Combination chemotherapy plus BCG in the treatment of disseminated malignant melanoma: a Southwest Oncology Group Study.

The Southwest Oncology Group performed a randomized study comparing combination chemotherapy alone versus combination chemotherapy plus BCG versus DTIC plus BCG in the treatment of disseminated malignant melanoma. A 31% response rate was noted with combination chemotherapy alone, a 27% response rate with combination chemotherapy plus BCG, and an 18% response rate with DTIC plus BCG. Survival was not influenced by type of therapy, but the responders had significantly longer survival than the nonresponders. There appeared to be some significant differences in response as related to age wherein those patients between the ages of 30 and 60 years had a higher response rate to combination chemotherapy as compared to DTIC plus BCG. Those patients older than 60 years of age had a higher response rate in the BCG groups. Furthermore, in those patients older than 60 years of age who responded, their duration of response was longer if they received BCG than those who did not receive BCG. It should be emphasized that those differences noted in various age groups could occur by chance alone. These differences should be studied in the future, by appropriate pretreatment stratifications. Patients with higher peripheral lymphocyte counts had significantly better response rates and those patients with higher numbers of positive delayed hypersensitivity skin tests had significantly greater survival. A significant improvement in survival was noted in patients whose PPD converted from negative to positive during therapy.

RCT Entities:   Population Interventions Outcomes