A randomized study of CCNU with and without benznidazole in the treatment of recurrent grades 3 and 4 astrocytoma. Report to the Medical Research Council by the Brain Tumor Working Party.
In a randomized, double-blind study, 44 patients with recurrent high grade malignant glioma were allocated to chemotherapy of CCNU, with or without benznidazole (BENZO). Of 42 eligible patients, 23 received CCNU alone, and 19 CCNU received BENZO. Only 8 patients received the full 6 courses of treatment. The mean number of courses given was 2.8 for placebo and 3.4 for benznidazole patients. Progressive disease caused termination of treatment early for the majority of patients. There was no evidence of increased toxicity-leucopenia, anemia or thrombocytopenia-in the BENZO group, and only one patient in each treatment group had chemotherapy terminated because of toxicity. The BENZO group did not demonstrate any survival advantage: median survival time was 25 weeks in the BENZO group and 30 weeks in the placebo group. The confidence interval for the treatment difference is wide but excludes a BENZO-related addition of more than 7 months to the median survival time.
Bleehen
N M
NM
Medical Research Council, London, U.K.
Freedman
L S
LS
Stenning
S P
SP
D000293:Adolescent; D000328:Adult; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy* / Q000532:radiotherapy; D006801:Humans; D008130:Lomustine / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000532:radiotherapy; D009593:Nitroimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D011379:Prognosis; D011897:Random Allocation
D009593:Nitroimidazoles; D008130:Lomustine; C009999:benzonidazole