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BackgroundThe purpose of this study was to evaluate the tolerability and efficacy of BMS-184476, an analog of paclitaxel, in patients with advanced non-small-cell lung cancer (NSCLC) progressing or relapsing following at least one prior chemotherapy regimen.Patients and methodsFifty-six previously treated advanced NSCLC patients received BMS-184476 at a dose of 60 mg/m(2) administered intravenously over 1 h every 21 days.ResultsThe median number of cycles delivered per patient was five (range one to 17). Dose reduction was required in only 3.8% of cycles. Grade 4 neutropenia occurred in 19.6% of patients, but no grade 4 thrombocytopenia or anemia was reported. Febrile neutropenia was observed in only two (3.6%) patients and there were no life-threatening events. Grade 3/4 peripheral sensory-motor neuropathy was reported in 9% of patients. Other non-hematological toxicities, such as nausea and vomiting, myalgia and arthralgia, diarrhea, and mucositis, were uncommon. Partial responses were observed in eight (14.3%) patients and stable disease in 33 (58.9%). Median progression-free survival was 3.7 months [95% confidence interval (CI) 2.7-5.4] and median overall survival was 10 months (95% CI 6-13.4).ConclusionsBMS-184476 was well tolerated at the dose of 60 mg/m(2) and showed evidence of antitumor activity in previously treated NSCLC.

Original publication

DOI

10.1093/annonc/mdi120

Type

Journal article

Journal

Annals of oncology : official journal of the European Society for Medical Oncology

Publication Date

04/2005

Volume

16

Pages

597 - 601

Addresses

Hospital General Universitario de Valencia, Valencia, Spain. camps_car@gva.es

Keywords

Spanish Lung Cancer Group, Humans, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Male, Gastrointestinal Diseases, Taxoids, Survival Analysis, Adult, Aged, Middle Aged, Female