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

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

doi:10.1200/JCO.21.00006

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

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

Gynecological Oncology

University Medical Centre Groningen
Mount Sinai Medical Center Miami Beach
Cambridge University Hospitals NHS Foundation Trust
Amsterdam UMC
Radboud University Medical Center
Leiden University Medical Centre
Maastricht University Medical Centre
Leuven Cancer Institute (LKI)
The Sahlgrenska Academy at the University of Gothenburg
University Medical Centre Utrecht
Netherlands Cancer Institute
Catharina Hospital
Nottingham University Hospitals NHS Trust
University College London
St James's University Hospital
University Hospital of South Manchester
University Hospital of Wales
Women and Infants Hospital of Rhode Island
University of Oklahoma
Charles University
University of Toronto
Centre Hospitalier de l'Université de Montréal
Jena University Hospital
University of Birmingham
Royal Surrey County Hospital NHS Foundation Trust
Norfolk and Norwich University Hospitals NHS Foundation Trust
South Tees Hospitals NHS Foundation Trust
Linköping University
University of Texas MD Anderson Cancer Center
Dalhousie University
Capio
Women's Cancer Center of Nevada
Ohio State University
Memorial Sloan-Kettering Cancer Center
University of Minnesota Twin Cities
Swansea Bay University Health Board
University Hospitals of Derby and Burton NHS Foundation Trust
Medical University of Graz
Morristown Medical Center
Lund University
University of Texas Southwestern Medical Center
St. Michael's Hospital
Central Hospital Karlstad
Oslo University Hospital
Maidstone and Tunbridge Wells NHS Trust
UC Irvine Medical Center
Barts and The London School of Medicine and Dentistry
Aarhus University Hospital
Uppsala University
University of North Carolina at Chapel Hill
St. Joseph's Hospital and Medical Center, Phoenix

Research output: Contribution to journal › Article › Academic › peer-review

115 Citations (Scopus)

66 Downloads (Pure)

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.

Original language	English
Pages (from-to)	3623-3632
Number of pages	10
Journal	Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume	39
Issue number	32
DOIs	https://doi.org/10.1200/JCO.21.00006
Publication status	Published - 10 Nov 2021

Bibliographical note

SUPPORT: Supported by the Dutch Cancer Society (KWF Kankerbestrijding), NRG Oncology.

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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., ... 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

@article{6852d0e49f43454a90a6713dc7ea00be,

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

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.",

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

note = "SUPPORT: Supported by the Dutch Cancer Society (KWF Kankerbestrijding), NRG Oncology.",

year = "2021",

month = nov,

day = "10",

doi = "10.1200/JCO.21.00006",

language = "English",

volume = "39",

pages = "3623--3632",

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

issn = "0732-183X",

publisher = "Lippincott Williams \& Wilkins",

number = "32",

}

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 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, vol. 39, no. 32, pp. 3623-3632. https://doi.org/10.1200/JCO.21.00006

Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II. / Oonk, Maaike H.M.; Slomovitz, Brian; Baldwin, Peter J.W. et al.
In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 39, No. 32, 10.11.2021, p. 3623-3632.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node

T2 - Results of GROINSS-V II

AU - Oonk, Maaike H.M.

AU - Slomovitz, Brian

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 F.M.

AU - Vergote, Ignace

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 A.

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, Preben

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 M.

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 - Eyjolfsdottir, 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.

N1 - SUPPORT: Supported by the Dutch Cancer Society (KWF Kankerbestrijding), NRG Oncology.

PY - 2021/11/10

Y1 - 2021/11/10

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85115664347

U2 - 10.1200/JCO.21.00006

DO - 10.1200/JCO.21.00006

M3 - Article

C2 - 34432481

AN - SCOPUS:85115664347

SN - 0732-183X

VL - 39

SP - 3623

EP - 3632

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

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

IS - 32

ER -

Oonk MHM, Slomovitz B, Baldwin PJW, van Doorn HC, van der Velden J, de Hullu JA 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. 2021 Nov 10;39(32):3623-3632. doi: 10.1200/JCO.21.00006

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

Abstract

Bibliographical note

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