title: First-line gefitinib therapy for elderly patients with non-small cell lung cancer harboring EGFR mutation: Central Japan Lung Study Group 0901.
abstract: BACKGROUND
  The population of elderly patients with lung cancer is increasing worldwide. Although first-line gefitinib is one of the standard treatments for advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutation, few data have been reported regarding gefitinib and elderly patients.
  
  
  METHODS
  Chemotherapy-naïve patients aged 70 years or older with stage IIIB or IV NSCLC harboring EGFR-activating mutation were enrolled and treated with 250 mg of gefitinib daily until disease progression. The primary end point was response rate, and secondary end points were survival, safety, and quality of life.
  
  
  RESULTS
  Twenty patients were enrolled, and the median age was 79.5 years (range 72-90). Overall response rate was 70% (95% CI 45.7-88.1%), and the disease control rate was 90% (95% CI 68.3-98.7%). The median progression-free survival and overall survival time were 10.0 and 26.4 months, respectively. The Functional Assessment of Cancer Therapy-Lung Cancer Subscale (FACT-LCS) scores improved significantly 4 weeks after the initiation of gefitinib (P = 0.037) and maintained favorably over a 12-week assessment period. Among the seven items of FACT-LCS, shortness of breath and cough improved significantly after 4 weeks of treatment (P = 0.046 and P = 0.008, respectively). The most common adverse events were rash and liver dysfunction. Although Grade 1 pneumonitis developed in one patient, no treatment-related death was observed.
  
  
  CONCLUSIONS
  First-line gefitinib therapy is effective and feasible for elderly patients harboring EGFR mutation, and improves disease-related symptoms, especially pulmonary symptoms like shortness of breath and cough.
authors.affiliation: Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, 18 Kuriyado Kake-machi, Okazaki, Aichi, 444-0011, Japan, ktakahashi@acc-aichi.com.
authors.forename: Kosuke
authors.initials: K
authors.lastname: Takahashi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Saito
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.forename: Masashi
authors.initials: M
authors.lastname: Yamamoto
authors.forename: Eiji
authors.initials: E
authors.lastname: Kojima
authors.forename: Yasuteru
authors.initials: Y
authors.lastname: Sugino
authors.forename: Tomoki
authors.initials: T
authors.lastname: Kimura
authors.forename: Fumio
authors.initials: F
authors.lastname: Nomura
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Ogasawara
authors.forename: Joe
authors.initials: J
authors.lastname: Shindoh
authors.forename: Norio
authors.initials: N
authors.lastname: Yoshida
authors.forename: Ryujiro
authors.initials: R
authors.lastname: Suzuki
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics / Q000473:pathology / Q000503:physiopathology; D018450:Disease Progression; D018572:Disease-Free Survival; D016903:Drug Monitoring / Q000379:methods; D004354:Drug Screening Assays, Antitumor; D066246:ErbB Receptors / Q000235:genetics*; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D000077156:Gefitinib; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008111:Liver Function Tests; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000235:genetics / Q000473:pathology / Q000503:physiopathology; D008297:Male; D009367:Neoplasm Staging; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib