title: Phase I, dose-finding study of capecitabine in combination with docetaxel and epirubicin as first-line chemotherapy for advanced breast cancer.
abstract: OBJECTIVE
  Capecitabine is an oral fluoropyrimidine with considerable activity and minimal myelosuppression and alopecia. This phase I study evaluated the addition of capecitabine to epirubicin/docetaxel combination therapy as first-line treatment for advanced breast cancer.
  
  
  METHODS
  Twenty-three female patients with advanced breast cancer received capecitabine (765-1060 mg/m2 twice daily on days 1-14 of a 3-week treatment cycle) in combination with epirubicin and docetaxel (75 mg/m2 i.v. on day 1).
  
  
  RESULTS
  The maximum tolerated dose of capecitabine was 985 mg/m2 and the principal dose-limiting toxicity was febrile neutropenia. No grade 3/4 anemia or thrombocytopenia occurred. There were no grade 4 non-hematological events and grade 3 events other than alopecia were rare. Alopecia occurred in all patients and treatment cycles, and asthenia occurred in all patients and in 84% of treatment cycles. Other frequent adverse events included nausea, vomiting, fever, paresthesia and elevated transaminase levels. An objective response to treatment was observed in 91% (95% confidence interval 72% to 99%) of patients.
  
  
  CONCLUSIONS
  The addition of capecitabine to docetaxel/epirubicin combination therapy provides a well-tolerated and active first-line chemotherapy regimen in patients with advanced breast cancer, and merits phase II/III evaluation.
authors.affiliation: Division of Medical Oncology, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. marco.venturini@istge.it
authors.forename: M
authors.initials: M
authors.lastname: Venturini
authors.forename: L
authors.initials: L
authors.lastname: Del Mastro
authors.forename: O
authors.initials: O
authors.lastname: Garrone
authors.forename: C
authors.initials: C
authors.lastname: Angiolini
authors.forename: M
authors.initials: M
authors.lastname: Merlano
authors.forename: M
authors.initials: M
authors.lastname: Bergaglio
authors.forename: G
authors.initials: G
authors.lastname: Tolino
authors.forename: A
authors.initials: A
authors.lastname: Lambiase
authors.forename: A
authors.initials: A
authors.lastname: Baldini
authors.forename: G
authors.initials: G
authors.lastname: Canavese
authors.forename: R
authors.initials: R
authors.lastname: Rosso
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil