Adjuvant ganglioside GM2-KLH/QS-21 vaccination versus observation after resection of primary tumor > 1.5 mm in patients with stage II melanoma: results of the EORTC 18961 randomized phase III trial.

Alexander M M Eggermont, Stefan Suciu, Piotr Rutkowski, Jeremy Marsden, Mario Santinami, Philippa Corrie, Steinar Aamdal, Paolo A. Ascierto, Poulam M. Patel, Wim H. Kruit, Lars Bastholt, Lorenzo Borgognoni, Maria Grazia Bernengo, Neville Davidson, Larissa Polders, Michel Praet, Alan Spatz

Research output: Contribution to journalArticlepeer-review

Abstract

The GM2 ganglioside is an antigen expressed in the majority of melanomas. The GM2-KLH/QS-21 vaccine induces high immunoglobulin M (IgM) and IgG antibody responses. The EORTC 18961 trial compared the efficacy of GM2-KLH/QS-21 vaccination versus observation. A total of 1,314 patients with a primary tumor > 1.50 mm in thickness (T3-4N0M0; American Joint Committee on Cancer stage II) were randomly assigned to GM2-KLH/QS-21 vaccination (n = 657) or observation (n = 657). Treatment consisted of subcutaneous injections once per week from week 1 to 4, then every 3 months for the first 2 years and every 6 months during the third year. Primary end point was relapse-free survival (RFS). Secondary end points were distant metastasis-free survival (DMFS) and overall survival (OS). Analyses were by intent to treat. After a median follow-up of 1.8 years, the trial was stopped at the second interim analysis for futility regarding RFS (hazard ratio [HR], 1.00; P = .99) and detrimental outcome regarding OS (HR, 1.66; P = .02). After a median follow-up of 4.2 years, we had recorded 400 relapses, nine deaths without relapse, a total of 236 deaths. At 4 years, the vaccination arm showed a decreased RFS rate of 1.2% (HR, 1.03; 95% CI, 0.84 to 1.25) and OS rate of 2.1% (HR, 1.16; 95% CI, 0.90 to 1.51). Toxicity was acceptable, with 4.6% of patients ending study participation because of toxicity. GM2-KLH/QS-21 vaccination does not improve outcome for patients with stage II melanoma.

Original languageEnglish
Pages (from-to)3831-3837
Number of pages7
JournalJournal of Clinical Oncology
Volume31
Issue number30
Publication statusPublished - Oct 20 2013

ASJC Scopus subject areas

  • Medicine(all)

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