Publication: Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis
Issued Date
2021-02-01
Resource Type
ISSN
14765551
08876924
08876924
Other identifier(s)
2-s2.0-85099095870
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Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Leukemia. Vol.35, No.2 (2021), 440-453
Suggested Citation
Hagop M. Kantarjian, Timothy P. Hughes, Richard A. Larson, Dong Wook Kim, Surapol Issaragrisil, Philipp le Coutre, Gabriel Etienne, Carla Boquimpani, Ricardo Pasquini, Richard E. Clark, Viviane Dubruille, Ian W. Flinn, Slawomira Kyrcz-Krzemien, Ewa Medras, Maria Zanichelli, Israel Bendit, Silvia Cacciatore, Ksenia Titorenko, Paola Aimone, Giuseppe Saglio, Andreas Hochhaus Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis. Leukemia. Vol.35, No.2 (2021), 440-453. doi:10.1038/s41375-020-01111-2 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/76294
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Title
Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis
Author(s)
Hagop M. Kantarjian
Timothy P. Hughes
Richard A. Larson
Dong Wook Kim
Surapol Issaragrisil
Philipp le Coutre
Gabriel Etienne
Carla Boquimpani
Ricardo Pasquini
Richard E. Clark
Viviane Dubruille
Ian W. Flinn
Slawomira Kyrcz-Krzemien
Ewa Medras
Maria Zanichelli
Israel Bendit
Silvia Cacciatore
Ksenia Titorenko
Paola Aimone
Giuseppe Saglio
Andreas Hochhaus
Timothy P. Hughes
Richard A. Larson
Dong Wook Kim
Surapol Issaragrisil
Philipp le Coutre
Gabriel Etienne
Carla Boquimpani
Ricardo Pasquini
Richard E. Clark
Viviane Dubruille
Ian W. Flinn
Slawomira Kyrcz-Krzemien
Ewa Medras
Maria Zanichelli
Israel Bendit
Silvia Cacciatore
Ksenia Titorenko
Paola Aimone
Giuseppe Saglio
Andreas Hochhaus
Other Contributor(s)
Siriraj Hospital
South Australian Health and Medical Research Institute
Section of Hematology Oncology, The University of Chicago
CHU de Nantes
Slaski Uniwersytet Medyczny w Katowicach
Charité – Universitätsmedizin Berlin
Royal Liverpool University Hospital
Universitätsklinikum Jena und Medizinische Fakultät
Sarah Cannon Research Institute
Universidade Federal do Parana
University of Texas MD Anderson Cancer Center
Università degli Studi di Torino
Novartis International AG
The University of Adelaide
Universidade de São Paulo
Wroclaw Medical University
Institut Bergonie
The Catholic University of Korea, College of Medicine
Novartis Pharma LLC
Oncoclínica Rio de Janeiro
Hemorio
South Australian Health and Medical Research Institute
Section of Hematology Oncology, The University of Chicago
CHU de Nantes
Slaski Uniwersytet Medyczny w Katowicach
Charité – Universitätsmedizin Berlin
Royal Liverpool University Hospital
Universitätsklinikum Jena und Medizinische Fakultät
Sarah Cannon Research Institute
Universidade Federal do Parana
University of Texas MD Anderson Cancer Center
Università degli Studi di Torino
Novartis International AG
The University of Adelaide
Universidade de São Paulo
Wroclaw Medical University
Institut Bergonie
The Catholic University of Korea, College of Medicine
Novartis Pharma LLC
Oncoclínica Rio de Janeiro
Hemorio
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.