title: Pemetrexed-Erlotinib, Pemetrexed Alone, or Erlotinib Alone as Second-Line Treatment for East Asian and Non-East Asian Never-Smokers with Locally Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer: Exploratory Subgroup Analysis of a Phase II Trial.
abstract: OBJECTIVE
  This subgroup analysis of a phase II trial was conducted to assess possible ethnicity-based trends in efficacy and safety in East Asian (EA) and non-EA populations with nonsquamous non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Never-smoker patients (n=240) with locally advanced or metastatic nonsquamous NSCLC included 133 EA patients randomized to pemetrexed supplemented with dexamethasone, folic acid, and vitamin B12 plus erlotinib (pemetrexed-erlotinib) (n=41), erlotinib (n=49), or pemetrexed (n=43), and 107 non-EA patients randomized to pemetrexed-erlotinib (n=37), erlotinib (n=33), or pemetrexed (n=37). The primary endpoint, progression-free survival (PFS), was analyzed using a multivariate Cox model.
  
  
  RESULTS
  Consistent with the results of the overall study, a statistically significant difference in PFS among the three arms was noted in the EA population favoring pemetrexed-erlotinib (overall p=0.003) as compared with either single-agent arm (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.29 to 0.79; p=0.004 vs. erlotinib; HR, 0.40; 95% CI, 0.23 to 0.70; p=0.001 vs. pemetrexed). The EA patients treated with pemetrexed-erlotinib achieved a longer median PFS (7.4 months) compared with erlotinib (4.5 months) and pemetrexed (4.0 months). The PFS results also numerically favored pemetrexed-erlotinib in the non-EA population (overall p=0.210) (HR, 0.62; 95% CI, 0.37 to 1.05; p=0.078 vs. erlotinib; HR, 0.75; 95% CI, 0.42 to 1.32; p=0.320 vs. pemetrexed) (median PFS: pemetrexed-erlotinib, 6.7 months; erlotinib, 3.0 months; pemetrexed, 4.4 months).
  
  
  CONCLUSIONS
  The PFS results from this subset analysis in both EA and non-EA populations are consistent with the results in the overall population. The PFS advantage for pemetrexed-erlotinib is significant compared with the single agents in EA patients.
authors: Department of Oncology, Asan Medical Center, Seoul, Korea.
authors: Dae Ho
authors: DH
authors: Lee
authors: Department of Oncology, Asan Medical Center, Seoul, Korea.
authors: Jung Shin
authors: JS
authors: Lee
authors: Department of Thoracic Medical Oncology, Beijing Tumor Hospital and Institute, Beijing, China.
authors: Jie
authors: J
authors: Wang
authors: Department of Respiratory Therapy, China Medical University and China Medical University Hospital, Taichung, Taiwan.
authors: Te-Chun
authors: TC
authors: Hsia
authors: Asia Pacific Statistical Sciences, Lilly China Drug Development and Medical Affairs Centre, Shanghai, China.
authors: Xin
authors: X
authors: Wang
authors: Medical Department, Lilly Korea Ltd., Seoul, Korea.
authors: Jongseok
authors: J
authors: Kim
authors: Medical Department, Eli-Lilly Interamerica Inc., Buenos Aires, Argentina.
authors: Mauro
authors: M
authors: Orlando
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D044466:Asian People; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology*; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D000068437:Pemetrexed / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D012449:Safety; D016896:Treatment Outcome; D028761:Withholding Treatment
chemical_list: D000068437:Pemetrexed; D000069347:Erlotinib Hydrochloride
keywords: East Asian; Erlotinib; Nonsquamous non-small cell lung cancer; Pemetrexed