title: Gemcitabine-docetaxel versus cisplatin-vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin.
abstract: BACKGROUND
  This multicenter, randomized, phase III study compared the efficacy, including progression-free survival (PFS), and safety of gemcitabine-docetaxel (GD) combination versus cisplatin-vinorelbine (CV) in the treatment of advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Chemonaive patients with stage IIIB or IV NSCLC were treated with GD (gemcitabine 1000 mg/m(2) days 1 and 8 plus docetaxel 85 mg/m(2) day 8, every 3 weeks for eight cycles) or CV (cisplatin 100 mg/m(2) day 1 plus vinorelbine 30 mg/m(2), days 1, 8, 15 and 22, every 4 weeks for six cycles).
  
  
  RESULTS
  A total of 311 patients were enrolled (155 GD and 156 CV). Neither PFS nor overall survival differed significantly between the two arms (median PFS 4.2 and 4 months; median survival 11.1 and 9.6 months; 1-year survival 46% and 42%, for GD and CV, respectively). For the GD arm compared with the CV arm, the hazard ratio for PFS was 1.04 [95% confidence interval (CI) 0.83-1.32], and for overall survival, it was 0.90 (95% CI 0.70-1.16). Objective response rates did not differ significantly (31% for GD, 35.9% for CV). Myelosupression, emesis and frequency of febrile neutropenia were less pronounced on the GD arm, whereas fluid retention and pulmonary events were more pronounced. The CV arm experienced a higher number of serious adverse events and a lower compliance with the protocol. There was no quality of life (QoL) difference between arms. Median time to definite impairment of health-related QoL was 153 and 168 days in GD and CV arms, respectively.
  
  
  CONCLUSIONS
  There was no advantage in PFS with GD compared with CV; however, the CV regimen had higher rate of toxic events, mainly myelosuppression. The herein, non-platinum-containing regimen could be considered as a rational alternative to the cisplatin-based doublet.
authors.affiliation: Montpellier University Hospital, Montpellier, France. pujol@cyber-sante.org
authors.forename: J-L
authors.initials: JL
authors.lastname: Pujol
authors.forename: J-L
authors.initials: JL
authors.lastname: Breton
authors.forename: R
authors.initials: R
authors.lastname: Gervais
authors.forename: P
authors.initials: P
authors.lastname: Rebattu
authors.forename: A
authors.initials: A
authors.lastname: Depierre
authors.forename: J-F
authors.initials: JF
authors.lastname: Morère
authors.forename: B
authors.initials: B
authors.lastname: Milleron
authors.forename: D
authors.initials: D
authors.lastname: Debieuvre
authors.forename: D
authors.initials: D
authors.lastname: Castéra
authors.forename: P-J
authors.initials: PJ
authors.lastname: Souquet
authors.forename: D
authors.initials: D
authors.lastname: Moro-Sibilot
authors.forename: E
authors.initials: E
authors.lastname: Lemarié
authors.forename: R
authors.initials: R
authors.lastname: Kessler
authors.forename: H
authors.initials: H
authors.lastname: Janicot
authors.forename: D
authors.initials: D
authors.lastname: Braun
authors.forename: D
authors.initials: D
authors.lastname: Spaeth
authors.forename: X
authors.initials: X
authors.lastname: Quantin
authors.forename: C
authors.initials: C
authors.lastname: Clary
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine