Phase II trial of docetaxel and vinorelbine in patients with advanced non-small-cell lung cancer Journal Article


Authors: Miller, V. A.; Krug, L. M.; Ng, K. K.; Pizzo, B.; Perez, W.; Heelan, R. T.; Kris, M. G.
Article Title: Phase II trial of docetaxel and vinorelbine in patients with advanced non-small-cell lung cancer
Abstract: Purpose: Docetaxel and vinorelbine are active agents in advanced non- small-cell lung cancer (NSCLC) and demonstrate preclinical synergism perhaps, in part, through their inactivation of the proto-oncogene bcl-2. We show that docetaxel (60 mg/m2) and vinorelbine (45 mg/m2) can be safely combined when given on an every 2-week schedule with filgrastim, with encouraging antitumor activity observed. Patients and Methods: Thirty-five chemotherapy naive patients with advanced NSCLC received vinorelbine as an intravenous push immediately followed by docetaxel as a 1-hour intravenous infusion once every 2 weeks. Prophylactic corticosteroids, ciprofloxacin, and filgrastim were used. Results: We delivered median doses of 450 mg/m2 of vinorelbine and 600 mg/m2 of docetaxel. The major objective response rate was 51% (95% confidence interval [CI], 34% to 68%). With a median follow-up of 14 months, the predicted median survival time was 14 months, and the 1-year survival rate was 60% (95% CI, 44% to 80%). Febrile neutropenia occurred in five patients and five (1.3%) of 384 treatments. No dose-limiting neurotoxicity occurred. Symptomatic onycholysis and excessive lacrimation were observed after several months or more of therapy. Conclusion: Docetoxel 60 mg/m2 and vinorelbine 45 mg/m2, both given every 2 weeks, is a highly active combination for the treatment of advanced NSCLC. Filgrastim largely obviates neutropenic fever and allows for the single-agent dose-intensity of both drugs to be delivered. The occurrence of certain late toxicities can limit use in some cases and suggests that the combination could also be beneficial in settings requiring briefer, fixed periods of treatment, such as in induction or postoperative therapy. (C) 2000 by American Society of Clinical Oncology.
Keywords: adult; cancer survival; clinical article; aged; middle aged; survival analysis; clinical trial; advanced cancer; drug safety; paclitaxel; cancer patient; phase 2 clinical trial; lung non small cell cancer; antineoplastic combined chemotherapy protocols; carcinoma, non-small-cell lung; lung neoplasms; antineoplastic activity; vinblastine; docetaxel; febrile neutropenia; ciprofloxacin; taxoids; corticosteroid; navelbine; recombinant granulocyte colony stimulating factor; filgrastim; humans; human; male; female; priority journal; article
Journal Title: Journal of Clinical Oncology
Volume: 18
Issue: 6
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2000-03-13
Start Page: 1346
End Page: 1350
Language: English
PUBMED: 10715307
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 18 November 2015 -- Source: Scopus