Annals of Oncology Advance Access originally published online on January 31, 2005
Annals of Oncology 2005 16(4):597-601; doi:10.1093/annonc/mdi120
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© 2005 European Society for Medical Oncology
Original articles |
Phase II trial of the novel taxane BMS-184476 as second-line in non-small-cell lung cancer
1 Hospital General Universitario de Valencia, Valencia; 2 Hospital Vall d'Hebrón, Barcelona; 3 Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Barcelona; 4 Hospital General de Alicante, Alicante; 5 Hospital Miguel Servet, Zaragoza; 6 Hospital Universitario Doce de Octubre, Madrid; 7 Hospital General de Elche, Alicante; 8 Hospital Arnau de Vilanova, Valencia, Spain; 9 Bristol-Myers Squibb-Europe, Waterloo, Belgium
* Correspondence to: Dr C. Camps, Servicio de Oncología Médica, Hospital General Universitario de Valencia, Avenida Tres Cruces, s/n, 46014 Valencia, Spain. Tel: +34-96-386-2993; Fax: +34-96-386-2993; Email: camps_car{at}gva.es
Background: The 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 methods: Fifty-six previously treated advanced NSCLC patients received BMS-184476 at a dose of 60 mg/m2 administered intravenously over 1 h every 21 days.
Results: The 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).
Conclusions: BMS-184476 was well tolerated at the dose of 60 mg/m2 and showed evidence of antitumor activity in previously treated NSCLC.
Key words: BMS-184476, novel taxane, NSCLC, second-line chemotherapy