DTIC VS IFN-ALPHA PINS DTIC IN THE TREATMENT OF PATIENTS WITH METASTATIC MALIGNANT-MELANOMA

In our study we evaluated and compared the therapeutic success in 70 p atients with cutaneous metastatic malignant melanoma (MM) treated at t he Institute of Oncology in Ljubljana during the period 1985-1994. Twe nty-nine patients received DTIC in a single 800 mg/m(2) i.v, dose (Gro up 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 DT IC application on day 5, given at the same dosage as in Group 1 (Group 2). The applications were repeated in three-week intervals until prog ression, 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 I: p = 0.078) t han that of non-responders. These patients also had significantly long er 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 a lone (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 no n-responders (5.1 vs. 4.9 months) from both groups. The toxicity of co mbined therapy was higher than that of chemotherapy alone, though it w as still moderate and acceptable. In view of our results, the addition of IFN-alpha to DTIC has shown an advantage over DTIC alone.