Unknown

Dataset Information

0

A Randomized Trial Comparing 3- versus 4-Monthly Cardiac Monitoring in Patients Receiving Trastuzumab-Based Chemotherapy for Early Breast Cancer.


ABSTRACT:

Purpose

The optimal frequency for cardiac monitoring of left ventricular ejection fraction (LVEF) in patients receiving trastuzumab-based therapy for early breast cancer (EBC) is unknown. We conducted a randomized controlled trial comparing 3- versus 4-monthly cardiac monitoring.

Patients and method

Patients scheduled to receive trastuzumab-containing cancer therapy for EBC with normal (>53%) baseline LVEF were randomized to undergo LVEF assessments every 3 or 4 months. The primary outcome was the change in LVEF from baseline. Secondary outcomes included the rate of cardiac dysfunction (defined as a decrease in the LVEF of ≥10 percentage points, to a value <53%), delays in or discontinuation of trastuzumab therapy, and cardiology referral.

Results

Of the 200 eligible and enrolled patients, 100 (50%) were randomized to 3-monthly and 100 (50%) to 4-monthly cardiac monitoring. Of these patients, 98 and 97 respectively underwent at least one cardiac scan. The estimated mean difference in LVEF from baseline was -0.94% (one-sided 95% lower bound: -2.14), which exceeded the pre-defined non-inferiority margin of -4%. There were also no significant differences between the two study arms for any of the secondary endpoints. The rate of detection of cardiac dysfunction was 16.3% (16/98) and 12.4% (12/97) in the 3- and 4-monthly arms, respectively (95% CI: 4.0 [-5.9, 13.8]).

Conclusions

Cardiac monitoring every 4 months was deemed non-inferior to that every 3 months in patients with HER2-positive EBC being treated with trastuzumab-based therapy. Given its costs and inconvenience, cardiac monitoring every 4 months should be considered standard practice. Registration: NCT02696707, 18 February 2016.

SUBMITTER: Dent S 

PROVIDER: S-EPMC8700071 | biostudies-literature |

REPOSITORIES: biostudies-literature

Similar Datasets

| S-EPMC4979214 | biostudies-literature
| S-EPMC3236650 | biostudies-literature
| S-EPMC3410828 | biostudies-literature
| S-EPMC9179451 | biostudies-literature
| S-EPMC8022886 | biostudies-literature
| S-EPMC6149535 | biostudies-literature
| S-EPMC5654518 | biostudies-literature
2018-04-01 | GSE109710 | GEO
| S-EPMC8283058 | biostudies-literature
| S-EPMC10257423 | biostudies-literature