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Appropriateness Criteria

Reference Study Type Patients/Events Study Objective(Purpose of Study) Study Results Study Quality
1. 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
2. Beller U, Quinn MA, Benedet JL, et al. Carcinoma of the vulva. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006;95 Suppl 1:S7-27. Review/Other-Tx N/A To review carcinoma of the vulva. No results reported in abstract. 4
3. Stroup AM, Harlan LC, Trimble EL. Demographic, clinical, and treatment trends among women diagnosed with vulvar cancer in the United States. Gynecol Oncol. 2008;108(3):577-583. Review/Other-Dx N/A To describe the treatment and 5-year survival patterns among a population-based sample of vulvar cancer patients diagnosed in 1999 who were identified for the National Cancer Institute’s (NCI) Patterns of Care Study using the Surveillance, Epidemiology and End-Results (SEER) Program,. Ninety percent of cases were diagnosed with in situ or early-stage invasive disease. Older patients were more likely to present at advanced stages. Twenty-five percent of women with Stage III-IV vulvar cancer received chemotherapy plus radiation. We noted widespread use of radical local excision among women with Stage I/II cancer, but 46-54% with invasive disease underwent a radical or total vulvectomy. Factors associated with cancer death were limited to age and stage. Women 75 years and older were at higher risk compared to women aged 20-49 years and the risk of death increased with advancing stage. 4
4. National Cancer Institute. SEER Program. Cancer Stat Facts: Vulvar Cancer.  Available at: www.seer.cancer.gov/statfacts/html/vulva.html. Review/Other-Dx N/A Cancer statistics for vulvar cancer. No abstract available. 4
5. Viens LJ, Henley SJ, Watson M, et al. Human Papillomavirus-Associated Cancers - United States, 2008-2012. MMWR Morb Mortal Wkly Rep. 2016;65(26):661-666. Review/Other-Dx N/A To assess the incidence of HPV-associated cancers, center of disease control and prevention (CDC) analyzed 2008-2012 high-quality data from the CDC's National Program of Cancer Registries and the National Cancer Institute's Surveillance, Epidemiology, and End Results program. During 2008-2012, an average of 38,793 Human papillomavirus (HPV)-associated cancers were diagnosed annually, including 23,000 (59%) among females and 15,793 (41%) among males. By multiplying these counts by the percentages attributable to HPV (3), CDC estimated that approximately 30,700 new cancers were attributable to HPV, including 19,200 among females and 11,600 among males. Cervical precancers can be detected through screening, and treatment can prevent progression to cancer; HPV vaccination can prevent infection with HPV types that cause cancer at cervical and other sites (3). Vaccines are available for HPV types 16 and 18, which cause 63% of all HPV-associated cancers in the United States, and for HPV types 31, 33, 45, 52, and 58, which cause an additional 10% (3). Among the oncogenic HPV types, HPV 16 is the most likely to both persist and to progress to cancer (3). 4
6. NCCN Clinical Practice Guidelines in Oncology. Vulvar Cancer (Squamous Cell Carcinoma). Version 2. 2019.  Available at: https://www.nccn.org/professionals/physician_gls/pdf/vulvar_blocks.pdf Review/Other-Dx N/A To provide clinical guidelines for vulvar cancer. No results stated in abstract. 4
7. Hacker NF. Revised FIGO staging for carcinoma of the vulva. Int J Gynaecol Obstet. 2009;105(2):105-106. Review/Other-Dx N/A To review the Revised The International Federation of Gynecology and Obstetrics (FIGO) staging for carcinoma of the vulva. No results stated in abstract. 4
8. Pecorelli S. Revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. Int J Gynaecol Obstet. 2009;105(2):103-104. Review/Other-Tx N/A A consensus document on revised FIGO staging for carcinoma of the vulva, cervix, and endometrium. No results stated in abstract. 4
9. 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
10. Sedlis A, Homesley H, Bundy BN, et al. Positive groin lymph nodes in superficial squamous cell vulvar cancer. A Gynecologic Oncology Group Study. Am J Obstet Gynecol. 1987;156(5):1159-1164. Observational-Dx 272 patients To present the results of our study analyzing the clinicopathologic risk factors for groin metastases in 272 women with superficial (~5 mm thick) vulvar cancer who were enrolled in a Gynecologic Oncology Group protocol between 1977 and 1984. No lymph node metastases occurred in approximately one fourth of patients with a combination of low-risk factors: no clinically suspicious nodes, negative capillary-like space, and nonmidline vulvar cancers that were either grade 1 and 1 to 5 mm thick or grade 2 and 1 to 2 mm thick. In contrast, all 10 patients with clinically suspicious nodes and grade 4 tumors had positive groin nodes. The risk of lymph node metastases is best determined by simultaneous evaluation of all risk factors rather than a single factor such as tumor thickness. 2
11. Burger MP, Hollema H, Emanuels AG, Krans M, Pras E, Bouma J. The importance of the groin node status for the survival of T1 and T2 vulval carcinoma patients. Gynecol Oncol. 1995;57(3):327-334. Observational-Dx 119 patients To analyze (1) the prognostic factors for survival of T1 and T2 carcinoma patients and (2) the impact of the initial groin node status for the time to recurrence and site of recurrence. Of the 119 patients who underwent lymphadenectomy but in whom no groin node metastases were found, 6 (5%) patients manifested an early recurrence (i.e., residual cancer or a recurrence within 2 years after the diagnosis). In contrast, of the 51 patients with histologically documented groin node metastases, 15 (29.4%) manifested an early recurrence and these recurrences appeared equally distributed over the primary site and other sites. 3
12. Homesley HD, Bundy BN, Sedlis A, et al. Assessment of current International Federation of Gynecology and Obstetrics staging of vulvar carcinoma relative to prognostic factors for survival (a Gynecologic Oncology Group study). Am J Obstet Gynecol. 1991;164(4):997-1003; discussion 1003-1004. Observational-Dx 588 patients To Assess the current International Federation of Gynecology and Obstetrics staging of vulvar carcinoma relative to prognostic factors for survival he 5-year relative survival rates were 98%, 87%, 75%, and 29% for the risk group categories of minimal (negative groin nodes and lesion diameter less than or equal to 2 cm), low (one positive groin node and lesion diameter less than or equal to 2 cm or negative groin nodes and fewer than two lesions less than or equal to 8 cm diameter), intermediate (negative groin nodes and lesion diameter greater than 8 cm diameter, one positive groin node and lesion diameter greater than 2 cm, or two unilaterally positive groin nodes and lesion diameter less than or equal to 8 cm), and high (three or more positive groin nodes or two bilaterally positive groin nodes), respectively. Applying the International Federation of Gynecology and Obstetrics staging (1988) to these data discriminated risk of death (caused by recurrent vulvar cancer); the 5-year rates were 98%, 85%, 74%, and 31% for stages I, II, III, and IV, respectively. However, within International Federation of Gynecology and Obstetrics stage III there were 47 low-, 95 intermediate-, and 28 high-risk patients with relative survivals of 95%, 74%, and 34%, respectively. 3
13. Maggino T, Landoni F, Sartori E, et al. Patterns of recurrence in patients with squamous cell carcinoma of the vulva. A multicenter CTF Study. Cancer. 2000;89(1):116-122. Observational-Dx 502 patients To discuss the limited number of articles in the literature regarding the patterns of recurrence as well as the clinical outcome of patients with recurrent disease based on a consistent and consecutive series of cases. Of 502 patients, 187 (37.3%) developed a recurrence. Distribution of the recurrences by site was as follows: perineal, 53.4%; inguinal, 18.7%; pelvic, 5.7%; distant, 7.9%; and multiple, 14.2%. In a multivariate analysis, 3 characteristics appeared to be statistically correlated with the risk of recurrence: International Federation of Gynecology and Obstetrics Stage > II (P = 0.029), positive lymph nodes (P = 0.009), and vascular space invasion (P = 0.004). The 5-year survival rate was 60% for perineal recurrences, 27% for inguinal and pelvic recurrences, 15% for distant recurrences, and 14% for multiple recurrences. 3
14. Aragona AM, Cuneo NA, Soderini AH, Alcoba EB. An analysis of reported independent prognostic factors for survival in squamous cell carcinoma of the vulva: is tumor size significance being underrated? Gynecol Oncol. 2014;132(3):643-648. Observational-Dx 194 patients To assess independent prognostic factors described in the literature. Thus, to identify different risk groups. 194 patients were included. Median age: 67 years. Median follow-up: 62 months. 5-year OS and DFS: 65.5% and 58.2%. Positive lymph nodes were found in 91 (46.9%) patients. After a multivariate analysis, the number of positive lymph nodes, extra-nodal growth, pathologic tumor size and DSI proved to be independent prognostic factors. A high risk group for failure to survive (5y-OS 24%) was identified: tumor size >/= 6-7.9 cm and DSI >4mm or >/= 8 cm irrespective of DSI; and extra-nodal growth or >/=2 positive lymph nodes irrespective of tumor size and DSI. 2
15. Klapdor R, Wolber L, Hanker L, et al. Predictive factors for lymph node metastases in vulvar cancer. An analysis of the AGO-CaRE-1 multicenter study. Gynecol Oncol 2019;154:565-70. Observational-Dx 1162 patients To assess risk factors for the incidence and extent of lymph node metastases which may help in selecting the optimal treatment strategy of each individual In total, 1162 patients were analyzed. Univariate analyses detected age, ECOG as well as multiple tumor characteristics such as FIGO stage, grading, depth of invasion, tumor diameter, and (lymph)vascular space invasion to be related with the prevalence of LN metastases. Interestingly, only tumor stage, tumor diameter and depth of infiltration were found to be significantly associated with the number of LN metastases. In multivariate analysis, age (OR 1.03), lymphvascular space invasion (OR 4.97), tumor stage (OR 2.22) and depth of infiltration (OR 1.08) showed an association with the prevalence of LN metastases. Regarding the number of metastatic LNs, only tumor stage (OR 2.21) or, if excluded, tumor diameter (OR 1.02) were tested significant. 4
16. Van der Zee AG, Oonk MH, De Hullu JA, et al. Sentinel node dissection is safe in the treatment of early-stage vulvar cancer. J Clin Oncol. 2008;26(6):884-889. Observational-Tx 403 assessable patients; 623 groins To investigate the safety and clinical utility of the sentinel node procedure in early-stage vulvar cancer patients. From March 2000 until June 2006, a sentinel node procedure was performed in 623 groins of 403 assessable patients. In 259 patients with unifocal vulvar disease and a negative sentinel node (median follow-up time, 35 months), six groin recurrences were diagnosed (2.3%; 95% CI, 0.6% to 5%), and 3-year survival rate was 97% (95% CI, 91% to 99%). Short-term morbidity was decreased in patients after sentinel node dissection only when compared with patients with a positive sentinel node who underwent inguinofemoral lymphadenectomy (wound breakdown in groin: 11.7% v 34.0%, respectively; P < .0001; and cellulitis: 4.5% v 21.3%, respectively; P < .0001). Long-term morbidity also was less frequently observed after removal of only the sentinel node compared with sentinel node removal and inguinofemoral lymphadenectomy (recurrent erysipelas: 0.4% v 16.2%, respectively; P < .0001; and lymphedema of the legs: 1.9% v 25.2%, respectively; P < .0001). 1
17. Beesley V, Janda M, Eakin E, Obermair A, Battistutta D. Lymphedema after gynecological cancer treatment : prevalence, correlates, and supportive care needs. Cancer. 2007;109(12):2607-2614. Review/Other-Dx 1774 women To establish prevalence, correlates, and supportive care needs of gynecological cancer survivors who develop lymphedema. Ten percent (95% confidence interval [CI], 8%-12%) of participants reported being diagnosed with lymphedema, and a further 15% (95% CI, 13%-17%) reported undiagnosed "symptomatic" lower limb swelling. Diagnosed lymphedema was more prevalent (36%) amongst vulvar cancer survivors. For cervical cancer survivors, those who had radiotherapy or who had lymph nodes removed had higher odds of developing swelling. For uterine and ovarian cancer survivors, those who had lymph nodes removed or who were overweight or obese had higher odds of developing swelling. Gynecological cancer survivors with lymphedema had higher supportive care needs in the information and symptom management domains compared with those who had no swelling. 4
18. Wills A, Obermair A. A review of complications associated with the surgical treatment of vulvar cancer. Gynecol Oncol. 2013;131(2):467-479. Review/Other-Dx 35 studies To review the complications associated with the surgical treatment of vulvar cancer. The heterogeneity of articles and differences in definitions and outcomes made this unsuitable for meta-analysis. Most studies advocated for change in surgical technique to reduce complications associated with inguino-femoral lymphadenectomy and surgery to the vulva, with varying success. The most effective means of preventing complications is by omitting systematic lymph node dissection. This can be achieved safely through sentinel lymph node biopsy. Saphenous vein sparing, VTE prophylaxis, the use of flaps and grafts, and preoperative counseling are additional ways to decrease morbidity. 4
19. Oonk MH, van Hemel BM, Hollema H, et al. Size of sentinel-node metastasis and chances of non-sentinel-node involvement and survival in early stage vulvar cancer: results from GROINSS-V, a multicentre observational study. Lancet Oncol. 2010;11(7):646-652. Observational-Dx 403 patients To assess the association between size of sentinel-node metastasis and risk of metastases in non-sentinel nodes, and risk of disease-specific survival in early stage vulvar cancer. Metastatic disease was identified in one or more sentinel nodes in 135 (33%) of 403 patients, and 115 (85%) of these patients had inguinofemoral lymphadenectomy. The risk of non-sentinel-node metastases was higher when the sentinel node was found to be positive with routine pathology than with ultrastaging (23 of 85 groins vs three of 56 groins, p=0.001). For this study, 723 sentinel nodes in 260 patients (2.8 sentinel nodes per patient) were reviewed. The proportion of patients with non-sentinel-node metastases increased with size of sentinel-node metastasis: one of 24 patients with individual tumour cells had a non-sentinel-node metastasis; two of 19 with metastases 2 mm or smaller; two of 15 with metastases larger than 2 mm to 5 mm; and ten of 21 with metastases larger than 5 mm. Disease-specific survival for patients with sentinel-node metastases larger than 2 mm was lower than for those with sentinel-node metastases 2 mm or smaller (69.5%vs 94.4%, p=0.001). 2
20. Te Grootenhuis NC, van der Zee AG, van Doorn HC, et al. Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I. Gynecol Oncol. 2016;140(1):8-14. Observational-Dx 377 patients To evaluate long-term follow-up of these patients regarding recurrences and survival. Themedian follow-up was 105 months (range 0-179). The overall local recurrence ratewas 27.2% at 5 years and 39.5% at 10 years after primary treatment, while for SN-negative patients 24.6% and 36.4%, and for SN-positive patients 33.2% and 46.4% respectively (p = 0.03). In 39/253 SN-negative patients (15.4%) an inguinofemoral lymphadenectomy was performed, because of a local recurrence. Isolated groin recurrence rate was 2.5% for SN-negative patients and 8.0% for SN-positive patients at 5 years. Disease-specific 10-year survival was 91% for SN-negative patients compared to 65% for SN-positive patients (p b .0001). For all patients, 10-year disease-specific survival decreased from 90% for patients without to 69% for patients with a local recurrence (p b .0001). 3
21. Covens A, Vella ET, Kennedy EB, Reade CJ, Jimenez W, Le T. Sentinel lymph node biopsy in vulvar cancer: Systematic review, meta-analysis and guideline recommendations. Gynecol Oncol. 2015;137(2):351-361. Review/Other-Dx N/A To systematically review and assess the potential for harms and benefits with the Sentinel lymph node biopsy (SLNB) procedure in order to make recommendations regarding the adoption of the procedure, selection of patients and appropriate technique and procedures. The evidence-base of a previously published health technology assessment was adopted. An additional search to update the health technology assessment (HTA) evidence base located three systematic reviews, and eleven individual studies that met the inclusion criteria. According to a meta-analysis, per groin detection rate for SLNB using radiocolloid tracer and blue dye was 87% [82-92]. The false negative rate with SLNB was 6.4% [4.4-8.8], and the recurrence rates with SLNB and inguinofemoral lymph node dissection (IFLD) were 2.8% [1.5-4.4] and 1.4% [0.5-2.6], respectively. An internal and external review process elicited concerns about the necessity of performing this procedure in an appropriate organizational context. 4
22. Oonk MH, van Os MA, de Bock GH, de Hullu JA, Ansink AC, van der Zee AG. A comparison of quality of life between vulvar cancer patients after sentinel lymph node procedure only and inguinofemoral lymphadenectomy. Gynecol Oncol. 2009;113(3):301-305. Review/Other-Tx 62 patients To compare quality of life in vulvar cancer patients who were treated with a SLN-procedure only to those who underwent inguinofemoral lymphadenectomy. With a response rate of 85%, 35 patients after the SLN-procedure and 27 patients after inguinofemoral lymphadenectomy filled out the questionnaires. No difference in overall quality of life was observed between the 2 groups. The major difference was the increase in complaints of lymphedema of the legs after inguinofemoral lymphadenectomy. The majority of patients would advise the SLN-procedure to relatives. Patients after inguinofemoral lymphadenectomy were more reserved concerning the acceptable false negative rate of a new diagnostic procedure. 4
23. Levenback CF, Ali S, Coleman RL, et al. Lymphatic mapping and sentinel lymph node biopsy in women with squamous cell carcinoma of the vulva: a gynecologic oncology group study. J Clin Oncol. 2012;30(31):3786-3791. Experimental-Dx 452 patients To determine the safety of SLN biopsy as a replacement for inguinal femoral lymphadenectomy in selected women with vulvar cancer. In all, 452 women underwent the planned procedures, and 418 had at least 1 SLN identified. There were 132 node-positive women, including 11 (8.3%) with false-negative nodes. 23% of the true-positive patients were detected by immunohistochemical analysis of the SLN. The sensitivity was 91.7% (90% lower confidence bound, 86.7%) and the false-negative predictive value (1-negative predictive value) was 3.7% (90% upper confidence bound, 6.1%). In women with tumor <4 cm, the false-negative predictive value was 2.0% (90% upper confidence bound, 4.5%). 2
24. Stehman FB, Look KY. Carcinoma of the vulva. Obstet Gynecol. 2006;107(3):719-733. Review/Other-Dx N/A To summarize the published data about squamous carcinoma of the vulva and to identify promising areas for future investigation. No results stated in abstract. 4
25. Land R, Herod J, Moskovic E, et al. Routine computerized tomography scanning, groin ultrasound with or without fine needle aspiration cytology in the surgical management of primary squamous cell carcinoma of the vulva. Int J Gynecol Cancer. 2006;16(1):312-317. Observational-Dx 75 groin To study whether computerized tomography (CT) scanning of the vulva and the groin and groin ultrasound scanning (USS) alone or with fine needle aspiration cytology (FNAC) (USS/FNAC) influenced or could influence the surgical management of primary squamous cell carcinoma of the vulva (SCCaV). A total of 75 groin dissections were performed. Twenty-five of the 44 patients (56.8%) did not have groin node metastasis, 14 had unilateral metastasis (31.8%), and 5 (11.4%) had bilateral metastasis. All cases with histologically proven nodal status were analyzed to compare the preoperative imaging status with the histology. The calculated sensitivity, specificity, negative predictive value, and positive predictive value for CT were 58%, 75%, 75%, and 58%, for USS alone-87%, 69%, 94%, and 48%, and for USS-guided FNAC-80%, 100%, 93%, and 100%, respectively. There was no patient in whom surgical planning for the vulval carcinoma or the groin nodes was or could be altered by the CT findings. 3
26. Andersen K, Zobbe V, Thranov IR, Pedersen KD. Relevance of computerized tomography in the preoperative evaluation of patients with vulvar cancer: a prospective study. Cancer Imaging. 15:8, 2015 Jun 10. Observational-Dx 30 patients To determine whether inclusion of computerized tomography (CT) in the prospective evaluation of vulvar cancer changed the surgical treatment strategy in terms of detection of lymph node metastases, tumor spread and comorbidity, and additionally to examine the logistical influence of adding further examinations prior to treating out-hospital patients referred from geographically distant areas. Thirty patients with a median age of 69 years (range 44-93 years) were included in the study. CT did not significantly change the initial surgical treatment plan for the patients. CT did not reveal lymph node enlargement outside the inguinofemoral area and was inaccurate compared to the sentinal node examination of the local lymph nodes. CT diagnosed no cases with distant metastases from the primary malignancy, but two cases with a secondary malignant disease were found. 3
