Summary Background Docetaxel in combination with cisplatin or gemcitabine are active chemotherapy reigimes against non-small-cell lung cancer. We compared the efficacy and safety of a combination of cisplatin and docetaxel (group 1) with that of gemcitabine and docetaxel (group 2) in the treatment of advanced non-small-cell lung cancer in a prospective, randomised, multicentre trial. Methods Patients with stage 1MB or IV lung cancer who had not had prior chemotherapy were allocated either to group 1 and treated with docetaxel (100 mg/m 2 , day 1) and cisplatin (80 mg/m 2 , day 2) or to group 2 and treated with gemcitabine (1100 mg/m 2 , days 1 and 8) and docetaxel (100 mg/m 2 , day 8). All patients received recombinant human granulocyte colony-stimulating factor (150 μg/m 2 ). All patients received recombinant human granulocyte colony-stimulating factor (150mg/m 2 ) had appropriate standard premedication. Response and toxicity were assessed using WHO criteria. Analysis was by intention to treat. Findings 441 patients were randomly assigned to receive docetaxel/cisplatin (group 1, n=219) or gemcitabine/ docetaxel (group 2, n=222). 14 patients in group 1 and 21 patients in group 2 were not evaluable. Objective response rates were similar in the two groups: group 1, 32·4% (95% CI 26·2–38·6%; 1·4% complete response and 31% partial response); group 2, 30·2% (24·5–36·2%; 0·9% complete response and 29·3% partial response). The two groups did not differ in median duration of response, time to tumour progression, overall survival, or 1 year or 2 year survival rates. Interpretation Both drug combinations had comparable activity in patients with advanced cancer who had not previously had chemotherapy; however, gemcitabine and docetaxel had the most favourable toxicity profile.
