A phase II study of docetaxel and vinorelbine combination chemotherapy in patients with advanced non-small cell lung cancer

A phase II study was conducted to determine the efficacy and the safety of docetaxel combined with vinorelbine as first-line chemotherapy in patients with metastatic or unresectable non-small cell lung cancer (NSCLC), 39 pati ents, median age 54 years (range: 35-69), with stage IIIB (5 patients; 13%) or IV (34 patients; 87%) NSCLC were treated with 75 mg/m(2) docetaxel give n intravenously (i.v.) over 1 h on day 1 and with 20 mg/m(2) vinorelbine gi ven i.v. over 15 to 30 min on days 1 and 5. Cycles were repeated every 3 we eks. 9 of the 39 patients had a partial response (overall response rate 23. 1%, 95% confidence interval (CI): 11.1-39.3%) with a median duration of res ponse of 20 weeks (95% CI; 17-30). The median survival was 40 weeks (95% CI : 21-49 weeks) with a 1-year survival rate of 31% in the intent-to-treat po pulation. Neutropenia grade IV occurred in 33 patients (92%). 16 patients ( 41%) experienced febrile neutropenia with a concomitant stomatitis in 9 pat ients (23%). One patient died due to febrile neutropenia associated with a grade 4 stomatitis and 1 patient due to a septicaemia concomitant with a gr ade 4 neutropenia. Although the combination of docetaxel and vinorelbine is feasible, the efficacy does not seem to be improved compared with single-a gent docetaxel or vinorelbine and the rate of febrile neutropenia is unacce ptable in this population with incurable disease. Therefore, different dose s and/or schedules are to be explored. (C) 2000 Published by Elsevier Scien ce Ltd. All rights reserved.