title: A phase I study of S-1 with concurrent radiotherapy in elderly patients with locally advanced non-small cell lung cancer.
abstract: BACKGROUND
  A phase I study was performed to evaluate dose-limiting toxicity and the recommended dose for the oral fluoropyrimidine S-1 administered concurrently with thoracic radiotherapy (TRT) in elderly (≥ 70 years of age) patients with locally advanced non-small cell lung cancer.
  
  
  METHODS
  S-1 was administered on days 1 to 14 and 22 to 35 at oral doses of 65 or 80 mg m(-2) day(-1). TRT was administered in 2-Gy fractions five times weekly for a total dose of 60 Gy. Twelve previously untreated patients were treated with S-1 at 65 (n=6) or 80 (n=6) mg m(-2) day(-1).
  
  
  RESULTS
  All patients completed the planned 60 Gy of TRT. Dose-limiting toxicity included pneumonitis (n=2), infection (n=1), and stomatitis (n=1), each of grade 3, but each event was reversible. The recommended dose for S-1 was determined to be 80 mg m(-2) day(-1). No patient experienced toxicity of grade 4. The dose intensity of S-1 was well maintained and the combination of S-1 plus TRT was well tolerated overall. The overall response rate was 83.3 %, with a median survival time of 34.0 months.
  
  
  CONCLUSIONS
  Administration of S-1 at 80 mg m(-2) day(-1) on days 1 to 14 and 22 to 35 can be safely combined with concurrent TRT in elderly patients with locally advanced non-small cell lung cancer.
authors.affiliation: Department of Medical Oncology, Kishiwada City Hospital, Osaka, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Ken
authors.initials: K
authors.lastname: Takezawa
authors.forename: Masaaki
authors.initials: M
authors.lastname: Miyazaki
authors.forename: Junji
authors.initials: J
authors.lastname: Tsurutani
authors.forename: Kimio
authors.initials: K
authors.lastname: Yonesaka
authors.forename: Ryotaroh
authors.initials: R
authors.lastname: Morinaga
authors.forename: Asuka
authors.initials: A
authors.lastname: Tsuya
authors.forename: Masaaki
authors.initials: M
authors.lastname: Terashima
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Kudoh
authors.forename: Koichi
authors.initials: K
authors.lastname: Azuma
authors.forename: Takayasu
authors.initials: T
authors.lastname: Kurata
authors.forename: Tatsuyuki
authors.initials: T
authors.lastname: Nishikawa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Fukuoka
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Nishimura
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nakagawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000532:radiotherapy*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid