title: Single-agent gefitinib with concurrent radiotherapy for locally advanced non-small cell lung cancer harboring mutations of the epidermal growth factor receptor.
abstract: BACKGROUND
  A feasibility study was performed to examine the safety and toxicity profile of daily gefitinib (250 mg) administration with concurrent definitive thoracic radiation therapy (TRT) in patients with unresectable non-small cell lung cancer (NSCLC) of stage III.
  
  
  METHODS
  Patients received a 14-day induction therapy with gefitinib at 250 mg daily. TRT was initiated on day 15 in 2-Gy fractions administered five times weekly to a total dose of 60 Gy. The primary end point of the study was the rate of treatment completion. Mutation status of the epidermal growth factor receptor gene (EGFR) was evaluated for patients with available tumor specimens.
  
  
  RESULTS
  Nine eligible patients enrolled in the study received induction gefitinib monotherapy. Two patients were unable to begin TRT because of the development of progressive disease during the first 2 weeks of the protocol. Three of the remaining seven patients treated with gefitinib and concurrent TRT were unable to complete the planned treatment (two because of pulmonary toxicity and one because of progressive disease), and the study was therefore closed according to the protocol definition. Tumor samples were available for eight patients. EGFR mutations (deletion in exon 19) were detected in two patients, both of whom achieved a partial response and exhibited an overall survival of >5 years.
  
  
  CONCLUSIONS
  Our results do not support further trials of gefitinib and TRT for unselected NSCLC patients. This therapeutic strategy may hold promise, however, for locally advanced NSCLC in patients with sensitizing EGFR mutations.
authors.affiliation: Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan. chi-okamoto@dotd.med.kindai.ac.jp
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Takahashi
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Okamoto
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
authors.forename: Koshiro
authors.initials: K
authors.lastname: Watanabe
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Nakamatsu
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Nishimura
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
mesh_terms: D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000532:radiotherapy*; D004252:DNA Mutational Analysis; D005240:Feasibility Studies; D005260:Female; D000077156:Gefitinib; D018773:Genes, erbB-1 / Q000235:genetics; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009154:Mutation / Q000235:genetics; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D011878:Radiotherapy; D028761:Withholding Treatment
chemical_list: D011799:Quinazolines; D000077156:Gefitinib