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.

• Authors: Susan Dent, Dean Fergusson, Olexiy Aseyev, Carol Stober, Gregory Pond, Arif A Awan, Sharon F McGee, Terry L Ng, Demetrios Simos, Lisa Vandermeer, Deanna Saunders, John F Hilton, Brian Hutton, Mark Clemons
• Journal: Current oncology (Toronto, Ont.) (Curr Oncol) Vol. 28 Issue 6 Pg. 5073-5083 (12 03 2021) ISSN: 1718-7729 [Electronic] Switzerland
• PMID: 34940066 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Receptor, ErbB-2
• Trastuzumab

Topics

• Breast Neoplasms (complications, drug therapy)
• Female
• Humans
• Receptor, ErbB-2
• Stroke Volume
• Trastuzumab (adverse effects)
• Ventricular Function, Left