27. Kamran MW, O'Toole F, Meghen K, Wahab AN, Saadeh FA, Gleeson N. Whole-body [18F]fluoro-2-deoxyglucose positron emission tomography scan as combined PET-CT staging prior to planned radical vulvectomy and inguinofemoral lymphadenectomy for squamous vulvar cancer: a correlation with groin node metastasis. Eur J Gynaecol Oncol. 2014;35(3):230-235. Observational-Dx 58 patients To determine the sensitivity, specificity, and predictive value of the modality in the detection of groin node metastases and thereby the identification of Stage III disease prior to definitive surgery for squamous vulvar cancer. In patients with histologically proven metastases to groin nodes, comparisons between PET/CT positive (True-positive) and negative (False-negative) groups vis-a-vis histology showed a tendency towards higher FDG avidity in the vulvar lesions, more bilateral nodes, multiple metastases, larger metastases and more extra-capsular extension in the True-positive group. Calculations per patient for PET/CT yielded a sensitivity of 50% and specificity at 100%. The positive predictive value was 100% and the negative predictive value was 57.1%. The test accuracy was 70% per patient. The high positive predictive value of PET/CT can be used to advance treatment planning prior to surgical staging of patients identified with Stage III disease. The poor sensitivity makes it unsuitable as a substitute for staging lymphadenectomy. 3
28. Crivellaro C, Guglielmo P, De Ponti E, et al. 18F-FDG PET/CT in preoperative staging of vulvar cancer patients: is it really effective? Medicine 2017;96:e7943. Observational-Dx 29 patients To assess the role of 18F-FDG PET/CT in preoperative staging of vulvar cancer patients. PET/CT analysis in consensus resulted negative at the inguinal LN level in 17 pts (10 true negative, 7 false negative) and positive in 12 pts (7 true positive, 5 false positive). Incidence of LN metastases resulted 48%. On pt-based analysis, sensitivity, specificity, accuracy, and negative and positive predictive value of PET/CT in detecting LN metastases were 50%, 67%, 59%, 59%, and 58%, respectively. On a groin-based analysis, considering overall 50 LN-sites, sensitivity, specificity, accuracy, and negative and positive predictive value of PET/CT were 53%, 85%, 73%, 67%, and 76%, respectively. The mean value of SUVmax was 6.1 (range 0.7-16.2) for metastatic nodes, whereas 1.6 (range 0.7 - 5.4) for negative lymph-nodes (P = .007). PET/CT detected pelvic (n = 1) and both pelvic/paraortic (n = 1) nodal metastases. 3
29. Lin G, Chen CY, Liu FY, et al. Computed tomography, magnetic resonance imaging and FDG positron emission tomography in the management of vulvar malignancies. Eur Radiol. 2015;25(5):1267-1278. Experimental-Dx 23 patients To prospectively evaluate the value of CT or MRI (CT/MRI) and PET in the management of vulvar malignancies. Twenty-three patients were enrolled, and 38 PET examinations were performed. CT/MRI and PET studies were used for primary staging (n = 17), monitoring the response (n = 7) and restaging after recurrence (n = 14). In primary staging, there was no significant difference between CT/MRI and PET in detecting metastatic inguinal lymph nodes (ILN). CT/MRI was significantly more efficacious than PET in detecting pelvic lymph node (PLN) or distant metastasis (p = 0.007 by ROC per patient basis). PET findings resulted in two positive impacts and one negative impact for both primary staging and restaging. 2
30. Robertson NL, Hricak H, Sonoda Y, et al. The impact of FDG-PET/CT in the management of patients with vulvar and vaginal cancer. Gynecologic Oncology. 140(3):420-4, 2016 Mar. Observational-Dx 50 patients To evaluate the changes in prognostic impression and patient management following positron emission tomography/computedtomography (PET/CT) in patients with vulvar and vaginal carcinoma; and to compare PET/CT findings with those of conventional imaging modalities. 54/83 (65%) studies included had a diagnosis of vulvar cancer, and the remaining 29/83 (35%), a diagnosis of vaginal cancer. Following FDG-PET/CT, the physician's prognostic impression changed in 51% of cases. A change in patient management, defined as a change to/from a non-interventional strategy (observation or additional imaging), to/from an interventional strategy (biopsy or treatment), was documented in 36% of studies. The electronic records demonstrated that 95% of the management strategies recorded in the physician questionnaires were implemented as planned. MRI and/or CT were performed within one month of the Fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) in 20/83 (24%) and 28/83 (34%) cases, respectively. FDG-PET/CT detected nodes suspicious for metastases on 29/83 (35%) studies performed. MRI and CT detected positive nodes on 6 and 11 studies respectively. Distant metastases were identified in 10 cases imaged with FDG-PET and 5 cases that had additional conventional CT imaging. All suspicious lesions seen on CT were positively identified on PET/CT. In 4 cases, an abnormality identified on PET/CT, was not seen on diagnostic CT. 3
31. Sohaib SA, Richards PS, Ind T, et al. MR imaging of carcinoma of the vulva. AJR Am J Roentgenol. 2002;178(2):373-377. Observational-Dx 22 patients To describe the magnetic resonance (MR) imaging features of cancer of the vulva and to determine the accuracy of MR imaging in staging the disease. The tumors were isointense to muscle on T1-weighted images and showed intermediate-to-high signal intensity on T2-weighted scans. After IV gadolinium was administered to four patients, tumor enhancement was seen in two (50%). MR imaging correctly staged the primary site in 14 (70%) of the 20 patients. If superficial inguinal nodes 10 mm or greater in short-axis diameter are considered abnormal, then the sensitivity for detection of malignant nodes was 40% and the specificity, 97%. If deep inguinal nodes 8 mm or greater in short-axis diameter are considered abnormal, then the sensitivity for detection of malignant nodes was 50% and the specificity, 100%. 3
