Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis


Kantarjian, Hagop M, Hughes, Timothy P, Larson, Richard A, Kim, Dong-Wook, Issaragrisil, Surapol, le Coutre, Philipp, Etienne, Gabriel, Boquimpani, Carla, Pasquini, Ricardo, Clark, Richard E ORCID: 0000-0002-1261-3299 et al (show 11 more authors) (2021) Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis. Leukemia, 35 (2). pp. 440-453.

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Abstract

<jats:title>Abstract</jats:title><jats:p>In the ENESTnd study, with ≥10 years follow-up in patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase, nilotinib demonstrated higher cumulative molecular response rates, lower rates of disease progression and CML-related death, and increased eligibility for treatment-free remission (TFR). Cumulative 10-year rates of MMR and MR<jats:sup>4.5</jats:sup> were higher with nilotinib (300 mg twice daily [BID], 77.7% and 61.0%, respectively; 400 mg BID, 79.7% and 61.2%, respectively) than with imatinib (400 mg once daily [QD], 62.5% and 39.2%, respectively). Cumulative rates of TFR eligibility at 10 years were higher with nilotinib (300 mg BID, 48.6%; 400 mg BID, 47.3%) vs imatinib (29.7%). Estimated 10-year overall survival rates in nilotinib and imatinib arms were 87.6%, 90.3%, and 88.3%, respectively. Overall frequency of adverse events was similar with nilotinib and imatinib. By 10 years, higher cumulative rates of cardiovascular events were reported with nilotinib (300 mg BID, 16.5%; 400 mg BID, 23.5%) vs imatinib (3.6%), including in Framingham low-risk patients. Overall efficacy and safety results support the use of nilotinib 300 mg BID as frontline therapy for optimal long-term outcomes, especially in patients aiming for TFR. The benefit-risk profile in context of individual treatment goals should be carefully assessed.</jats:p>

Item Type: Article
Uncontrolled Keywords: Humans, Pyrimidines, Antineoplastic Combined Chemotherapy Protocols, Prognosis, Survival Rate, Follow-Up Studies, Middle Aged, Female, Male, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Imatinib Mesylate
Depositing User: Symplectic Admin
Date Deposited: 15 Jan 2021 10:33
Last Modified: 18 Jan 2023 23:03
DOI: 10.1038/s41375-020-01111-2
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3113727
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