title: [Trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer].
abstract: OBJECTIVE
  To investigate the safety and efficacy of trastuzumab administered concurrently with anthracycline-containing adjuvant regimen for breast cancer.
  
  
  METHODS
  It is a prospective, randomized and controlled trial. Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen. The primary endpoint was cardiac safety. The second endpoints were disease-free survival (DFS) and overall survival (OS).
  
  
  RESULTS
  One hundred and nine breast cancer patients were enrolled and randomized in this trial. Fifty-five participants received trastuzumab administered concurrently with anthracycline-containing adjuvant regimen and 54 patients received trastuzumab administered sequentially with anthracycline. The primary cardiac event was asymptomatic decrease in the left ventricular ejection fraction (LVEF). There was no significant difference between concurrent and sequential groups in cardiac event rates (9.1% vs13.0%, P = 0.556), neither of LVEF values at basline or at 3, 6, 9 and 12 months during trastuzumab treatment (P > 0.05). Four patients (7.3%) in the concurrent group suffered local recurrences or distant metastases, and 6 participants (11.1%) in the sequential group had distant metastases. There was no significant difference between the two groups in DFS (P = 0.724). There was no death in both groups.
  
  
  CONCLUSIONS
  Trastuzumab administered concurrently with anthracycline is a safe adjuvant regimen for breast cancer and does not increase cardiac events. Further research is needed to determine the efficacy of this treatment regimen.
authors.affiliation: Department of Breast Surgery, Peking Union Medical College Hospital, Beijing 100730, China.
authors.forename: Songjie
authors.initials: S
authors.lastname: Shen
authors.forename: Ying
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Email: sunqiangpumc@163.com.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Sun
authors.forename: Changjun
authors.initials: C
authors.lastname: Wang
authors.forename: Yidong
authors.initials: Y
authors.lastname: Zhou
authors.forename: Feng
authors.initials: F
authors.lastname: Mao
authors.forename: Jinghong
authors.initials: J
authors.lastname: Guan
authors.forename: Yan
authors.initials: Y
authors.lastname: Lin
authors.forename: Xuejing
authors.initials: X
authors.lastname: Wang
authors.forename: Shaomei
authors.initials: S
authors.lastname: Han
mesh_terms: D000328:Adult; D018943:Anthracyclines / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D013318:Stroke Volume; D000068878:Trastuzumab
chemical_list: D018943:Anthracyclines; D061067:Antibodies, Monoclonal, Humanized; D000068878:Trastuzumab