title: First-line gefitinib for elderly patients with advanced NSCLC harboring EGFR mutations. A combined analysis of North-East Japan Study Group studies.
abstract: OBJECTIVE
  To assess outcomes of elderly patients with advanced NSCLC harboring an EGFR mutation treated with gefitinib, as well as safety and impact on quality of life (QoL).
  
  
  METHODS
  We performed a retrospective analysis of pooled data from one Phase III and two Phase II studies of 71 patients aged ≥ 70 years with a performance status of 0 - 2. The main outcome measures were progression-free survival (PFS), overall survival (OS) and response rate (RR), as well as incidence of adverse events and time to 9.1% deterioration in QoL.
  
  
  RESULTS
  Median PFS (14.3 vs 5.7 months, p < 0.001) and overall RR (73.2 vs 26.5%, p < 0.001) in the gefitinib group were superior to those in the standard chemotherapy group, whereas median OS was not significantly different (30.8 vs 26.4 months, p = 0.42). Elevation of aspartate transaminase and/or alanine transaminase (18.3%) was the most common adverse event, and one treatment-related death (pneumonitis) occurred. Time to 9.1% deterioration in the QoL domains of pain and dyspnea, anxiety, and daily functioning was similar between the two age groups.
  
  
  CONCLUSIONS
  First-line gefitinib is efficacious with acceptable toxicity in relatively fit elderly patients with advanced NSCLC harboring an EGFR mutation.
authors.affiliation: Iwate Medical University School of Medicine, Division of Pulmonary Medicine, Allergy, and Rheumatology, Department of Internal Medicine , 19-1 Uchimaru, Morioka, Iwate 020-8505 , Japan +81 19 651 5111 (ext. 2334) ; +81 19 626 8040 ; carcinoma@nifty.com.
authors.forename: Naoto
authors.initials: N
authors.lastname: Morikawa
authors.forename: Yuji
authors.initials: Y
authors.lastname: Minegishi
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Kobayashi
authors.forename: Shunichi
authors.initials: S
authors.lastname: Sugawara
authors.forename: Masao
authors.initials: M
authors.lastname: Harada
authors.forename: Koichi
authors.initials: K
authors.lastname: Hagiwara
authors.forename: Shoji
authors.initials: S
authors.lastname: Okinaga
authors.forename: Satoshi
authors.initials: S
authors.lastname: Oizumi
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D018572:Disease-Free Survival; D066246:ErbB Receptors / Q000235:genetics*; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics; D015337:Multicenter Studies as Topic; D009154:Mutation; D011788:Quality of Life; D011799:Quinazolines / Q000627:therapeutic use*; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D066246:ErbB Receptors; D000077156:Gefitinib
keywords: EGFR tyrosine kinase inhibitors; NSCLC; elderly patients; gefitinib