Among patients with chronic lymphocytic leukemia (CLL) with deletion 17p (del[17p]), evidence from clinical trials for the effectiveness of single-agent ibrutinib as first-line (1L) therapy is limited. This retrospective analysis compared real-world clinical outcomes among patients with CLL, with and without del(17p), treated with 1L ibrutinib monotherapy. Overall survival (OS), time-to-next-treatment (TTNT), time-to-treatmentdiscontinuation (TTD), and reasons for ibrutinib discontinuation were evaluated. Using data from a real-world database, patients included were aged .18 years, had been diagnosed with CLL between 1/1/2011 and 12/31/2019, had received cytogenetic testing, and had received 1L ibrutinib monotherapy. A total of 1,069 patients were included in the analysis (62.7% male; median age 69 years); 23.8% (n=254) had del(17p). Median OS was significantly shorter in del(17p)-present patients than in patients without (57.7 months vs. median not reached; P=0.0006). Similar results were observed for median TTNT (49.4 months vs. median not reached, P=0.0330). Median TTD was non-significantly shorter in the del(17p)-present group (32.5 months vs. 42.9 months, P=0.3370). Adjusted Cox proportional hazards model results showed that the del(17p)-present group was at significantly higher risk of death than the del(17p)-absent group (HR 1.70, P=0.0031). Event rates for switching to new treatment and discontinuation were higher but not statistically significant. The most common reason for ibrutinib discontinuation in both groups was toxicity, but discontinuation due to progression was significantly higher among del(17p)-present patients (20% vs. 6%; P
Ibrutinib, a Bruton's tyrosine kinase inhibitor, is often used as first‐line (1L) treatment of chronic lymphocytic leukaemia (CLL); however, it is associated with an increased risk for cardiovascular adverse events (CVAEs). This real‐world study adds to existing literature by simultaneously investigating the correlation between pre‐existing CV risk factors and the relative cardiotoxicity of ibrutinib vs other therapies in CLL/small lymphocytic lymphoma (SLL). Using a real‐world database, the risk of subsequent CVAEs (any CVAE, atrial fibrillation [AF], or hypertension) were compared among patients who received 1L ibrutinib monotherapy or another type of non‐ibrutinib therapy, grouped as intensive (IT) or non‐intensive therapy (NIT). Each patient's baseline CV risk was estimated using the Framingham risk score. Inverse probability treatment weighting was incorporated into a logistic regression model to reduce baseline imbalance. Results showed ibrutinib was significantly associated with higher risk of CVAEs regardless of baseline CV risk. Compared with IT, odds ratios of any CVAE, hypertension, or AF were 2.61, 3.66, and 3.02, respectively vs 1.88, 2.13, and 2.46, respectively, with NIT. Sensitivity analyses confirmed the findings were robust. These results suggest clinical caution should be taken when selecting ibrutinib for patients with CLL/SLL, especially in those with high baseline CV risk.
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