title: A phase II study of S-1 chemotherapy with concurrent thoracic radiotherapy in elderly patients with locally advanced non-small-cell lung cancer: the Okayama Lung Cancer Study Group Trial 0801.
abstract: BACKGROUND
  Although thoracic irradiation (TRT) is a standard treatment for elderly patients with locally advanced non-small-cell lung cancer (LA-NSCLC), treatment outcomes are poor. We previously reported a phase I trial combining S-1, an oral 5-fluorouracil derivative, and thoracic radiation, which yielded safe and effective outcomes.
  
  
  METHODS
  In this phase II trial, 30 patients aged 76 years or older with LA-NSCLC received S-1 (80 mg/m(2) on days 1-14 and 29-42) and TRT (60Gy). The primary end-point was the response rate.
  
  
  RESULTS
  The median age and pre-treatment Charlson score were 79 years and 1, respectively. The mean proportions of the actual doses of S-1 and TRT delivered relative to the planned doses were 95% and 98%, respectively. Partial responses were observed in 19 patients (63%; 95% confidence interval: 45-82%), which did not attain the end-point. At a median follow-up time of 23.7 months, the median progression-free survival and median survival times were 13.0 months and 27.9 months, respectively. No difference in efficacy was observed upon stratification by tumour histology. Toxicities were generally mild, except for grade 3 or greater febrile neutropenia and pneumonitis in 7% and 10% of patients, respectively. No patient developed severe oesophagitis.
  
  
  CONCLUSIONS
  Although the primary end-point was not met, concurrent S-1 chemotherapy and radiotherapy yielded favourable survival data. Also, the combined treatment was well-tolerated in elderly patients with LA-NSCLC.
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Aoe
authors.affiliation: Department of General Internal Medicine 4, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan.
authors.forename: Nagio
authors.initials: N
authors.lastname: Takigawa
authors.affiliation: Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan. Electronic address: khotta@md.okayama-u.ac.jp.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Hotta
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Tadashi
authors.initials: T
authors.lastname: Maeda
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Daizo
authors.initials: D
authors.lastname: Kishino
authors.affiliation: Department of Thoracic Oncology and Medicine, NHO Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tabata
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Harita
authors.affiliation: Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Okada
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan; Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Kubo
authors.affiliation: Department of Respiratory Medicine, Okayama Red Cross Hospital, Okayama, Japan.
authors.forename: Shinobu
authors.initials: S
authors.lastname: Hosokawa
authors.affiliation: Department of Respiratory Medicine, NHO Okayama Medical Center, Okayama, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Fujiwara
authors.affiliation: Department of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan; Department of Respiratory Medicine, NHO Fukuyama Medical Center, Fukuyama, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Gemba
authors.affiliation: Department of Respiratory Medicine, NHO Fukuyama Medical Center, Fukuyama, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Yasugi
authors.affiliation: Department of Thoracic Oncology and Medicine, NHO Shikoku Cancer Center, Matsuyama, Japan.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kozuki
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Yuka
authors.initials: Y
authors.lastname: Kato
authors.affiliation: Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Kuniaki
authors.initials: K
authors.lastname: Katsui
authors.affiliation: Department of Radiology, Okayama University Hospital, Okayama, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Kanazawa
authors.affiliation: Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ueoka
authors.affiliation: Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
authors.forename: Mitsune
authors.initials: M
authors.lastname: Tanimoto
authors.affiliation: Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Kiura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D018450:Disease Progression; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D009362:Neoplasm Metastasis; D010094:Oxonic Acid / Q000627:therapeutic use*; D012008:Recurrence; D005641:Tegafur / Q000627:therapeutic use*; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D005472:Fluorouracil
keywords: Elderly patients; Non-small-cell lung cancer; Radiation; S-1