Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II

PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL

Unilateral inguinofemoral lymphadenectomy in patients with early-stage vulvar squamous cell carcinoma and a unilateral metastatic sentinel lymph node is safe.

OBJECTIVE: Optimal management of the contralateral groin in patients with early-stage vulvar squamous cell carcinoma (VSCC) and a metastatic unilateral inguinal sentinel lymph node (SN) is unclear. We analyzed patients who participated in GROINSS-V I or II to determine whether treatment of the contralateral groin can safely be omitted in patients with a unilateral metastatic SN. METHODS: We selected the patients with a unilateral metastatic SN from the GROINSS-V I and II databases. We determined the incidence of contralateral additional non-SN metastases in patients with unilateral SN-metastasis who underwent bilateral inguinofemoral lymphadenectomy (IFL). In those who underwent only ipsilateral groin treatment or no further treatment, we determined the incidence of contralateral groin recurrences during follow-up. RESULTS: Of 1912 patients with early-stage VSCC, 366 had a unilateral metastatic SN. Subsequently, 244 had an IFL or no treatment of the contralateral groin. In seven patients (7/244; 2.9% [95% CI: 1.4%-5.8%]) disease was diagnosed in the contralateral groin: five had contralateral non-SN metastasis at IFL and two developed an isolated contralateral groin recurrence after no further treatment. Five of them had a primary tumor ≥30 mm. Bilateral radiotherapy was administered in 122 patients, of whom one (1/122; 0.8% [95% CI: 0.1%-4.5%]) had a contralateral groin recurrence. CONCLUSION: The risk of contralateral lymph node metastases in patients with early-stage VSCC and a unilateral metastatic SN is low. It appears safe to limit groin treatment to unilateral IFL or inguinofemoral radiotherapy in these cases

Prediction of lymph node metastases in vulvar cancer: a review

The aim of this study was to review the literature on currently available non- and minimally-invasive diagnostic methods and analysis of primary tumor characteristics for prediction of inguinofemoral lymph node metastases in patients with primary squamous cell carcinoma of the vulva. We used the English language literature in Pubmed and reference lists from selected articles. Search terms included vulvar carcinoma, prognosis, lymph node metastases, ultrasound, computer tomography, magnetic resonance imaging, positron emission tomography, and sentinel lymph node. No study type restrictions were imposed. Currently no noninvasive imaging techniques exist that are able to predict lymph node metastases with a high enough negative predictive value. A depth of invasio

Pitfalls in the sentinel lymph node procedure in vulvar cancer

Objectives. There is an increasing interest among gynecologic oncologists to implement the sentinel lymph node (SLN) procedure in vulvar cancer patients in clinical practice. However, the safety of this promising method of staging still has to be proven in a randomized trial.Materials and methods. Two vulvar cancer patients are reported to illustrate pitfalls in the sentinel lymph node procedure.Results. The phenomena of bypassing the sentinel lymph node and confusion about the number of removed sentinel lymph nodes are presented and discussed.Conclusion. Gynecological oncologists who perform the sentinel lymph node procedure in vulvar cancer patients should perform this technique by following a strict protocol and within the protection of a clinical trial. (C) 2004 Elsevier Inc. All rights reserved.</p

