title: Phase II trial of the novel taxane BMS-184476 as second-line in non-small-cell lung cancer.
abstract: 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.
  
  
  METHODS
  Fifty-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.
  
  
  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/m(2) and showed evidence of antitumor activity in previously treated NSCLC.
authors.affiliation: Hospital General Universitario de Valencia, Valencia, Spain. camps_car@gva.es
authors.forename: C
authors.initials: C
authors.lastname: Camps
authors.forename: E
authors.initials: E
authors.lastname: Felip
authors.forename: J M
authors.initials: JM
authors.lastname: Sanchez
authors.forename: B
authors.initials: B
authors.lastname: Massuti
authors.forename: A
authors.initials: A
authors.lastname: Artal
authors.forename: L
authors.initials: L
authors.lastname: Paz-Ares
authors.forename: A
authors.initials: A
authors.lastname: Carrato
authors.forename: V
authors.initials: V
authors.lastname: Alberola
authors.forename: A
authors.initials: A
authors.lastname: Blasco
authors.forename: J
authors.initials: J
authors.lastname: Baselga
authors.forename: L
authors.initials: L
authors.lastname: Astier
authors.forename: M
authors.initials: M
authors.lastname: Voi
authors.forename: R
authors.initials: R
authors.lastname: Rosell
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D043823:Taxoids; C426424:7-methylthiomethylpaclitaxel