Chemotherapy for non-small cell lung cancer: a randomized trial of cisplatin/vindesine v no chemotherapy.

Separate but almost identical randomized trials testing the role of chemotherapy in non-small cell lung cancer (NSCLC) were started in Southampton, United Kingdom (UK) and in several centers in Australia. Between 1983 and 1987, 201 patients were assigned to either a chemotherapy arm: cisplatin 120 mg/m2 every 4 weeks and vindesine 3 mg/m2 weekly, or a no chemotherapy arm. Of 188 evaluable patients, 157 were randomized in Australia and 31 in Southampton. Objective responses after two cycles of cisplatin/vindesine were seen in 26 patients (28%). Median survival was 23 weeks for the treatment arm and 16 weeks in the no treatment arm (P = NS). Analysis of those patients with limited disease showed a median survival of 43 weeks for the chemotherapy arm and 26 weeks for the non-treatment arm (this difference approaches statistical significance). Toxicity was severe in the treatment arm, and all patients experienced subjective toxicity; 17 (18%) had WHO (World Health Organization) grade 3-4 myelotoxicity, 73% had grade 3-4 nausea and vomiting. There is a modest trend towards improved overall survival in patients with limited disease treated with chemotherapy. Because chemotherapy is palliative, future studies should have an appropriate control arm and should measure quality of life.

RCT Entities:   Population Interventions Outcomes