RESUMO
UNLABELLED: This retrospective analysis of 150 consecutive high-risk melanoma patients treated with high-dose interferon alfa-2b at a single institution demonstrates similar relapse-free and overall survival data, as previously published from Eastern Cooperative Oncology Group (ECOG) and Intergroup trials. The data suggest at least a transient dose dependency of the treatment effect on relapse-free and overall survival with high-dose interferon in high-risk melanoma patients. BACKGROUND: Adjuvant high-dose interferon seems to be the best adjuvant treatment option for patients with high-risk melanoma (AJCC-stage IIC, III) after definitive surgery. METHODS: One-hundred fifty consecutive patients were treated at our institution during the period from September 1997 to March 2003 were retrospectively studied. RESULTS: After a median follow-up of 35 months, 63% of patients had developed a melanoma relapse, and 37% were relapse- free. Fifty-five percent of patients are still alive, and 45% had died-all but 3 patients from melanoma. Patients with stage IIC disease demonstrated a similar unfavorable course of disease as patients with stage IIIC disease (2-year relapse-free survival 18% and 26%). We identified two groups of patients with different cumulative interferon dose-levels (> or =90% and <90% of the projected dose, according to the protocol), who demonstrated at least transient differences, both in terms of relapse-free and overall survival; the predictive impact was statistically independent upon the Cox regression analysis. CONCLUSIONS: Our clinical data are consistent with the published ECOG and Intergroup data dealing with highdose interferon in high-risk melanoma patients. The data suggest a dose-dependency on the treatment effect and, therefore, support further prospective trials comparing different dose-distribution patterns in high-dose interferon.