title: A randomized study of gemcitabine plus cisplatin and vinorelbine plus cisplatin in patients with advanced non-small-cell lung cancer.
abstract: BACKGROUND
  Gemcitabine plus cisplatin (GC) and vinorelbine plus cisplatin (VC) are active and well-tolerated regimens for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). We conducted this study to compare the safety and efficacy of these regimens as front-line chemotherapy for patients with NSCLC.
  
  
  METHODS
  Eligible patients were randomized to receive either gemcitabine (1000 mg/m2) on days 1, 8, and 15 plus cisplatin (80 mg/m2) on day 15 (arm GC), or vinorelbine (20 mg/m2) on days 1, 8, and 15 plus cisplatin (80 mg/m2) on day 15 (arm VC). Treatments were repeated every 28 days. The costs of treatment were retrieved from the Health Care Reporting System of Chang Gung Memorial Hospital at the time of final data analysis.
  
  
  RESULTS
  Eighty-three patients (GC, n=39; VC, n=44) were enrolled in the study. Seventy-three patients were analyzed. Response rates were 38% and 31% and median survivals were 12.9 and 9.0 months for the 34 patients in the GC arm and 39 patients in the VC arm, respectively. One-year survival was 55.9% in the GC arm and 33.3% in the VC arm. There was no difference in the response rate (p=0.622), progression free survival (p=0.443) and median survival (p = 0.4197) between the two arms. Grade 3-4 toxicities were vomiting (GC: 16.3% vs. VC: 36.3%), neutropenia (GC: 14.7% vs. VC: 20%), and thrombocytopenia (GC: 8.68% vs. VC: 5%). There was a significant increase in all-grade thrombocytopenia (p=0.002) in the GC arm. The GC arm had higher total expenses than the VC arm (p=0.020).
  
  
  CONCLUSIONS
  Both vinorelbine plus cisplatin and gemcitabine plus cisplatin yielded similar efficacies for NSCLC.
authors.affiliation: Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Chang Gung University College of Medicine, Taoyuan, Taiwan.
authors.forename: John Wen-Cheng
authors.initials: JW
authors.lastname: Chang
authors.forename: Thomas Chang-Yao
authors.initials: TC
authors.lastname: Tsao
authors.forename: Cheng-Ta
authors.initials: CT
authors.lastname: Yang
authors.forename: Meng-Chih
authors.initials: MC
authors.lastname: Lin
authors.forename: Yun-Chung
authors.initials: YC
authors.lastname: Cheung
authors.forename: Chung-Chi
authors.initials: CC
authors.lastname: Liaw
authors.forename: Chih-Hung
authors.initials: CH
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine