title: Epirubicin and docetaxel with or without capecitabine as neoadjuvant treatment for early breast cancer: final results of a randomized phase III study (ABCSG-24).
abstract: BACKGROUND
  This randomized phase III trial compared pathologic complete response (pCR) rates of early breast cancer (EBC) following neoadjuvant epirubicin-docetaxel (ED)±capecitabine (C), and evaluated the addition of trastuzumab in HER2-positive tumors.
  
  
  METHODS
  Patients with invasive breast cancer (except T4d) were randomly assigned to receive six 3-weekly cycles of ED (both 75 mg/m2)±C (1000 mg/m2, twice daily, days 1-14). Patients with HER2-positive disease were further randomized to receive trastuzumab (8 mg/kg, then 6 mg/kg every 3 weeks) or not. Primary end point: pCR rate at the time of surgery.
  
  
  RESULTS
  Five hundred thirty-six patients were randomized to ED (n=266) or EDC (n=270); 93 patients were further randomized to trastuzumab (n=44) or not (n=49). pCR rate was significantly increased with EDC (23.0% versus 15.4% ED, P=0.027), and nonsignificantly further increased with trastuzumab (38.6% EDC versus 26.5% ED, P=0.212). Rates of axillary node involvement at surgery and breast conservation were improved with EDC versus ED, but not significantly; the addition of trastuzumab had no further impact. Hormone receptor status, tumor size, grade, and C (all P≤0.035) were independent prognostic factors for pCR. Trastuzumab added to ED±C significantly increased the number of serious adverse events (35 versus 18; P=0.020), mainly due to infusion-related reactions.
  
  
  CONCLUSIONS
  These findings show that the integration of C into a neoadjuvant taxane-/anthracycline-based regimen is a feasible, safe, and effective treatment option, with incorporation of trastuzumab in HER2-positive disease.
  
  
  BACKGROUND
  NCT00309556, www.clinicaltrials.gov.
authors.affiliation: Department of Internal Medicine I, Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna.
authors.forename: G G
authors.initials: GG
authors.lastname: Steger
authors.forename: R
authors.initials: R
authors.lastname: Greil
authors.forename: A
authors.initials: A
authors.lastname: Lang
authors.forename: M
authors.initials: M
authors.lastname: Rudas
authors.forename: F
authors.initials: F
authors.lastname: Fitzal
authors.forename: B
authors.initials: B
authors.lastname: Mlineritsch
authors.forename: B L
authors.initials: BL
authors.lastname: Hartmann
authors.forename: R
authors.initials: R
authors.lastname: Bartsch
authors.forename: E
authors.initials: E
authors.lastname: Melbinger
authors.forename: M
authors.initials: M
authors.lastname: Hubalek
authors.forename: H
authors.initials: H
authors.lastname: Stoeger
authors.forename: P
authors.initials: P
authors.lastname: Dubsky
authors.forename: S
authors.initials: S
authors.lastname: Ressler
authors.forename: A L
authors.initials: AL
authors.lastname: Petzer
authors.forename: C F
authors.initials: CF
authors.lastname: Singer
authors.forename: C
authors.initials: C
authors.lastname: Muss
authors.forename: R
authors.initials: R
authors.lastname: Jakesz
authors.forename: S P
authors.initials: SP
authors.lastname: Gampenrieder
authors.forename: C C
authors.initials: CC
authors.lastname: Zielinski
authors.forename: C
authors.initials: C
authors.lastname: Fesl
authors.forename: M
authors.initials: M
authors.lastname: Gnant
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D005472:Fluorouracil
keywords: capecitabine; docetaxel; early breast cancer; epirubicin; neoadjuvant treatment