Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, Webcast
Grant support
P30 CA008748
NCI NIH HHS - United States
P30 CA016058
NCI NIH HHS - United States
UG1 CA233193
NCI NIH HHS - United States
UG1 CA233331
NCI NIH HHS - United States
PubMed
34432481
PubMed Central
PMC8577685
DOI
10.1200/jco.21.00006
Knihovny.cz E-resources
- MeSH
- Time Factors MeSH
- Radiation Dosage * MeSH
- Middle Aged MeSH
- Humans MeSH
- Lymph Node Excision * adverse effects mortality MeSH
- Lymphatic Metastasis MeSH
- Neoplasm Micrometastasis MeSH
- Vulvar Neoplasms mortality pathology therapy MeSH
- Prospective Studies MeSH
- Aged MeSH
- Sentinel Lymph Node pathology radiation effects surgery MeSH
- Neoplasm Staging MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Comparative Study MeSH
- Webcast MeSH
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.
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
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
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