Purpose: This article investigates the safety and efficacy of a simple cisplatin-based biochemotherapy regimen, containing single-agent cisplatin plus recombinant interleukin-2 (rIL-2) and recombinant interferon-alpha (rIFN-alpha), in the treatment of metastatic melanoma.
Patients and methods: Between December 1990 and April 1997, 129 patients were treated with cisplatin (100 mg/m2, day 0) plus continuous intravenous infusion rIL-2 (18 MIU/m2/day, days 3-6 and days 17-21) and subcutaneous rIFN-alpha (9 MIU three times per week) plus or minus tamoxifen (160 mg/day) on three different protocols. Tumor response, disease-free survival, and overall survival were evaluated for all evaluable patients (N = 127).
Results: The overall response rate was 49%, and 10% of patients achieved a complete response. Responses were observed at all sites of metastases. In one case, a patient with a large cutaneous inguinal mass experienced a dramatic regression of that lesion within 1 month. The median disease-free survival was 5 months, and median overall survival was 11 months. Patients who responded had a significant survival advantage over nonresponders, and patients who achieved a complete response had a significant survival advantage over patients with a partial response. Toxicities were manageable and reversible upon discontinuation of therapy.
Conclusion: The response rates achieved with this simple biochemotherapy regimen are comparable to those for other cisplatin-based biochemotherapy regimens, which use more complex multiagent chemotherapy regimens. We found no added clinical benefit from the addition of tamoxifen to cisplatin.