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Quality-of-Life–Adjusted Survival Analysis of High-Dose Adjuvant Interferon Alfa-2b for High-Risk Melanoma Patients Using Intergroup Clinical Trial Data

From the University of Virginia, Charlottesville, VA; Dartmouth Hitchcock Medical Center, Lebanon, NH; University of Pittsburgh, Pittsburgh, PA; Massachusetts General Hospital, Beth Israel Deaconess Medical Center, and Dana-Farber Cancer Institute, Boston, MA; Moffitt Cancer Center, Tampa, FL; and Washington University, St. Louis, MO.

Address reprint requests to Kerry Laing Kilbridge, MD, Department of Health Evaluation Sciences, University of Virginia Health System, HSC PO Box 800821, Charlottesville, VA 22908-0821; email: kk4h{at}virginia.edu

PURPOSE: High-dose adjuvant interferon alfa-2b (IFN2b) for high-risk melanoma is a 1-year regimen that improves relapse-free and overall survival but has significant toxicity. A quality-of-life–adjusted survival (QAS) analysis analysis of two cooperative group phase III trials, E1684 and E1690/S9111/C9190, was performed, incorporating patient values (utilities) for the toxicity of IFN2b treatment and melanoma recurrence.

PATIENTS AND METHODS: Quality-Adjusted Time Without Symptoms or Toxicity methodology was used with melanoma patient utilities and trial data to estimate the effect of IFN2b on QAS. The increase or decrease in QAS that patients could expect from treatment was estimated based on their utilities. Eleven utility predictor questions were tested to identify patients with utilities that result in decreased QAS.

RESULTS: Using E1684 data, IFN2b would result in an increase in QAS for all sets of patient utilities. This benefit was significant (P < .05) for 16% of patients. Using E1690/S9111/C9190 data, 77% of patients would experience a benefit in QAS from IFN2b and 23% would experience a decrease in QAS; neither of these effects was statistically significant. Using utility predictors and the E1690/S9111/C9190 analysis, a decision rule was formulated that helps identify patients in whom IFN2b may detract from QAS.

CONCLUSION: Most patients experienced improvement in QAS in both trials, but this benefit was statistically significant in only 16% of patients in E1684. Change in QAS depends more on the utility for IFN2b toxicity than on the utility for melanoma recurrence. Cancer patients probably have higher utilities for IFN2b toxicity than members of the general population and will tend to favor IFN2b treatment as a result.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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