title: Customized chemotherapy based on epidermal growth factor receptor mutation status for elderly patients with advanced non-small-cell lung cancer: a phase II trial.
abstract: BACKGROUND
  Elderly patients are more vulnerable to toxicity from chemotherapy. Activating epidermal growth factor receptor (EGFR) mutations in non-small-cell lung cancer (NSCLC) are associated with enhanced response to EGFR tyrosine-kinase inhibitors. We studied patients with advanced NSCLC for whom treatment was customized based on EGFR mutation status.
  
  
  METHODS
  We screened 57 chemotherapy-naïve patients with histologically or cytologically confirmed NSCLC, stage IIIB or IV, aged 70 years or older, and with an Eastern Cooperative Oncology Group performance status 0 or 1, for EGFR exon 19 codon 746-750 deletion and exon 21 L858R mutation. Twenty-two patients with EGFR mutations received gefitinib; 32 patients without mutations received vinorelbine or gemcitabine. The primary endpoint was the response rate.
  
  
  RESULTS
  The response rate was 45.5% (95% confidence interval [CI]: 24.4%, 67.8%) in patients with EGFR mutations and 18.8% (95% CI: 7.2%, 36.4%) in patients without EGFR mutations. The median overall survival was 27.9 months (95%CI: 24.4 months, undeterminable months) in patients with EGFR mutations and 14.9 months (95%CI: 11.0 months, 22.4 months) in patients without EGFR mutations. In the gefitinib group, grade 3/4 hepatic dysfunction and dermatitis occurred in 23% and 5% of patients, respectively. In patients treated with vinorelbine or gemcitabine, the most common grade 3 or 4 adverse events were neutropenia (47%; four had febrile neutropenia), anemia (13%), and anorexia (9%). No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  Treatment customization based on EGFR mutation status deserves consideration, particularly for elderly patients who often cannot receive second-line chemotherapy due to poor organ function or comorbidities.
  
  
  BACKGROUND
  This trial is registered at University hospital Medical Information Network-clinical trial registration (http://www.umin.ac.jp/ctr/index/htm) with the registration identification number C000000436.
authors.affiliation: Institute of Biomedical Research and Innovation Hospital, 2-2 Minatojima Minami-machi, Chuo-ku, Kobe, 650-0047, Japan. jp.shirofujita@gmail.com
authors.forename: Shiro
authors.initials: S
authors.lastname: Fujita
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Katsuhiro
authors.initials: K
authors.lastname: Masago
authors.forename: Hiroshige
authors.initials: H
authors.lastname: Yoshioka
authors.forename: Keisuke
authors.initials: K
authors.lastname: Tomii
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Kaneda
authors.forename: Masataka
authors.initials: M
authors.lastname: Hirabayashi
authors.forename: Kei
authors.initials: K
authors.lastname: Kunimasa
authors.forename: Toshio
authors.initials: T
authors.lastname: Morizane
authors.forename: Tadashi
authors.initials: T
authors.lastname: Mio
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000235:genetics* / Q000401:mortality / Q000473:pathology; D066246:ErbB Receptors / Q000235:genetics*; D005260:Female; D006801:Humans; D008297:Male; D009154:Mutation; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D066246:ErbB Receptors