title: A phase II study of epirubicin, cisplatin and capecitabine as neoadjuvant chemotherapy in locally advanced or inflammatory breast cancer.
abstract: OBJECTIVE
  To assess the efficacy and safety of epirubicin, capecitabine and cisplatin (EXC) combination therapy in locally advanced breast cancer (LABC) and investigate the predictive value of selected biomarkers.
  
  
  METHODS
  Newly diagnosed LABC patients received four 3-weekly cycles of neoadjuvant EXC (epirubicin 60 mg/m(2) day 1; capecitabine 1000 mg/m(2) bid, days 1-14; cisplatin 60 mg/m(2)day 1) and two cycles of post-operative EXC.
  
  
  RESULTS
  Eight (17%) of 48 patients had inflammatory breast cancer. Overall response rate was 74% (95% CI: 59-86%), including complete responses in 13% (95% CI: 5-26%). Nine (22%; 95% CI: 11-38%) of 41 patients undergoing surgery achieved pathologic complete response (pCR), giving a pCR rate of 19% (95% CI: 9-33%) in the intent-to-treat population. Haematological toxicity was manageable. The most problematic toxicities were chemotherapy-induced nausea/vomiting and hypercoagulative disorders. None of the biomarkers investigated, including HER2, predicted response.
  
  
  CONCLUSIONS
  EXC showed high efficacy in LABC, with high clinical response and pCR rate. Nausea and vomiting were unexpectedly frequent, and more aggressive prophylaxis and management of these side effects is recommended in future studies of this combination.
authors.affiliation: Department of Oncology, Orebro University Hospital, Orebro, Sweden. kenneth.villman@orebroll.se
authors.forename: Kenneth
authors.initials: K
authors.lastname: Villman
authors.forename: John F
authors.initials: JF
authors.lastname: Ohd
authors.forename: Elisabet
authors.initials: E
authors.lastname: Lidbrink
authors.forename: Lena
authors.initials: L
authors.lastname: Malmberg
authors.forename: Birgitta
authors.initials: B
authors.lastname: Lindh
authors.forename: Carl
authors.initials: C
authors.lastname: Blomqvist
authors.forename: Hans
authors.initials: H
authors.lastname: Nordgren
authors.forename: Jonas
authors.initials: J
authors.lastname: Bergh
authors.forename: Daniel
authors.initials: D
authors.lastname: Bergström
authors.forename: Johan
authors.initials: J
authors.lastname: Ahlgren
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D015409:Mastectomy, Radical; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000932:Antiemetics; D014408:Biomarkers, Tumor; D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil