title: Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations.
abstract: BACKGROUND
  This study prospectively assessed the efficacy of gefitinib and the survival benefit for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations.
  
  
  METHODS
  Patients with either recurrent disease after undergoing surgery or advanced NSCLC disease (IIIB or IV) which demonstrated EGFR mutations were eligible for this study. EGFR mutations in exons 19-21 were examined. The patients with EGFR mutations were enrolled in this study after obtaining their informed consent a second time, and they were thereafter treated with gefitinib.
  
  
  RESULTS
  EGFR mutations were detected in 20 of 48 patients with NSCLC, and 19 patients were enrolled onto this study and treated with gefitinib. Seven patients had an exon 19 deletion, 10 had L858R, 1 had both, and 1 had an exon 19 deletion and G796A. The overall response rate was 63.2%, and the disease control rate was 89.5%. In patients with an exon 19 del and L858R, the response rates were 71.4% and 60.0%, respectively. The median progression-free survival time was 7.1 months, and the median survival time was 20.0 months. No life-threatening toxicity was observed. Four of five acquired resistant tumors showed an acquired T790M mutation.
  
  
  CONCLUSIONS
  EGFR mutations in exons 19 or 21 are considered to be a good predictor of the efficacy of gefitinib.
authors.affiliation: Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan. kensugio@med.uoeh-u.ac.jp
authors.forename: Kenji
authors.initials: K
authors.lastname: Sugio
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Uramoto
authors.forename: Takamitsu
authors.initials: T
authors.lastname: Onitsuka
authors.forename: Makiko
authors.initials: M
authors.lastname: Mizukami
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Ichiki
authors.forename: Masakazu
authors.initials: M
authors.lastname: Sugaya
authors.forename: Manabu
authors.initials: M
authors.lastname: Yasuda
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Takenoyama
authors.forename: Tsunehiro
authors.initials: T
authors.lastname: Oyama
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hanagiri
authors.forename: Kosei
authors.initials: K
authors.lastname: Yasumoto
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D005091:Exons; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation; D009367:Neoplasm Staging; D011446:Prospective Studies; D011799:Quinazolines / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib