Durable treatment-free remission in patients with chronic myeloid leukemia in chronic phase following frontline nilotinib: 96-week update of the ENESTfreedom study.

Journal of Cancer Research and Clinical Oncology
David M RossA Hochhaus

Abstract

ENESTfreedom is evaluating treatment-free remission (TFR) following frontline nilotinib in patients with chronic myeloid leukemia (CML) in chronic phase. Following our primary analysis at 48 weeks, we here provide an updated 96-week analysis. Attempting TFR required ≥ 3 years of nilotinib, a molecular response of MR4.5 [BCR-ABL1 ≤ 0.0032% on the International Scale (BCR-ABL1IS)], and sustained deep molecular response (DMR) during a 1-year consolidation phase. Patients restarted nilotinib following loss of major molecular response (MMR; BCR-ABL1IS ≤ 0.1%). Ninety-six weeks after stopping treatment (3.6-year median prior nilotinib duration), 93 of 190 patients (48.9%) remained in TFR. Of 88 patients who restarted nilotinib following loss of MMR, 87 regained MMR and 81 regained MR4.5 by the data cut-off. Ninety-six-week TFR rates were 61.3, 50.0, and 28.6% in patients with low, intermediate, and high Sokal risk scores at diagnosis, respectively. Patients consistently in MR4.5 during consolidation had higher TFR rates (50.6%) than patients with ≥ 1 assessment without MR4.5 during consolidation (35.0%). In a landmark analysis, 96-week TFR rates for patients with MR4.5, MR4 (BCR-ABL1IS ≤ 0.01%) but not MR4.5, and MMR but not MR4 at T...Continue Reading

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Citations

Jun 19, 2018·Leukemia & Lymphoma·Philippe Rousselot
Nov 6, 2018·American Journal of Hematology·Jorge CortesJeffrey H Lipton
Mar 10, 2018·Current Treatment Options in Oncology·Pierre Laneuville
Jul 5, 2019·British Journal of Haematology·Marc G BergerUNKNOWN (France Intergroupe des Leucémies Myéloïdes Chroniques)
Jan 21, 2020·Journal of Cellular and Molecular Medicine·Andreas B HerrmannJochen J Frietsch
Jan 19, 2020·Expert Review of Hematology·Patrick HarringtonHugues de Lavallade
Apr 3, 2020·American Journal of Hematology·Elias Jabbour, Hagop Kantarjian
May 19, 2020·Japanese Journal of Clinical Oncology·Masahiro Ashizawa, Yoshinobu Kanda
Apr 13, 2020·International Journal of Hematology·Masayuki HinoNaoto Takahashi
May 22, 2020·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Caitlin R Rausch, Shilpa Paul
Oct 23, 2019·International Journal of Molecular Medicine·Simona BernardiDomenico Russo
May 8, 2020·Nature Reviews. Clinical Oncology·David M Ross, Timothy P Hughes
Dec 15, 2018·Future Oncology·Tomasz Sacha, Giuseppe Saglio
May 28, 2019·Leukemia·Mohammad HoushmandRobert Peter Gale
Feb 12, 2020·Nanomaterials·Mohammad HoushmandClaudia Giachino
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Oct 7, 2020·Journal of the National Comprehensive Cancer Network : JNCCN·Michael W DeiningerHema Sundar
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Apr 10, 2021·International Journal of Laboratory Hematology·Osman IlhanIbrahim C Haznedaroglu
Apr 19, 2021·Current Treatment Options in Oncology·Nuno CerveiraJosé M Mariz

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Clinical Trials Mentioned

NCT01784068

Software Mentioned

ENESTfreedom
ENESTop

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