Radiotherapy instead of inguinofemoral lymphadenectomy in vulvar cancer patients with a metastatic sentinel node: results of GROINSS-V II

医学放射治疗腹股沟外阴癌外科转移微转移哨兵节点放射科癌症内科学外阴乳腺癌

作者

MHM Oonk,Brian M. Slomovitz,Peter Baldwin,HC van Doorn,Jacobus van der Velden,Joanne A. de Hullu,B.F.M. Slangen,Katja N. Gaarenstroom,Ignace Vergote,Mats Brännström,E.B.L. van Dorst,Willemien J. van Driel,Ralph H.M. Hermans,David Nunns,Martin Widschwendter,David Nugent,Cathrine Holland,Paul DiSilvestro,Ajay Sharma,Robert S. Mannel,Dorry Boll,Allan Covens,David Cibula,Diane Provencher,David Luesley,Peter Ellis,Timothy J. Duncan,Ming Y. Tjiong,Derek Cruickshank,Preben Kjølhede,Charles Levenback,J Bouda,Katharina Kieser,Ingo B. Runnebaum,Connie Palle,Nick M. Spirtos,David M. O’Malley,Mario M. Leitao,Melissa A. Geller,Karl Tamussino,K. K. Dhar,Daniel H. Tobias,Christer Borgfeldt,Tashanna Myers,Jayanthi Lea,Jo Bailey,P Persson,B.J. Monk,Carien L. Creutzberg,Ate G.J. van der Zee

标识

DOI：10.1136/ijgc-2019-esgo.16

摘要

Introduction/Background

Introduction: GROINSS-V II investigated whether radiotherapy is a safe alternative for inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN).

Methodology

Methods: In GROINSS-V II, a prospective multicentre phase II trial, patients were included with early-stage squamous cell carcinoma (SCC) of the vulva (diameter <4cm) without suspicious lymph nodes at imaging, who had primary surgery with SN-procedure. In case of a metastatic SN (metastasis of any size), radiotherapy was given to the groin(s) (50Gy). In case of a negative SN, patients were followed-up for ≥2 years. Stopping rules were defined for both groups to monitor groin recurrence rate.

Results

From December 2005 until October 2016, 1552 eligible patients were registered. SN-metastasis occurred in 324/1552 (21%) patients. After 54 months of inclusion the stopping-rule for SN-positive patients was activated; interim analysis showed an increased risk for groin recurrence in case of SN-metastasis >2 mm and/or extranodal extension (ENE). After amendment of the protocol only patients with SN-micrometastasis ≤2 mm received radiotherapy, while those with SN metastasis >2 mm underwent IFL (with radiotherapy if >1 metastasis or ENE). Final analysis after ≥2 years of follow-up revealed six isolated groin recurrences in 157 patients with a SN-micrometastasis (3.8%). Four could not be considered radiotherapy failures: two developed recurrence in the contralateral (SN-negative) groin, two refused radiotherapy. Twenty-eight patients did not get radiotherapy (2 recurrences;7.1%). Among 129 patients who received radiotherapy to the groin(s) only two isolated groin recurrences were diagnosed (1.6%: 95%CI:0–3.8%). The combination of radiotherapy with SN was associated with minimal toxicity: 5/118(4.2%) grade 3 toxicity, no grade 4 or 5 toxicity. In 38/1222 SN-negative patients (3.1%: 95%CI:2.1–4.1%) isolated groin recurrences were diagnosed with clear protocol violations in 6 patients: incomplete treatment of the groin (n=3); primary tumor >4cm (n=1); not all SNs visualized on the lymphoscintigram removed (n=2). After exclusion of these protocol violations an isolated groin recurrence rate of 2.6% (95%CI:1.7–3.5%) was observed.

Conclusion

Radiotherapy to the groins is a safe alternative for IFL in patients with SN metastasis ≤2 mm, with minimal toxicity. We further established the safety of omitting IFL in patients with SCC of the vulva <4cm and a negative SN. For patients with SN metastasis >2 mm, radiotherapy with a total dose of 50Gy was no safe alternative for IFL; dose escalation and/or chemoradiation should be investigated in these patients.

Disclosure

Funded by Dutch Cancer Society.