Fotemustine and dacarbazine plus recombinant interferon alpha2a in the treatment of advanced melanoma

Forty-three consecutive patients with advanced melanoma not previously treated with cytotoxic drugs (22 of them had already received adjuvant recombinant interferon alpha2a (rIFNα2a)) were given a combination of intravenous (i.v.) fotemustine (FM), 100 mg/m2 on day 1, and dacarbazine (DTIC), 250 mg/m² i.v. on days 2-5, every 3 weeks. rIFNα2a was administered at the dosage of 3 MIU subcutaneously 3 times a week until progression. Four complete and 13 partial responses were registered, for an overall response rate of 40% (95% CI, 25-56%). Activity of this regimen was similar in patients with mainly Visceral (10/22, 45%) or soft tissue (6/13, 46%) involvement. The median duration of responses was 24 weeks. Median survival time was 40 weeks, with a 13% 2 year survival rate. Neutropenia and thrombocytopenia affected 67% and 51% of patients, but were of WHO grade 4 in only 2% and 5% of them, respectively. Side-effects attributable to rIFNα2a were mild and manageable. In conclusion, the combination of FM + DTIC and rIFNα2a seemed well tolerated and relatively active in patients with advanced melanoma. However, the role of rIFNα2a in affecting the long-term outcome of patients is still questionable.