Background and importance Ibrutinib treatment has been associated with the development of unwanted cardiovascular (CV) and bleeding events, which may lead to the loss of a line of treatment in patients with so few therapeutic options.
Aim and objectives The objective of this study was to evaluate the rate of events related to cardiovascular toxicity during treatment with ibrutinib.
Material and methods Observational, retrospective study carried out between July 2015 and September 2021, which included all patients treated with ibrutinib. Clinical and demographic variables: age at the start of treatment, sex, diagnosis, previous therapeutic lines, duration of treatment, death, dose reduction and suspension of treatment. Previous CV risk factors were recorded: diabetes mellitus (DM), arterial hypertension (AHT), dyslipidaemia; and the underlying CV pathologies: heart failure (HF), atrial fibrillation (AF), ventricular tachyarrhythmia (VT). The appearance of new CV events related to ibrutinib treatment was recorded: AF, HF, VT, AHT and bleeding events. The rates of their appearance were calculated, excluding patients who had been treated for a period of less than 6 months.
Results A total of 66 patients were included (median age 72.7 (47–90) years, 68.2% men). 75.8% suffered from chronic lymphocytic leukaemia, 10.6% from mantle cell leukaemia, 12.1% from Waldenstrom macroglobulinemia and non-Hodgkin lymphoma as off-label use. 34.8% first-line treatment, 33.3% second-line, 15.1% third-line, 10.6% fourth-line, 6.1% fifth and subsequent lines. The mean duration of treatment was 22.6 [7.3–80.2] months. 63.6% keep the treatment going, 21.2% progressed and 15.5% died during treatment. 37.9% (25) did not have any risk factor at the beginning of the treatment, 22.7% (15) had two basic risk factors, and 10.6% (7) had three risk factors. 9.1% (6) had underlying CV pathology. During treatment, 34.8% (23) of patients developed some CV episode associated with ibrutinib use: 13.6% (9) AHT, 12.1% (8) AF, 7.6% (5) bleeding events, 1.5% (1) HF and 1.5% (1) VT. The dose was reduced in 2 patients and ibrutinib was suspended in 2 patients (3%).
Conclusion and relevance This study shows that 65% of patients do not develop any type of cardiovascular toxicity. Only a small percentage of patients need a dose reduction or suspension of treatment due to cardiovascular adverse events, requiring a multidisciplinary approach in the proper management of the drug.
Conflict of interest No conflict of interest
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