A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2)

Fei Fei Gong; Eli Grunblatt; Woo Bin Voss; Vibhav Rangarajan; Sasan Raissi; Kimberly Chow; Lua Jafari; Nikita P. Patel; Inga Vaitenas; Milica Marion; Haydee Ramirez; Manyun Zhao; Adin Christian Andrei; Abigail S. Baldridge; Gillian Murtagh; Kameswari Maganti; Vera H. Rigolin; Nausheen Akhter

doi:10.1186/s40959-024-00291-5

A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2)

Fei Fei Gong, Eli Grunblatt, Woo Bin Voss, Vibhav Rangarajan, Sasan Raissi, Kimberly Chow, Lua Jafari, Nikita P. Patel, Inga Vaitenas, Milica Marion, Haydee Ramirez, Manyun Zhao, Adin Christian Andrei, Abigail S. Baldridge, Gillian Murtagh, Kameswari Maganti, Vera H. Rigolin, Nausheen Akhter^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Background: Global longitudinal strain (GLS) has been used to identify patients at risk for cancer-therapy related cardiac dysfunction (CTRCD). However, there is limited data on the effectiveness of initiating cardioprotective therapy based on a strain-guided strategy in early stage HER2+ breast cancer patients. This randomized clinical trial assessed if treatment with carvedilol based on a strain-guided strategy can prevent development of CTRCD in HER2+ breast cancer patients on non-anthracycline based regimens. Methods: Study participants were prospectively assigned to one of four arms. Patients with normal LVEF and GLS remained in Arm A. Patients whose GLS decreased by > 15% from baseline or to < -15% during follow up were randomized 1:1 to prophylactic carvedilol (Arm B) or no therapy (Arm C). Patients who developed CTRCD were assigned to Arm D. The primary endpoint was GLS stability. The secondary endpoints were development of CTRCD and rate of anti-HER2 treatment interruption. Results: Among 110 patients who completed follow up, 84 were assigned to Arm A, 10 each were randomized to Arms B or C, and 6 were assigned to Arm D. At the end of the study period, there were no significant differences in GLS stability, development of CTRCD, or number of cancer therapy cycles completed between patients who did and did not receive cardioprotective therapy. Conclusions: In this prospective randomized GLS-guided study of prophylactic carvedilol in early stage HER2+ breast cancer patients on non-anthracycline regimens, there were no significant difference between groups in GLS stability, CTRCD or trastuzumab cycles held. These findings may identify a low-risk group of patients who may be considered for less intensive cardiac surveillance. Trial registration: https://clinicaltrials.gov/study/NCT02993198. Start date: 4/2015. This trial included patients who were retrospectively registered. Graphical abstract: (Figure presented.)

Original language	English (US)
Article number	85
Journal	Cardio-Oncology
Volume	10
Issue number	1
DOIs	https://doi.org/10.1186/s40959-024-00291-5
State	Published - Dec 2024

Funding

Michael Reese Faculty Foundation Grant and Abbott Laboratories Investigator Initiated Grant.

Keywords

CTRCD
Cardioprotective therapy
Global longitudinal strain
HER2+ breast cancer

ASJC Scopus subject areas

Oncology
Cardiology and Cardiovascular Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1186/s40959-024-00291-5

Cite this

Gong, F. F., Grunblatt, E., Voss, W. B., Rangarajan, V., Raissi, S., Chow, K., Jafari, L., Patel, N. P., Vaitenas, I., Marion, M., Ramirez, H., Zhao, M., Andrei, A. C., Baldridge, A. S., Murtagh, G., Maganti, K., Rigolin, V. H., & Akhter, N. (2024). A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2). Cardio-Oncology, 10(1), Article 85. https://doi.org/10.1186/s40959-024-00291-5

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title = "A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2)",

abstract = "Background: Global longitudinal strain (GLS) has been used to identify patients at risk for cancer-therapy related cardiac dysfunction (CTRCD). However, there is limited data on the effectiveness of initiating cardioprotective therapy based on a strain-guided strategy in early stage HER2+ breast cancer patients. This randomized clinical trial assessed if treatment with carvedilol based on a strain-guided strategy can prevent development of CTRCD in HER2+ breast cancer patients on non-anthracycline based regimens. Methods: Study participants were prospectively assigned to one of four arms. Patients with normal LVEF and GLS remained in Arm A. Patients whose GLS decreased by > 15% from baseline or to < -15% during follow up were randomized 1:1 to prophylactic carvedilol (Arm B) or no therapy (Arm C). Patients who developed CTRCD were assigned to Arm D. The primary endpoint was GLS stability. The secondary endpoints were development of CTRCD and rate of anti-HER2 treatment interruption. Results: Among 110 patients who completed follow up, 84 were assigned to Arm A, 10 each were randomized to Arms B or C, and 6 were assigned to Arm D. At the end of the study period, there were no significant differences in GLS stability, development of CTRCD, or number of cancer therapy cycles completed between patients who did and did not receive cardioprotective therapy. Conclusions: In this prospective randomized GLS-guided study of prophylactic carvedilol in early stage HER2+ breast cancer patients on non-anthracycline regimens, there were no significant difference between groups in GLS stability, CTRCD or trastuzumab cycles held. These findings may identify a low-risk group of patients who may be considered for less intensive cardiac surveillance. Trial registration: https://clinicaltrials.gov/study/NCT02993198. Start date: 4/2015. This trial included patients who were retrospectively registered. Graphical abstract: (Figure presented.)",

keywords = "CTRCD, Cardioprotective therapy, Global longitudinal strain, HER2+ breast cancer",

