title: Quality of life with gefitinib in patients with EGFR-mutated non-small cell lung cancer: quality of life analysis of North East Japan Study Group 002 Trial.
abstract: BACKGROUND
  For non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations, first-line gefitinib produced a longer progression-free survival interval than first-line carboplatin plus paclitaxel but did not show any survival advantage in the North East Japan 002 study. This report describes the quality of life (QoL) analysis of that study.
  
  
  METHODS
  Chemotherapy-naïve patients with sensitive EGFR-mutated, advanced NSCLC were randomized to receive gefitinib or chemotherapy (carboplatin and paclitaxel). Patient QoL was assessed weekly using the Care Notebook, and the primary endpoint of the QoL analysis was time to deterioration from baseline on each of the physical, mental, and life well-being QoL scales. Kaplan-Meier probability curves and log-rank tests were employed to clarify differences.
  
  
  RESULTS
  QoL data from 148 patients (72 in the gefitinib arm and 76 in the carboplatin plus paclitaxel arm) were analyzed. Time to defined deterioration in physical and life well-being significantly favored gefitinib over chemotherapy (hazard ratio [HR] of time to deterioration, 0.34; 95% confidence interval [CI], 0.23-0.50; p < .0001 and HR, 0.43; 95% CI, 0.28-0.65; p < .0001, respectively).
  
  
  CONCLUSIONS
  QoL was maintained much longer in patients treated with gefitinib than in patients treated with standard chemotherapy, indicating that gefitinib should be considered as the standard first-line therapy for advanced EGFR-mutated NSCLC in spite of no survival advantage.
authors.affiliation: Department of Respiratory Medicine, Saitama International Medical Center, 1397-1 Yamane, Hidaka City, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Oizumi
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Kobayashi
authors.forename: Akira
authors.initials: A
authors.lastname: Inoue
authors.forename: Makoto
authors.initials: M
authors.lastname: Maemondo
authors.forename: Shunichi
authors.initials: S
authors.lastname: Sugawara
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Yoshizawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Isobe
authors.forename: Masao
authors.initials: M
authors.lastname: Harada
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kinoshita
authors.forename: Shoji
authors.initials: S
authors.lastname: Okinaga
authors.forename: Terufumi
authors.initials: T
authors.lastname: Kato
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Harada
authors.forename: Akihiko
authors.initials: A
authors.lastname: Gemma
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Saijo
authors.forename: Yuki
authors.initials: Y
authors.lastname: Yokomizo
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Koichi
authors.initials: K
authors.lastname: Hagiwara
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Nukiwa
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics; D018572:Disease-Free Survival; D023381:Endpoint Determination; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D009154:Mutation; D017239:Paclitaxel / Q000627:therapeutic use; D011446:Prospective Studies; D011788:Quality of Life; D011799:Quinazolines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D016190:Carboplatin; D066246:ErbB Receptors; D017239:Paclitaxel; D000077156:Gefitinib