title: Multicenter, randomized trial for stage IIIB or IV non-small-cell lung cancer using weekly paclitaxel and carboplatin followed by maintenance weekly paclitaxel or observation.
abstract: OBJECTIVE
  To explore the efficacy and safety of three regimens of weekly paclitaxel plus carboplatin as initial therapy and the feasibility of subsequent maintenance therapy versus observation in patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Four hundred one patients were randomly assigned to one of the following arms: arm 1, paclitaxel 100 mg/m2 weekly for 3 of 4 weeks with carboplatin (area under the curve [AUC] = 6) on day 1; arm 2, paclitaxel 100 mg/m2 and carboplatin (AUC = 2) weekly for 3 of 4 weeks; or arm 3, paclitaxel 150 mg/m2 cycle 1 and 100 mg/m2 cycle 2 and carboplatin (AUC = 2) weekly for 6 of 8 weeks. Patients who responded (n = 130) at week 16 were randomly assigned to either weekly paclitaxel therapy (70 mg/m2, 3 of 4 weeks; n = 65) or observation (n = 65).
  
  
  RESULTS
  For the 390 assessable patients, the objective response rates observed with initial therapy were 32% for arm 1, 24% for arm 2, and 18% for arm 3. The median time to progression and median survival times were 30 and 49 weeks for arm 1, 21 and 31 weeks for arm 2, and 27 and 40 weeks for arm 3, respectively. The 1-year survival rates were 47% for arm 1, 31% for arm 2, and 41% for arm 3.
  
  
  CONCLUSIONS
  Arm 1, paclitaxel 100 mg/m2 weekly for 3 of 4 weeks with carboplatin (AUC = 6) administered on day 1, demonstrates the most favorable therapeutic index in patients with advanced NSCLC.
authors.affiliation: University of Pittsburgh Cancer Institute, Pittsburgh, PA 15232, USA. belanicp@msx.upmc.edu.
authors.forename: Chandra P
authors.initials: CP
authors.lastname: Belani
authors.forename: John
authors.initials: J
authors.lastname: Barstis
authors.forename: Michael C
authors.initials: MC
authors.lastname: Perry
authors.forename: Renato V
authors.initials: RV
authors.lastname: La Rocca
authors.forename: Sreenivasa R
authors.initials: SR
authors.lastname: Nattam
authors.forename: David
authors.initials: D
authors.lastname: Rinaldi
authors.forename: Ray
authors.initials: R
authors.lastname: Clark
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Mills
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel