No benefit of BCG for melanoma patients

A randomised controlled trial published in Cancer found no benefit with BCG in patients with melanoma.Historically controlled trials from the 1970s suggested an improvement in disease free survival in melanoma patients treated with the bacillus Calmette-Guerin (BCG). Thirteen small randomised trials that included a total of 1952 patients did not confirm these results. This randomised controlled trial included patients with surgically resected cutaneous melanoma localised to the skin or metastatic to regional lymph nodes and had a median follow-up projected to 30 years. Cohort I included patients with melanoma localised to the skin or those with regional lymph node involvement from melanoma of the head and neck and 256 patients were randomised to observation and 260 were randomised to injection with BCG. Cohort II had lymph node involvement from melanomas originating on the trunk and 104 were randomised to dacarbazine and BCG and 98 to BCG alone. There were 708 patients in the intention to treat analysis and 618 in the eligible population analysis.Results showed no statistical difference between the observation group or the BCG group in disease free or overall survival. Five-year survival was 67% with BCG compared to 62% for observation (p = 0.04 for the intention to treat and 0.37 for the eligible population). There was no benefit in cohort II for the addition of dacarbazine to BCG alone.Moderate induration and punctate abscesses occurred more than twice for one-third of the patients. Regional adenopathy and systemic reactions to BCG occurred 10-13% of the time. Emesis was severe in 26% of the patients on dacarbazine. Conversion from tuberculin negative to positive occurred in 40% of patients in cohort I and 50% of patients in cohort II. The authors concluded "the use of BCG as adjuvant therapy for melanoma is not recommended for any stage of this disease."Reference...