Cisplatin, interleukin-2, interferon-alpha and tamoxifen in metastatic melanoma. A phase II study

Purpose: To evaluate the efficacy and toxicity of an immuno-hormonal-chemot herapeutic combination of cisplatin, interleukin-2, interferon-alpha and ta moxifen in metastatic malignant melanoma. Patients and methods: Fifteen consecutive patients were treated with cispla tin at a dose of 100 mg/m(2) on day 1, interleukin-2 subcutaneously at a do se of 18 MU from days 3-6 and from days 17-21, interferon-alpha 2-b subcuta neously at a dose of 3 MU three times weekly and tamoxifen orally at a dose of 20 mg daily. The cycle was repeated on day 28. Patients were evaluated after two cycles. Patients with progressive disease stopped the treatment w hile responding patients and those with stable disease underwent two furthe r cycles. No maintenance regimen was employed. Results: Two partial remissions (PR, 13%), 5 stable disease (SD, 33%) and 8 progression disease (PD, 53%) were observed. Patients with PR and SD had b etter survival than those with PD (11 vs 6 months). Toxicity was predominantly fever and vomiting besides chills, fatigue and f lu-like syndrome, normally related to cytokine administration and often inf luencing the quality of life. Conclusions: Our results, unlike the good results of previous trials, are v ery poor. Therefore we do not recommend this combination for routine treatm ent of advanced melanoma.