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

Content Provider	Europe PMC
Author	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. Dubruille, Viviane Flinn, Ian W. Kyrcz-Krzemien, Slawomira Medras, Ewa Zanichelli, Maria Bendit, Israel Cacciatore, Silvia Titorenko, Ksenia Aimone, Paola Saglio, Giuseppe Hochhaus, Andreas
Abstract	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 MR4.5 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.
ISSN	08876924
Journal	Leukemia
Volume Number	35
PubMed Central reference number	PMC7862065
Issue Number	2
PubMed reference number	33414482
e-ISSN	14765551
DOI	10.1038/s41375-020-01111-2
Language	English
Publisher	Nature Publishing Group UK
Publisher Date	2021-01-07
Publisher Place	London
Access Restriction	Open
Rights License	Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/. © The Author(s) 2021
Subject Keyword	Chronic myeloid leukaemia Haematological cancer
Content Type	Text
Resource Type	Article
Subject	Hematology Cancer Research Anesthesiology and Pain Medicine Oncology