Category: Professional Posters
Purpose: Most of the current studies focus on the effect of trastuzumab on left ventricular systolic function, little literature is concerned about the adverse effects on left ventricular diastolic function, right heart function and other aspects of cardiac function. The aim of this research was to comprehensively evaluate the cardiac safety of trastuzumab targeted therapy in the patients with HER2 positive tumors.
Methods: The clinical data of adult HER2 positive breast cancer and gastric cancer patients who had been treated by trastuzumab at least once in our hospital from November 2015 to October 2018 and accept regular cardiac function examination were collected retrospectively . The cardiac safety was evaluated according to clinical manifestations and examination results (electrocardiogram and echocardiography). The criteria and classification of this study were determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). P wave, PR interval, QT interval, left ventricular ejection fraction (LVEF), pulmonary artery systolic pressure (PASP), atrioventricular structure, valvular regurgitation and pericardial effusion were used as the main indexes to evaluate trastuzumab related adverse cardiac events. Normally distributed continuous variables were expressed as the mean ± standard deviation (SD), and groups were compared using the independent Student’s t-test. Non-normally distributed continuous variables were presented as the median (quartile spacing) [M (Q1, Q3)], and groups were compared using the rank-sum test. In addition, categorical variables were expressed as numbers (percentages) and analysed using the chi-squared test or Fisher’s exact test. Further, logistic regression models were used to assess independent risk factors for adverse cardiac events. Multiple logistic regression models were used to identify variables with P value less than 0.2 in descriptive analysis; these variables were further examined in multivariate analysis to identify independent risk factors.
Results: 163 of 210 cases HER2 positive cancer patients treated with trastuzumab were eventually included, of which 58 (35.58%) showed arrhythmia, including 22 (13.49%) sinus bradycardia, 20 (12.27%) sinus tachycardia, 18 (11.04%) premature contraction, 15 (9.20%) atrioventricular block and 14 (8.59%) arose QT interval prolongation. 33 (20.25%) cases turned up valvular reflux (added or aggravated) while 24 (14.72%) appeared abnormal cardiac structure. 15 (9.20%) emerged increased PASP, 7 (4.91%) had pericardial effusion and 6 (4.29%) accompany with LVEF reduction. Multiple logistic regression analysis showed that age (P=0.015, OR=2.768) was an independent risk factor for valvular regurgitation, and the type of tumor2s (P=0.014, OR=3.148) was an independent risk factor for cardiac structural abnormalities.
Conclusion: Though the incidence of adverse cardiac events is high, trastuzumab do less severe harm to cardiac structure or function in HER2 positive cancer patients, the general safety is good. The cardiac function evaluation and monitoring should be carried out regularly during and after the treatment so as to effectively prevent and promptly respond to the potential adverse cardiac events. Some patients failed to follow up regularly and had potential safety hazards. Clinical pharmacists should cooperate with doctors to strengthen the medication education of patients, promote regular follow-up of patients, and ensure the safety,especially cardiac safety of trastuzumab treatment.