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 Brannstrom; 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 Brannstrom, 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 MannelDorry 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

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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 (US)
Pages (from-to)	3623-3632
Number of pages	10
Journal	Journal of Clinical Oncology
Volume	39
Issue number	32
DOIs	https://doi.org/10.1200/JCO.21.00006
State	Published - Nov 10 2021

ASJC Scopus subject areas

Oncology
Cancer Research

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

@article{fe70c67f4bb04d0290132d8b1e321e59,

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 Brannstrom 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.}",

year = "2021",

month = nov,

day = "10",

doi = "10.1200/JCO.21.00006",

language = "English (US)",

volume = "39",

pages = "3623--3632",

journal = "Journal of Clinical Oncology",

issn = "0732-183X",

publisher = "American Society of Clinical Oncology",

number = "32",

}

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 - Brannstrom, 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.

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.

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SN - 0732-183X

VL - 39

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JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

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ER -

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

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