title: Pathological complete response and prognosis in patients receiving neoadjuvant paclitaxel and trastuzumab with and without anthracyclines for stage II and III, HER2-positive operable breast cancer: a single-institute experience.
abstract: BACKGROUND
  Trastuzumab and various chemotherapy combinations have shown superior results in patients with primary and metastatic breast cancer. However, cardiotoxicity becomes a major adverse event when trastuzumab is used with anthracycline-containing regimens. The purpose of this study was to determine the clinical and pathological efficacy of neoadjuvant chemotherapy (NAC), using trastuzumab and chemotherapy, with or without anthracyclines, for patients with primary breast cancer and human epidermal growth factor receptor 2 (HER2-)-positive tumors.
  
  
  METHODS
  A retrospective analysis of 41 patients with stage II and III primary breast cancer and HER2-positive tumors treated with NAC was performed. NAC consisted of weekly paclitaxel plus trastuzumab with (PTA group, n=21) or without anthracycline (PT group, n=20). Patients in the PTA group received four courses of 5-fluorouracil, epirubicin, and cyclophosphamide every 3 weeks followed by concomitant 80 mg/m² paclitaxel and trastuzumab weekly for 12 weeks, and those in the PT group received four courses of 80 mg/m² paclitaxel weekly (days 1, 8, and 15) followed by a 1-week break and trastuzumab weekly (days 1, 8, 15, and 29).
  
  
  RESULTS
  The median age of the patients was 50 years. Of 41 patients, 21 (51%) had a pathological complete response (pCR). Patients with clinical stage II cancer had a higher pCR rate compared with those with clinical stage III. Patients with estrogen receptor (ER)-negative tumors showed a trend toward a higher pCR rate. No significant difference was observed according age, clinical stage, ER status, clinical response, or pathological response between the PTA and the PT groups. The pCR rate of the PTA and the PT groups was 47.6% and 55.0%, respectively. No significant difference in disease-free survival was observed between the two groups at a median follow-up of 32 months.
  
  
  CONCLUSIONS
  Trastuzumab-containing NAC is effective irrespective of anthracycline use for treating patients with primary breast cancer and HER2-positive tumors.
authors.affiliation: Breast and Endocrine Surgery, Gunma University Hospital, 3-39-15 Showa-machi, Maebashi, Gunma 371-8511, Japan. junhorig@showa.gunma-u.ac.jp
authors.forename: Jun
authors.initials: J
authors.lastname: Horiguchi
authors.forename: Tetsunari
authors.initials: T
authors.lastname: Oyama
authors.forename: Daisuke
authors.initials: D
authors.lastname: Takata
authors.forename: Nana
authors.initials: N
authors.lastname: Rokutanda
authors.forename: Rin
authors.initials: R
authors.lastname: Nagaoka
authors.forename: Hiroki
authors.initials: H
authors.lastname: Odawara
authors.forename: Hideaki
authors.initials: H
authors.lastname: Tokiniwa
authors.forename: Katsunori
authors.initials: K
authors.lastname: Tozuka
authors.forename: Mami
authors.initials: M
authors.lastname: Kikuchi
authors.forename: Ayako
authors.initials: A
authors.lastname: Sato
authors.forename: Izumi
authors.initials: I
authors.lastname: Takeyoshi
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012074:Remission Induction; D000068878:Trastuzumab
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human