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

Purpose: To evaluate the efficacy and toxicity of an immuno-hormonal- chemotherapeutic combination of cisplatin, interleukin-2, interferon-α and tamoxifen in metastatic malignant melanoma. Patients and methods: Fifteen consecutive patients were treated with cisplatin at a dose of 100 mg/m² on day 1, interleukin-2 subcutaneously at a dose of 18 MU from days 3-6 and from days 17-21, interferon-α 2-b subcutaneously 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 while responding patients and those with stable disease underwent two further 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 better survival than those with PD (11 vs 6 months). Toxicity was predominantly fever and vomiting besides chills, fatigue and flu-like syndrome, normally related to cytokine administration and often influencing the quality of life. Conclusions: Our results, unlike the good results of previous trials, are very poor. Therefore we do not recommend this combination for routine treatment of advanced melanoma.