Abstract | PURPOSE: PATIENTS AND METHODS: 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. RESULTS: 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. CONCLUSION: GM2-KLH/ QS-21 vaccination does not improve outcome for patients with stage II melanoma.
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Authors | 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 |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 31
Issue 30
Pg. 3831-7
(Oct 20 2013)
ISSN: 1527-7755 [Electronic] United States |
PMID | 24019551
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adjuvants, Immunologic
- Cancer Vaccines
- Saponins
- G(M2) Ganglioside
- saponin QA-21V1
- Hemocyanins
- keyhole-limpet hemocyanin
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Topics |
- Adjuvants, Immunologic
(therapeutic use)
- Adult
- Aged
- Aged, 80 and over
- Cancer Vaccines
(therapeutic use)
- Disease-Free Survival
- Female
- G(M2) Ganglioside
(therapeutic use)
- Hemocyanins
(therapeutic use)
- Humans
- Kaplan-Meier Estimate
- Lymph Nodes
(pathology, surgery)
- Lymphatic Metastasis
- Male
- Melanoma
(mortality, pathology, prevention & control, surgery)
- Middle Aged
- Neoplasm Staging
- Saponins
(therapeutic use)
- Skin Neoplasms
(mortality, pathology, prevention & control, surgery)
- Watchful Waiting
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