Misonidazole combined with radiotherapy in the treatment of non-small cell lung cancer. A randomized double-blind trial.
Forty-one patients with inoperable non-small cell lung cancer were randomized to receive irradiation therapy 45 Gy in ten fractions over eight weeks, plus either placebo or misonidazole 1.2 g/m2 orally on treatment day. The irradiated area was the primary tumour. Twenty-one patients received misonidazole and 20 received placebo. Minimal observation time for the study was 36 months. No clear difference was observed in the pattern of relapse between the groups. 43% of the patients in the misonidazole group attained a complete response (CR) or partial response (PR) as compared with 65% in the placebo group. Median survival time was twelve months in the misonidazole group and 14 months in the placebo group.