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)

Abstract

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 × 10⁶ IU m⁻², days 3–5, week 4; 5 × 10⁶ IU m⁻², days 1, 3, 5, week 5) and s.c. IFN-α (5 × 10⁶ 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.