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COMPLETED RESEARCH: CLINICAL/TRANSLATIONAL RESEARCH
Abstract #CT12

The Incidence of Arterial and Venous Thromboembolism in Patients with Chronic Myeloid Leukemia or Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia Who Are Treated with Ponatinib

JHOP - March 2021 Vol 11 Special Feature - HOPA Abstracts, Leukemia, Thromboembolism

Presenter: Serena Chew, PharmD, BCOP, Clinical Specialist, MD Anderson Cancer Center

Co-Authors: Nadya Jammal, PharmD, BCOP, MD Anderson Cancer Center; Jeffrey Bryan, PharmD, MD Anderson Cancer Center; E. Dan Nichols, PharmD, BCOP, MD Anderson Cancer Center; Adam DiPippo, PharmD, BCOP, MD Anderson Cancer Center

Background: Ponatinib is a third-generation tyrosine kinase inhibitor linked to dose-dependent increase of serious cardiovascular (CV) events, including venous thromboembolism (VTE) and arterial occlusive (AO) events. The incidence of serious CV events has been 20% in the first 12 months; however, the incidence of CV events is infrequently reported in real-life patients with chronic myeloid leukemia (CML), and even less so in Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL).

Objectives: The primary end point was to determine the incidence of VTE and AO events in real-life patients with CML and patients with Ph+ ALL receiving ponatinib. Secondary end points were to determine the use of thromboprophylaxis and cardioprotective medications, define the time to first episode of serious CV events, and analyze the incidence of major and minor bleeding in patients receiving thromboprophylaxis.

Methods: This retrospective, single-center cohort study included adults with CML or Ph+ ALL who received ponatinib therapy from March 2016 to April 2020. Patients with active VTE or AO events before starting ponatinib therapy were excluded. All data were retrieved from the electronic medical record, utilizing a standardized collection form. Variables of interest included occurrence of VTE, AO events, and sudden death within the first 12 months of starting ponatinib therapy; timing of serious CV events; and episodes of major or minor bleeding. Baseline medical history, chemotherapy treatments, and concomitant medications were collected for each patient. The results are reported using descriptive statistics, as appropriate.

Results: Of the 155 patients included in the study, 20.6% received ponatinib at a starting dose of 45 mg daily, 63.9% received 30 mg daily, and 14.8% received 15 mg daily. The overall incidence of VTE and AO events was 11.6% and 1.3%, respectively. A total of 68 (44%) patients received cardioprotective medications with aspirin (9%), statin (14%), or both (21%) during ponatinib treatment. The median time to first episode of a serious CV event was 89 days (range, 3-277 days). In all, 3 cases of sudden or unexplained death thought to be related to ponatinib were reported. A total of 4 (2.5%) patients had minor bleeding, 2 had a hemorrhagic stroke (1 received aspirin, and 1 had no documented reasons); no patient had major bleeding.

Conclusion: Although the overall incidence of serious CV events was lower than previous reports, the rate of VTE was still relatively high. Given the risk of CV events with ponatinib, thorough CV risk stratification and surveillance should be considered as part of the management for patients with Ph+ ALL or with CML. Further studies on the impact of CV event preventive strategies are needed.

  1. Cortes JE, Kim DW, Pinilla-Ibarz J, et al; for the PACE investigators. A phase 2 trial of ponatinib in Philadelphia chromosome–positive leukemias. N Engl J Med. 2013;369:1783-1796.
  2. Caocci G, Mulas O, Abruzzese E, et al. Arterial occlusive events in chronic myeloid leukemia patients treated with ponatinib in the real-life practice are predicted by the Systematic Coronary Risk Evaluation (SCORE) chart. Hematol Oncol. 2019;37:296-302.
  3. Heiblig M, Rea D, Chrétien ML, et al. Ponatinib evaluation and safety in real-life chronic myelogenous leukemia patients failing more than two tyrosine kinase inhibitors: the PEARL observational study. Exp Hematol. 2018;67:41-48.
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