SUBCUTANEOUS LOW-DOSES OF INTERLEUKIN-2 AND RECOMBINANT INTERFERON-ALPHA WITH CARBOPLATIN AND VINBLASTINE IN PATIENTS WITH ADVANCED MELANOMA

Twenty-three patients with advanced melanoma were treated with a combi nation of subcutaneous recombinant human interleukin-2 (IL-2), and rec ombinant interferon alpha-2a (IFN-alpha) with chemotherapy consisting of four cycles of carboplatin (300 mg/m(2), day 1) and vinblastine (6 mg/m(2), day 1), every 28 days (CV-IL-IF), IL-2 was given at a dose of 4.5 x 10(6) U twice daily on days 3-6 and days 21-24 of each cycle; I FN-alpha dose was 4.5 x 10(6) U, Starting on day 2, thrice weekly. Imm unotherapy was intended to continue for 6 months, Of the 23 analyzed p atients, 4 (17%) achieved an objective response, including 1 complete and 3 partial responses, in nonvisceral metastatic disease, The median time to progression was 5 months and the median survival from onset o f the treatment 6 months (range 1-14 months), Four patients discontinu ed the treatment, due to nonhaematologic toxicity; 3 for severe weakne ss and the 4th patient for long-lasting CNS side-effects, Other grade 3-4 toxicities included weight loss (22%), nausea and vomiting (17%) a nd alopecia (13%), The haematologic toxicity was acceptable. No toxic death was noted, It is con eluded that the CV-IL-IF regimen has limite d activity and moderate toxicity.