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Oonk MHM, Slomovitz B, Baldwin PJW, et al. Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II. J Clin Oncol. 2021;39(32):3623-3632doi: 10.1200/JCO.21.00006.
Oonk, M. H. M., Slomovitz, B., Baldwin, P. J. W., van Doorn, H. C., van der Velden, J., de Hullu, J. A., Gaarenstroom, K. N., Slangen, B. F. M., Vergote, I., Brännström, M., van Dorst, E. B. L., van Driel, W. J., Hermans, R. H., Nunns, D., Widschwendter, M., Nugent, D., Holland, C. M., Sharma, A., DiSilvestro, P. A., Mannel, R., Boll, D., Cibula, D., Covens, A., Provencher, D., Runnebaum, I. B., Luesley, D., Ellis, P., Duncan, T. J., Tjiong, M. Y., Cruickshank, D. J., Kjølhede, P., Levenback, C. F., Bouda, J., Kieser, K. E., Palle, C., Spirtos, N. M., O'Malley, D. M., Leitao, M. M., Geller, M. A., Dhar, K., Asher, V., Tamussino, K., Tobias, D. H., Borgfeldt, C., Lea, J. S., Bailey, J., Lood, M., Eyjolfsdottir, B., Attard-Montalto, S., Tewari, K. S., Manchanda, R., Jensen, P. T., Persson, P., Van Le, L., Putter, H., de Bock, G. H., Monk, B. J., Creutzberg, C. L., & van der Zee, A. G. J. (2021). Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 39(32), 3623-3632. https://doi.org/10.1200/JCO.21.00006
Oonk, Maaike H M, et al. "Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II." Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 39,32 (2021): 3623-3632. doi: https://doi.org/10.1200/JCO.21.00006
Oonk MHM, Slomovitz B, Baldwin PJW, van Doorn HC, van der Velden J, de Hullu JA, Gaarenstroom KN, Slangen BFM, Vergote I, Brännström M, van Dorst EBL, van Driel WJ, Hermans RH, Nunns D, Widschwendter M, Nugent D, Holland CM, Sharma A, DiSilvestro PA, Mannel R, Boll D, Cibula D, Covens A, Provencher D, Runnebaum IB, Luesley D, Ellis P, Duncan TJ, Tjiong MY, Cruickshank DJ, Kjølhede P, Levenback CF, Bouda J, Kieser KE, Palle C, Spirtos NM, O'Malley DM, Leitao MM, Geller MA, Dhar K, Asher V, Tamussino K, Tobias DH, Borgfeldt C, Lea JS, Bailey J, Lood M, Eyjolfsdottir B, Attard-Montalto S, Tewari KS, Manchanda R, Jensen PT, Persson P, Van Le L, Putter H, de Bock GH, Monk BJ, Creutzberg CL, van der Zee AGJ. Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II. J Clin Oncol. 2021 Nov 10;39(32):3623-3632. doi: 10.1200/JCO.21.00006. Epub 2021 Aug 25. PMID: 34432481; PMCID: PMC8577685.
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J Clin Oncol. 2021 Nov 10;39(32):3623-3632. doi: 10.1200/JCO.21.00006. Epub 2021 Aug 25.

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

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Maaike H M Oonk, Brian Slomovitz, Peter J W Baldwin, Helena C van Doorn, Jacobus van der Velden, Joanne A de Hullu, Katja N Gaarenstroom, Brigitte F M Slangen, Ignace Vergote, Mats Brännström, Eleonora B L van Dorst, Willemien J van Driel, Ralph H Hermans, David Nunns, Martin Widschwendter, David Nugent, Cathrine M Holland, Aarti Sharma, Paul A DiSilvestro, Robert Mannel, Dorry Boll, David Cibula, Al Covens, Diane Provencher, Ingo B Runnebaum, David Luesley, Patricia Ellis, Timothy J Duncan, Ming Y Tjiong, Derek J Cruickshank, Preben Kjølhede, Charles F Levenback, Jiri Bouda, Katharina E Kieser, Connie Palle, Nicola M Spirtos, David M O'Malley, Mario M Leitao, Melissa A Geller, Kalyan Dhar, Viren Asher, Karl Tamussino, Daniel H Tobias, Christer Borgfeldt, Jayanthi S Lea, Jo Bailey, Margareta Lood, Brynhildur Eyjolfsdottir, Stephen Attard-Montalto, Krishnansu S Tewari, Ranjit Manchanda, Pernille T Jensen, Par Persson, Linda Van Le, Hein Putter, Geertruida H de Bock, Bradley J Monk, Carien L Creutzberg, Ate G J van der Zee

