title: Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: the TAX 326 study group.
abstract: OBJECTIVE
  To investigate whether docetaxel plus platinum regimens improve survival and affect quality of life (QoL) in advanced non-small-cell lung cancer (NSCLC) compared with vinorelbine plus cisplatin as first-line chemotherapy.
  
  
  METHODS
  Patients (n = 1,218) with stage IIIB to IV NSCLC were randomly assigned to receive docetaxel 75 mg/m2 and cisplatin 75 mg/m2 every 3 weeks (DC); docetaxel 75 mg/m2 and carboplatin area under the curve of 6 mg/mL * min every 3 weeks (DCb); or vinorelbine 25 mg/m2/wk and cisplatin 100 mg/m2 every 4 weeks (VC).
  
  
  RESULTS
  Patients treated with DC had a median survival of 11.3 v 10.1 months for VC-treated patients (P =.044; hazard ratio, 1.183 [97.2% confidence interval, 0.989 to 1.416]). The 2-year survival rate was 21% for DC-treated patients and 14% for VC-treated patients. Overall response rate was 31.6% for DC-treated patients v 24.5% for VC-treated patients (P =.029). Median survival (9.4 v 9.9 months [for VC]; P =.657; hazard ratio, 1.048 [97.2 confidence interval, 0.877 to 1.253]) and response (23.9%) with DCb were similar to those results for VC. Neutropenia, thrombocytopenia, infection, and febrile neutropenia were similar with all three regimens. Grade 3 to 4 anemia, nausea, and vomiting were more common (P <.01) with VC than with DC or DCb. Patients treated with either docetaxel regimen had consistently improved QoL compared with VC-treated patients, who experienced deterioration in QoL.
  
  
  CONCLUSIONS
  DC resulted in a more favorable overall response and survival rate than VC. Both DC and DCb were better tolerated and provided patients with consistently improved QoL compared with VC. These findings demonstrate that a docetaxel plus platinum combination is an effective treatment option with a favorable therapeutic index for first-line treatment of advanced or metastatic NSCLC.
authors.affiliation: Division of Medical Oncology, University of Pittsburgh Cancer Institute, University of Pittsburgh Medical Center Cancer Pavilion, 5150 Center Ave, Suite 570, Pittsburgh, PA 15232, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Fossella
authors.forename: Jose R
authors.initials: JR
authors.lastname: Pereira
authors.forename: Joachim
authors.initials: J
authors.lastname: von Pawel
authors.forename: Anna
authors.initials: A
authors.lastname: Pluzanska
authors.forename: Vera
authors.initials: V
authors.lastname: Gorbounova
authors.forename: Eckhard
authors.initials: E
authors.lastname: Kaukel
authors.forename: Karin V
authors.initials: KV
authors.lastname: Mattson
authors.forename: Rodryg
authors.initials: R
authors.lastname: Ramlau
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Szczesna
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Fidias
authors.forename: Michael
authors.initials: M
authors.lastname: Millward
authors.forename: Chandra P
authors.initials: CP
authors.lastname: Belani
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D011788:Quality of Life; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel; D002945:Cisplatin