Optimal follow-up duration of cardiac function tests in patients treated with trastuzumab: an analysis using the Japanese Adverse Drug Event Report (JADER) database.

Abstract

Background: One of the most serious adverse events associated with trastuzumab treatment is cardiac dysfunction, including congestive heart failure. Therefore, regular cardiac screening with echocardiography is commonly performed during trastuzumab treatment, although it is unclear for how long the patient will continue to be evaluated. We investigated the time to the occurrence of trastuzumab-induced cardiac dysfunction using the Japanese Adverse Drug Event Report (JADER) database. We examined the optimal duration of cardiac function evaluation in patients treated with trastuzumab.

Methods: This study used data registered between April 2004 and September 2023 in the JADER database. We investigated the time to onset of cardiotoxicity in patients treated with trastuzumab, trastuzumab emtansine, or trastuzumab deruxtecan. We considered the time to exclude outliers detected using the Smirnov-Grubbs test as the optimal follow-up duration for cardiac function tests.

Results: Of 868,478 patients who reported adverse drug events, 977 experienced cardiac dysfunctions among those treated with trastuzumab. A total of 375 patients were included in the analysis after excluding patients for whom the time to onset of cardiotoxicity was unknown or those who experienced cardiac dysfunction after receiving trastuzumab followed by anthracycline. The median time to cardiotoxicity was 4.5 months (range 0-100 months). However, ≥ 19 months after the start of trastuzumab administration was detected as an outlier in the target population (P = 0.036).

Conclusion: The duration of regular follow-up of cardiac function using echocardiography during anti-HER2 therapy can be 18 months from the start of treatment.