32. Kataoka MY, Sala E, Baldwin P, et al. The accuracy of magnetic resonance imaging in staging of vulvar cancer: a retrospective multi-centre study. Gynecol Oncol. 2010;117(1):82-87. Observational-Dx 49 patients To retrospectively evaluate the diagnostic accuracy and clinical relevance of magnetic resonance imaging (MRI) in the management of primary and recurrent vulvar cancer and to examine the added value of contrast-enhanced MRI (CE-MRI). The size of the vulvar lesion was accurately characterized on MRI in 83% of patients. Accuracy in staging of primary vulvar cancers on unenhanced MRI was 69.4% (n=36). Adding CE-MRI increased lesion detection and raised staging accuracy from 75% to 85% (n=20). For groin lymph node metastasis prediction, the ratio of the short- to the long-axis diameter and the reader's diagnosis of lymph node metastasis yielded accuracy of 85% and 87%, respectively, in groin-by-groin analysis. 2
33. Bipat S, Fransen GA, Spijkerboer AM, et al. Is there a role for magnetic resonance imaging in the evaluation of inguinal lymph node metastases in patients with vulva carcinoma? Gynecol Oncol. 2006;103(3):1001-1006. Observational-Dx 119 patients To study the accuracy of magnetic resonance imaging (MRI) in lymph node detection in patients with vulva carcinoma. One hundred nineteen groins were examined either by sentinel node procedure or surgery, of which 23 groins were malignant. Sensitivity, specificity, positive and negative predictive values were 52%, 85%, 46% and 87% for observer 1 and 52% 89%, 52% and 89% for observer 2. The interobserver agreement was 104/119 (kappa 0.62), representing good agreement. 3
34. Singh K, Orakwue CO, Honest H, Balogun M, Lopez C, Luesley DM. Accuracy of magnetic resonance imaging of inguinofemoral lymph nodes in vulval cancer. Int J Gynecol Cancer. 2006;16(3):1179-1183. Observational-Dx 59 women To assess the accuracy of magnetic resonance imaging (MRI) in predicting inguinofemoral lymph nodes metastasis in women with vulval cancer. Clinical and MRI findings were compared with histology result to assess test accuracy. MRI had a positive likelihood ratio (LR+) of 4.8 (95% confidence interval of 2.7-8.6) and negative likelihood ratio (LR-) of 0.17 (0.06-0.49). It had a sensitivity of 85.7% (63.7-97), specificity of 82.1% (69.6-91.1), positive predictive value (PPV) of 64.3% (44.1-81.4), and negative predictive value (NPV) of 93.9% (83.1-98.7). Clinical examination had an LR+ of 6.1 (1.8-21.6) and LR- of 0.69 (0.5-0.96). It had a sensitivity of 35% (15.3-59.4), specificity of 94.3% (84.3-98.8), PPV of 70% (34.7-93.3), and NPV of 79.4% (67.3-88.5). Kappa statistics for interobserver and intraobserver agreement were 0.9091 and 0.8475, respectively. 2
35. Hawnaur JM, Reynolds K, Wilson G, Hillier V, Kitchener HC. Identification of inguinal lymph node metastases from vulval carcinoma by magnetic resonance imaging: an initial report. Clin Radiol. 2002;57(11):995-1000. Observational-Dx 10 patients To measure the accuracy of Magnetic Resonance Imaging (MRI) in identifying inguinal metastases by demonstrating abnormal lymph node morphology. MRI had a positive predictive value of 89%, negative predictive value of 91%, sensitivity of 89%, specificity of 91% and accuracy of 90%. The most useful observations on MRI to identify metastatic lymphadenopathy were those of lymph node contour irregularity, cystic change in a lymph node, short axis diameter exceeding 10mm and abnormal long: short axis diameter ratio. 3
36. de Gregorio N, Ebner F, Schwentner L, et al. The role of preoperative ultrasound evaluation of inguinal lymph nodes in patients with vulvar malignancy. Gynecol Oncol. 2013;131(1):113-117. Observational-Dx 60 patients To evaluate ultrasonography as a predictor of inguinal lymph node involvement. Histopathologically confirmed lymph node status was available for 107 of the inguinal nodes examined by ultrasound, and lymph node metastases were found in 38 (35.5%) cases. The presence or absence of inguinal lymph node metastases was correctly identified by sonography in 92 (86.0%) of the scanned areas. Sensitivity was 76.3%, specificity was 91.3%, and positive and negative predictive values were 82.9% and 87.5%, respectively 3
37. Moskovic EC, Shepherd JH, Barton DP, Trott PA, Nasiri N, Thomas JM. The role of high resolution ultrasound with guided cytology of groin lymph nodes in the management of squamous cell carcinoma of the vulva: a pilot study. Br J Obstet Gynaecol. 1999;106(8):863-867. Experimental-Dx 43 groins To test the accuracy of ultrasound and guided fine needle aspiration cytology in this setting. Of the 43 groins dissected, ultrasound correctly diagnosed the lymph node status in 36, with five false positive and two false negative results. Cytology in 40 groins showed no false positive and five false negative results. The sensitivity and specificity for the combined techniques were 83% and 82% respectively. Assessed together, the combined technique failed to detect metastatic disease in two groins; in both cases the extent of nodal metastatic involvement was a solitary focus < 3 mm in diameter. The ultrasound and fine needle aspiration procedure is safe and well tolerated and can be repeated as needed for surveillance. 3
