title: Pemetrexed plus platinum or gemcitabine plus platinum for advanced non-small cell lung cancer: final survival analysis from a multicentre randomized phase II trial in the East Asia region and a meta-analysis.
abstract: OBJECTIVE
  Pemetrexed plus platinum has shown efficacy as a first-line treatment for advanced non-small cell lung cancer (NSCLC), but little is known about its efficacy and safety in East Asian patients. We report the final analysis of overall survival (OS) from a multicentre, randomized, phase II trial in chemotherapy-naive Chinese patients with advanced NSCLC. An additional meta-analysis was performed to systematically evaluate pemetrexed/platinum as first-line treatment for advanced NSCLC.
  
  
  METHODS
  Eligible patients received up to six cycles of pemetrexed, 500 mg/m(2) plus cisplatin, 75 mg/m(2) (day 1) or gemcitabine, 1000 mg/m(2) (days 1 and 8) plus cisplatin, 75 mg/m(2) (day 1). OS and toxicity were assessed.
  
  
  RESULTS
  A total of 254 patients were randomized, and 251 were eligible for inclusion in the efficacy and safety analyses. Median OS in the pemetrexed/cisplatin arm was 15.3 months, compared with 16.9 months in the gemcitabine/cisplatin arm [hazard ratio (HR) 1.09; 95% confidence interval (CI) 0.80-1.48; log-rank P = 0.4888). There was a trend towards improved survival in both arms. Patients in the pemetrexed/cisplatin arm showed a lower incidence of drug-related grade 3 to 4 leukopenia and thrombocytopenia. Meta-analysis showed that pemetrexed-platinum treatment was associated with 19% longer survival among females (HR 0.81; 95% CI 0.69-0.96) and 17% longer survival among patients with non-squamous cell lung cancer (HR 0.83; 95% CI 0.73-0.95).
  
  
  CONCLUSIONS
  In Chinese patients with advanced NSCLC, pemetrexed/cisplatin treatment resulted in comparable OS outcomes and was better tolerated than gemcitabine/cisplatin. Meta-analysis supports the use of pemetrexed-platinum as first-line treatment for female patients and those with the non-squamous cell subtype of advanced NSCLC.
authors.affiliation: Department of Health Statistics, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
authors.forename: Xinji
authors.initials: X
authors.lastname: Zhang
authors.forename: Jian
authors.initials: J
authors.lastname: Lu
authors.forename: Jinfang
authors.initials: J
authors.lastname: Xu
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.forename: Jingyi
authors.initials: J
authors.lastname: Wang
authors.forename: Yingyi
authors.initials: Y
authors.lastname: Qin
authors.forename: Pilin
authors.initials: P
authors.lastname: Ma
authors.forename: Lixin
authors.initials: L
authors.lastname: Wei
authors.forename: Jia
authors.initials: J
authors.lastname: He
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001208:Asia; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005971:Glutamates / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D000068437:Pemetrexed; D010984:Platinum / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D010984:Platinum; D006147:Guanine; D000093542:Gemcitabine