Abstract
Chronic lymphocytic leukemia (CLL) patients are at increased risk for major hemorrhage (MH). We examined incidence of and risk factors for MH in CLL patients before introduction of newer CLL therapies such as ibrutinib, which includes bleeding risk. This study included 24 198 CLL patients treated in the VA system before FDA approval of ibrutinib as CLL therapy. Data came from VA databases from 1999 to 2013. MH incidence was 1.9/100 person‐years (95% CI: 1.8‐1.9), with cumulative incidences of 2.3%, 5.2%, and 7.3% by year 1, 3, and 5, respectively. Median time from CLL diagnosis to MH was 2.8 years (range: 0‐15.7 years). In multivariate analyses, concurrent anticoagulant and antiplatelet use (HR: 4.2; 95% CI: 3.2‐5.6), anticoagulant use only (HR: 2.6; 95% CI: 2.3‐3.1), and antiplatelet use only (HR: 1.5; 95% CI: 1.3‐1.7) increased MH risk vs not receiving those medications; being nonwhite, male, having MH history, renal impairment, anemia, thrombocytopenia, and alcohol abuse were associated with increased MH risk. These pre‐ibrutinib data are important for providing context for interpreting MH risk in ibrutinib‐treated patients. As ibrutinib clinical use is increasing, updated analyses of MH risk among ibrutinib‐treated VA patients with CLL may provide additional useful insight.
Highlights
Patients with chronic lymphocytic leukemia (CLL) are at increased risk for major hemorrhage compared with the general population.[1]
An analysis of the Surveillance, Epidemiology, and End Results (SEER)‐Medicare database showed that the hazard ratio (HR) for development of a major hemorrhage among 6717 treated CLL/small lymphocytic lymphoma (SLL) patients compared with 14 816 age‐ and gender‐ matched noncancer patients was 8.3 (95% confidence interval [CI]: 7.5‐9.2).[1]
The incidence rate of major hemorrhage was 1.9 per 100 person‐years
Summary
Patients with chronic lymphocytic leukemia (CLL) are at increased risk for major hemorrhage compared with the general population.[1]. Use of anticoagulants or antiplatelet agents is common in CLL patients (25%‐54%),[2,3] who are generally elderly[4] and often have comorbid conditions,[5,6] a number of which require use of anti‐hemostatic medications.[7,8]. Clinical studies indicate that use of ibrutinib and other BTK inhibitors is associated with platelet dysfunction and increased bleeding risk.[10-17]. In order to put ibrutinib into a clinical context, it is important to understand incidence of and risk factors for major hemorrhage in the CLL patient population before ibrutinib is widely used. The effect sizes of potential risk factors (such as sociodemographic characteristics, comorbid conditions, and anticoagulant and antiplatelet medications) for major hemorrhage among CLL patients were not well established prior to introduction of ibrutinib into clinical practice
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