DTIC vs. IFN-alpha plus DTIC in the treatment of patients with metastatic malignant melanoma.

In our study we evaluated and compared the therapeutic success in 70 patients with cutaneous metastatic malignant melanoma (MM) treated at the Institute of Oncology in Ljubljana during the period 1985-1994. Twenty-nine patients received DTIC in a single 800 mg/m2 i.v. dose (Group 1) and 41 patients were receiving i.m. applications of IFN-alpha in 2 MU daily doses from days 1 to 4, completing the treatment with a DTIC application on day 5, given at the same dosage as in Group 1 (Group 2). The applications were repeated in three-week intervals until progression, or-in the case of a complete response-for up to 6 months. The rate and median duration of treatment response were higher in the group of patients treated by IFN-alpha plus DTIC (17% vs. 27%; 2.7 vs. 6.1 months), though the difference was not statistically significant. The survival of responders was either significantly higher (Group 2: p = 0.0007) or borderline-significantly higher (Group 1; p = 0.078) than that of non-responders. These patients also had significantly longer median survival (Group 1: 13.7 vs. 5.1 months, p = 0.019; Group 2: 19.3 vs. 4.9 months, p = 0.0003). The patients treated with IFN-alpha plus DTIC survived significantly better than those treated with DTIC alone (p = 0.043). There were no differences in the median duration of survival between both groups (6.6 vs. 6.7 months), and neither in the median duration of survival of responders (13.7 vs. 19.3 months) or non-responders (5.1 vs. 4.9 months) from both groups. The toxicity of combined therapy was higher than that of chemotherapy alone, though it was still moderate and acceptable. In view of our results, the addition of IFN-alpha to DTIC has shown an advantage over DTIC along.