title: Randomized study of vinorelbine--gemcitabine versus vinorelbine--carboplatin in patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The objective of this trial was to compare two vinorelbine-based doublets with carboplatin (CBDCA-VC) or with gemcitabine (VG) in patients with stage IIIB-IV non-small cell lung cancer (NSCLC).
  
  
  METHODS
  A total of 316 patients with advanced NSCLC previously untreated were randomized to either vinorelbine 30 mg/m(2) D1,8 with carboplatin AUC 5 D1 (VC) or vinorelbine 25mg/m(2) with gemcitabine (VG) 1000 mg/m(2) both given D1,8 every 3 weeks. The primary endpoint was response rate with secondary parameters being survival (OS), progression-free survival (PFS), tolerance and clinical benefit.
  
  
  RESULTS
  The median number of cycles was four in each arm with a total of 1268 cycles. The objective response (OR) on intent-to-treat was 20.8% in VC and 28% in VG (p=0.15). Median PFS was 3.9 months in VC and 4.4 months (mo) in VG (p=0.18). Median survival was significantly longer (p=0.01) for VG with 11.5 mo compared to 8.6 mo in VC with 1 year survival at 48.9 and 34.4%, respectively. Tolerance was better in the VG arm as compared to the VC patients. Four toxic deaths were recorded in the VC group. Clinical benefit response rate was 32.4% compared to 40.9% in 111 and 110 evaluable patients in VC and VG, respectively.
  
  
  CONCLUSIONS
  VG compared to VC resulted in a similar overall response rate, favourable median survival and a better toxicity profile. For non-cisplatin-based chemotherapy, VG is a useful alternative.
authors: National Cancer Centre, 11 Hospital Drive, Singapore 169610, Singapore.
authors: E H
authors: EH
authors: Tan
authors: A
authors: A
authors: Szczesna
authors: M
authors: M
authors: Krzakowski
authors: H N
authors: HN
authors: Macha
authors: U
authors: U
authors: Gatzemeier
authors: K
authors: K
authors: Mattson
authors: M
authors: M
authors: Wernli
authors: P
authors: P
authors: Reiterer
authors: R
authors: R
authors: Hui
authors: J Von
authors: JV
authors: Pawel
authors: O
authors: O
authors: Bertetto
authors: J C
authors: JC
authors: Pouget
authors: J P
authors: JP
authors: Burillon
authors: Y
authors: Y
authors: Parlier
authors: R
authors: R
authors: Abratt
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007390:International Agencies; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine; D000093542:Gemcitabine