title: In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer: the GEPARTRIO pilot study.
abstract: BACKGROUND
  Response to the first two cycles of preoperative chemotherapy might differentiate subgroups of breast cancer patients with high or minimal chances for a pathologic complete response (pCR) and may be used as an in vivo chemosensitivity test.
  
  
  METHODS
  Breast cancer patients were treated with two cycles of TAC (docetaxel 75 mg/m(2), doxorubicin 50 mg/m(2), cyclophosphamide 500 mg/m(2) every 21 days). Patients whose tumors showed a response received four more cycles. Patients whose tumors did not respond were randomized to four additional cycles TAC or NX (vinorelbine 25 mg/m(2) days 1 and 8, capecitabine 2000 mg/m(2) days 1-14, every 21 days). The primary end point was pCR at surgery.
  
  
  RESULTS
  Two hundred and eighty-five patients showed a clinical response, in 73.0% after two cycles, in 88.4% at surgery, and a pCR was seen in 17.9%. Breast conservation was possible in 72.2%. Responding patients obtained a pCR in 22.6% whereas non-responding patients reached a pCR in 7.3% and 3.1% with TAC or NX, respectively. Grade III/IV neutropenia and febrile neutropenia were observed during TAC in 70.2% and 13.5%, respectively. Significantly less toxicity were observed with NX.
  
  
  CONCLUSIONS
  Early response to TAC can reliably identify patients with a high chance of achieving a pCR. New effective treatments need to be explored for patients without an early response.
authors.affiliation: The German Breast Group, Frankfurt, Germany. Minckwitz@germanbreastgroup.de
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: J-U
authors.initials: JU
authors.lastname: Blohmer
authors.forename: G
authors.initials: G
authors.lastname: Raab
authors.forename: A
authors.initials: A
authors.lastname: Löhr
authors.forename: B
authors.initials: B
authors.lastname: Gerber
authors.forename: G
authors.initials: G
authors.lastname: Heinrich
authors.forename: H
authors.initials: H
authors.lastname: Eidtmann
authors.forename: M
authors.initials: M
authors.lastname: Kaufmann
authors.forename: J
authors.initials: J
authors.lastname: Hilfrich
authors.forename: C
authors.initials: C
authors.lastname: Jackisch
authors.forename: I
authors.initials: I
authors.lastname: Zuna
authors.forename: S D
authors.initials: SD
authors.lastname: Costa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000069287:Capecitabine; D003520:Cyclophosphamide / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009503:Neutropenia / Q000139:chemically induced; D011379:Prognosis; D043823:Taxoids / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000077235:Vinorelbine; D005472:Fluorouracil