A study of the effect of misonidazole in conjunction with radiotherapy for the treatment of grades 3 and 4 astrocytomas. A report from the MRC Working Party on misonidazole in gliomas.

Four hundred and thirty-six patients were treated between January 1979 and November 1981 in a double-blind randomised study of the effect of the hypoxic cell sensitiser misonidazole (Ro 07-0582, MISO) in conjunction with radiotherapy on grades 3 and 4 astrocytoma. Radiotherapy was given in 20 fractions over 4 weeks to a minimum tumour dose of 4500 cGy. Misonidazole or placebo capsules were taken four to five hours before each radiotherapy treatment to a total dose of 11-13 g m-2. Survival rates at 12 months, among the 384 eligible patients, were similar in the misonidazole treated patients (25%) and those receiving placebo (28%). The estimated hazard ratio was 1.05, indicating a slight disadvantage to misonidazole which was not statistically significant (logrank test: chi 2 = 0.18 on 1 d.f., p = 0.7). Peripheral neuropathy was noted in 11% of the misonidazole group and was mostly mild. Possible reasons for the failure to demonstrate any therapeutic gain from misonidazole are discussed.

RCT Entities:   Population Interventions Outcomes