title: Retrospective analysis of cardiac tolerability of concurrent administration of trastuzumab and anthracycline-based regimen for breast cancer, to address one-year-term issues in LVEF.
abstract: BACKGROUND
  Patients with HER2-positive breast cancer, who received paclitaxel (P) followed by epirubicin at 75 mg/m2, fluorouracil, and cyclophosphamide (FEC75) and concurrent trastuzumab (Trastuzumab Group) show good cardiac tolerability. We assessed left ventricular ejection fraction (LVEF) of these patients regularly, and compared with that of HER2-negative breast cancer patients who administered P followed by FEC100 (Standard Group), and followed for more one year, and address the longer-term issues in LVEF.
  
  
  OBJECTIVE
  We routinely assessed LVEF, at the time of initiation, after P, after FEC, and after 1 year, and compared them between 49 patients in Trastuzumab Group and 45 patients in Standard Group.
  
  
  RESULTS
  In Trastuzumab Group, LVEF was reduced from the initial level (63.1%) to 60.4 at ``After FEC'' (p= 0.007), but had recovered to 60.9% at ``After 1 year''. A two-way repeated-measures ANOVA demonstrated a significant decline in LVEF level along the time course (p< 0.002), but there was no interaction revealed between time course of LVEF and treatment with or without trastuzumab (p= 0.834). In addition, there was no significant difference between groups (p= 0.386)CONCLUSIONS: P followed by FEC75 with concurrent trastuzumab could provide enough evidence of cardiac safety.
authors.affiliation: Department of Breast Surgery, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Watanabe
authors.affiliation: Department of Breast Surgery, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
authors.forename: Shoko
authors.initials: S
authors.lastname: Otsuka
authors.affiliation: Department of Breast Surgery, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Sasaki
authors.affiliation: Department of Breast Surgery, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yuasa
authors.affiliation: Department of Pharmaceutics, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Shimada
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000494:pharmacology*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D012189:Retrospective Studies; D013318:Stroke Volume / Q000187:drug effects*; D013997:Time Factors; D000068878:Trastuzumab / Q000008:administration & dosage; D016277:Ventricular Function, Left / Q000187:drug effects*
chemical_list: D003520:Cyclophosphamide; D015251:Epirubicin; D005472:Fluorouracil; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
keywords: Anthracyclines; adjuvant chemotherapy; breast cancer; cardiotoxicity; trastuzumab