun. Observational-Dx 50 transsexual women To assess the possibility to perform mammography and breast sonography in transsexual women. Twenty-three percent of patients are not aware of the type of breast implants and 79% do not know their position to the pectoral muscles. Patient satisfaction with the appearance of their breasts was rather high (7.94 on a scale of 0–10). Mean expected and experienced pain from mammography was low (4.37 and 2.00 respectively). There was no statistically significant difference in expected pain between those who already had mammography and those who did not. There was a significant positive correlation between the expected and the experienced pain. 3
12. Hartley RL, Stone JP, Temple-Oberle C. Breast cancer in transgender patients: A systematic review. Part 1: Male to female. [Review]. Eur J Surg Oncol. 44(10):1455-1462, 2018 10. Review/Other-Dx N/A To identify breast cancer events in MtF transgender persons. Qualitative analysis was performed on study characteristics, patient demographics, breast cancer characteristics, and breast cancer presentation and management. Eighteen articles met inclusion criteria representing 22 breast cancer events. Median age at breast cancer diagnosis was 51.5 years. The most common breast cancer type was adenocarcinomas (59.1%) and half of the breast cancers were hormone sensitive, with estrogen receptor positive status in 10 of 19 tested and progesterone receptor positive status in 5 of 14 tested. The most common presentation was breast lump (n = 6, 42.9%), two patients had palpable lymph nodes at presentation (14.3%), and six patients eventually developed metastases (42.9%). Seven patients had a recorded positive breast cancer family history and one was BRCA2 positive. Breast cancers were treated with mastectomies (simple, modified radical, and radical), wide local excision, lumpectomy, or were unclear. Four patients received hormone therapy (23.5%), two received radiation (11.8%), and seven received chemotherapy (41.2%). Breast cancer is present in MtF patients and commonly presents at a younger age with a palpable mass. Major gaps in the literature include lack of transgender population data and long term follow-up. This work highlights the need for screening recommendations. 4
13. Nota NM, Dekker MJHJ, Klaver M, et al. Prolactin levels during short- and long-term cross-sex hormone treatment: an observational study in transgender persons. Andrologia. 49(6), 2017 Aug. Observational-Dx 55 female-to-males (FtMs) / 61 male-to-females (MtFs) To examine the short- and long-term effects of cross-sex hormone treatment (CHT) on prolactin levels in transgender persons. Because long-term prolactin data were not available in this population, we studied these levels in a retrospective population of 25 FtMs and 38 MtFs who underwent gonadectomy. FtMs were treated with testosterone and MtFs with estradiol, with or without the anti-androgen cyproterone acetate (CPA) (after gonadectomy CPA is cessated). During the first year of CHT, prolactin decreased with 25% (95CI: -33%, -12%) in FtMs and increased with 193% (95CI: 156%, 219%) in MtFs. Eighteen MtFs developed hyperprolactinemia (=0.6 IU L-1 ). In the retrospective population, post-gonadectomy levels in FtMs were lower than baseline levels (-39%; 95CI: -51%, -20%) while in MtFs post-gonadectomy levels and baseline levels were comparable (-6%; 95CI: -24%, 15%). No hyperprolactinemia was found after gonadectomy. 3
14. 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
15. Holbrook AI, Moy L, Akin EA, et al. ACR Appropriateness Criteria® Breast Pain. J Am Coll Radiol 2018;15:S276-S82. 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 breast pain. No results stated in abstract. 4
16. Expert Panel on Breast Imaging:, Lee SJ, Trikha S, et al. ACR Appropriateness Criteria R Evaluation of Nipple Discharge. [Review]. J. Am. Coll. Radiol.. 14(5S):S138-S153, 2017 May. 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 evaluation of nipple discharge No results stated in abstract. 4
17. Lourenco AP, Moy L, Baron P, et al. ACR Appropriateness Criteria R Breast Implant Evaluation. Journal of the American College of Radiology. 15(5S):S13-S25, 2018 May.J. Am. Coll. Radiol.. 15(5S):S13-S25, 2018 May. 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 breast implant evaluation. No results stated in abstract. 4
18. Asscheman H, Giltay EJ, Megens JA, de Ronde WP, van Trotsenburg MA, Gooren LJ. A long-term follow-up study of mortality in transsexuals receiving treatment with cross-sex hormones. EUR. J. ENDOCRINOL.. 164(4):635-42, 2011 Apr. Observational-Dx 966 male-to-female (MtF) / 365 female-to-male (FtM) transsexuals To assess mortality rates in transsexual subjects receiving long-term cross-sex hormones. In the MtF group, total mortality was 51% higher than in the general population, mainly from increased mortality rates due to suicide, acquired immunodeficiency syndrome, cardiovascular disease, drug abuse, and unknown cause. No increase was observed in total cancer mortality, but lung and hematological cancer mortality rates were elevated. Current, but not past ethinyl estradiol use was associated with an independent threefold increased risk of cardiovascular death. In FtM transsexuals, total mortality and cause-specific mortality were not significantly different from those of the general population. 4
19. Hulley S, Grady D, Bush T, et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 280(7):605-13, 1998 Aug 19. Experimental-Dx 2763 women To determine if estrogen plus progestin therapy alters the risk for CHD events in postmenopausal women with established coronary disease. Overall, there were no significant differences between groups in the primary outcome or in any of the secondary cardiovascular outcomes: 172 women in the hormone group and 176 women in the placebo group had MI or CHD death (relative hazard [RH], 0.99; 95% confidence interval [CI], 0.80-1.22). The lack of an overall effect occurred despite a net 11% lower low-density lipoprotein cholesterol level and 10% higher high-density lipoprotein cholesterol level in the hormone group compared with the placebo group (each P<.001). Within the overall null effect, there was a statistically significant time trend, with more CHD events in the hormone group than in the placebo group in year 1 and fewer in years 4 and 5. More women in the hormone group than in the placebo group experienced venous thromboembolic events (34 vs 12; RH, 2.89; 95% CI, 1.50-5.58) and gallbladder disease (84 vs 62; RH, 1.38; 95% CI, 1.00-1.92). There were no significant differences in several other end points for which power was limited, including fracture, cancer, and total mortality (131 vs 123 deaths; RH, 1.08; 95% CI, 0.84-1.38). 2
20. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 288(3):321-33, 2002 Jul 17. Experimental-Dx 16,608 women To assess the major health benefits and risks of the most commonly used combined hormone preparation in the United States. On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits. This report includes data on the major clinical outcomes through April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases; breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85) with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63 (0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47 cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs) for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer, 0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks per 10 000 person-years attributable to estrogen plus progestin were 7 more CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers, while absolute risk reductions per 10 000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. The absolute excess risk of events included in the global index was 19 per 10 000 person-years. 2
21. Teoh ZH, Archampong D, Gate T. Breast cancer in male-to-female (MtF) transgender patients: is hormone receptor negativity a feature?. BMJ Case Rep. 2015, 2015 May 20. Review/Other-Dx 1 MtF transgender patient To investigate triple assessment confirming a triple-negative invasive ductal carcinoma in a 41-year-old male-to-female (MtF) transgender patient. No results in abstract. 4
22. Gao Y, Goldberg JE, Young TK, Babb JS, Moy L, Heller SL. Breast Cancer Screening in High-Risk Men: A 12-year Longitudinal Observational Study of Male Breast Imaging Utilization and Outcomes. Radiology. 293(2):282-291, 2019 11. Observational-Dx 1869 men To evaluate patterns of male breast imaging utilization, to determine high-risk screening outcomes, and to delineate risk factors associated with cancer diagnosis. A total of 1869 men (median age, 55 years; range, 18-96 years) underwent 2052 examinations yielding 2304 breast lesions and resulting in 149 (6.5%) biopsies in 133 men; 41 (27.5%) were malignant and 108 (72.5%) were benign. There were 1781 (86.8%) diagnostic and 271 (13.2%) screening examinations. All men undergoing screening had personal or family history of breast cancer and/or genetic mutations. There was a significant increase in the number of examinations in men relative to the number of examinations in women over time (Spearman correlation, r = 0.85; P < .001). Five node-negative cancers resulted from screening mammography, yielding a cancer detection rate of 18 per 1000 examinations (95% confidence interval [CI]: 7, 41), with cancers diagnosed on average after 4 person-years of screening (range, 1-10 person-years). Mammographic screening sensitivity, specificity, and positive predictive value of biopsy were 100% (95% CI: 50%, 100%), 95.0% (95% CI: 93.1%, 98%), and 50% (95% CI: 22.2%, 77.8%). Older age (P < .001), Ashkenazi descent (P < .001), genetic mutations (P = .006), personal history (P < .001), and first-degree family history (P = .03) were associated with breast cancer. Non-first-degree family history was not associated with cancer (P = .09). 3
23. Marino MA, Gucalp A, Leithner D, et al. Mammographic screening in male patients at high risk for breast cancer: is it worth it?. Breast Cancer Research & Treatment. 177(3):705-711, 2019 Oct. Observational-Dx 163 patients To investigate the utility of mammography for breast cancer screening in a population of males at increased risk for breast cancer. 163 asymptomatic men (age: mean 63 years, range 24–87 years) underwent 806 screening mammograms. 125/163(77%) had a personal history of breast cancer and 72/163 (44%) had a family history of breast cancer. 24/163 (15%) wereknown mutation carriers: 4/24 (17%) BRCA1 and 20/24 (83%) BRCA2. 792/806 (98%) of the screening mammograms werenegative (BI-RADS 1 or 2); 10/806 (1.2%) were classified as BI-RADS 3, all of which were eventually downgraded to BIRADS2 on follow-up. 4/806 (0.4%) mammograms were abnormal (BI-RADS 4/5): all were malignant. The cancer detectionrate in this cohort was 4.9 cancers/1000 examinations. 3
24. Colebunders B, T'Sjoen G, Weyers S, Monstrey S. Hormonal and surgical treatment in trans-women with BRCA1 mutations: a controversial topic. J Sex Med. 11(10):2496-9, 2014 Oct. Review/Other-Dx 1 patient To discuss the hormonal and surgical options in the treatment of trans-women with a genetic predisposition for breast cancer. The patient underwent a breast augmentation. She refused a prophylactic mastectomy followed by a primary breast reconstruction. She also underwent a vaginoplasty and a bilateral castration. Androgen blocking treatment was stopped after surgery; estradiol treatment however was continued. 4
25. Mainiero MB, Moy L, Baron P, et al. ACR Appropriateness Criteria® Breast Cancer Screening. J Am Coll Radiol 2017;14:S383-S90. Review/Other-Dx N/A To provide evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decision for breast cancer screening. No results stated in abstract. 4
26. Gethins M.. Breast cancer in men. J Natl Cancer Inst. 104(6):436-8, 2012 Mar 21. Review/Other-Dx N/A To discuss risk of breast cancer, treatment approaches, and patient experience for men. No results stated. 4
27. Rebbeck TR, Friebel T, Lynch HT, et al. Bilateral prophylactic mastectomy reduces breast cancer risk in BRCA1 and BRCA2 mutation carriers: the PROSE Study Group. J Clin Oncol. 22(6):1055-62, 2004 Mar 15. Observational-Dx 483 women To estimate the degree of breast cancer risk reduction after surgery in women who carry these mutations. Breast cancer was diagnosed in two (1.9%) of 105 women who had bilateral prophylactic mastectomy and in 184 (48.7%) of 378 matched controls who did not have the procedure, with a mean follow-up of 6.4 years. Bilateral prophylactic mastectomy reduced the risk of breast cancer by approximately 95% in women with prior or concurrent bilateral prophylactic oophorectomy and by approximately 90% in women with intact ovaries. 3
28. American College of Radiology. ACR Appropriateness Criteria®: Imaging after Mastectomy and Breast Reconstruction. Available at: https://acsearch.acr.org/docs/3155410/Narrative/. 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 a specific clinical condition. No abstract available. 4
