title: Phase II tailored S-1 regimen study of first-line chemotherapy in elderly patients with advanced and recurrent non-small cell lung cancer.
abstract: OBJECTIVE
  We investigated the efficacy and toxicity of a novel oral 5-fluorouracil (5-FU) formulation (S-1), administered according to a tailored dose regimen.
  
  
  METHODS
  S-1 was administered orally for 28 days, followed by 14 days of no treatment, in 23 patients who received a tailored dose of S-1, adjusted on the basis of individual creatinine clearance and body surface area. In 8 of the patients, pharmacokinetic study was performed on the 6 points on 7th day after S-1 administration.
  
  
  RESULTS
  Of the 23 patients enrolled in this study, 2 (8.7 %) had a partial response and 14 (60.9 %) had stable disease. The disease control rate was 69.6 % (16/23) (95 % confidence interval, 50.8-88.4 %). Grade 3/4 hematologic and non-hematologic toxicities were minor. In the pharmacokinetic study group, the maximum plasma concentration (C (max)) and the area under the plasma concentration curve of 5-FU at all 6 points after administration of the tailored S-1 dose regimen were similar to the values reported in a previous study describing cancer patients with normal renal function who received a standard dose of S-1 (80 mg/m(2)/day).
  
  
  CONCLUSIONS
  Our results suggest that tailored S-1 monotherapy is safe and therapeutically useful as first-line treatment for elderly patients with advanced and recurrent non-small cell lung cancer.
authors.affiliation: Department of Respiratory Medicine, Osaka Police Hospital, Kitayama-chou, Tennoji-ku, Japan. takayuki.s12@hotmail.co.jp
authors.forename: Takayuki
authors.initials: T
authors.lastname: Shiroyama
authors.forename: Takashi
authors.initials: T
authors.lastname: Kijima
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Komuta
authors.forename: Suguru
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Seigo
authors.initials: S
authors.lastname: Minami
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Ogata
authors.forename: Kouhei
authors.initials: K
authors.lastname: Okafuji
authors.forename: Fumio
authors.initials: F
authors.lastname: Imamura
authors.forename: Tomonori
authors.initials: T
authors.lastname: Hirashima
authors.forename: Isao
authors.initials: I
authors.lastname: Tachibana
authors.forename: Ichiro
authors.initials: I
authors.lastname: Kawase
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kumanogoh
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D001830:Body Surface Area; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003404:Creatinine / Q000097:blood; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D003404:Creatinine; D005472:Fluorouracil