author = "Gong, {Fei Fei} and Eli Grunblatt and Voss, {Woo Bin} and Vibhav Rangarajan and Sasan Raissi and Kimberly Chow and Lua Jafari and Patel, {Nikita P.} and Inga Vaitenas and Milica Marion and Haydee Ramirez and Manyun Zhao and Andrei, {Adin Christian} and Baldridge, {Abigail S.} and Gillian Murtagh and Kameswari Maganti and Rigolin, {Vera H.} and Nausheen Akhter",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = dec,

doi = "10.1186/s40959-024-00291-5",

language = "English (US)",

volume = "10",

journal = "Cardio-Oncology",

issn = "2057-3804",

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Gong, FF, Grunblatt, E, Voss, WB, Rangarajan, V, Raissi, S, Chow, K, Jafari, L, Patel, NP, Vaitenas, I, Marion, M, Ramirez, H, Zhao, M, Andrei, AC, Baldridge, AS, Murtagh, G, Maganti, K, Rigolin, VH & Akhter, N 2024, 'A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2)', Cardio-Oncology, vol. 10, no. 1, 85. https://doi.org/10.1186/s40959-024-00291-5

TY - JOUR

T1 - A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2)

AU - Gong, Fei Fei

AU - Grunblatt, Eli

AU - Voss, Woo Bin

AU - Rangarajan, Vibhav

AU - Raissi, Sasan

AU - Chow, Kimberly

AU - Jafari, Lua

AU - Patel, Nikita P.

AU - Vaitenas, Inga

AU - Marion, Milica

AU - Ramirez, Haydee

AU - Zhao, Manyun

AU - Andrei, Adin Christian

AU - Baldridge, Abigail S.

AU - Murtagh, Gillian

AU - Maganti, Kameswari

AU - Rigolin, Vera H.

AU - Akhter, Nausheen

PY - 2024/12

Y1 - 2024/12

N2 - Background: Global longitudinal strain (GLS) has been used to identify patients at risk for cancer-therapy related cardiac dysfunction (CTRCD). However, there is limited data on the effectiveness of initiating cardioprotective therapy based on a strain-guided strategy in early stage HER2+ breast cancer patients. This randomized clinical trial assessed if treatment with carvedilol based on a strain-guided strategy can prevent development of CTRCD in HER2+ breast cancer patients on non-anthracycline based regimens. Methods: Study participants were prospectively assigned to one of four arms. Patients with normal LVEF and GLS remained in Arm A. Patients whose GLS decreased by > 15% from baseline or to < -15% during follow up were randomized 1:1 to prophylactic carvedilol (Arm B) or no therapy (Arm C). Patients who developed CTRCD were assigned to Arm D. The primary endpoint was GLS stability. The secondary endpoints were development of CTRCD and rate of anti-HER2 treatment interruption. Results: Among 110 patients who completed follow up, 84 were assigned to Arm A, 10 each were randomized to Arms B or C, and 6 were assigned to Arm D. At the end of the study period, there were no significant differences in GLS stability, development of CTRCD, or number of cancer therapy cycles completed between patients who did and did not receive cardioprotective therapy. Conclusions: In this prospective randomized GLS-guided study of prophylactic carvedilol in early stage HER2+ breast cancer patients on non-anthracycline regimens, there were no significant difference between groups in GLS stability, CTRCD or trastuzumab cycles held. These findings may identify a low-risk group of patients who may be considered for less intensive cardiac surveillance. Trial registration: https://clinicaltrials.gov/study/NCT02993198. Start date: 4/2015. This trial included patients who were retrospectively registered. Graphical abstract: (Figure presented.)

AB - Background: Global longitudinal strain (GLS) has been used to identify patients at risk for cancer-therapy related cardiac dysfunction (CTRCD). However, there is limited data on the effectiveness of initiating cardioprotective therapy based on a strain-guided strategy in early stage HER2+ breast cancer patients. This randomized clinical trial assessed if treatment with carvedilol based on a strain-guided strategy can prevent development of CTRCD in HER2+ breast cancer patients on non-anthracycline based regimens. Methods: Study participants were prospectively assigned to one of four arms. Patients with normal LVEF and GLS remained in Arm A. Patients whose GLS decreased by > 15% from baseline or to < -15% during follow up were randomized 1:1 to prophylactic carvedilol (Arm B) or no therapy (Arm C). Patients who developed CTRCD were assigned to Arm D. The primary endpoint was GLS stability. The secondary endpoints were development of CTRCD and rate of anti-HER2 treatment interruption. Results: Among 110 patients who completed follow up, 84 were assigned to Arm A, 10 each were randomized to Arms B or C, and 6 were assigned to Arm D. At the end of the study period, there were no significant differences in GLS stability, development of CTRCD, or number of cancer therapy cycles completed between patients who did and did not receive cardioprotective therapy. Conclusions: In this prospective randomized GLS-guided study of prophylactic carvedilol in early stage HER2+ breast cancer patients on non-anthracycline regimens, there were no significant difference between groups in GLS stability, CTRCD or trastuzumab cycles held. These findings may identify a low-risk group of patients who may be considered for less intensive cardiac surveillance. Trial registration: https://clinicaltrials.gov/study/NCT02993198. Start date: 4/2015. This trial included patients who were retrospectively registered. Graphical abstract: (Figure presented.)

KW - CTRCD

KW - Cardioprotective therapy

KW - Global longitudinal strain

KW - HER2+ breast cancer

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DO - 10.1186/s40959-024-00291-5

M3 - Article

C2 - 39605014

AN - SCOPUS:85210526058

SN - 2057-3804

VL - 10

JO - Cardio-Oncology

JF - Cardio-Oncology

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M1 - 85

ER -

A strain-guided trial of cardioprotection in early-stage breast cancer patients on anti-HER2 therapy (PROTECT HER2)

Abstract

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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