Randomized controlled trial of adjuvant chemoimmunotherapy with DTIC and BCG after complete excision of primary melanoma with a poor prognosis or melanoma metastases.

A clinical study was undertaken in 57 patients with completely excised nodular or superficial spreading melanoma invasive to Clark's level 3, 4 or 5 (stage I) and 37 patients with completely resected in transit or lymph node metastases (stage III). The patients were randomly allocated to either a treatment group or a control group. Those in the treatment group received dimethyltriazeno imidazole carboxamide (DTIC) and bacille Calmette-Guérin (BCG). Those in the control group received only careful observation--the same periodic clinical and laboratory investigation that the treatment group underwent. Among the patients in the treatment group a delay in recurrence and an increase in survival were noted only in those with stage III disease, and the improvement was not statistically significant. The survival rates of the control subjects were much higher than those suggested from previously reported studies involving historical or nonrandomized control subjects, and they provide a basis on which to estimate the number of patients required for further trials of adjuvant treatment in melanoma.