Adjuvant treatment of malignant melanoma with DTIC + estracyt or BCG.

Eighty-two patients with invasive malignant melanoma and no distant metastases were prospectively randomized following their surgical treatment to 1) observation; 2) chemotherapy with Dacarbazine (DTIC) 200 mg/M2 I.V. daily X 5 every 4 weeks and Estracyt 15 mg/kg orally daily for 1 year; and 3) immunotherapy with TICE BCG 1 ml to an area of scarification near the primary site, every 4 weeks for 1 year. At a median follow-up of 73.4 months 31 patients (38%) have relapsed. There was no significant difference in survival according to the treatment, but a weak effect on the course of the disease by either of the treatment protocols cannot be ruled out due to the small sample of patients. Survival and disease-free interval varied significantly according to the histologic status of the regional nodes. The estimated 5-year disease-free rate of patients with negative nodes was 85% and for those with positive nodes it was 35% (P less than 0.0001).