title: Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program.
abstract: BACKGROUND
  A retrospective source review identifying predictive factors and assessing safety and efficacy in pretreated metastatic breast cancer (MBC) patients treated with capecitabine in a French compassionate-use program.
  
  
  METHODS
  197 patients received capecitabine at an initial total dose 0.25-3.0 g/m2/day, twice daily for 14 consecutive days, every 3 weeks.
  
  
  RESULTS
  Median patient age was 56 years (range, 31-88), 19% had performance status (PS) 3-4. Prior palliative and adjuvant treatment was reported in 96 and 61% of patients respectively. Best overall response rate (ORR) was 15% (95% confidence interval [CI], 11-21%) and 49% had benefit (CR, PR or SD). Median time to progression (TTP) and overall survival were 4.8 and 14.7 months, respectively. Median TTP in responders was 8.9 months (95%CI 6.1-11.7). Grade 3/4 neutropenia and grade 3 thrombocytopenia occurred in 8 and 3% of patients respectively. Hand-foot syndrome (grade 3/4 in 16% of patients), diarrhea, stomatitis and asthenia were prevalent. Multivariate analysis showed ORR was significantly influenced by PS > or = 2 (p = 0.004), time from metastases diagnosis to capecitabine treatment (p = 0.015) and presence of liver metastases at inclusion (p = 0.047). Abnormal liver function tests at baseline were associated with severe thrombocytopenia and anemia. Four treatment-related deaths occurred.
  
  
  CONCLUSIONS
  Capecitabine is active in heavily pretreated MBC patients and has a favorable toxicity profile with the added advantage of being an oral drug administered in an outpatient setting.
authors.affiliation: Institut Curie, 75005 Paris, France.
authors.forename: J Y
authors.initials: JY
authors.lastname: Pierga
authors.forename: P
authors.initials: P
authors.lastname: Fumoleau
authors.forename: Y
authors.initials: Y
authors.lastname: Brewer
authors.forename: L
authors.initials: L
authors.lastname: Zelek
authors.forename: D
authors.initials: D
authors.lastname: Martin
authors.forename: F L
authors.initials: FL
authors.lastname: Turpin
authors.forename: M J
authors.initials: MJ
authors.lastname: Goudier
authors.forename: M
authors.initials: M
authors.lastname: Gil-Delgado
authors.forename: J L
authors.initials: JL
authors.lastname: Baticle
authors.forename: M
authors.initials: M
authors.lastname: Namer
authors.forename: P
authors.initials: P
authors.lastname: Chollet
authors.forename: W
authors.initials: W
authors.lastname: Sutherland
authors.forename: J C
authors.initials: JC
authors.lastname: Barats
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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*; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D005602:France; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010045:Outpatients; D012189:Retrospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil