volume 39 issue 32 pages 3623-3632

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

Maaike HM Oonk 1
Brian M Slomovitz 2
Peter J W Baldwin 3
Helena C. van Doorn 4
Jacobus Van Der Velden 5
Joanne A de Hullu 6
Katja N. Gaarenstroom 7
Brigitte Slangen 8
Ignace B. Vergote 9
Mats Brännström 10
Eleonora B L Van Dorst 11
Willemien J. van Driel 12
Ralph H. Hermans 13
David Nunns 14
Martin Widschwendter 15
David Nugent 16
Cathrine M. Holland 17
Aarti Sharma 18
Paul Disilvestro 19
Robert Mannel 20
Dorry Boll 13
David Cibula 21
Al Covens 22
Diane Provencher 23
Ingo B. Runnebaum 24
David Luesley 25
Patricia Ellis 26
Timothy J Duncan 27
Ming Y. Tjiong 5
Derek J. Cruickshank 28
P. Kjølhede 29
Charles F. Levenback 30
Jiri Bouda 31
Katharina E. Kieser 32
Connie Palle 33
Nicola M. Spirtos 34
David M. O’Malley 35
Mario Leitao 36
Melissa A Geller 37
Kalyan Dhar 38
Viren Asher 39
KARL TAMUSSINO 40
Daniel H. Tobias 41
Christer Borgfeldt 42
Jayanthi S Lea 43
Jo Bailey 44
Margareta Lood 45
Brynhildur Eyjólfsdóttir 46
Stephen Attard Montalto 47
Krishnansu S. Tewari 48
Ranjit Manchanda 49
Pernille T. Jensen 50
Par Persson 51
Linda Van Le 52
Hein Putter 7
Geertruida H. de Bock 1
Bradley J. Monk 53
Ate G. J. van der Zee 1
2
 
Mount Sinai Medical Center, Miami Beach, FL
16
 
Leeds Teaching Hospitals NHS Trust, St James' University Hospital, Leeds, United Kingdom
18
 
University Hospital of Wales, Cardiff, United Kingdom
19
 
Women and Infants Hospital of Rhode Island, Providence, RI
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
33
 
Capio, Part of Ramsey Santé, Hellerup, Denmark
34
 
Women's Cancer Center of Nevada, Las Vegas, NV
38
 
Singleton Hospital, Swansea, United Kingdom
39
 
University Hospitals of Derby and Burton, Derby, United Kingdom
41
 
Morristown Medical Center, Morristown, NJ
44
 
St Michaels Hospital, Bristol, United Kingdom
47
 
West Kent Cancer Centre, Maidstone Hospital, Maidstone, United Kingdom
53
 
St Josephs Hospital and Medical Center, Phoenix, AZ
Publication typeJournal Article
Publication date2021-11-10
scimago Q1
wos Q1
SJR11.205
CiteScore38.9
Impact factor41.9
ISSN0732183X, 15277755
PubMed ID:  34432481
Cancer Research
Oncology
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.

Found 
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GOST Copy
Oonk M. H. 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. 2021. Vol. 39. No. 32. pp. 3623-3632.
GOST all authors (up to 50) Copy
Oonk M. H. 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. 2021. Vol. 39. No. 32. pp. 3623-3632.
RIS |
Cite this
RIS Copy
TY - JOUR
DO - 10.1200/jco.21.00006
UR - https://doi.org/10.1200/jco.21.00006
TI - Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II
T2 - Journal of Clinical Oncology
AU - Oonk, Maaike HM
AU - Slomovitz, Brian M
AU - Baldwin, Peter J W
AU - van Doorn, Helena C.
AU - Van Der Velden, Jacobus
AU - de Hullu, Joanne A
AU - Gaarenstroom, Katja N.
AU - Slangen, Brigitte
AU - Vergote, Ignace B.
AU - Brännström, Mats
AU - Van Dorst, Eleonora B L
AU - van Driel, Willemien J.
AU - Hermans, Ralph H.
AU - Nunns, David
AU - Widschwendter, Martin
AU - Nugent, David
AU - Holland, Cathrine M.
AU - Sharma, Aarti
AU - Disilvestro, Paul
AU - Mannel, Robert
AU - Boll, Dorry
AU - Cibula, David
AU - Covens, Al
AU - Provencher, Diane
AU - Runnebaum, Ingo B.
AU - Luesley, David
AU - Ellis, Patricia
AU - Duncan, Timothy J
AU - Tjiong, Ming Y.
AU - Cruickshank, Derek J.
AU - Kjølhede, P.
AU - Levenback, Charles F.
AU - Bouda, Jiri
AU - Kieser, Katharina E.
AU - Palle, Connie
AU - Spirtos, Nicola M.
AU - O’Malley, David M.
AU - Leitao, Mario
AU - Geller, Melissa A
AU - Dhar, Kalyan
AU - Asher, Viren
AU - TAMUSSINO, KARL
AU - Tobias, Daniel H.
AU - Borgfeldt, Christer
AU - Lea, Jayanthi S
AU - Bailey, Jo
AU - Lood, Margareta
AU - Eyjólfsdóttir, Brynhildur
AU - Attard Montalto, Stephen
AU - Tewari, Krishnansu S.
AU - Manchanda, Ranjit
AU - Jensen, Pernille T.
AU - Persson, Par
AU - Van Le, Linda
AU - Putter, Hein
AU - de Bock, Geertruida H.
AU - Monk, Bradley J.
AU - Creutzberg, Carien L.
AU - van der Zee, Ate G. J.
PY - 2021
DA - 2021/11/10
PB - American Society of Clinical Oncology (ASCO)
SP - 3623-3632
IS - 32
VL - 39
PMID - 34432481
SN - 0732-183X
SN - 1527-7755
ER -
BibTex |
Cite this
BibTex (up to 50 authors) Copy
@article{2021_Oonk,
author = {Maaike HM Oonk and Brian M Slomovitz and Peter J W Baldwin and Helena C. van Doorn and Jacobus Van Der Velden and Joanne A de Hullu and Katja N. Gaarenstroom and Brigitte Slangen and Ignace B. Vergote and Mats Brännström and Eleonora B L Van Dorst and Willemien J. van Driel and Ralph H. Hermans and David Nunns and Martin Widschwendter and David Nugent and Cathrine M. Holland and Aarti Sharma and Paul Disilvestro and Robert Mannel and Dorry Boll and David Cibula and Al Covens and Diane Provencher and Ingo B. Runnebaum and David Luesley and Patricia Ellis and Timothy J Duncan and Ming Y. Tjiong and Derek J. Cruickshank and P. Kjølhede and Charles F. Levenback and Jiri Bouda and Katharina E. Kieser and Connie Palle and Nicola M. Spirtos and David M. O’Malley and Mario Leitao and Melissa A Geller and Kalyan Dhar and Viren Asher and KARL TAMUSSINO and Daniel H. Tobias and Christer Borgfeldt and Jayanthi S Lea and Jo Bailey and Margareta Lood and Brynhildur Eyjólfsdóttir and Stephen Attard Montalto and Krishnansu S. Tewari and others},
title = {Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II},
journal = {Journal of Clinical Oncology},
year = {2021},
volume = {39},
publisher = {American Society of Clinical Oncology (ASCO)},
month = {nov},
url = {https://doi.org/10.1200/jco.21.00006},
number = {32},
pages = {3623--3632},
doi = {10.1200/jco.21.00006}
}
MLA
Cite this
MLA Copy
Oonk, Maaike HM, 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, vol. 39, no. 32, Nov. 2021, pp. 3623-3632. https://doi.org/10.1200/jco.21.00006.