title: Induction chemotherapy followed by gefitinib and concurrent thoracic radiotherapy for unresectable locally advanced adenocarcinoma of the lung: a multicenter feasibility study (JCOG 0402).
abstract: BACKGROUND
  We conducted a feasibility study of induction chemotherapy followed by gefitinib and thoracic radiotherapy (TRT) for unresectable locally advanced adenocarcinoma of the lung.
  
  
  METHODS
  Patients received induction chemotherapy with cisplatin (80 mg/m(2), days 1 and 22) and vinorelbine (25 mg/m(2), days 1, 8, 22, and 29) followed by gefitinib (250 mg daily, beginning on day 43, for 1 year) and TRT (60 Gy/30 fractions, days 57-98). The primary end point was feasibility, which was defined as the proportion of patients who completed 60 Gy of TRT and received >75% of the planned dose of gefitinib without developing grade 2 or worse pneumonitis.
  
  
  RESULTS
  Of the 38 enrolled patients, 23 patients [60.5% ; 80% confidence interval (CI) 48.8-71.3] completed treatment without experiencing grade 2 or worse pneumonitis. During the chemoradiation phase, grade 3-4 alanine aminotransferase elevations were observed in 37.1% of the patients. The overall response rate was 73.0% . The median survival time was 28.5 months (95% CI 22.5-38.2), and the 2-year survival rate was 65.4% .
  
  
  CONCLUSIONS
  Although the results did not meet our criterion for feasibility, the toxicity was acceptable. This treatment warrants further evaluation among patients with locally advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations.
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa. Electronic address: siniho@east.ncc.go.jp.
authors.forename: S
authors.initials: S
authors.lastname: Niho
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa.
authors.forename: Y
authors.initials: Y
authors.lastname: Ohe
authors.affiliation: Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya.
authors.forename: S
authors.initials: S
authors.lastname: Ishikura
authors.affiliation: Department of Thoracic Oncology, Division of Internal Medicine, NHO Kinki-Chuo Chest Medical Center, Sakai.
authors.forename: S
authors.initials: S
authors.lastname: Atagi
authors.affiliation: Department of Internal Medicine, Niigata Cancer Center, Niigata.
authors.forename: A
authors.initials: A
authors.lastname: Yokoyama
authors.affiliation: Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka.
authors.forename: Y
authors.initials: Y
authors.lastname: Ichinose
authors.affiliation: Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama.
authors.forename: H
authors.initials: H
authors.lastname: Okamoto
authors.affiliation: Department of Clinical Oncology, Osaka City General Hospital, Osaka.
authors.forename: K
authors.initials: K
authors.lastname: Takeda
authors.affiliation: Japan Clinical Oncology Group Data Center, Multi-institutional Clinical Trial Support Center, National Cancer Center, Tokyo.
authors.forename: T
authors.initials: T
authors.lastname: Shibata
authors.affiliation: Division of Thoracic Oncology, National Cancer Center Hospital, Tokyo.
authors.forename: T
authors.initials: T
authors.lastname: Tamura
authors.affiliation: Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Saijo
authors.affiliation: Department of Medical Oncology, Kinki University School of Medicine, Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Fukuoka
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000077192:Adenocarcinoma of Lung; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D000077156:Gefitinib; D006801:Humans; D060828:Induction Chemotherapy; D053208:Kaplan-Meier Estimate; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010349:Patient Compliance; D011014:Pneumonia / Q000139:chemically induced; D011799:Quinazolines / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D011799:Quinazolines; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000077156:Gefitinib