title: First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy.
abstract: OBJECTIVE
  This multicenter phase II study was undertaken to investigate the efficacy and feasibility of gefitinib for patients with advanced non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations without indication for chemotherapy as a result of poor performance status (PS).
  
  
  METHODS
  Chemotherapy-naïve patients with poor PS (patients 20 to 74 years of age with Eastern Cooperative Oncology Group PS 3 to 4, 75 to 79 years of age with PS 2 to 4, and >or= 80 years of age with PS 1 to 4) who had EGFR mutations examined by the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method were enrolled and received gefitinib (250 mg/d) alone.
  
  
  RESULTS
  Between February 2006 and May 2007, 30 patients with NSCLC and poor PS, including 22 patients with PS 3 to 4, were enrolled. The overall response rate was 66% (90% CI, 51% to 80%), and the disease control rate was 90%. PS improvement rate was 79% (P < .00005); in particular, 68% of the 22 patients improved from >or= PS 3 at baseline to <or= PS 1. The median progression-free survival, median survival time, and 1-year survival rate were 6.5 months, 17.8 months, and 63%, respectively. No treatment-related deaths were observed.
  
  
  CONCLUSIONS
  This is the first report indicating that EGFR mutation-positive patients with extremely poor PS benefit from first-line gefitinib. Because there previously has been no standard treatment for these patients with short life expectancy other than best supportive care, examination of EGFR mutations as a biomarker is recommended in this patient population.
authors.affiliation: Tohoku University, Graduate School of Medicine and School of Medicine, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Kobayashi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Usui
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Shoji
authors.initials: S
authors.lastname: Okinaga
authors.forename: Iwao
authors.initials: I
authors.lastname: Mikami
authors.forename: Masahiro
authors.initials: M
authors.lastname: Ando
authors.forename: Koichi
authors.initials: K
authors.lastname: Yamazaki
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Saijo
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Miyazawa
authors.forename: Tomoaki
authors.initials: T
authors.lastname: Tanaka
authors.forename: Kenji
authors.initials: K
authors.lastname: Ikebuchi
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Koichi
authors.initials: K
authors.lastname: Hagiwara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics*; D066246:ErbB Receptors / Q000235:genetics*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics*; D008875:Middle Aged; D009154:Mutation; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D066246:ErbB Receptors