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

被引：87

作者：

Oonk, Maaike H. M. ^{[1
]}

Slomovitz, Brian ^{[2
]}

Baldwin, Peter J. W. ^{[3
]}

van Doorn, Helena C. ^{[4
]}

van der Velden, Jacobus ^{[5
]}

de Hullu, Joanne A. ^{[6
]}

Gaarenstroom, Katja N. ^{[7
]}

Slangen, Brigitte F. M. ^{[8
]}

Vergote, Ignace ^{[9
]}

Brannstrom, Mats ^{[10
]}

van Dorst, Eleonora B. L. ^{[11
]}

van Driel, Willemien J. ^{[12
]}

Hermans, Ralph H. ^{[13
]}

Nunns, David ^{[14
]}

Widschwendter, Martin ^{[15
]}

Nugent, David ^{[16
]}

Holland, Cathrine M. ^{[17
]}

Sharma, Aarti ^{[18
]}

DiSilvestro, Paul A. ^{[19
]}

Mannel, Robert ^{[20
]}

Boll, Dorry ^{[13
]}

Cibula, David ^{[21
,22
]}

Covens, Al ^{[23
]}

Provencher, Diane ^{[24
]}

Runnebaum, Ingo B. ^{[25
]}

Luesley, David ^{[26
]}

Ellis, Patricia ^{[27
]}

Duncan, Timothy J. ^{[28
]}

Tjiong, Ming Y. ^{[5
]}

Cruickshank, Derek J. ^{[29
]}

Kjolhede, Preben ^{[30
]}

Levenback, Charles F. ^{[31
]}

Bouda, Jiri ^{[32
]}

Kieser, Katharina E. ^{[33
]}

Palle, Connie ^{[34
]}

Spirtos, Nicola M. ^{[35
]}

O'Malley, David M. ^{[36
]}

Leitao, Mario M. ^{[37
]}

Geller, Melissa A. ^{[38
]}

Dhar, Kalyan ^{[39
]}

Asher, Viren ^{[40
]}

Tamussino, Karl ^{[41
]}

Tobias, Daniel H. ^{[42
]}

Borgfeldt, Christer ^{[43
]}

Lea, Jayanthi S. ^{[44
]}

Bailey, Jo ^{[45
]}

Lood, Margareta ^{[46
]}

Eyjolfsdottir, Brynhildur ^{[47
]}

Attard-Montalto, Stephen ^{[48
]}

Tewari, Krishnansu S. ^{[49
]}

机构：

[1] Univ Groningen, Univ Med Ctr Groningen, Groningen, Netherlands

[2] Mt Sinai Med Ctr, Miami Beach, FL 33140 USA

[3] Cambridge Univ Hosp NHS Fdn Trust, Cambridge, England

[4] Univ Med Ctr Rotterdam, Erasmus MC Canc Inst, Rotterdam, Netherlands

[5] Amsterdam Univ Med Ctr, Amsterdam, Netherlands

[6] Radboud Univ Nijmegen Med Ctr, Nijmegen, Netherlands

[7] Leiden Univ Med Ctr, Leiden, Netherlands

[8] Maastricht Univ Med Ctr, Maastricht, Netherlands

[9] Leuven Canc Inst, Leuven, Belgium

[10] Univ Gothenburg, Sahlgrenska Acad, Gothenburg, Sweden

[11] Univ Med Ctr Utrecht, Utrecht, Netherlands

[12] Netherlands Canc Inst, Ctr Gynecol Oncol Amsterdam, Amsterdam, Netherlands

[13] Catharina Ziekenhuis Eindhoven, Catharina Ziekenhuis Ein, Netherlands

[14] Nottingham Univ Hosp NHS Trust, Nottingham, England

[15] UCL, UCL EGA Inst Womens Hlth, London, England

[16] Leeds Teaching Hosp NHS Trust, St James Univ Hosp, Leeds, W Yorkshire, England

[17] Manchester Univ NHS Fdn Trust, St Marys Hosp, Manchester, Lancs, England

[18] Univ Hosp Wales, Cardiff, Wales

[19] Women & Infants Hosp Rhode Isl, Providence, RI 02908 USA

[20] Univ Oklahoma, Stephenson Canc Ctr, Oklahoma City, OK USA

[21] Charles Univ Prague, Fac Med 1, Prague, Czech Republic

[22] Gen Univ Hosp Prague, Prague, Czech Republic

[23] Univ Toronto, Toronto, ON, Canada

[24] Univ Montreal, CHUM, Montreal, PQ, Canada

[25] Friedrich Schiller Univ, Jena Univ Hosp, Jena, Germany

[26] Univ Birmingham, Birmingham, W Midlands, England

[27] Royal Surrey NHS Fdn Trust, Guildford, Surrey, England

[28] Norfolk & Norwich Univ Hosp NHS Trust, Norwich, Norfolk, England

[29] South Tees NHS Fdn Trust, James Cook Univ Hosp, Middlesbrough, Cleveland, England

[30] Linkoping Univ, Linkoping, Sweden

[31] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[32] Charles Univ Prague, Univ Hosp Pilsen, Fac Med, Plzen, Czech Republic

[33] Dalhousie Univ, Halifax, NS, Canada

[34] Capio, Hellerup, Denmark

[35] Womens Canc Ctr Nevada, Las Vegas, NV USA

[36] Ohio State Univ, Comprehens Canc Ctr, James Canc Hosp, Columbus, OH 43210 USA

[37] Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA

[38] Univ Minnesota, Minneapolis, MN USA

[39] Singleton Hosp, Swansea, W Glam, Wales

[40] Univ Hosp Derby & Burton, Derby, England

[41] Med Univ Graz, Graz, Austria

[42] Morristown Med Ctr, Morristown, NJ USA

[43] Lund Univ, Skane Univ Hosp, Lund, Sweden

[44] UT Southwestern Med Ctr, Dallas, TX USA

[45] St Michaels Hosp, Bristol, Avon, England

[46] Cent Hosp Karlstad, Karlstad, Sweden

[47] Oslo Univ Hosp, Radiumhosp, Oslo, Norway

[48] Maidstone Hlth Author, West Kent Canc Ctr, Maidstone, Kent, England

[49] UC Irvine Hlth Med Ctr, Orange, CA USA

[50] Queen Mary Univ London, Wolfson Inst Populat Hlth, London, England

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2021年 / 39卷 / 32期

关键词：

RADIATION;

D O I：

10.1200/JCO.21.00006

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2021 by American Society of Clinical Oncology

引用

页码：3623 / +

页数：11

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