Adjuvant Ganglioside GM2-KLH/QS-21 Vaccination Versus Observation After Resection of Primary Tumor %26gt; 1.5 mm in Patients With Stage II Melanoma: Results of the EORTC 18961 Randomized Phase III Trial

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

来源：Journal of Clinical Oncology, 2013, 31(30): 3831-+.

DOI：10.1200/JCO.2012.47.9303

Purpose %26lt;br%26gt;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. %26lt;br%26gt;Patients and Methods %26lt;br%26gt;A total of 1,314 patients with a primary tumor %26gt; 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. %26lt;br%26gt;Results %26lt;br%26gt;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. %26lt;br%26gt;Conclusion %26lt;br%26gt;GM2-KLH/QS-21 vaccination does not improve outcome for patients with stage II melanoma.

• 出版日期2013-10-20
• 单位河北医科大学