title: Efficacy of S-1 in patients with castration-resistant prostate cancer: a phase II study.
abstract: OBJECTIVE
  This study was conducted to evaluate the efficacy and safety of S-1, an oral fluoropyrimidine derivative, in Japanese patients with castration-resistant prostate cancer (CRPC). The primary endpoint was prostate-specific antigen (PSA) response.
  
  
  METHODS
  In this open-label phase II study, S-1 was started at a dose of 80, 100 or 120 mg daily based on body surface area (BSA) for 28 days, followed by 14 days of rest. Patients with histological proof of prostate cancer refractory to hormonal therapies were eligible. Patients who received prior chemotherapy were excluded. All patients provided written informed consent. To observe 20% confirmed PSA response, 33 assessable patients were needed. Treatment was continued until disease progression or the development of intolerable toxicity.
  
  
  RESULTS
  A total of 35 eligible patients were enrolled. The median number of treatment cycles was 3. PSA response was observed in 8 patients (22.9%, 90% CI 11.9-37.5), including 3 in which (8.6%) the PSA level normalized. The median overall survival was 25.4 months. The most common treatment-related grade 3 toxicity was anorexia (14.3%). There was no death during the study.
  
  
  CONCLUSIONS
  S-1 monotherapy is active against castration-resistant prostate cancer and has acceptable toxicity.
authors.affiliation: Department of Urology and Andrology, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan. akazah@md.tsukuba.ac.jp
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
authors.forename: Isao
authors.initials: I
authors.lastname: Ikemoto
authors.forename: Mikio
authors.initials: M
authors.lastname: Namiki
authors.forename: Michiyuki
authors.initials: M
authors.lastname: Usami
authors.forename: Mikio
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujimoto
authors.forename: Taiji
authors.initials: T
authors.lastname: Tsukamoto
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
mesh_terms: D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000726:Androgen Antagonists / Q000627:therapeutic use; D000855:Anorexia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use* / Q000633:toxicity; D001219:Aspartate Aminotransferases / Q000097:blood; D001663:Bilirubin / Q000097:blood; D001830:Body Surface Area; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004361:Drug Tolerance; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D010094:Oxonic Acid / Q000627:therapeutic use* / Q000633:toxicity; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D012449:Safety; D005641:Tegafur / Q000627:therapeutic use* / Q000633:toxicity; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D017430:Prostate-Specific Antigen; D001663:Bilirubin