Combination chemotherapy with or without s.c. IL-2 and IFN-α: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM)

The purpose of this randomized trial was to evaluate the efficacy of combination chemoimmunotherapy compared with chemotherapy alone. A total of 124 patients were randomized to receive intravenous cisplatin (35 mg m(−2), days 1–3), carmustine (150 mg m(−2), day 1, cycles 1 and 3 only), dacarbacine (220 mg m(−2), days 1–3) and oral tamoxifen (20 mg m(−2), daily) in combination with (n=64) or without (n=60) sequential subcutaneous IL-2 and IFN-α. In those patients who received sequential immunotherapy, each cycle of chemotherapy was followed by outpatient s.c. IL-2 (10×10(6) IU m(−2), days 3–5, week 4; 5×10(6) IU m(−2), days 1, 3, 5, week 5) and s.c. IFN-α (5×10(6) IU m(−2), day 1, week 4; days 1, 3, 5, week 5). The overall response rate of patients treated with the combination of chemotherapy and IL-2/IFN-α was 34.3% with seven complete responses (10.9%) and 15 partial responses (23.4%). In patients treated with chemotherapy, only, the overall response rate was 29.9% with eight complete responses (13.3%) and 10 partial responses (16.6%). There was no significant difference in median progression free survival (0 months vs 4 months) and in median overall survival (12 months vs 13 months) for combined chemoimmunotherapy and for chemotherapy, respectively. British Journal of Cancer (2002) 86, 179–184. DOI: 10.1038/sj/bjc/6600043 www.bjcancer.com © 2002 The Cancer Research Campaign