title: Survival after adding capecitabine and trastuzumab to neoadjuvant anthracycline-taxane-based chemotherapy for primary breast cancer (GBG 40--GeparQuattro).
abstract: BACKGROUND
  The GeparQuattro study showed that adding capecitabine or prolonging the duration of anthracycline-taxane-based neoadjuvant chemotherapy from 24 to 36 weeks did not increase pathological complete response (pCR) rates. Trastuzumab-treated patients with HER2-positive disease showed a higher pCR rate than patients with HER2-negative disease treated with chemotherapy alone. We here present disease-free (DFS) and overall survival (OS) analyses.
  
  
  METHODS
  Patients (n = 1495) with cT ≥ 3 tumors, or negative hormone-receptor status, or positive hormone-receptor and clinically node-positive disease received four times epirubicin/cyclophosphamide and were thereafter randomly assigned to four times docetaxel (Taxotere), or four times docetaxel/capecitabine over 24 weeks, or four times docetaxel followed by capecitabine over 36 weeks. Patients with HER2-positive tumors received 1 year of trastuzumab, starting with the first chemotherapy cycle. Follow-up was available for a median of 5.4 years.
  
  
  RESULTS
  Outcome was not improved for patients receiving capecitabine (HR 0.92; P = 0.463 for DFS and HR 93; P = 0.618 for OS) as well as for patients receiving 36 weeks of chemotherapy (HR 0.97; P = 0.818 for DFS and HR 0.97; P = 0.825 for OS). Trastuzumab-treated patients with HER2-positive disease showed similar DFS (P = 0.305) but a significantly better adjusted OS (P = 0.040) when compared with patients with HER2-negative disease treated with chemotherapy alone. Recorded long-term cardiac toxicity was low.
  
  
  CONCLUSIONS
  Long-term results, similar to the results of pCR, do not support the use of capecitabine in the neoadjuvant setting in addition to an anthracycline-taxane-based chemotherapy. However, the results support previous data showing a benefit of trastuzumab as predicted by higher pCR rates.
authors.affiliation: German Breast Group, Neu-Isenburg.
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: M
authors.initials: M
authors.lastname: Rezai
authors.forename: P A
authors.initials: PA
authors.lastname: Fasching
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.forename: H
authors.initials: H
authors.lastname: Tesch
authors.forename: I
authors.initials: I
authors.lastname: Bauerfeind
authors.forename: J
authors.initials: J
authors.lastname: Hilfrich
authors.forename: H
authors.initials: H
authors.lastname: Eidtmann
authors.forename: B
authors.initials: B
authors.lastname: Gerber
authors.forename: C
authors.initials: C
authors.lastname: Hanusch
authors.forename: J U
authors.initials: JU
authors.lastname: Blohmer
authors.forename: S D
authors.initials: SD
authors.lastname: Costa
authors.forename: C
authors.initials: C
authors.lastname: Jackisch
authors.forename: S
authors.initials: S
authors.lastname: Paepke
authors.forename: A
authors.initials: A
authors.lastname: Schneeweiss
authors.forename: S
authors.initials: S
authors.lastname: Kümmel
authors.forename: C
authors.initials: C
authors.lastname: Denkert
authors.forename: K
authors.initials: K
authors.lastname: Mehta
authors.forename: S
authors.initials: S
authors.lastname: Loibl
authors.forename: M
authors.initials: M
authors.lastname: Untch
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D000069287:Capecitabine; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D020360:Neoadjuvant Therapy; D016016:Proportional Hazards Models; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D015251:Epirubicin; D000069287:Capecitabine; D003520:Cyclophosphamide; D000068878:Trastuzumab; D005472:Fluorouracil
keywords: capecitabine; disease-free survival; neoadjuvant chemotherapy; overall survival; trastuzumab