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

MHM. Oonk, B. Slomovitz, PJW. Baldwin, HC. van Doorn, J. van der Velden, JA. de Hullu, KN. Gaarenstroom, BFM. Slangen, I. Vergote, M. Brännström, EBL. van Dorst, WJ. van Driel, RH. Hermans, D. Nunns, M. Widschwendter, D. Nugent, CM. Holland, A....

. 2021 ; 39 (32) : 3623-3632. [pub] 20210825

Language English Country United States

Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Webcast

Persistent link   https://www.medvik.cz/link/bmc22003213

Grant support
UG1 CA233193 NCI NIH HHS - United States
UG1 CA233331 NCI NIH HHS - United States

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.

1st Faculty of Medicine Charles University and General University Hospital Prague Prague Czech Republic

Aarhus University Hospital Aarhus Denmark

Amsterdam University Medical Center Amsterdam the Netherlands

Cambridge University Hospitals NHS Foundation Trust Cambridge United Kingdom

Capio Part of Ramsey Santé Hellerup Denmark

Catharina Ziekenhuis Eindhoven the Netherlands

Center of Gynecological Oncology Amsterdam The Netherlands Cancer Institute Amsterdam the Netherlands

Central Hospital Karlstad Karlstad Sweden

CHUM Université de Montréal Montréal Quebec Canada

Dalhousie University Halifax Nova Scotia Canada

Erasmus MC Cancer Institute University Medical Center Rotterdam Rotterdam the Netherlands

James Cook University Hospital South Tees NHS Foundation Trust Middlesbrough United Kingdom

Jena University Hospital Friedrich Schiller University Jena Germany

Leeds Teaching Hospitals NHS Trust St James' University Hospital Leeds United Kingdom

Leiden University Medical Center Leiden the Netherlands

Leuven Cancer Institute Leuven Belgium

Linköping University Linköping Sweden

Maastricht University Medical Center Maastricht the Netherlands

Manchester University NHS Foundation Trust St Marys Hospital Manchester United Kingdom

MD Anderson Cancer Center Houston TX

Medical University Graz Graz Austria

Memorial Sloan Kettering Cancer Center New York NY

Morristown Medical Center Morristown NJ

Mount Sinai Medical Center Miami Beach FL

Norfolk and Norwich University Hospital NHS Trust Norwich United Kingdom

Nottingham University Hospitals NHS Trust Nottingham United Kingdom

Ohio State University Comprehensive Cancer Center James Cancer Hospital Columbus OH

Oslo University Hospital Radiumhospitalet Oslo Norway

Radboud University Medical Center Nijmegen the Netherlands

Royal Surrey NHS Foundation Trust Guildford United Kingdom

Sahlgrenska Academy University of Gothenburg Göteborg Sweden

Singleton Hospital Swansea United Kingdom

Skåne University Hospital Lund University Lund Sweden

St Josephs Hospital and Medical Center Phoenix AZ

St Michaels Hospital Bristol United Kingdom

Stephenson Cancer Center University of Oklahoma Oklahoma City OK

UC Irvine Health Medical Center Orange CA

UCL EGA Institute for Women's Health University College London London United Kingdom

University Hospital of Wales Cardiff United Kingdom

University Hospital Pilsen Charles University Faculty of Medicine Pilsen Czech Republic

University Hospitals of Derby and Burton Derby United Kingdom

University Medical Center Groningen University of Groningen Groningen the Netherlands

University Medical Center Utrecht Utrecht the Netherlands

University of Birmingham Birmingham United Kingdom

University of Minnesota Minneapolis MN

University of North Carolina Chapel Hill NC

University of Toronto Toronto Ontario Canada

Uppsala University Uppsala Sweden

UT Southwestern Medical Center Dallas TX

West Kent Cancer Centre Maidstone Hospital Maidstone United Kingdom

Wolfson Institute of Population Health Queen Mary University of London London United Kingdom

Women and Infants Hospital of Rhode Island Providence RI

Women's Cancer Center of Nevada Las Vegas NV

References provided by Crossref.org

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