Prospective randomized trial of the treatment of patients with metastatic melanoma using chemotherapy with cisplatin, dacarbazine, and tamoxifen alone or in combination with interleukin-2 and interferon alfa-2b

Purpose: The combination of chemotherapy with immunotherapeutic agents such as interleukin-a and interferon alfa-2b has been reported to provide impro ved treatment results in patients with metastatic melanoma, compared with t he use of chemotherapy alone, We have performed a prospective randomized tr ial in patients with metastatic melanoma, comparing treatment with chemothe rapy to treatment with chemoimmunotherapy. Patients and Methods: One hundred two patients with metastatic melanoma wer e prospectively randomized to receive chemotherapy composed of tamoxifen, c isplatin, and dacarbazine or this same chemotherapy followed by interferon alfa-2b and interleukin-2 Objective responses, survival, and toxicity in th e two groups were evaluated at a median potential follow-vp of 42 months. Results: In 52 patients randomized to receive chemotherapy, there were 14 o bjective responses (27%), including four complete responses. in SO patients randomized to receive chemoimmunotherapy, there were 22 objective response s (44%) (P-2 = .071), including three complete responses. In both treatment groups, the duration of partial responses was often short, and there was a trend toward a survival advantage for patients receiving chemotherapy alon e (P-2 = .052; median survival of 15.8 months compared with 10.7 months). T reatment-related toxicities were greater in patients receiving chemoimmunot herapy, Conclusion: With the treatment regimens used in this study the addi tion of immunotherapy to combination chemotherapy increased toxicity but di d not increase survival, The use of combination chemoimmunotherapy regimens is nat recommended in the absence of well-designed, prospective, randomize d protocols showing the benefit of this treatment strategy. (C) 1999 by Ame rican Society of Clinical Oncology.