title: Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002).
abstract: BACKGROUND
  NEJ002 study, comparing gefitinib with carboplatin (CBDCA) and paclitaxel (PTX; Taxol) as the first-line treatment for advanced non-small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation, previously reported superiority of gefitinib over CBDCA/PTX on progression-free survival (PFS). Subsequent analysis was carried out mainly regarding overall survival (OS).
  
  
  METHODS
  For all 228 patients in NEJ002, survival data were updated in December, 2010. Detailed information regarding subsequent chemotherapy after the protocol treatment was also assessed retrospectively and the impact of some key drugs on OS was evaluated.
  
  
  RESULTS
  The median survival time (MST) was 27.7 months for the gefitinib group, and was 26.6 months for the CBDCA/PTX group (HR, 0.887; P=0.483). The OS of patients who received platinum throughout their treatment (n=186) was not statistically different from that of patients who never received platinum (n=40). The MST of patients treated with gefitinib, platinum, and pemetrexed (PEM) or docetaxel (DOC, Taxotere; n=76) was around 3 years.
  
  
  CONCLUSIONS
  No significant difference in OS was observed between gefitinib and CBDCA/PTX in the NEJ002 study, probably due to a high crossover use of gefitinib in the CBDCA/PTX group. Considering the many benefits and the risk of missing an opportunity to use the most effective agent for EGFR-mutated NSCLC, the first-line gefitinib is strongly recommended.
authors.affiliation: Department of Respiratory Medicine, Tohoku University Hospital, Sendai, Japan. akinoue@idac.tohoku.ac.jp
authors.forename: A
authors.initials: A
authors.lastname: Inoue
authors.forename: K
authors.initials: K
authors.lastname: Kobayashi
authors.forename: M
authors.initials: M
authors.lastname: Maemondo
authors.forename: S
authors.initials: S
authors.lastname: Sugawara
authors.forename: S
authors.initials: S
authors.lastname: Oizumi
authors.forename: H
authors.initials: H
authors.lastname: Isobe
authors.forename: A
authors.initials: A
authors.lastname: Gemma
authors.forename: M
authors.initials: M
authors.lastname: Harada
authors.forename: H
authors.initials: H
authors.lastname: Yoshizawa
authors.forename: I
authors.initials: I
authors.lastname: Kinoshita
authors.forename: Y
authors.initials: Y
authors.lastname: Fujita
authors.forename: S
authors.initials: S
authors.lastname: Okinaga
authors.forename: H
authors.initials: H
authors.lastname: Hirano
authors.forename: K
authors.initials: K
authors.lastname: Yoshimori
authors.forename: T
authors.initials: T
authors.lastname: Harada
authors.forename: Y
authors.initials: Y
authors.lastname: Saijo
authors.forename: K
authors.initials: K
authors.lastname: Hagiwara
authors.forename: S
authors.initials: S
authors.lastname: Morita
authors.forename: T
authors.initials: T
authors.lastname: Nukiwa
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D009154:Mutation; D017239:Paclitaxel / Q000008:administration & dosage; D011799:Quinazolines / Q000008:administration & dosage; D016019:Survival Analysis
chemical_list: D011799:Quinazolines; D016190:Carboplatin; D066246:ErbB Receptors; D017239:Paclitaxel; D000077156:Gefitinib