Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study

被引:0
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作者
A Hochhaus
T Masszi
F J Giles
J P Radich
D M Ross
M T Gómez Casares
A Hellmann
J Stentoft
E Conneally
V García-Gutiérrez
N Gattermann
W Wiktor-Jedrzejczak
P D le Coutre
B Martino
S Saussele
H D Menssen
W Deng
N Krunic
V Bedoucha
G Saglio
机构
[1] Universitätsklinikum Jena,Abteilung Hämatologie/Onkologie
[2] Department of Haematology and Stem Cell Transplantation St István and St László Hospital,Clinical Research Division
[3] Developmental Therapeutics Program,Department of Hematology
[4] Feinberg School of Medicine,undefined
[5] Northwestern University,undefined
[6] Fred Hutchinson Cancer Research Center,undefined
[7] SA Pathology,undefined
[8] Hospital Universitario Doctor Negrin,undefined
[9] Medical University of Gdańsk,undefined
[10] Aarhus University Hospital,undefined
[11] St James Hospital,undefined
[12] Servicio de Hematología,undefined
[13] Hospital Universitario Ramón y Cajal (IRYCIS),undefined
[14] Universitätsklinikum Düsseldorf,undefined
[15] Medical University of Warsaw,undefined
[16] Charité Universitätsmedizin Berlin,undefined
[17] Azienda Ospedaliera Bianchi Melacrino Morelli,undefined
[18] III. Med. Klinik,undefined
[19] Medizinische Fakultät Mannheim der Universität Heidelberg,undefined
[20] Novartis Pharma AG,undefined
[21] Novartis Pharmaceuticals Corporation,undefined
[22] Novartis Institute for Biomedical Research,undefined
[23] University of Turin,undefined
来源
Leukemia | 2017年 / 31卷
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摘要
The single-arm, phase 2 ENESTfreedom trial assessed the potential for treatment-free remission (TFR; i.e., the ability to maintain a molecular response after stopping therapy) following frontline nilotinib treatment. Patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with MR4.5 (BCR-ABL1⩽0.0032% on the International Scale (BCR-ABL1IS)) and ⩾2 years of frontline nilotinib therapy were enrolled. Patients with sustained deep molecular response during the 1-year nilotinib consolidation phase were eligible to stop treatment and enter the TFR phase. Patients with loss of major molecular response (MMR; BCR-ABL1IS⩽0.1%) during the TFR phase reinitiated nilotinib. In total, 215 patients entered the consolidation phase, of whom 190 entered the TFR phase. The median duration of nilotinib before stopping treatment was 43.5 months. At 48 weeks after stopping nilotinib, 98 patients (51.6%; 95% confidence interval, 44.2–58.9%) remained in MMR or better (primary end point). Of the 86 patients who restarted nilotinib in the treatment reinitiation phase after loss of MMR, 98.8% and 88.4%, respectively, regained MMR and MR4.5 by the data cutoff date. Consistent with prior reports of imatinib-treated patients, musculoskeletal pain-related events were reported in 24.7% of patients in the TFR phase (consolidation phase, 16.3%).
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页码:1525 / 1531
页数:6
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