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• W2588263816 abstract "Purpose: Vaccine alternatives to high-dose interferon alfa-2b therapy (HDI), the current standard adjuvant therapy for high-risk melanoma, are of interest because of toxicity associated with HDI. The GM2 ganglioside is a well-defined melanoma antigen, and antiGM2 antibodies have been associated with improved prognosis. We conducted a prospective, randomized, intergroup trial to evaluate the efficacy of HDI for 1 year versus vaccination with GM2 conjugated to keyhole limpet hemocyanin and administered with QS-21 (GMK) for 96 weeks (weekly 3 4 then every 12 weeks 3 8). Patients and Methods: Eligible patients had resected stage IIB/III melanoma. Patients were stratified by sex and number of positive nodes. Primary end points were relapse-free survival (RFS) and overall survival (OS). Results: Eight hundred eighty patients were randomized (440 per treatment group); 774 patients were eligible for efficacy analysis. The trial was closed after interim analysis indicated inferiority of GMK compared with HDI. For eligible patients, HDI provided a statistically significant RFS benefit (hazard ratio [HR] 5 1.47, P 5 .0015) and OS benefit (HR 5 1.52, P 5 .009) for GMK versus HDI. Similar benefit was observed in the intentto-treat analysis (RFS HR 5 1.49; OS HR 5 1.38). HDI was associated with a treatment benefit in all subsets of patients with zero to > four positive nodes, but the greatest benefit was observed in the node-negative subset (RFS HR 5 2.07; OS HR 5 2.71 [eligible population]). Antibody responses to GM2 (ie, titers > 1:80) at days 29, 85, 365, and 720 were associated with a trend toward improved RFS and OS (P2 5 .068 at day 29). Conclusion: This trial demonstrated a significant treatment benefit of HDI versus GMK in terms of RFS and OS in melanoma patients at high risk of recurrence. J Clin Oncol 19:2370-2380. © 2001 by American Society of Clinical Oncology." @default.
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• W2588263816 date "2001-01-01" @default.
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• W2588263816 title "High-Dose I nterferon A lfa-2b S ignificantly P rolongs Relapse-Free a nd O verall S urvival C ompared W ith t he GM2-KLH/QS-21 V accine i n P atients W ith R esected S tage IIB-III M elanoma: R esults o f I ntergroup T rial E1694/S9512/C509 801" @default.
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