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Clinical Trials |
1 University of Pittsburgh Medical Center, Department of Medicine, Department of Pathology, University of Pittsburgh Cancer Institute Melanoma Center, Department of Medicine, Division of Hematology-Oncology, Pittsburgh, Pennsylvania; 2 Dana-Farber Cancer Institute, Boston, Massachusetts; 3 Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; 4 Department of Surgery, Division of Surgical Oncology, University of Michigan, Ann Arbor, Michigan; and 5 Department of Medicine, Division of Hematology-Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Purpose: Nearly 2000 patients with stage IIB and III melanoma have participated in four multicenter, randomized trials, conducted by the Eastern Cooperative Oncology Group and the Intergroup, investigating adjuvant high-dose IFN-
2b therapy. The objectives of this study were to update the analyses of each individual trial and to analyze prognostic factors and treatment effects based on pooled data.
Experimental Design: Survival and disease status were updated to April 2001. Analysis of prognostic factors using optimized statistical models was based on data from patients in E1684, E1690, E1694, and E2696. Analysis of treatment effects versus observation (Obs) was based on data from 713 patients randomized to high-dose IFN- 2b (HDI) or Obs in Trials E1684 and E1690.
Results: Updated analysis of E1684, E1690, and E1694 confirmed their original conclusions, now at median follow-up intervals of 2.1–12.6 years. Based on two-sided univariate log-rank analysis of pooled data from E1684 and E1690 (median follow-up, 7.2 years), relapse-free survival (RFS)—but not overall survival (OS)—was significantly prolonged (two-sided log-rank P value = 0.006) for patients treated with HDI versus Obs. Among all patients, prognostic factors that significantly negatively impacted RFS and OS included ulceration, recurrent disease at entry, enrollment in E1684, and age > 49 years. Multivariate statistical models adjusting for these factors confirmed the statistically significant RFS benefit of HDI versus Obs but did not demonstrate a significant OS benefit in the pooled populations.
Conclusions: In patients with high-risk resected melanoma, HDI is effective adjuvant therapy with strong evidence for improved RFS and evidence for moderate improvement in OS based on two prospective randomized studies but not the pooled analysis. Analyses of predictors of relapse and response are now needed to improve the therapeutic value of this modality.
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