title: Phase II study of erlotinib in elderly patients with non-small cell lung cancer harboring epidermal growth factor receptor mutations.
abstract: OBJECTIVE
  Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors are key drugs in the treatment of non-small cell lung cancer (NSCLC) harboring EGFR activating mutations. We assessed the efficacy and safety of one EGFR tyrosine kinase inhibitor, erlotinib, in elderly Japanese patients with EGFR-mutated NSCLC.
  
  
  METHODS
  Elderly patients aged 75 or older with advanced or recurrent NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) were enrolled in this prospective phase II trial. Patients received 150 mg erlotinib per day orally. The primary end point was the overall response rate.
  
  
  RESULTS
  Between March 2013 and November 2014, 32 patients were enrolled with median age 80 years. All tumors had adenocarcinoma histology, and 20 patients (62.5 %) had an L858R mutation. The response rate was 56.3 % [95 % confidence interval (CI) 39.4-72.0 %], and the disease control rate was 90.6 % (95 % CI 75.2-97.6 %). Median progression-free survival was 15.5 months (95 % CI 11.2-not reached). Skin disorder was the most common adverse event, and grade 4 drug-related interstitial lung disease occurred in one patient.
  
  
  CONCLUSIONS
  Erlotinib is effective and tolerated in elderly patients with EGFR mutation-positive NSCLC.
authors.affiliation: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, 1-20-1 Handayama, Higashi-ku, Hamamatsu, 431-3192, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Inoue
authors.forename: Naoki
authors.initials: N
authors.lastname: Inui
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Asada
authors.forename: Masato
authors.initials: M
authors.lastname: Karayama
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Matsuda
authors.forename: Koshi
authors.initials: K
authors.lastname: Yokomura
authors.forename: Naoki
authors.initials: N
authors.lastname: Koshimizu
authors.forename: Shiro
authors.initials: S
authors.lastname: Imokawa
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamada
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Shirai
authors.forename: Norio
authors.initials: N
authors.lastname: Kasamatsu
authors.forename: Takafumi
authors.initials: T
authors.lastname: Suda
mesh_terms: 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*; D000069347:Erlotinib Hydrochloride; D005091:Exons; D005260:Female; D017353:Gene Deletion; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000235:genetics; D008297:Male; D009154:Mutation; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; C512478:EGFR protein, human; D066246:ErbB Receptors