Arterial Thrombotic Events Associated With First-line Nilotinib for CML in Older Adults
Older patients with CML displayed a higher rate of ATEs in those tested.
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Arterial thrombotic events (ATEs) appear to occur in only 8.7% of patients with chronic myeloid leukemia (CML) treated with first-line nilotinib. However, in patients with CML who are older than 64 years, the relative risk of ATEs was found to be 6.7 times higher compared with patients younger than 50 years, according to data presented at the 2017 American Society of Hematology Annual Meeting (ASH 2017).
Gabriele Gugliotta, MD, PhD, of the DIMES Institute of Hematology "L. e A. Seràgnoli," University of Bologna, Italy, and colleagues reported that after a median follow-up of almost 5 years, 8.7% of patients treated in first-line with nilotinib had ATEs. The researchers found that ATEs in half of the patient were managed with medical treatment only. The remaining patients required invasive procedures, including major surgeries (20%).
The study also demonstrated that no patient deaths were due to ATEs. Furthermore, ATEs did not significantly affect response rates and long-term outcome for patients with CML treated with nilotinib as first-line therapy.
The investigators concluded that nilotinib appears to be more efficacious than imatinib and may lead to higher rates of treatment-free remission.
The researchers retrospectively analyzed 345 patients with chronic-phase CML enrolled in multicenter prospective clinical trials investigating nilotinib as first-line treatment (ClinicalTrials.gov Identifiers: NCT00481052; NCT00769327; NCT01535391). The median age at CML diagnosis was 53 years (range, 18 to 86 years) and the median follow-up was 58 months (range, 22 to 82 months). The researchers analyzed the rate, type, management, and outcome of ATEs. In addition, they compared the molecular response rates and the long-term outcome of patients with and without ATEs.
For this analysis, ATEs included peripheral arterial obstructive disease (PAOD), ischemic heart disease (IHD), significant carotid stenosis, and ischemic stroke or other significant ischemic events. The study showed there were 30 ATEs (8.7%), and the most common were IHD (4.1%), PAOD (2.3%), and (asymptomatic) carotid stenosis (1.1%).
Age played a significant factor and the median age at CML diagnosis for these 30 patients was 64 years, and the median age at ATE was 67 years. In patients aged 18 to 49 years, the rate of ATEs was 2%; in patients aged 50 to 64 years, it was 11%; and in those older than 64 years, the rate of ATEs was 15.7%.
Among these patients, 50% received medical treatment only. The patients who required invasive interventions underwent coronary angioplasty with stent positioning (30%), lower limb amputations (10%), and peripheral vascular bypass (7%). The researchers found that 70% of these patients were hospitalized and 80% (7% of cohort) permanently discontinued nilotinib due to ATEs. They concluded that nilotinib appears to be associated with a higher incidence of ATEs, which may limit its use in selected patients.
Gugliotta G, Castagnetti F, Breccia M, et al. Arterial thrombotic events in CML patients treated with first-line nilotinib: incidence, management and impact on the long term outcome – a Gimema CML WP Analysis. Poster presentation at: 2017 American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. Abstract 1625.