29. Gartlehner G, Thaler KJ, Chapman A, et al. Adjunct ultrasonography for breast cancer screening in women at average risk: a systematic review. Int J Evid Based Healthc. 2013;11(2):87-93. Review/Other-Dx N/A To systematically assess the comparative benefits and harms of mammography with adjunct breast ultrasonography and mammography only in breast cancer screening. We did not detect any controlled studies that provide evidence for (or against) the use of adjunct ultrasonography for screening in women at average risk for breast cancer. Extrapolations of results from women at elevated risk for breast cancer indicate that the false-positive rates in women at average risk who were recalled because of positive ultrasonographies will exceed 98%. In women with dense or very dense breast tissue, the evidence regarding the use of adjunct ultrasonography is not conclusive. 4
30. Winkler NS, Raza S, Mackesy M, Birdwell RL. Breast density: clinical implications and assessment methods. Radiographics. 2015;35(2):316-324. Review/Other-Dx N/A To discuss the clinical implications and assessment methods for breast density No results stated in abstract 4
31. Lee CH, Dershaw DD, Kopans D, et al. Breast cancer screening with imaging: recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast ultrasound, and other technologies for the detection of clinically occult breast cancer. J Am Coll Radiol. 2010;7(1):18-27. Review/Other-Dx N/A Recommendations from the Society of Breast Imaging and the ACR on the use of mammography, breast MRI, breast US, and other technologies for the detection of clinically occult breast cancer. N/A 4
32. Brem RF, Tabar L, Duffy SW, et al. Assessing improvement in detection of breast cancer with three-dimensional automated breast US in women with dense breast tissue: the SomoInsight Study. Radiology. 274(3):663-73, 2015 Mar. Observational-Dx 112 women To determine improvement in breast cancer detection by using supplemental three-dimensional (3D) automated breast (AB) ultrasonography (US) with screening mammography versus screening mammography alone in asymptomatic women with dense breasts. Breast cancer was diagnosed at screening in 112 women: 82 with screening mammography and an additional 30 with AB US. Addition of AB US to screening mammography yielded an additional 1.9 detected cancers per 1000 women screened (95% confidence interval [CI]: 1.2, 2.7; P < .001). Of cancers detected with screening mammography, 62.2% (51 of 82) were invasive versus 93.3% (28 of 30) of additional cancers detected with AB US (P = .001). Of the 82 cancers detected with either screening mammography alone or the combined read, 17 were detected with screening mammography alone. Of these, 64.7% (11 of 17) were ductal carcinoma in situ versus 6.7% (two of 30) of cancers detected with AB US alone. Sensitivity for the combined read increased by 26.7% (95% CI: 18.3%, 35.1%); the increase in the recall rate per 1000 women screened was 284.9 (95% CI: 278.0, 292.2; P < .001). 3
33. Chae EY, Kim HH, Cha JH, Shin HJ, Kim H. Evaluation of screening whole-breast sonography as a supplemental tool in conjunction with mammography in women with dense breasts. J Ultrasound Med. 2013;32(9):1573-1578. Observational-Dx 20,864 women To evaluate the use and performance of supplemental screening whole-breast sonography in conjunction with mammography in asymptomatic women with dense breast tissue. Among the 20,864 women with dense breasts, 35 cancers were diagnosed, with a mean size of 13 mm. The cancer detection yield was 0.480 per 1000 women in the mammography-only group and increased to 2.871 in the mammography-plus-sonography group. Of 24 cancers detected in the mammography-plus-sonography group, the mean size was 11 mm, and the axillary lymph nodes were negative in 19 of 20. The sensitivity was significantly higher in the mammography-plus-sonography group than the mammography-only group (100% versus 54.55%; P = .002). The positive predictive values of sonographically prompted biopsy were 11.1% for the mammography-plus-sonography group and 50% for the mammography-only group. 3
