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Optimal follow-up duration of cardiac function tests in patients treated with trastuzumab: an analysis using the
Katsuya Makihara1, Keisuke Kongo2, Kayo Motomura2
1Department of Pharmacy, Yodogawa Christian Hospital, 1-7-50 Kunijima, Higashi Yodogawa-Ku, Osaka, 533-0024, Japan. katsuya.ych@gmail.com.
Insights
Trastuzumab treatment can cause cardiac dysfunction. This study analyzed the Japanese Adverse Drug Event Report database to determine the optimal duration for cardiac monitoring, suggesting 18 months of follow-up for anti-HER2 therapy.
Area of Science:
- Cardiology
- Oncology
- Pharmacovigilance
Background:
- Trastuzumab therapy is associated with serious cardiac dysfunction, including congestive heart failure.
- Current cardiac screening protocols using echocardiography lack defined optimal follow-up durations.
- Investigating trastuzumab-induced cardiotoxicity onset is crucial for patient safety.
Purpose of the Study:
- To determine the optimal duration for cardiac function evaluation in patients undergoing trastuzumab treatment.
- To analyze the time to onset of cardiotoxicity associated with trastuzumab and its derivatives.
- To establish evidence-based guidelines for cardiac monitoring during anti-HER2 therapy.
Main Methods:
- Utilized the Japanese Adverse Drug Event Report (JADER) database from April 2004 to September 2023.
- Analyzed time to onset of cardiotoxicity in patients treated with trastuzumab, trastuzumab emtansine, or trastuzumab deruxtecan.
- Applied the Smirnov-Grubbs test to identify and exclude outliers for determining optimal follow-up duration.
Main Results:
- Out of 868,478 reported adverse events, 977 involved cardiac dysfunction in trastuzumab-treated patients.
- After exclusions, 375 patients were analyzed; median time to cardiotoxicity was 4.5 months (range 0-100 months).
- Data indicated that events occurring ≥19 months post-trastuzumab initiation were outliers (P=0.036).
Conclusions:
- The optimal duration for regular cardiac function follow-up via echocardiography during anti-HER2 therapy is 18 months from treatment initiation.
- This finding supports refining monitoring guidelines to balance efficacy and cardiac safety.
- Further research may explore personalized monitoring based on individual risk factors.
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.
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