38. Hall TB, Barton DP, Trott PA, et al. The role of ultrasound-guided cytology of groin lymph nodes in the management of squamous cell carcinoma of the vulva: 5-year experience in 44 patients. Clin Radiol. 2003;58(5):367-371. Observational-Dx 44 patients To assess the accuracy of ultrasound combined with fine-needle aspiration cytology (FNAC) in the detection of lymph node metastasis in patients with squamous cell carcinoma of the vulva. Histology demonstrated metastatic disease in 28 groins and no evidence of metastatic disease in 45. Ultrasound agreed with the histology in 67 of the 73 groins (92%), with two false-positives, four false-negatives and two indeterminate appearances. Cytology agreed with the histology in 65 of 72 FNAC samples obtained (90%), with six false-negatives, and one indeterminate result. No false-positive cytology results were seen. Ultrasound and FNAC together failed to detect metastatic disease in four groins, one with an indeterminate ultrasound appearance, another with indeterminate cytology, the two others each having a single positive inguinal node despite a negative ultrasound and FNAC. 3
39. Shylasree TS, Bryant A, Howells RE. Chemoradiation for advanced primary vulval cancer. Cochrane Database Syst Rev. 2011(4):CD003752. Review/Other-Dx N/A To evaluate the effectiveness and safety of neoadjuvant and primary chemoradiation for women with locally advanced primary vulval cancer compared to other primary modalities of treatment such as primary surgery or primary radiation. One RCT and two non-randomised studies that allowed for multivariate analyses met the inclusion criteria and included a total of 141 women.One RCT found that neoadjuvant chemoradiation did not appear to offer longer survival compared to primary surgery in advanced vulval tumours (RR = 1.29, 95% confidence interval (CI) 0.87 to 1.91). There was also no statistically significant difference in survival between primary chemoradiation and primary surgery in a study that included 63 women (pooled adjusted HR= 1.09, 95% CI 0.37 to 3.17) and in another study that only included 12 eligible women and compared the same interventions (HR was non-informative when statistical adjustment was made).Adverse events were extensively reported in only one study, which found no statistically significant difference in risk of adverse events between primary chemoradiation and primary surgery due to the very small numbers in each group. In the RCT there was no observed statistically significant difference between neoadjuvant chemoradiation and primary surgery. Adverse events were not reported in the largest study of 63 women. Quality of life (QoL) was not reported in any of the included studies. All studies were at high risk of bias. 4
40. van Doorn HC, Ansink A, Verhaar-Langereis M, Stalpers L. Neoadjuvant chemoradiation for advanced primary vulvar cancer. Cochrane Database Syst Rev. 2006(3):CD003752. Review/Other-Dx 28 studies To determine whether the combined treatment strategy using concurrent neoadjuvant chemoradiation therapy followed by surgery is effective and safe in vulvar cancer patients with advanced primary disease. Main outcomes of interest were: types of surgical intervention following chemoradiation and survival, recurrence and complication rates. Chemotherapy was given uniformly within each of the five selected studies. However, four different chemoradiation schedules were applied. Radiotherapy dose fractionation techniques, fields and target definitions varied. Skin toxicity was observed in nearly all patients. Wound breakdown, infection, lymphedema, lymphorrhea and lymphoceles were also common. Operability was achieved in 63 to 92% of cases in the four studies using 5FU and CDDP or 5FU and MMC. In contrast, only 20% of the patients who received Bleomycin were operable after chemoradiation. After a follow up of 5 to 125 months, 26 to 63% of participants were alive and well. A total of 27 to 85% of participants died due to treatment related causes or disease. The five studies included in this review show that preoperative chemoradiotherapy reduces tumour size and improves operability. However, complications of treatment are considerable and information on the effects of quality of life (QOL) is not available. Furthermore, treatment results of the respective studies diverge considerably. 4
41. Garganese G, Collarino A, Fragomeni SM, et al. Groin sentinel node biopsy and 18F-FDG PET/CT-supported preoperative lymph node assessment in cN0 patients with vulvar cancer currently unfit for minimally invasive inguinal surgery: The GroSNaPET study. Eur J Surg Oncol. 43(9):1776-1783, 2017 Sep. Observational-Dx 47 patients To verify the role of sentinel node biopsy (SNB) in a subset of patients with clinical N0 (cN0) invasive vulvar cancer (VC) who were still candidates for radical inguinal surgery according to the current guidelines and to investigate whether a preoperative (18)F-FDG PET/CT (PET/CT) evaluation could improve the selection of node negative patients. Forty-seven patients entered the study for a total of 73 groins. Histopathology revealed 12 metastatic SNs in 9 groins. No false negative SNs were found (NPV 100%). PET/CT showed a negative predictive value of 93%. 3
42. Gonzalez Bosquet J, Magrina JF, Gaffey TA, et al. Long-term survival and disease recurrence in patients with primary squamous cell carcinoma of the vulva. Gynecol Oncol. 2005;97(3):828-833. Observational-Dx 330 patients To assess time to failure and sites of failure with extended follow-up of patients with squamous cell carcinoma (SCC) of the vulva. All 330 patients in the cohort underwent lymphadenectomy; 113 patients (34.2%) had involvement of the inguinofemoral nodes and 88 patients (26.7%) had treatment failure. Treatment failures occurred more frequently in patients who presented with inguinal metastasis at the primary surgery and during the first 2 years of follow-up. After 2 years, both groups, with or without positive inguinal nodes, had similar treatment failure rates. Most patients with disease recurrence in the groin died within the first 2 years of follow-up. Involvement of the inguinal nodes was the main independent predictive factor for survival, disease recurrence, and metastasis. 3
43. Salani R, Backes FJ, Fung MF, et al. Posttreatment surveillance and diagnosis of recurrence in women with gynecologic malignancies: Society of Gynecologic Oncologists recommendations. [Review]. American Journal of Obstetrics & Gynecology. 204(6):466-78, 2011 Jun. Review/Other-Tx N/A To review the most recent data on surveillance for gynecologic cancer recurrence in women who have had a complete response to primary cancer therapy. Although gynecologic cancers account for only 10% of all new cancer cases in women, these cancers account for 20% of all female cancer survivors. Improvements in cancer care have resulted in almost 10 million cancer survivors, and this number is expected to grow. Therefore, determining the most cost-effective clinical surveillance for detection of recurrence is critical. Unfortunately, there has been a paucity of research in what are the most cost-effective strategies for surveillance once patients have achieved a complete response. Currently, most recommendations are based on retrospective studies and expert opinion. Taking a thorough history, performing a thorough examination, and educating cancer survivors about concerning symptoms is the most effective method for the detection of most gynecologic cancer recurrences. There is very little evidence that routine cytologic procedures or imaging improves the ability to detect gynecologic cancer recurrence at a stage that will impact cure or response rates to salvage therapy. 4
44. Donati OF, Lakhman Y, Sala E, et al. Role of preoperative MR imaging in the evaluation of patients with persistent or recurrent gynaecological malignancies before pelvic exenteration. European Radiology. 23(10):2906-15, 2013 Oct. Observational-Dx 50 patients To determine the diagnostic performance of MRI in assessing local tumour extent and evaluate associations between MRI features and survival in patients undergoing MRI before pelvic exenteration for persistent or recurrent gynaecological cancers. Areas under receiver operating characteristic curves (AUCs) for invasion of the bladder, rectum and pelvic sidewall were 0.96, 0.90 and 0.98 for reader 1 and 0.95, 0.88 and 0.90 for reader 2. Corresponding sensitivities/specificities were 87.0 %/92.6 %, 81.3 %/97.0 % and 87.5 %/97.2 % for reader 1, and 87.0 %/100.0 %, 75.0 %/97.0 % and 75.0 %/94.4 % for reader 2. Inter-reader agreement was excellent for organ invasion (kappa = 0.81-0.85). Pelvic sidewall invasion on MRI was associated with overall and recurrence-free survival (P = 0.01-0.04 for the two readers). 3
45. Vargas HA, Burger IA, Donati OF, et al. Magnetic resonance imaging/positron emission tomography provides a roadmap for surgical planning and serves as a predictive biomarker in patients with recurrent gynecological cancers undergoing pelvic exenteration. Int J Gynecol Cancer. 2013;23(8):1512-1519. Observational-Dx 31 patients To evaluate the incremental value of fused Magnetic resonance imaging (MRI)/PET over MRI or fluorodeoxyglucose  positron emission tomography/computed tomography (PET/CT) alone for assessing local disease extent in patients with recurrent gynecological cancers undergoing pelvic exenteration and determined the associations between imaging findings and clinical outcomes in this patient population. Compared with MRI or PET/CT, fused MRI/PET correctly improved readers' diagnostic confidence in detecting bladder, rectum, or pelvic sidewall invasion in up to 52% of patients. Interreader agreement was consistently in the highest ("almost perfect") range only for MRI/PET (kappa = 0.84-1.0). The highest sensitivities (0.82-1.0), specificities (0.91-1.0), and predictive values (0.80-1.0) were consistently achieved with fused MRI/PET (although the differences were not statistically significant [P > 0.05]). Pelvic sidewall invasion on MRI/PET was the only finding significantly associated with both progression-free and overall survival for both readers (P = 0.0067-0.0440). 2
46. Burger IA, Vargas HA, Donati OF, et al. The value of 18F-FDG PET/CT in recurrent gynecologic malignancies prior to pelvic exenteration. Gynecologic Oncology. 129(3):586-592, 2013 Jun. Observational-Dx 33 patients To assess the performance of [(18)F]-FDG PET/CT for delineating disease extent and evaluated the association between quantitative FDG uptake metrics (SUVmax, total lesion glycolysis [TLG] and metabolic tumor volume [MTV]) and progression-free survival (PFS) and overall survival (OS). 33 patients (mean age 56years, range: 28-81) were included; primary sites of disease were the cervix (n=18), uterus (n=8) and vagina/vulva (n=7). AUCs for organ invasion ranged from 0.74 to 0.96. There was a significant association between FDG uptake metrics incorporating tumor volume (TLG and MTV) and OS (p</=0.001) as well as between MTV and PFS (p=0.001). No significant association was identified between SUVmax and OS/PFS (p=0.604/0.652). Inter-reader agreement for organ invasion was fair to substantial (k=0.36-0.74) and almost perfect for FDG quantification (ICC=0.97-0.99). 2
47. 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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