34. Giuliano V, Giuliano C. Improved breast cancer detection in asymptomatic women using 3D-automated breast ultrasound in mammographically dense breasts. Clin Imaging 2013;37:480-6. Observational-Dx 3418 women To demonstrate that ABUS increases the detection of non-palpable breast cancers in mammographically dense breasts when used as an adjunct diagnostic modality in asymptomatic women Automated breast ultrasound (ABUS)was performed in 3418 asymptomatic women with mammographically dense breasts. The addition of ABUS to mammography in women with greater than 50% breast density resulted in the detection of 12.3 per 1,000 breast cancers, compared to 4.6 per 1,000 by mammography alone. The mean tumor size was 14.3 mm and overall attributable risk of breast cancer was 19.92 (95% confidence level, 16.75 - 23.61) in our screened population. These preliminary results may justify the cost-benefit of implementing the judicious us of ABUS in conjunction with mammography in the dense breast screening population. 2
35. Monticciolo DL, Newell MS, Hendrick RE, et al. Breast Cancer Screening for Average-Risk Women: Recommendations From the ACR Commission on Breast Imaging. Journal of the American College of Radiology. 14(9):1137-1143, 2017 Sep. Review/Other-Dx N/A To provide recommendations from the ACR Commission on Breast Imaging on breast cancer screening for average-risk women. The ACR recommends annual mammography screening starting at age 40 for women of average risk of developing breast cancer. 4
36. Friedlander LC, Roth SO, Gavenonis SC. Results of MR imaging screening for breast cancer in high-risk patients with lobular carcinoma in situ. Radiology. 261(2):421-7, 2011 Nov. Observational-Dx 198 patients To determine the outcome of screening breast magnetic resonance (MR) imaging examinations performed in patients with lobular carcinoma in situ (LCIS) at the authors' institution. A total of 445 breast MR examinations in 198 patients with LCIS were identified. Of these, 308 were screening examinations in 134 patients. One patient was a BRCA mutation carrier and was excluded. Of the remaining 307 screening examinations, 254 (82.7%) had BI-RADS category 1 or 2 findings; 27 (8.8%) had BI-RADS category 3 findings; and 27 (8.8%) had B-IRADS category 4 or 5 findings. Of the 27 studies that led to a biopsy recommendation, 10 (37%) yielded benign pathologic findings, five (18.5%) yielded malignant pathologic findings, and seven (25.9%) yielded high-risk lesions. Of the 27 studies with BI-RADS 3 findings, two (7.4%) resulted in biopsy, findings of both were benign. Overall, malignancy was detected in five of 307 screening studies (1.6%) and in five of 133 screened patients (3.8%). The positive predictive value (PPV) of these screening studies for which biopsy was recommended was 18.5%. The PPV 3 (studies for which biopsy was recommended and actually performed, as described in the BI-RADS guidelines) was 23.8%. 3
37. Sung JS, Malak SF, Bajaj P, Alis R, Dershaw DD, Morris EA. Screening breast MR imaging in women with a history of lobular carcinoma in situ. Radiology. 261(2):414-20, 2011 Nov. Observational-Dx 220 women To assess the utility of screening MR imaging in the detection of otherwise occult breast cancers in women with a history of lobular carcinoma in situ (LCIS). Biopsy was recommended in 63 lesions seen in 58 (9%) of 670 screening MR studies. Eight additional lesions were identified at short-term follow-up MR imaging for a total of 71 lesions in 59 patients. Twelve cancers (20%) were identified in 60 lesions sampled. Biopsy was recommended in 26 additional lesions identified at mammography; biopsy was performed in 25 of these lesions and revealed malignancy in five (20%). Overall, 17 cancers were detected in 14 patients during the study period. Of these, 12 were detected with MR imaging alone, and five were detected with mammography alone. Of the 12 cancers detected at MR imaging, there were nine invasive cancers and three cases of ductal carcinoma in situ (DCIS). Of the five cancers detected at mammography, two were invasive and three were DCIS. MR imaging is a useful adjunct modality with which to screen women with a history of LCIS at high-risk of developing breast cancer, resulting in a 4.5% incremental cancer detection rate. Sensitivity in the detection of breast cancers with a combination of MR imaging and mammography was higher than sensitivity of either modality alone. 4
