title: Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group.
abstract: OBJECTIVE
  To confirm the promising phase II results of docetaxel monotherapy, this phase III trial was conducted of chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) who had previously failed platinum-containing chemotherapy.
  
  
  METHODS
  A total of 373 patients were randomized to receive either docetaxel 100 mg/m(2) (D100) or 75 mg/m(2) (D75) versus a control regimen of vinorelbine or ifosfamide (V/I). The three treatment groups were well-balanced for key patient characteristics.
  
  
  RESULTS
  Overall response rates were 10.8% with D100 and 6.7% with D75, each significantly higher than the 0.8% response with V/I (P =.001 and P =.036, respectively). Patients who received docetaxel had a longer time to progression (P =.046, by log-rank test) and a greater progression-free survival at 26 weeks (P =.005, by chi(2) test). Although overall survival was not significantly different between the three groups, the 1-year survival was significantly greater with D75 than with the control treatment (32% v 19%; P =.025, by chi(2) test). Prior exposure to paclitaxel did not decrease the likelihood of response to docetaxel, nor did it impact survival. There was a trend toward greater efficacy in patients whose disease was platinum-resistant rather than platinum-refractory and in patients with performance status of 0 or 1 versus 2. Toxicity was greatest with D100, but the D75 arm was well-tolerated.
  
  
  CONCLUSIONS
  This first randomized trial in this setting demonstrates that D75 every 3 weeks can offer clinically meaningful benefit to patients with advanced NSCLC whose disease has relapsed or progressed after platinum-based chemotherapy.
authors.affiliation: Department of Thoracic/ Head and Neck Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston 77030-4009, USA. fossell@mdanderson.org
authors.forename: F V
authors.initials: FV
authors.lastname: Fossella
authors.forename: R
authors.initials: R
authors.lastname: DeVore
authors.forename: R N
authors.initials: RN
authors.lastname: Kerr
authors.forename: J
authors.initials: J
authors.lastname: Crawford
authors.forename: R R
authors.initials: RR
authors.lastname: Natale
authors.forename: F
authors.initials: F
authors.lastname: Dunphy
authors.forename: L
authors.initials: L
authors.lastname: Kalman
authors.forename: V
authors.initials: V
authors.lastname: Miller
authors.forename: J S
authors.initials: JS
authors.lastname: Lee
authors.forename: M
authors.initials: M
authors.lastname: Moore
authors.forename: D
authors.initials: D
authors.lastname: Gandara
authors.forename: D
authors.initials: D
authors.lastname: Karp
authors.forename: E
authors.initials: E
authors.lastname: Vokes
authors.forename: M
authors.initials: M
authors.lastname: Kris
authors.forename: Y
authors.initials: Y
authors.lastname: Kim
authors.forename: F
authors.initials: F
authors.lastname: Gamza
authors.forename: L
authors.initials: L
authors.lastname: Hammershaimb
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016019:Survival Analysis; D043823:Taxoids; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine; D007069:Ifosfamide