[Chemotherapy of advanced stage melanoma using cisplatin, epirubicin and alpha-interferon]

To evaluate the activity and toxicity of cisplatin (DDP), epirubicin (EPI) and interferon alfa-2a (a-IFN) in patients (pts) with metastatic melanoma.

Thirty-seven pts with histologically-proven metastatic melanoma were treated with DDP 75 mg/m2 e.v. and EPI 90 mg/m2 e.v. on day 1 + alpha-IFN 9 MUI/die s.c. on days 4 to 8 and 18 to 22. Cycles were repeated every 4 weeks.

Characteristics of the patients were the following: median age 55 years (range, 24-75), median WHO performance status 1 (range, 0-2), prior chemotherapy 9, prior immunotherapy 16 (adjuvant/advanced 11/5), sites of disease: soft tissue only 10, lung 22, liver 11, bone 1, brain 3. In 35 evaluable patients we have obtained 3 complete and 10 partial responses, for an overall response rate of 37%. Dose-limiting toxicity was myelosuppression with grade (G) 4 neutropenia in 59.5% of patients and G4 thrombocytopenia in 11% of patients. Other toxicities were generally mild to moderate with nausea and vomiting in 67.5% of patients, flu-like syndrome in 78.5% and fatigue in 48.5% of the patients. Median time to response, median time to progression and survival were 3 (range, 2-6), 7 (range, 2-45+) and 10 months (range, 4-45+), respectively.

This combination is active and well tolerated in metastatic melanoma. Toxicity was manageable and has enabled us to conduct this trial on an outpatient basis.