title: The Clinical Efficacy and Cardiotoxicity of Fixed-Dose Monthly Trastuzumab in HER2-Positive Breast Cancer: A Single Institutional Analysis.
abstract: OBJECTIVE
  Trastuzumab-containing treatment regimens have been shown to improve survival outcomes in HER2-positive breast cancer (BC). It is much easier to infuse a fixed one-vial dose to every patient on a regular schedule in the general clinical setting. The aims of this study were evaluating the efficacy of a 440 mg fixed-dose of trastuzumab administered on a monthly infusion schedule, and the risk factors for cardiac events.
  
  
  METHODS
  We retrospectively reviewed data from 300 HER2-positive BC patients in our institute: 208 were early-stage BC patients undergoing adjuvant trastuzumab treatment, and 92 were metastatic BC patients treated with trastuzumab infusions until disease progression. There were 181 patients receiving regular trastuzumab infusions every 3 weeks (Q3W; 8 mg/kg loading dose followed by 6 mg/kg every 3 weeks), and the other 119 patients were treated monthly with a fixed 440 mg dose (QM; fixed 440 mg every 4 weeks).
  
  
  RESULTS
  The medians of progression-free survival (PFS) and overall survival (OS) in the adjuvant setting were not reached in both treatment groups. In the metastatic setting, there was no significant difference between groups in PFS or OS. The median time to significant cardiovascular (CV) dysfunction was 4.54 months. The incidence of congestive heart failure requiring medication in our cohort was 3.4%.
  
  
  CONCLUSIONS
  In our study, we found that fixed-dose monthly trastuzumab was feasible and effective. In addition, the CV risk was not higher with the fixed-dose protocol. This treatment modality could lower the cost and was easier to implement in clinical practice. Larger prospective randomized studies with longer-term follow up are needed to confirm our results.
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.|Graduate Institute of Life Sciences, National Defense Medical Center, Taipei City, Taiwan, Republic of China.
authors.forename: Yi-Ying
authors.initials: YY
authors.lastname: Wu
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Tzu-Chuan
authors.initials: TC
authors.lastname: Huang
authors.affiliation: Graduate Institute of Life Sciences, National Defense Medical Center, Taipei City, Taiwan, Republic of China.|Division of Cardiology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Tsung-Neng
authors.initials: TN
authors.lastname: Tsai
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.|Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei City, Taiwan, Republic of China.
authors.forename: Jia-Hong
authors.initials: JH
authors.lastname: Chen
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Ming-Shen
authors.initials: MS
authors.lastname: Dai
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Ping-Ying
authors.initials: PY
authors.lastname: Chang
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Ching-Liang
authors.initials: CL
authors.lastname: Ho
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Ren-Hua
authors.initials: RH
authors.lastname: Ye
authors.affiliation: National Institute of Cancer Research, Miaoli County, Taiwan, Republic of China.
authors.forename: Tsai-Rong
authors.initials: TR
authors.lastname: Chung
authors.affiliation: Division of Hematology/Oncology, Department of Medicine, Tri-Service General Hospital, Taipei City, Taiwan, Republic of China.
authors.forename: Yeu-Chin
authors.initials: YC
authors.lastname: Chen
authors.affiliation: Graduate Institute of Life Sciences, National Defense Medical Center, Taipei City, Taiwan, Republic of China.|Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei City, Taiwan, Republic of China.|Division of Hematology and Oncology, Department of Medicine, Taipei Medical University, Shuang-Ho Hospital, New Taipei City, Taiwan, Republic of China.
authors.forename: Tsu-Yi
authors.initials: TY
authors.lastname: Chao
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism* / Q000401:mortality / Q000473:pathology; D066126:Cardiotoxicity; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009367:Neoplasm Staging; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012189:Retrospective Studies; D000068878:Trastuzumab / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab