title: An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer.
abstract: BACKGROUND
  Phase II/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability.
  
  
  METHODS
  Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, CI, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% CI, 8.5-15.3).
  
  
  CONCLUSIONS
  Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.
authors.affiliation: Medical Oncology Department, Negrar, Italy. venturini.m@gmail.com
authors.forename: M
authors.initials: M
authors.lastname: Venturini
authors.forename: R
authors.initials: R
authors.lastname: Paridaens
authors.forename: D
authors.initials: D
authors.lastname: Rossner
authors.forename: M M
authors.initials: MM
authors.lastname: Vaslamatzis
authors.forename: J W R
authors.initials: JW
authors.lastname: Nortier
authors.forename: M
authors.initials: M
authors.lastname: Salzberg
authors.forename: H
authors.initials: H
authors.lastname: Rodrigues
authors.forename: R
authors.initials: R
authors.lastname: Bell
mesh_terms: D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil