Wang Qiming, Zhang Xuejiao, Wang Chunhui, Ye Yanrong, Li Xiaoyu, Liu Peng
Objective To evaluate the cardiovascular safety of ibrutinib in patients with B-cell malignancies. Methods This retrospective cohort study included patients with B-cell malignancies who received ibrutinib for the first time at Shanghai Geriatrics Center and Zhongshan Hospital affiliated to Fudan University between August 2021 and August 2024. Patients were divided into 3 groups: group A (patients with chronic lymphocytic leukemia/small lymphocytic lymphoma), group B (patients with lymphoplasmacytic lymphoma/Waldenström macroglobulinemia/marginal zone lymphoma), and group C (patients with mantle cell lymphoma/diffuse large B-cell lymphoma). Baseline data (age, sex, clinical diagnosis, comorbidities, and baseline blood pressure, cardiac biomarkers, electrocardiogram, and echocardiography), clinical data (initiation time of ibrutinib, concomitant medications), follow-up data (blood pressure, cardiac biomarkers, electrocardiogram, and echocardiography during treatment), and cardiovascular adverse events (time of onset, clinical manifestations, grading, management, and outcomes) were collected and recorded. Cardiovascular adverse events were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (5 grades in total), and their occurrence was compared among the 3 groups. Results A total of 122 patients were included, comprising 81 males and 41 females, aged 68±9 years with a range of 36-91 years. There were 59 patients in group A, 50 in group B, and 13 in group C, respectively. The differences in baseline data in patients of the 3 groups were not statistically significant (all P>0.05). Cardiovascular adverse events occurred in 79 patients, with an incidence of 64.8%, and the median time to onset was 72 (65, 81) days. A total of 177 cardiovascular adverse events were observed, including 154 gradeⅠevents (87.0%) and 23 gradeⅡevents (13.0%); no gradeⅢor more severer events were reported. The most common adverse events were T-wave changes (35 cases, 28.7%) and ST-T changes (31 cases, 25.4%), both of which were gradeⅠ. Atrial fibrillation had the lowest incidence ［8.2% (10/122)］, all cases were gradeⅡ. No statistically significant differences in the incidence of cardiovascular adverse events were observed among the 3 groups (all P>0.05). All gradeⅠadverse events resolved spontaneously, and gradeⅡevents were manageable with standard interventions, allowing patients to continue antitumor therapy with reduced-dose ibrutinib or alternative Bruton′s tyrosine kinase inhibitors. Conclusion Cardiovascular adverse events are relatively common in patients with B-cell malignancies treated with ibrutinib; however, most are gradeⅠevents, reflecting an acceptable overall safety profile.
