[Chemotherapy in advanced malignant melanoma. Results of a controlled trial comparing a combination of dacarbazine (DTIC) and detorubicin with dacarbazine alone]

Abstract

51 patients with malignant melanomas who had not previously received chemotherapy were studied in a phase III trial. They were all advanced cases, either in relapse or showing metastatic spread and with one or several measurable tumor sites. They were judged to be too advanced for surgery or radiotherapy. They were split at random into two groups. Both groups received DTIC (250 mg/m2, IV, over 4 days every three weeks) and one group received detorubicin (120 mg/m2, IV every three weeks) as well. Detorubicin is a new anthracyclin drug which has shown promise in the treatment of these tumors in a previous trial. The combination of the two drugs produced better results than dacarbazine alone. Eight 50% regressions were obtained out of 22 cases studied (36%) with the combination, as opposed to 4 out of 26 (15%) with the single drug. The average length of response was also longer for the combination, i.e. 6 months opposed to 5 for the single drug. The differences were not, however, statistically significant (X2 = 2.09). Toxic reactions were also more frequent with the combination therapy (65%) than with DTIC alone (40%) (X2 = 0.42), as well as more serious because of the myocardial toxicity of the anthracyclin drug. This trial showed that a combination of dacarbazine with detorubicin improves the therapeutic outcome. Whether this represents a real benefit will need statistical confirmation from trials of combinations using other anthracyclins.