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Old 01-24-2020, 07:31 AM   #1
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T-DM1–Associated Cardiotoxicity in Advanced HER2-Positive Breast Cancer

T-DM1–Associated Cardiotoxicity in Advanced HER2-Positive Breast Cancer
James Chih-Hsin Yang et. al.,

European Journal of Cancer


This pooled analysis was designed to characterize trastuzumab emtansine (T-DM1)–associated cardiotoxicity among patients with HER2+ breast cancer. The total cardiac event rate was 3.37%, and the majority of events experienced were asymptomatic drops in LVEF. Age ≥65 years was a risk factor for cardiac events. Most cardiac events resolved with discontinuation of T-DM1.

The incidence of cardiac events associated with T-DM1 use in patients with HER2+ breast cancer was low, but older patients should be carefully monitored.

– Neil Majithia MD


T-DM1 has been approved for the treatment of HER2+ breast cancer. Cardiac dysfunction is a side effect of trastuzumab, a component of T-DM1. However, little is known about T-DM1-associated cardiotoxicity.


We have conducted a pooled analysis of T-DM1 trials in advanced HER2+ breast cancer cases to understand the incidence, clinical presentation as well as to establish possible risk factors for T-DM1-associated cardiotoxicity. The primary endpoint was the incidence of cardiac events (CEs). CEs were categorized as follows: (1) congestive heart failure (CHF) or grade 3/4 LVEF drop; (2) cardiac ischemia, (3) cardiac arrhythmia, (4) grade 1/2 LVEF drop. Secondary endpoints included CE recovery rate and impact of CEs on treatment discontinuation. Logistic regression was used to assess possible risk factors for CEs.


Individual patient-level data from 1961 patients exposed to T-DM1 in seven trials were pooled. Of these, 1544 received T-DM1 and 417 T-DM1 + pertuzumab. CHF/LVEF drop grade 3/4 was reported in 0.71%, cardiac ischemia in 0.1%, cardiac arrhythmia in 0.71% and grade 1/2 LVEF drop in 2.04%. The total CE rate was 3.37% (95% confidence interval (CI), 2.6%-4.3%). Multivariate analysis showed patient's age ≥65 (OR 3.0; 95% CI, 1.77-5.14; P-value <0.001) and baseline LVEF<55% (OR 2.62; 95% CI, 1.29-5.32; P-value 0.008) as risk factors. CEs resolved in most (79%) patients after treatment discontinuation.


The incidence of CEs in patients receiving T-DM1 was low. Older patients receiving T-DM1 should be carefully followed for cardiac safety during treatment.
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