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Lisinopril or Coreg CR in reducing cardiotoxicity in women with breast cancer receiving trastuzumab: A rationale and design of a randomized clinical trial.

Abstract Trastuzumab (TZB) is an established therapy for HER2-positive breast cancer. The use of TZB is commonly associated with cardiotoxicity manifesting as asymptomatic decrease in left ventricular ejection fraction (LVEF) or overt heart failure. Several studies demonstrated favorable effects of angiotensin-converting enzyme (ACE) inhibitors and β-blockers (BBs) in the prevention of chemotherapy-induced cardiotoxicity. We hypothesize that patients, randomized to receive an ACE inhibitor or a BB during trastuzumab therapy for breast cancer, will maintain a higher LVEF than patients randomized to placebo.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title american heart journal
Publication Year Start




PMID- 28577685
OWN - NLM
STAT- In-Process
DA  - 20170604
LR  - 20170606
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 188
DP  - 2017 Jun
TI  - Lisinopril or Coreg CR in reducing cardiotoxicity in women with breast cancer
      receiving trastuzumab: A rationale and design of a randomized clinical trial.
PG  - 87-92
LID - S0002-8703(17)30093-5 [pii]
LID - 10.1016/j.ahj.2017.03.010 [doi]
AB  - BACKGROUND: Trastuzumab (TZB) is an established therapy for HER2-positive breast 
      cancer. The use of TZB is commonly associated with cardiotoxicity manifesting as 
      asymptomatic decrease in left ventricular ejection fraction (LVEF) or overt heart
      failure. Several studies demonstrated favorable effects of angiotensin-converting
      enzyme (ACE) inhibitors and beta-blockers (BBs) in the prevention of
      chemotherapy-induced cardiotoxicity. We hypothesize that patients, randomized to 
      receive an ACE inhibitor or a BB during trastuzumab therapy for breast cancer,
      will maintain a higher LVEF than patients randomized to placebo. METHODS AND
      RESULTS: We designed a prospective, multicenter, randomized, phase II
      placebo-controlled clinical trial to evaluate the effects of an ACE inhibitor
      (lisinopril) and a BB (carvedilol phosphate-extended release) on cardiotoxicity
      in patients with breast cancer who are receiving adjuvant or neoadjuvant TZB
      therapy. The primary objectives include (1) comparison of incidence of
      cardiotoxicity and (2) comparison of LVEF as a continuous variable in between the
      arms. Cardiotoxicity was defined as an absolute decrease in LVEF from baseline of
      >/=10% at follow-up or an absolute decrease of >/=5% in LVEF from baseline for
      individuals with <50% LVEF at follow-up. The target accrual is 468 participants, 
      representing patients both with and without anthracycline exposure. The
      enrollment is completed. The trial is co-sponsored by University of South Florida
      and National Cancer Institute. The LVEF is being evaluated by echocardiography or
      multigated acquisition scan. CONCLUSIONS: If we can demonstrate that the use of
      an ACE inhibitor or a BB can reduce the degree of TZB-induced cardiotoxicity, it 
      is hoped that patients will receive complete and uninterrupted TZB therapy for
      breast cancer without compromising cardiac function.
CI  - Copyright (c) 2017 Elsevier Inc. All rights reserved.
FAU - Guglin, Maya
AU  - Guglin M
AD  - University of Kentucky, Lexington, KY. Electronic address: [email protected]
FAU - Munster, Pamela
AU  - Munster P
AD  - University of San Francisco, San Francisco, CA.
FAU - Fink, Angelina
AU  - Fink A
AD  - University of South Florida, Tampa, FL.
FAU - Krischer, Jeffrey
AU  - Krischer J
AD  - University of South Florida, Tampa, FL.
LA  - eng
GR  - U10 CA081920/CA/NCI NIH HHS/United States
PT  - Journal Article
DEP - 20170322
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
PMC - PMC5458618
MID - NIHMS861961
EDAT- 2017/06/05 06:00
MHDA- 2017/06/05 06:00
CRDT- 2017/06/05 06:00
PMCR- 2018/06/01
PHST- 2016/09/04 [received]
PHST- 2017/03/20 [accepted]
AID - S0002-8703(17)30093-5 [pii]
AID - 10.1016/j.ahj.2017.03.010 [doi]
PST - ppublish
SO  - Am Heart J. 2017 Jun;188:87-92. doi: 10.1016/j.ahj.2017.03.010. Epub 2017 Mar 22.

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