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

Author:

Oonk Maaike H. M.1ORCID,Slomovitz Brian2ORCID,Baldwin Peter J. W.3,van Doorn Helena C.4,van der Velden Jacobus5ORCID,de Hullu Joanne A.6,Gaarenstroom Katja N.7,Slangen Brigitte F. M.8ORCID,Vergote Ignace9ORCID,Brännström Mats10ORCID,van Dorst Eleonora B. L.11,van Driel Willemien J.12ORCID,Hermans Ralph H.13,Nunns David14,Widschwendter Martin15,Nugent David16,Holland Cathrine M.17,Sharma Aarti18,DiSilvestro Paul A.19ORCID,Mannel Robert20,Boll Dorry13,Cibula David21ORCID,Covens Al22,Provencher Diane23,Runnebaum Ingo B.24,Luesley David25ORCID,Ellis Patricia26,Duncan Timothy J.27,Tjiong Ming Y.5,Cruickshank Derek J.28,Kjølhede Preben29ORCID,Levenback Charles F.30,Bouda Jiri31ORCID,Kieser Katharina E.32,Palle Connie33ORCID,Spirtos Nicola M.34,O'Malley David M.35ORCID,Leitao Mario M.36ORCID,Geller Melissa A.37,Dhar Kalyan38ORCID,Asher Viren39,Tamussino Karl40ORCID,Tobias Daniel H.41,Borgfeldt Christer42,Lea Jayanthi S.43,Bailey Jo44,Lood Margareta45,Eyjolfsdottir Brynhildur46,Attard-Montalto Stephen47,Tewari Krishnansu S.48ORCID,Manchanda Ranjit49ORCID,Jensen Pernille T.50ORCID,Persson Par51,Van Le Linda52ORCID,Putter Hein7ORCID,de Bock Geertruida H.1ORCID,Monk Bradley J.53ORCID,Creutzberg Carien L.7ORCID,van der Zee Ate G. J.1

Affiliation:

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

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 ( 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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Cited by 85 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3