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

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DOI

  • Maaike H M Oonk, University Medical Center Groningen, University of Groningen, Groningen
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  • Brian Slomovitz, Mount Sinai Medical Center
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  • Peter J W Baldwin, Cambridge University Hospitals NHS Foundation Trust
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  • Helena C van Doorn, University Medical Center Rotterdam
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  • Jacobus van der Velden, Amsterdam University Medical Center
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  • Joanne A de Hullu, Radboud University Medical Center
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  • Katja N Gaarenstroom, Leiden University Medical Center, Leiden, The Netherlands.
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  • Brigitte F M Slangen, Maastricht University Medical Center
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  • Ignace Vergote, Leuven Cancer Institute, Leuven, Belgium
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  • Mats Brännström, Univ Gothenburg, University of Gothenburg, Gothenburg Global Biodivers Ctr
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  • Eleonora B L van Dorst, University Medical Center Utrecht
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  • Willemien J van Driel, The Netherlands Cancer Institute, Amsterdam, The Netherlands
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  • Ralph H Hermans, Department of Surgery, Catharina Ziekenhuis Eindhoven, Eindhoven, The Netherlands.
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  • David Nunns, Nottingham University Hospitals NHS Trust
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  • Martin Widschwendter, University College London, London
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  • David Nugent, St. James University Hospital, Leeds
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  • Cathrine M Holland, Manchester University NHS Foundation Trust-St Marys Hospital
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  • Aarti Sharma, All Wales Medical Genetics Services, University Hospital of Wales.
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  • Paul A DiSilvestro, Women and Infants Hospital of Rhode Island
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  • Robert Mannel, Univ Oklahoma, University of Oklahoma - Norman, University of Oklahoma System
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  • Dorry Boll, Department of Surgery, Catharina Ziekenhuis Eindhoven, Eindhoven, The Netherlands.
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  • David Cibula, Charles University in Prague, 1st Medical Faculty and General University Hospital in Prague, Prague, Czech Republic.
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  • Al Covens, Toronto Western Hosp, University of Toronto, University Health Network Toronto
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  • Diane Provencher, Health Innovation and Evaluation Hub, CHUM Research Centre, Montreal
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  • Ingo B Runnebaum, SRH Waldklinikum Gera, University Hospital Jena, Jena
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  • David Luesley, University Hospitals Birmingham, Birmingham, UK.
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  • Patricia Ellis, Royal Surrey County Hospital NHS Foundation Trust
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  • Timothy J Duncan, Norfolk and Norwich University Hospital NHS Trust
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  • Ming Y Tjiong, Amsterdam University Medical Center
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  • Derek J Cruickshank, James Cook University Hospital
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  • Preben Kjølhede, Linköping University, Linköping, Sweden
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  • Charles F Levenback, MD Anderson Cancer Center Orlando
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  • Jiri Bouda, Charles Darwin Univ, Charles Darwin University, RIEL
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  • Katharina E Kieser, Dalhousie Univ, Dalhousie University, Dept Biol
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  • Connie Palle, Capio CFR
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  • Nicola M Spirtos, Women's Cancer Center of Nevada
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  • David M O'Malley, Ohio State University Comprehensive Cancer Center-James Cancer Hospital
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  • Mario M Leitao, Mem Sloan Kettering Canc Ctr, Memorial Sloan Kettering Cancer Center, Dept Surg, Gynecol Serv
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  • Melissa A Geller, Univ Minnesota, University of Minnesota Twin Cities, University of Minnesota System, University of Minnesota Duluth, Dept Earth & Environm Sci
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  • Kalyan Dhar, Singleton Hospital
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  • Viren Asher, University Hospitals of Derby and Burton
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  • Karl Tamussino, Cancer Biology Unit, Department of Dermatology, Medical University of Graz, Graz, Austria; Center for Medical Research, Medical University of Graz, Graz, Austria.
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  • Daniel H Tobias, Morristown Medical Center
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  • Christer Borgfeldt, Department of Nephrology in Lund, Clinical Sciences Lund, Skåne University Hospital and Lund University, Lund, Sweden.
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  • Jayanthi S Lea, UT Southwestern Medical Center (M.K.J.)
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  • Jo Bailey, St Michaels Hospital, Bristol
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  • Margareta Lood, Karlstad Central Hospital
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  • Brynhildur Eyjolfsdottir, Department of Gynaecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Institute for Cancer Genetics and Informatics, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Faculty of Medicine, University of Oslo, Oslo, Norway.
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  • Stephen Attard-Montalto, Maidstone Hospital
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  • Krishnansu S. Tewari, University of California
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  • Ranjit Manchanda, Queen Mary University of London
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  • Pernille T Jensen
  • Par Persson, Uppsala University
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  • Linda Van Le , University of North Carolina
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  • Hein Putter, Leiden University
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  • Geertruida H de Bock, University of Groningen, Danmark
  • Bradley J. Monk, St Josephs Hospital, Phoenix
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  • Carien L Creutzberg, Leiden University
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  • Ate G. J. van der Zee, University of Groningen

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.

OriginalsprogEngelsk
TidsskriftJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Vol/bind39
Nummer32
Sider (fra-til) 3623-3632
Antal sider10
ISSN0732-183X
DOI
StatusUdgivet - nov. 2021

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