38. Brennan S, Liberman L, Dershaw DD, Morris E. Breast MRI screening of women with a personal history of breast cancer. AJR Am J Roentgenol. 2010;195(2):510-516. Observational-Dx 144 women To determine the cancer detection and biopsy rate among women who have breast MRI screening solely on the basis of a personal history of breast cancer. Of 144 women, 44 (31% [95% CI, 15%–29%]) underwent biopsies prompted by MRI examination. Biopsies revealed malignancies in 17 women (12% [95% CI, 7%–18%]) and benign findings only in 27 women (19% [95% CI, 13%–26%]). Of the 17 women in whom cancer was detected, 7 also had benign biopsy results. In total, 18 malignancies were found. One woman had 2 metachronous cancers. MRI screening resulted in a total of 61 biopsies, with a positive predictive value of 39% (95% CI, 27%–53%). The malignancies found included 17 carcinomas and 1 myxoid liposarcoma. Of the 17 cancers, 12 (71%) were invasive, 5 (29%) were DCIS, and 10 (59%) were minimal breast cancers. Of 17 cancers, 10 were detected by MRI only. The 10 cancers detected by MRI only, vs 7 cancers later found by other means, were more likely to be DCIS (4/10 [40%] vs 1/7 [14%]; P=0.25) or minimal breast cancers (7/10 [70%] vs 3/7 [43%]; P=0.26). 3
39. 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
40. Berg WA, Blume JD, Cormack JB, et al. Combined screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer. JAMA. 2008;299(18):2151-2163. Experimental-Dx 2725 women Prospective, multicenter trial to compare the diagnostic yield, defined as the proportion of women with positive screen test results and positive reference standard, and performance of screening with US plus mammography vs mammography alone in women at elevated risk of breast cancer. 40 participants (41 breasts) were diagnosed with cancer: 8 suspicious on both US and mammography, 12 on US alone, 12 on mammography alone, and 8 participants (9 breasts) on neither. The diagnostic yield for mammography was 7.6 per 1000 women screened (20 of 2637) and increased to 11.8 per 1000 (31 of 2637) for combined mammography plus US; the supplemental yield was 4.2 per 1000 women screened (95% CI, 1.1-7.2 per 1000; P = .003 that supplemental yield is 0). The diagnostic accuracy for mammography was 0.78 (95% CI, 0.67-0.87) and increased to 0.91 (95% CI, 0.84-0.96) for mammography plus ultrasound (P = .003 that difference is 0). Of 12 supplemental cancers detected by ultrasound alone, 11 (92%) were invasive with a median size of 10 mm (range, 5-40 mm; mean [SE], 12.6 [3.0] mm) and 8 of the 9 lesions (89%) reported had negative nodes. The positive predictive value of biopsy recommendation after full diagnostic workup was 19 of 84 for mammography (22.6%; 95% CI, 14.2%-33%), 21 of 235 for ultrasound (8.9%, 95% CI, 5.6%-13.3%), and 31 of 276 for combined mammography plus ultrasound (11.2%; 95% CI. 7.8%-15.6%). Adding a single screening US to mammography will yield an additional 1.1 to 7.2 cancers per 1000 high-risk women, but it will also substantially increase the number of false positives. 1
41. 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
42. Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57(2):75-89. Review/Other-Dx N/A To provide new evidence on breast MRI screening guidelines for the early detection of breast cancer in women. A guideline panel has reviewed this evidence and developed new recommendations for women at different defined levels of risk. Screening MRI is recommended for women with an approximately 20%–25% or greater lifetime risk of breast cancer, including women with a strong family history of breast or ovarian cancer and women who were treated for Hodgkin disease. There are several risk subgroups for which the available data are insufficient to recommend for or against screening, including women with a personal history of breast cancer, carcinoma in situ, atypical hyperplasia, and extremely dense breasts on mammography. 4
43. Hagen AI, Kvistad KA, Maehle L, et al. Sensitivity of MRI versus conventional screening in the diagnosis of BRCA-associated breast cancer in a national prospective series. Breast. 2007;16(4):367-374. Observational-Dx 867 MRI in 445 BRCA1 and 46 BRCA2 mutation carriers To compare the sensitivities of breast MRI and the conventional screening programme consisting of mammography (XRM) +/- US for early diagnosis of breast cancer in BRCA1/2 mutation carriers in a national prospective series. 25 cancers were observed, five (20%) as interval cancers. At the time of diagnosis, sensitivity to detect cancer was 19/22=86% for MRI and 12/24=50% for XRM. Twenty-one were examined by both methods at the time of diagnosis. In the19 BRCA1 mutation carriers among them, MRI had a sensitivity of 1/3(33%) to diagnose DCIS and 15/16 (94%) among the invasive cancers. For XRM the sensitivities were 1/3(33%) for DCIS, 3/7(42%) for pT1b, 3/6(50%) for pT1c, and 3/3/100%) for pT2. In the two BRCA2 mutation carriers, both were demonstrated by breast MRI, neither was detected by XRM. Breast MRI had increased sensitivity compared to XRM to diagnose all cancers staged less than pT2. 3
