Gemcitabine plus vinorelbine as first-line chemotherapy in advanced nonsmall cell lung carcinoma a Phase II trial

BACKGROUND. Response and survival in patients with advanced or metastatic n onsmall cell lung carcinoma (NSCLC) remain poor. As single agents, the nucl eoside analog gemcitabine, and the semisynthetic vinca alkaloid vinorelbine , have been shown to be effective in NSCLC and to have a low toxicity profi le. METHODS. Fifty-four chemotherapy-naive patients with NSCLC Stage IIIB (any TN3M0 or T4 any NM0) or IV (any T any NM1) were enrolled in this single-ins titution Phase II study. Gemcitabine 1250 mg/m(2) and vinorelbine 25 mg/m(2 ) were both administered on Days 1 and 8 every 3 weeks for up to 9 courses unless disease progression or severe toxicity required their discontinuatio n. RESULTS. partial tumor regression was observed in 16 patients, for an overa ll response rate of 30% (95% confidence interval, 18.4-46.7%) on an intent- to-treat basis. The median time to progression was 5 months (range, 3-20). The median survival was 12 months (range, 5-42+); 1-year and 2-year surviva l rates were 49.1% and 17%, respectively. Hematologic toxicity was mild wit h only 11% of the patients developing Grade 3 neutropenia. None of the pati ents developed any Grade 4 toxicity. CONCLUSIONS. The combination of gemcitabine plus vinorelbine is feasible on an outpatient basis. The good activity and tolerability of the regimen mak e it a suitable candidate for further trials, using platinum-based regimens as comparators and possibly selecting elderly and less fit patients. Cance r 2000;89:763-8. (C) 2000 American Cancer Society.