COLUMBIA, SC—Understanding that chronic lymphocytic leukemia patients are at increased risk for major hemorrhage, a study published in Cancer Medicine examined incidence of and risk factors for MH in CLL patients before introduction of newer CLL therapies such as ibrutinib, which includes bleeding risk.

The study led by researchers from the William Jennings Bryan Dorn VAMC included more than 24,000 CLL patients treated in the VA system before FDA approval of ibrutinib as CLL therapy, with data pulled from VA databases from 1999 to 2013.

Results indicated that 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 Years 1, 3 and 5, respectively. The study team calculated that median time from CLL diagnosis to MH was 2.8 years (range: 0-15.7 years).

Increasing MH risk, according to multivariate analyses, were 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) vs. not receiving those medications. Other factors linked to greater major hemorrhage risk were being nonwhite, male, having MH history, renal impairment, anemia, thrombocytopenia and alcohol abuse.

“These pre-ibrutinib data are important for providing context for interpreting MH risk in ibrutinib-treated patients,” study authors wrote. “As ibrutinib clinical use is increasing, updated analyses of MH risk among ibrutinib-treated VA patients with CLL may provide additional useful insight.”

1 Georgantopoulos P, Yang H, Norris LB, Bennett CL. Major hemorrhage in chronic lymphocytic leukemia patients in the US Veterans Health Administration system in the pre-ibrutinib era: Incidence and risk factors. Cancer Med. 2019 Apr 14. doi: 10.1002/cam4.2134. [Epub ahead of print] PubMed PMID: 30983123.