44. Kriege M, Brekelmans CT, Boetes C, et al. Differences between first and subsequent rounds of the MRISC breast cancer screening program for women with a familial or genetic predisposition. Cancer. 2006;106(11):2318-2326. Observational-Dx 1909 eligible women To determine whether previously reported increased diagnostic accuracy of MRI compared with mammography would be maintained during subsequent screening rounds. The difference in sensitivity for invasive cancers between mammography and MRI was largest in the first round of women previously screened with mammography (20.0 vs. 93.3%; P = .003), but also in subsequent rounds, there was a significant difference in favor of MRI (29.4 vs. 76.5%; P = .02). The difference in false-positive rate between mammography and MRI was also largest in the first round of women previously screened with mammography (5.5 vs. 14.0%; P<.001), and it remained significant in subsequent rounds (4.6 vs. 8.2%; P<.001). Screen-detected tumors were smaller and more often lymph node negative than symptomatic tumors in age-matched control patients, but no major differences in tumor stage were found between tumors detected at subsequent rounds compared with those in the first round. In subsequent rounds, a significantly higher sensitivity and better discriminating capacity of MRI compared with mammography was maintained, and a favorable tumor stage compared with age-matched symptomatic controls. 4
45. Kuhl C, Weigel S, Schrading S, Arand B, Bieling H, König R, Tombach B, Leutner C, Rieber-Brambs A, Nordhoff D, Heindel W, Reiser M, Schild HH. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial. J Clin Oncol. 2010 Mar 20;28(9):1450-7. Observational-Dx 687 women To investigate the respective contribution (in terms of cancer yield and stage at diagnosis) of clinical breast examination (CBE), mammography, ultrasound, and quality-assured breast magnetic resonance imaging (MRI), used alone or in different combination, for screening women at elevated risk for breast cancer. Twenty-seven women were diagnosed with breast cancer: 11 ductal carcinoma in situ (41%) and 16 invasive cancers (59%). Three (11%) of 27 were node positive. All cancers were detected during annual screening; no interval cancer occurred; no cancer was identified during half-yearly ultrasound. The cancer yield of ultrasound (6.0 of 1,000) and mammography (5.4 of 1,000) was equivalent; it increased nonsignificantly (7.7 of 1,000) if both methods were combined. Cancer yield achieved by MRI alone (14.9 of 1,000) was significantly higher; it was not significantly improved by adding mammography (MRI plus mammography: 16.0 of 1,000) and did not change by adding ultrasound (MRI plus ultrasound: 14.9 of 1,000). Positive predictive value was 39% for mammography, 36% for ultrasound, and 48% for MRI. 1
46. Kuhl CK, Schrading S, Leutner CC, et al. Mammography, breast ultrasound, and magnetic resonance imaging for surveillance of women at high familial risk for breast cancer. J Clin Oncol. 2005;23(33):8469-8476. Observational-Dx 529 asymptomatic women To compare the effectiveness of mammography, breast US, and MRI for surveillance of women at increased familial risk for breast cancer (lifetime risk of 20% or more). 43 breast cancers were identified in the total cohort (34 invasive, nine ductal carcinoma-in-situ). Overall sensitivity of diagnostic imaging was 93% (40 of 43 breast cancers); overall node-positive rate was 16%, and one interval cancer occurred (one of 43 cancers, or 2%). In the analysis by modality, sensitivity was low for mammography (33%) and US(40%) or the combination of both (49%). MRI offered a significantly higher sensitivity (91%). The sensitivity of mammography in the higher risk groups was 25%, compared with 100% for MRI. Specificity of MRI (97.2%) was equivalent to that of mammography (96.8%). Mammography alone, and also mammography combined with breast US, seems insufficient for early diagnosis of breast cancer in women who are at increased familial risk with or without documented BRCA mutation. If MRI is used for surveillance, diagnosis of intraductal and invasive familial or hereditary cancer is achieved with a significantly higher sensitivity and at a more favorable stage. 2