The value of routine follow-up in patients treated for carcinoma of the vulva

BACKGROUND. Vulvar carcinoma patients traditionally are offered follow-up after their primary treatment because earlier diagnosis of recurrent disease is believed to improve chances for curative treatment. The objective of the current study was to determine the value of a strict routine follow-up protocol for the detection of recurrences in a large series of patients who were treated for carcinoma of the vulva. METHODS. Clinicopathologic data for patients with primary squamous cell carcinoma of the vulva who were treated between January 1990 and July 2000 were prospectively stored in a database. After treatment, patients visited the outpatient clinic at the study institution at gradually increasing intervals. When a recurrence was diagnosed, it was indicated whether the recurrence was local, occurred in the skin bridge, occurred in the inguinal region, or was distant, and this information was registered. Moreover, it was noted whether the diagnosis was made at a routinely scheduled or at an interval follow-up meeting and whether symptoms as noted by the patient herself led to the diagnosis. RESULTS. Data from 238 patients with International Federation of Gynecology and Obstetrics (FIGO) Stage I-IV vulvar carcinoma were analyzed with a mean follow-up of 63 months (median, 58 months; range, 6-149 months). Sixty-five of 238 patients (27%) developed recurrent disease; 49 were local recurrences, 2 recurrences were found in the skin bridge, 6 were found in the inguinal region, and 8 were distant recurrences. Forty-two of these 65 recurrences (65%) were detected at a routinely scheduled follow-up meeting, at which time 21 of the 42 patients with recurrent disease (50%) reported symptoms or signs. Local recurrences diagnosed at a routinely scheduled follow-up meeting were found to have a smaller greater dimension (mean, 2.1 cm and median, 1.6 cm; range, 0.3-8.0 cm) compared with recurrences detected at an interval meeting (mean, 3.1 cm and median, 3.0 cm; range, 0.4-7.0 cm) (P = 0.04). CONCLUSIONS. T he data from the current study indicated that routinely scheduled follow-up meetings with patients with carcinoma of the vulva result in the detection of smaller recurrences in a substantial proportion of patients compared with self-reported recurrences, without a measurable effect on morbidity or mortality. (C) 2003 American Cancer Society

Adjuvant radiotherapy in patients with vulvar cancer and one intra capsular lymph node metastasis is not beneficial

Aim of the study. The aim of the study was to analyze the benefit from adjuvant radiotherapy in patients with vulvar cancer and a single positive node without extra capsular spread. Materials and methods. The Study population comprised data of 75 patients with vulvar cancer and one lymph node metastasis. The patients were treated in three different university centers in Amsterdam, Groningen and Rotterdam between 1984 and 2005. Results. Out of 75 patients, 31 (41%) were treated with adjuvant radiotherapy. Both disease-free survival (DFS) and disease-specific survival (DSS) were comparable between the groups who did and who did not receive adjuvant radiotherapy (HR 0.98, 95% CI 0.45-2.14, p=0.97 and HR = 1.02, 95% CI 0.42-2.47, p = 0.96). Conclusion. We could not demonstrate any beneficial effect of adjuvant radiotherapy in the group Of patients with one intra capsular metastasis. (C) 2009 Elsevier Inc. All rights reserved

Repeat sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma is feasible

Objective. Standard treatment of primary T1 squamous cell carcinoma (SCC) of the vulva <4 cm consists of wide local excision (WLE) and sentinel lymph node (SLN) procedure of the groin(s). In case of a local recurrence WLE and inguino femoral lymphadenectomy (IFL) is generally recommended. In this study we assessed the feasibility of repeat SLN procedure in patients with recurrent vulvar SCC who were not able or willing to undergo IFL. Methods. A retrospective study was performed in consecutive patients with recurrent vulvar SCC who underwent a repeat SLN procedure between 2006 and 2014. We present the clinical and pathological outcomes. The study conforms to the STROBE guidelines. Results. A total number of 27 patients aged 35-87 years at first diagnosis of SCC of the vulva were identified. Median follow-up after 2nd surgery was 27.4 (range 2-96) months. In 78% of patients and in 84% of the groins the repeat SLN procedure was successful. No structured questionnaires were used to describe details on the repeat SLN procedures but in general the gynecologic oncologists experienced repeat SLN procedures more challenging compared to primary procedures. There were no groin recurrences documented. Conclusions. Our findings suggest that it is feasible to perform a repeat SLN procedure in recurrent vulvar SCC, but the procedure appears technically more challenging compared to primary setting, resulting in a lower SLN identification rate. (C) 2016 Elsevier Inc. All rights reserved