title: Phase II study of 4-weekly capecitabine monotherapy in advanced/metastatic breast cancer.
abstract: BACKGROUND
  A multicenter, phase II study was conducted to evaluate the efficacy and safety of the Japanese intermittent 4-week regimen of capecitabine in patients with advanced/metastatic breast cancer.
  
  
  METHODS
  Fifty patients who had received no more than one prior chemotherapy regimen for advanced/metastatic disease were enrolled from 23 centers and received at least two 4-weekly cycles of capecitabine (828 mg/m² orally twice daily for 3 weeks followed by a 1-week rest period).
  
  
  RESULTS
  The overall response rate assessed by the Independent Review Committee (standard population, n = 46) was 28.3% (95% confidence interval 16.0-43.5%), including complete responses in 6.5%. Stable disease was observed in 20 patients and maintained for more than 6 months in 10 patients. The median duration of response in 13 evaluable responders was 5.3 months. Among evaluable patients (n = 47), median time to disease progression was 5.1 months. Median overall survival was 20.2 months. The most common treatment-related adverse events (all grades) were hand-foot syndrome (66%), nausea (26%), stomatitis (22%) and diarrhea (20%). Grade 3/4 treatment-related adverse events were seen in 23 patients (46%). The most common grade 3/4 adverse events were lymphocytopenia (22%), hand-foot syndrome (18%) and hyperbilirubinemia (10%).
  
  
  CONCLUSIONS
  Although the target overall response rate was not reached, the Japanese intermittent 4-week regimen of capecitabine was shown to be an effective and well-tolerated first- or second-line therapy for advanced/metastatic breast cancer.
authors.affiliation: Tokyo Medical University, Shinjuku-ku, Japan. kusama@breastcenter.jp
authors.forename: Mikihiro
authors.initials: M
authors.lastname: Kusama
authors.forename: Tadashi
authors.initials: T
authors.lastname: Nomizu
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.forename: Masataka
authors.initials: M
authors.lastname: Yoshimoto
authors.forename: Noboru
authors.initials: N
authors.lastname: Horikoshi
authors.forename: Toshio
authors.initials: T
authors.lastname: Tabei
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
authors.forename: Shigeto
authors.initials: S
authors.lastname: Miura
authors.forename: Norio
authors.initials: N
authors.lastname: Yoshimura
authors.forename: Morihiko
authors.initials: M
authors.lastname: Kimura
authors.forename: Kazushige
authors.initials: K
authors.lastname: Toyama
authors.forename: Eisei
authors.initials: E
authors.lastname: Shin
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil