title: Pemetrexed in combination with cisplatin versus cisplatin monotherapy in East Asian patients with recurrent or metastatic head and neck cancer: Results of an exploratory subgroup analysis of a phase III trial.
abstract: OBJECTIVE
  An exploratory subgroup analysis of East Asian (EA) patients in a phase III trial was conducted to assess efficacy and safety trends based on ethnicity.
  
  
  METHODS
  The 795 patients with recurrent or metastatic squamous cell carcinoma of the head and neck included 111 EA patients randomized to pemetrexed-cisplatin (n = 55) and placebo-cisplatin (n = 56) and 684 non- EA patients randomized to pemetrexed-cisplatin (n = 343) and placebo-cisplatin (n = 341). Treatment differences in median overall survival and progression-free survival were compared using a stratified log-rank test. Survival was estimated using the Kaplan-Meier method.
  
  
  RESULTS
  The median overall survival in the pemetrexed-cisplatin and placebo-cisplatin arms of the EA group (6.8 and 5.7 months, respectively [P = 0.275]) was similar to that in the global population (7.3 and 6.3 months, respectively [P = 0.082]); the median progression-free survival in the pemetrexed-cisplatin and placebo-cisplatin arms in the EA group (2.8 and 1.9 months, respectively [P = 0.748]) was similar to that in the global population (3.6 and 2.8 months, respectively [P = 0.166]). Compared to the findings in the global population, overall survival for the EA group receiving prior platinum-based therapy was longer (P = 0.042 vs P = 0.065). There was no significant interaction between treatment arms and ethnicity.
  
  
  CONCLUSIONS
  Consistent with findings in the global population, pemetrexed-cisplatin did not improve survival compared with placebo-cisplatin for the EA group. However, in a subgroup analysis, pemetrexed-cisplatin showed an overall survival advantage in EA patients receiving prior platinum-based therapy.
authors: University of Michigan Comprehensive Cancer Center, Division of Hematology/Oncology, Ann Arbor, Michigan, USA.
authors: Susan
authors: S
authors: Urba
authors: Ruey-Long
authors: RL
authors: Hong
authors: Anwar M
authors: AM
authors: Hossain
authors: Rebecca
authors: R
authors: Cheng
authors: Mauro
authors: M
authors: Orlando
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000208:ethnology*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000208:ethnology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000208:ethnology; D000068437:Pemetrexed; D000077195:Squamous Cell Carcinoma of Head and Neck; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D002945:Cisplatin
keywords: cisplatin; clinical trial; head and neck neoplasm; pemetrexed; phase III