title: First-line gefitinib treatment in elderly patients (aged ≥75 years) with non-small cell lung cancer harboring EGFR mutations.
abstract: OBJECTIVE
  The efficacy of gefitinib [an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor] in elderly patients with non-small cell lung cancer (NSCLC) and EGFR mutation has not been elucidated. Therefore, the objective of this study was to investigate the efficacy and feasibility of gefitinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations.
  
  
  METHODS
  We retrospectively evaluated the clinical effects of gefitinib as a first-line treatment for elderly (≥75 years) NSCLC patients with EGFR mutations (exon 19 deletion or exon 21 L858R mutation). All patients were initially treated with gefitinib (250 mg/day) at seven institutions.
  
  
  RESULTS
  Between January 2006 and December 2012, 62 patients (17 men, 45 women) with a median age of 80 years (range, 75-89 years) were included in our analysis. The overall response and disease control rates were 61.2 and 83.8 %, respectively, and the median progression-free survival and overall survival were 13.2 and 19.0 months, respectively. Common adverse events included rash, diarrhea, and liver dysfunction. Major grade 3 or 4 toxicities included skin rash (3.2 %) and increased levels of aspartate aminotransferase or alanine aminotransferase (21.0 %). Gefitinib treatment was discontinued owing to adverse events of liver dysfunction in 3 patients, drug-induced pneumonitis in 2, and diarrhea in 1.
  
  
  CONCLUSIONS
  First-line gefitinib could be a preferable standard treatment in elderly patients with advanced NSCLC harboring sensitive EGFR mutations.
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Tomohito
authors.initials: T
authors.lastname: Kuwako
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. m06701014@gunma-u.ac.jp.
authors.forename: Hisao
authors.initials: H
authors.lastname: Imai
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Tomomi
authors.initials: T
authors.lastname: Masuda
authors.affiliation: Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta, Gunma, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Miura
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Seki
authors.affiliation: Division of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma, Japan.
authors.forename: Reiko
authors.initials: R
authors.lastname: Yoshino
authors.affiliation: Department of Oncology Clinical Development, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Kyoichi
authors.initials: K
authors.lastname: Kaira
authors.affiliation: Division of Internal Medicine, Kiryu Kosei General Hospital, Kiryu, Gunma, Japan.
authors.forename: Mitsuyoshi
authors.initials: M
authors.lastname: Utsugi
authors.affiliation: Department of Thoracic Visceral Organ Surgery, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Shimizu
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Sunaga
authors.affiliation: Division of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Tomizawa
authors.affiliation: Division of Internal Medicine, Isesaki Municipal Hospital, Isesaki, Gunma, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Ishihara
authors.affiliation: Division of Internal Medicine, Public Tomioka General Hospital, Tomioka, Gunma, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Ishizuka
authors.affiliation: Department of General Surgical Science, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Mogi
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hisada
authors.affiliation: Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ohta, Gunma, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Minato
authors.affiliation: Division of Respiratory Medicine, Maebashi Red Cross Hospital, Maebashi, Gunma, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Takise
authors.affiliation: Division of Respiratory Medicine, National Hospital Organization Nishigunma Hospital, Shibukawa, Gunma, Japan.
authors.forename: Ryusei
authors.initials: R
authors.lastname: Saito
authors.affiliation: Department of Medicine and Molecular Science, Gunma University Graduate School of Medicine, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan.
authors.forename: Masanobu
authors.initials: M
authors.lastname: Yamada
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics; D003875:Drug Eruptions / Q000453:epidemiology / Q000503:physiopathology; D016903:Drug Monitoring; D066246:ErbB Receptors / Q000037:antagonists & inhibitors / Q000235:genetics*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D000077156:Gefitinib; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D009154:Mutation; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib
keywords: Advanced non-small cell lung cancer; EGFR mutations; Elderly patients; First-line chemotherapy; Gefitinib; Non-small cell lung cancer