title: Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non--small-cell lung cancer: a Southwest Oncology Group trial.
abstract: OBJECTIVE
  This randomized trial was designed to determine whether paclitaxel plus carboplatin (PC) offered a survival advantage over vinorelbine plus cisplatin (VC) for patients with advanced non--small-cell lung cancer. Secondary objectives were to compare toxicity, tolerability, quality of life (QOL), and resource utilization.
  
  
  METHODS
  Two hundred two patients received VC (vinorelbine 25 mg/m(2)/wk and cisplatin 100 mg/m(2)/d, day 1 every 28 days) and 206 patients received PC (paclitaxel 225 mg/m(2) over 3 hours with carboplatin area under the curve of 6, day 1 every 21 days). Patients completed QOL questionnaires at baseline, 13 weeks, and 25 weeks. Resource utilization forms were completed at five time points through 24 months.
  
  
  RESULTS
  Patient characteristics were similar between the groups. The objective response rate was 28% in the VC arm and 25% in the PC arm. Median survival was 8 months in both arms, with 1-year survival rates of 36% and 38%, respectively. Grade 3 and 4 leukopenia (P =.002) and neutropenia (P =.008) occurred more frequently on the VC arm. Grade 3 nausea and vomiting were higher on the VC arm (P =.001, P =.007), and grade 3 peripheral neuropathy was higher on the PC arm (P <.001). More patients on the VC arm discontinued therapy because of toxicity (P =.001). No difference in QOL was observed. Overall costs on the PC arm were higher than on the VC arm because of drug costs.
  
  
  CONCLUSIONS
  PC is equally efficacious as VC for the treatment of advanced non--small-cell lung cancer. PC is less toxic and better tolerated but more expensive than VC. New treatment strategies should be pursued.
authors: University of Colorado, Denver, CO, USA.
authors: K
authors: K
authors: Kelly
authors: J
authors: J
authors: Crowley
authors: P A
authors: PA
authors: Bunn
authors: C A
authors: CA
authors: Presant
authors: P K
authors: PK
authors: Grevstad
authors: C M
authors: CM
authors: Moinpour
authors: S D
authors: SD
authors: Ramsey
authors: A J
authors: AJ
authors: Wozniak
authors: G R
authors: GR
authors: Weiss
authors: D F
authors: DF
authors: Moore
authors: V K
authors: VK
authors: Israel
authors: R B
authors: RB
authors: Livingston
authors: D R
authors: DR
authors: Gandara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000628:therapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006295:Health Resources / Q000706:statistics & numerical data; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D012044:Regression Analysis; D015996:Survival Rate; D014481:United States / Q000453:epidemiology; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin; D000077235:Vinorelbine