BACKGROUND: An open-label, single-arm prospective study was conducted to evaluate the efficacy and toxicity of the combination of gemcitabine and tegafur-uracil (UFT) in patients with advanced nonsmall-cell lung cancer (NSCLC) after the failure of previous platinum-containing regimens. PATIENTS AND METHODS: Patients with advanced NSCLC received 200 mg/m of UFT twice daily from day 1 through 14 plus 900 mg/m of gemcitabine per day via intravenous injection on days 8 and 15. This regimen was repeated every 3 or 4 weeks. RESULTS: A total of 40 patients were enrolled. Eleven patients (28%; 95% confidence interval [CI], 15-44%) achieved a partial response. The median progression-free survival, median overall survival, and 1-year survival rate were 4.0 months (95% CI, 3.3-6.7 months), 12.6 months (95% CI, 7.0-22.3 months), and 51% (95% CI, 33-66%), respectively. The most common grade 3 or 4 toxicity was neutropenia (38%; 95% CI, 23-54%) and the rate of grade 3 or 4 nonhematologic toxicity remained at less than 5%. A multivariate Cox model showed that adenocarcinoma, nonsmoking history, and good performance status predicted better survival. CONCLUSIONS: Combination chemotherapy with UFT and gemcitabine showed a promising effectiveness and acceptable toxicity for patients with platinum-resistant NSCLC.
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