title: Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: results of a European multicenter trial including 612 patients.
abstract: OBJECTIVE
  We designed a prospective randomized trial to compare vinorelbine and cisplatin (NVB-P) with vindesine and cisplatin (VDS-P) and to evaluate whether the best of these regimens affords a survival benefit compared with vinorelbine alone (NVB), an outpatient regimen, in patients with non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Forty-five centers included 612 patients in this study: 206 on NVB-P, 200 on VDS-P, and 206 on NVB. Vinorelbine was administered at a dose of 30 mg/m2 weekly, cisplatin at 120 mg/m2 on days 1 and 29 and then every 6 weeks, and vindesine at 3 mg/m2 weekly for 6 weeks and then every other week. Treatment was continued until progression or toxicity. Four percent of the patients entered were ineligible and 59% had metastatic disease.
  
  
  RESULTS
  An objective response rate was observed in 30% of patients in the NVB-P arm versus 19% in the VDS-P arm (P = .02) and 14% in the NVB arm (P < .001). The median duration of survival was 40 weeks in the NVB-P arm, compared with 32 weeks in the VDS-P arm and 31 weeks in the NVB arm. Comparison of survival among the three groups demonstrated an advantage for NVB-P compared with VDS-P (P = .04) and NVB (P = .01). Neutropenia was significantly higher in the NVB-P group (P < .001), and neurotoxicity was more frequent with VDS-P (P < .004).
  
  
  CONCLUSIONS
  Since our results have demonstrated that NVB-P yields a longer survival duration and a higher response rate than VDS-P or NVB alone, with acceptable toxicity, this combination should be considered a relevant regimen in advanced NSCLC.
authors.affiliation: Department of Medicine, Institut Gustave-Roussy, Villejuif, France.
authors.forename: T
authors.initials: T
authors.lastname: Le Chevalier
authors.forename: D
authors.initials: D
authors.lastname: Brisgand
authors.forename: J Y
authors.initials: JY
authors.lastname: Douillard
authors.forename: J L
authors.initials: JL
authors.lastname: Pujol
authors.forename: V
authors.initials: V
authors.lastname: Alberola
authors.forename: A
authors.initials: A
authors.lastname: Monnier
authors.forename: A
authors.initials: A
authors.lastname: Riviere
authors.forename: P
authors.initials: P
authors.lastname: Lianes
authors.forename: P
authors.initials: P
authors.lastname: Chomy
authors.forename: S
authors.initials: S
authors.lastname: Cigolari
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014751:Vindesine / Q000008:administration & dosage; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D014751:Vindesine