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).
Department of Surgical Oncology, Roswell Park Memorial Institute, Buffalo, NY 14263.
C P
CP
Karakousis
L J
LJ
Emrich
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001500:BCG Vaccine / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000627:therapeutic use*; D004961:Estramustine / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000601:surgery / Q000628:therapy; D008875:Middle Aged; D009588:Nitrogen Mustard Compounds / Q000627:therapeutic use*; D011446:Prospective Studies; D011897:Random Allocation
D001500:BCG Vaccine; D009588:Nitrogen Mustard Compounds; D004961:Estramustine; D003606:Dacarbazine