Combination chemotherapy in metastatic malignant melanoma: a randomized study of three DTIC-containing combination.

The activity of three DTIC-containing combinations was compared in a prospective randomized study. Of 101 patients randomized to receive one of the three regimens, 95 received adequate trials. Response rates were as follows: DTIC + cyclophosphamide 7/29 (24%); DTIC + vinblastine 6/34 (18%); DTIC + procarbazine 4/32 (13%). None of these response rates is significantly superior to any of the others. When the activity of the combination is analyzed by sex, DTIC + cyclophosphamide appears more active in females than the other regimens, but the difference is not statistically significant. Response to treatment is associated with significant prolongation of life; the median survival among responders was 11 months, while those who progressed lived a median of 4 months from the start of therapy. Toxicity of all regimens appeared to be about the same; therapy with DTIC + procarbazine was associated with significantly more nausea and vomiting. This study has failed to demonstrate clearly that any of three combinations is superior to any of the others.

RCT Entities:   Population Interventions Outcomes