Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: An Eastern Cooperative Oncology Group Study

B. F. Cole, R. D. Gelber, J. M. Kirkwood, A. Goldhirsch, E. Barylak, E. Borden

Research output: Contribution to journalArticle

Abstract

Purpose: To evaluate the quality-of-life effects of adjuvant high-dose interferon alfa-2b (IFNα2b) treatment of high-risk melanoma. Patients and Methods: A quality-of-life-adjusted survival analysis (Quality-Adjusted Time Without Symptoms, and Toxicity [Q-TWiST]) was applied to the Eastern Cooperative Oncology Group Trial E1684, which compared high-dose IFNα2b treatment for 1 year versus observation in 280 high-risk patients. IFNα2b was administered at a dosage of 20 mU/m2 intravenously daily for 5 days per week for 4 weeks, and then three times weekly at 10 mU/m2 subcutaneously for 48 weeks. Results: After 84 months of median follow-up time, the IFNα2b group gained a mean of 8.9 months without disease relapse (P = .03) and 7.0 months of overall survival (P = .07) as compared with the observation group, but had severe treatment-related toxicity for 5.8 months, on average. The IFNα2b group had more quality-of-life-adjusted time than the observation group regardless of the relative valuations placed on time with toxicity (Tox) and time with relapse (Rel). This gain was significant (P <.05) for patients who consider Tox to have a high relative value and Rel to have a low relative value. In contrast, for patients who value Tox about the same as Rel, the quality-adjusted gain for IFNα2b was not statistically significant. An analysis stratified according to tumor burden indicated that the benefit of IFNα2b was greatest in the node-positive strata. Conclusion: For patients with high-risk melanoma, the clinical benefits of high-dose IFNα2b can offset the toxic effects. The optimal treatment for an individual patient depends on the patient's tumor burden and preferences regarding toxicity and disease relapse.

Original languageEnglish
Pages (from-to)2666-2673
Number of pages8
JournalJournal of Clinical Oncology
Volume14
Issue number10
Publication statusPublished - 1996

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ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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