Affiliations

  1. University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
  2. Mount Sinai Medical Center, Miami Beach, FL.
  3. Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.
  4. Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands.
  5. Amsterdam University Medical Center, Amsterdam, the Netherlands.
  6. Radboud University Medical Center, Nijmegen, the Netherlands.
  7. Leiden University Medical Center, Leiden, the Netherlands.
  8. Maastricht University Medical Center+, Maastricht, the Netherlands.
  9. Leuven Cancer Institute, Leuven, Belgium.
  10. Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.
  11. University Medical Center Utrecht, Utrecht, the Netherlands.
  12. Center of Gynecological Oncology Amsterdam, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
  13. Catharina Ziekenhuis Eindhoven, the Netherlands.
  14. Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.
  15. UCL EGA Institute for Women's Health, University College London, London, United Kingdom.
  16. Leeds Teaching Hospitals NHS Trust, St James' University Hospital, Leeds, United Kingdom.
  17. Manchester University NHS Foundation Trust-St Marys Hospital, Manchester, United Kingdom.
  18. University Hospital of Wales, Cardiff, United Kingdom.
  19. Women and Infants Hospital of Rhode Island, Providence, RI.
  20. Stephenson Cancer Center, University of Oklahoma, Oklahoma City, OK.
  21. First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic.
  22. University of Toronto, Toronto, Ontario, Canada.
  23. CHUM, Université de Montréal, Montréal, Quebec, Canada.
  24. Jena University Hospital, Friedrich Schiller University, Jena, Germany.
  25. University of Birmingham, Birmingham, United Kingdom.
  26. Royal Surrey NHS Foundation Trust, Guildford, United Kingdom.
  27. Norfolk and Norwich University Hospital NHS Trust, Norwich, United Kingdom.
  28. James Cook University Hospital, South Tees NHS Foundation Trust, Middlesbrough, United Kingdom.
  29. Linköping University, Linköping, Sweden.
  30. MD Anderson Cancer Center, Houston, TX.
  31. University Hospital Pilsen, Charles University, Faculty of Medicine, Pilsen, Czech Republic.
  32. Dalhousie University, Halifax, Nova Scotia, Canada.
  33. Capio, Part of Ramsey Santé, Hellerup, Denmark.
  34. Women's Cancer Center of Nevada, Las Vegas, NV.
  35. Ohio State University Comprehensive Cancer Center-James Cancer Hospital, Columbus, OH.
  36. Memorial Sloan Kettering Cancer Center, New York, NY.
  37. University of Minnesota, Minneapolis, MN.
  38. Singleton Hospital, Swansea, United Kingdom.
  39. University Hospitals of Derby and Burton, Derby, United Kingdom.
  40. Medical University Graz, Graz, Austria.
  41. Morristown Medical Center, Morristown, NJ.
  42. Skåne University Hospital, Lund University, Lund, Sweden.
  43. UT Southwestern Medical Center, Dallas, TX.
  44. St Michaels Hospital, Bristol, United Kingdom.
  45. Central Hospital Karlstad, Karlstad, Sweden.
  46. Oslo University Hospital, Radiumhospitalet, Oslo, Norway.
  47. West Kent Cancer Centre, Maidstone Hospital, Maidstone, United Kingdom.
  48. UC Irvine Health Medical Center, Orange, CA.
  49. Wolfson Institute of Population Health, Queen Mary University of London, London, United Kingdom.
  50. Aarhus University Hospital, Aarhus, Denmark.
  51. Uppsala University, Uppsala, Sweden.
  52. University of North Carolina, Chapel Hill, NC.
  53. St Josephs Hospital and Medical Center, Phoenix, AZ.

PMID: 34432481 PMCID: PMC8577685 DOI: 10.1200/JCO.21.00006

Abstract

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 (

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.

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