Controlled study with imidazole carboxamide (DTIC), DTIC + bacillus Calmette-Guérin (BCG), and DTIC + corynebacterium parvum in advanced malignant melanoma. W.H.O. Collaborating Centres for Evaluation of Methods of Diagnosis and Treatment of Melanoma.
From 1976 to 1980, 377 randomized patients were entered in a multicentric study supported by the W.H.O. Melanoma Group. In this report, only 196 patients are considered for analysis: 31.6% were excluded because of inadequate treatment or protocol violations. Three arms of treatment were compared: DTIC alone, DTIC plus bacillus Calmette-Guérin, and DTIC plus Corynebacterium parvum. No significant difference in terms of complete response plus partial response was detected among the three regimens. Twenty-five patients (12.7%) responded with complete tumor regression, and 18 (9.3%) with partial regression. Complete plus partial responses were thus achieved in 22% of evaluable patients. Responders had a longer median survival than nonresponders. Overall median survival was 6 months. Brain metastases were detected in 17% of the patients. Median time from the beginning of treatment to the diagnosis of CNS involvement was 4 months. There is no evidence that active aspecific immunotherapy added to DTIC increases the response rate in patients with disseminated disease. The toxic effects were acceptable, and no drug-related death was observed.
D001500:BCG Vaccine / Q000008:administration & dosage*; D001428:Bacterial Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D001932:Brain Neoplasms / Q000401:mortality / Q000556:secondary; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000628:therapy*; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D011425:Propionibacterium acnes / Q000276:immunology*; D012737:Sex Factors; D013997:Time Factors
D001500:BCG Vaccine; D001428:Bacterial Vaccines; D003606:Dacarbazine