47. Leach MO, Boggis CR, Dixon AK, et al. Screening with magnetic resonance imaging and mammography of a UK population at high familial risk of breast cancer: a prospective multicentre cohort study (MARIBS). Lancet. 2005;365(9473):1769-1778. Observational-Dx 649 women To compare contrast enhanced MRI (CE MRI) with mammography for screening. 35 cancers were diagnosed in 649 women screened with both mammography and CE MRI (1881 screens): 19 by CE MRI only, six by mammography only, and eight by both, with two interval cases. Sensitivity was significantly higher for CE MRI (77%, 95% CI 60-90) than for mammography (40%, 24-58; p=0.01), and was 94% (81-99) when both methods were used. Specificity was 93% (92-95) for mammography, 81% (80-83) for CE MRI (p<0.0001), and 77% (75-79) with both methods. The difference between CE MRI and mammography sensitivities was particularly pronounced in BRCA1 carriers (13 cancers; 92%vs 23%, p=0.004). Findings indicate that CE MRI is more sensitive than mammography for cancer detection. Specificity for both procedures was acceptable. Despite a high proportion of grade 3 cancers, tumours were small and few women were node positive. Annual screening, combining CE MRI and mammography, would detect most tumours in this risk group. 2
48. Saadatmand S, Vos JR, Hooning MJ, et al. Relevance and efficacy of breast cancer screening in BRCA1 and BRCA2 mutation carriers above 60 years: a national cohort study. Int J Cancer. 135(12):2940-9, 2014 Dec 15. Observational-Dx 548 patients To address the clinical relevance and extent of this issue, we first assess the proportion of BRCA1/2 mutation carriers with remaining breast tissue at risk at age 60, in an on-going nationwide cohort study and a family cancer clinic cohort. Secondly, to determine the optimal breast cancer screening strategy for BRCA1/2 mutation carriers 60, we compared tumour stage at detection per screening strategy. Of 548 BRCA1/2 mutation carriers >/=60 years in 2012, 395 (72%) did not have bilateral mastectomy before the age of 60. Of these 395, 224 (57%) had a history of breast or other invasive carcinoma. In 136 BRCA1/2 mutation carriers, we compared 148 breast cancers (including interval cancers) detected >/=60, of which 84 (57%) were first breast cancers. With biennial mammography 53% (30/57) of carcinomas were detected in unfavourable stage, compared to 21% (12/56) with annual mammography (adjusted odds ratio: 4.07, 95% confidence interval [1.79-9.28], p = 0.001). With biennial screening 40% of breast cancers were interval cancers, compared to 20% with annual screening (p = 0.016). 3
49. Sardanelli F, Podo F, D'Agnolo G, et al. Multicenter comparative multimodality surveillance of women at genetic-familial high risk for breast cancer (HIBCRIT study): interim results. Radiology. 242(3):698-715, 2007 Mar. Observational-Dx 278 women Prospective, multicenter trial to compare clinical breast examination (CBE), mammography, US, and contrast material-enhanced MR imaging for screening women at genetic-familial high risk for breast cancer and report interim results, with pathologic findings as standard. Breast cancer was found in 11 of 278 women at first round and seven of 99 at second round (14 invasive, four intraductal; eight were 2
50. Weinstein SP, Localio AR, Conant EF, Rosen M, Thomas KM, Schnall MD. Multimodality screening of high-risk women: a prospective cohort study. J Clin Oncol. 2009 Dec 20;27(36):6124-8. Observational-Dx 609 women To prospectively compare cancer detection of digital mammography (DM), whole-breast ultrasound (WBUS), and contrast-enhanced MRI in a high-risk screening population previously screened negative by film screen mammogram (FSM). Twenty cancers were diagnosed in 18 patients (nine ductal carcinomas in situ and 11 invasive breast cancers). The overall cancer yield on a per-patient basis was 3.0% (18 of 609 patients). The cancer yield by modality was 1.0% for FSM (six of 597 women), 1.2% for DM (seven of 569 women), 0.53% for WBUS (three of 567 women), and 2.1% for MRI (12 of 571 women). Of the 20 cancers detected, some were only detected on one imaging modality (FSM, n = 1; DM, n = 3; WBUS, n = 1; and MRI, n = 8). 1
51. 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
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