title: Clinical efficacy of S-1 in pretreated metastatic breast cancer patients.
abstract: BACKGROUND
  S-1, an oral fluoropyrimidine carbamate, is an active and well-tolerated agent against solid cancer. However, the clinical efficacy of S-1 in patients with metastatic breast cancer has not been determined.
  
  
  METHODS
  We retrospectively evaluated the efficacy of S-1 and identified its adverse effects in patients with metastatic breast cancer who had failed to respond to prior chemotherapy regimens. All the patients were treated at the National Cancer Center Hospital and received S-1 twice daily at a dose of 80 mg/m(2) for 4 weeks, followed by a 2-week rest interval.
  
  
  RESULTS
  Between 2003 and 2007, 37 women with metastatic breast cancer received S-1 as a third line or greater chemotherapy regimen. All the patients had been previously treated with both anthracyclines and taxanes prior to S-1 chemotherapy. The median order of S-1 administration was as a fifth-line treatment, and 23 patients (62%) received S-1 as their final anticancer drug. One (3%) partial response and two (5%) stable diseases were observed. The median time to progression (TTP) was 84 days. Grade 2 adverse events, such as diarrhea, stomatitis and neutropenia occurred in 5 (16%), 1 (3%) and 1 (3%) patients, respectively.
  
  
  CONCLUSIONS
  S-1 was safety administered to heavily treated metastatic breast cancer patients with limited efficacy. Further evaluation of S-1 is necessary to elucidate its clinical role in breast cancer treatment.
authors.affiliation: Division of Surgical Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
authors.forename: Tadahiko
authors.initials: T
authors.lastname: Shien
authors.forename: Chikako
authors.initials: C
authors.lastname: Shimizu
authors.forename: Sadako
authors.initials: S
authors.lastname: Akashi-Tanaka
authors.forename: Kan
authors.initials: K
authors.lastname: Yonemori
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Kohno
authors.forename: Takashi
authors.initials: T
authors.lastname: Hojo
authors.forename: Masashi
authors.initials: M
authors.lastname: Ando
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Katsumata
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Fujiwara
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy*; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D010094:Oxonic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D005641:Tegafur / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid