Adjuvant high-dose interferon alfa-2b in patients with high-risk melanoma

We performed an analysis of toxicity and survival in stage III melanoma pat ients receiving adjuvant interferon alfa-2b (IFN). This was a retrospective single-arm analysis of 40 patients with stage III melanoma who received (I FN) administered at maximum tolerated doses of 20 mU/m(2)/day intravenously (IV) for 1 month and 10 mU/m(2) three times per week subcutaneously (SC) f or 48 weeks. Toxicity in our series is comparable to that experienced in th e Eastern Cooperative Oncology Group (ECOG) 1684 trial, except for higher r ates of dose-limiting myelosuppression and hepatotoxicity. AU 40 patients e xperienced constitutional symptoms, but only 14/40 (35%) experienced grade 3 to 4 symptoms. Of the 40 patients, 36 (90%) experienced neurologic sympto ms, but only seven (17.5%) experienced grade 3 to 4 neurotoxicity. Two pati ents stopped treatment because of severe psychiatric symptoms; one patient attempted suicide, and a psychosis developed in another. Thirty-nine (97.5% ) patients experienced myelosuppression; 31 (77.5%) developing grade 3 to 4 myelosuppression. Hepatotoxicity was evident in 39 (97.5%) patients, and 2 6 (65%) experienced grade 3 to 4 hepatotoxicity. Three patients (7.5%) expe rienced mild renal toxicity. At a median follow-up of 27 months from initia tion of therapy, there have been 19 relapses (47.5% disease-free survival [ DFS]) and 10 deaths (75% OS) resulting from progression of disease. The DFS compares with the treatment arm in ECOG 1684 at 27 months, but overall sur vival is higher in our series of patients at the same time point. In a sing le program setting, IFN can be administered with similar side effects and o utcome profiles seen in multi-institutional studies. Modifications in the i nduction regimen resulted in notably higher hematologic and hepatic toxicit ies but did not preclude administering further therapy and did not result i n increased attrition rate among patients: only nine patients (22.5%) had t heir treatment stopped as a result of IFN-related toxicity. In comparison, 26% of patients had to have their treatment discontinued because of toxicit y in ECOG 1684.