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

Authors
  • Kantarjian, Hagop M1
  • Hughes, Timothy P2, 3
  • Larson, Richard A4
  • Kim, Dong-Wook5
  • Issaragrisil, Surapol6
  • le Coutre, Philipp7
  • Etienne, Gabriel8
  • Boquimpani, Carla9, 10
  • Pasquini, Ricardo11
  • Clark, Richard E12
  • Dubruille, Viviane13
  • Flinn, Ian W14
  • Kyrcz-Krzemien, Slawomira15
  • Medras, Ewa16
  • Zanichelli, Maria17
  • Bendit, Israel18
  • Cacciatore, Silvia19
  • Titorenko, Ksenia20
  • Aimone, Paola19
  • Saglio, Giuseppe21
  • And 1 more
  • 1 The University of Texas MD Anderson Cancer Center, Houston, TX, USA. [email protected]
  • 2 South Australian Health and Medical Research Institute, Adelaide, SA, Australia. , (Australia)
  • 3 University of Adelaide, Adelaide, SA, Australia. , (Australia)
  • 4 Department of Medicine, Section of Hematology/Oncology, University of Chicago, Chicago, IL, USA.
  • 5 Seoul St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, South Korea. , (North Korea)
  • 6 Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand. , (Thailand)
  • 7 Charité - Universitätsmedizin Berlin, Berlin, Germany. , (Germany)
  • 8 Hematology Department, Institut Bergonié, Bordeaux, France. , (France)
  • 9 Hemorio, Institute of Hematology, Rio de Janeiro, Brazil. , (Brazil)
  • 10 Oncoclínica Rio de Janeiro, Rio de Janeiro, Brazil. , (Brazil)
  • 11 Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil. , (Brazil)
  • 12 Royal Liverpool University Hospital, Liverpool, United Kingdom. , (United Kingdom)
  • 13 Clinical Hematology, Nantes University Hospital, Nantes, France. , (France)
  • 14 Sarah Cannon Research Institute, Nashville, TN, USA.
  • 15 Department of Hematology and Bone Marrow Transplantation, Medical University of Silesia, Katowice, Poland. , (Poland)
  • 16 Department of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Wroclaw, Poland. , (Poland)
  • 17 Instituto de Tratamento do Câncer Infantil, Instituto da Criança, Hospital das Clínicas, Universidade de São Paulo, São Paulo, Brazil. , (Brazil)
  • 18 Laboratory of Medical Investigation in Pathogenesis and Targeted Therapy in Onco-Immuno-Hematology (LIM-31), Department of Hematology, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil. , (Brazil)
  • 19 Novartis Pharma AG, Basel, Switzerland. , (Switzerland)
  • 20 Novartis Pharmaceuticals Corporation, Moscow, Russian Federation. , (Russia)
  • 21 Division of Internal Medicine and Hematology, University of Turin, Turin, Italy. , (Italy)
  • 22 Universitätsklinikum Jena, Jena, Germany. , (Germany)
Type
Published Article
Journal
Leukemia
Publisher
Springer Nature
Publication Date
Feb 01, 2021
Volume
35
Issue
2
Pages
440–453
Identifiers
DOI: 10.1038/s41375-020-01111-2
PMID: 33414482
Source
Medline
Language
English
License
Unknown

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.

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