title: Clinical benefit of gemcitabine plus cisplatin 3-week regimen for patients with advanced non-small cell lung cancer: a prospective observational study.
abstract: BACKGROUND
  Platinum-based chemotherapy has been proved effective in patients with advanced non-small cell lung cancer (NSCLC). This study evaluated the effectiveness and safety of first-line chemotherapy with gemcitabine plus cisplatin (GEM-Cis) 3-week regimen in routine care of Chinese patients with advanced NSCLC.
  
  
  METHODS
  Two hundred and twenty-one patients with NSCLC stage IIIb or IV were enrolled and 209 were eligible for effectiveness and safety analysis. The median age was 58 (range 29 to 79) years. The percents of cases in stage IV and stage IIIb were 52.2% and 47.8%; of Karnofsky performance score (KPS) less than 80 and 80 - 100 were 37.3% and 62.7% and of adeno-cancer and non-adeno-cancer were 59.8% and 40.2%. The average number of completed chemotherapy cycles was three. Measures of effectiveness included clinical benefit, significant clinical response (SCR) and adverse effects of GEM-Cis in the treatment of NSCLC at stages IIIb/IV.
  
  
  RESULTS
  KPS increased from 79 +/- 9 at baseline to 86 +/- 10 after chemotherapy (P < 0.01). Lung cancer symptom scale (LCSS) score of pain, dyspnea and cough increased from 77 +/- 24, 74 +/- 22 and 63 +/- 19 to 92 +/- 15, 90 +/- 14 and 86 +/- 15, respectively (P < 0.01). The clinical benefit rate was 85.2% [95% confidence interval (CI) 80.3% - 90.0%]. The SCR was 89.5% (95% CI 85.3% - 93.7%). Median survival time was 7.8 months (95% CI 7.1 months-9.1 months). Sixty-four patients (30.6%) experienced an adverse effect that was deemed clinically significant. Only one patient (0.5%) was hospitalized due to chemotherapy related adverse effects. Life-threatening toxicity was observed in two patients (1.0%).
  
  
  CONCLUSIONS
  First-line chemotherapy with GEM-Cis in the routine care of Chinese patients with advanced NSCLC is effective and safe.
authors.affiliation: Department of Medicine, Eli Lilly Asia Inc., Shanghai 200021, China. wang_li_l@lilly.com
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.forename: Mei-Lin
authors.initials: ML
authors.lastname: Liao
authors.forename: Long-Yun
authors.initials: LY
authors.lastname: Li
authors.forename: Huan-Ying
authors.initials: HY
authors.lastname: Wan
authors.forename: Nong
authors.initials: N
authors.lastname: Xu
authors.forename: Ji-Wei
authors.initials: JW
authors.lastname: Liu
authors.forename: Hou-Jie
authors.initials: HJ
authors.lastname: Liang
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 / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine