Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/89658
Citations
Scopus Web of Science® Altmetric
?
?
Type: Journal article
Title: TIDEL-II: first-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets
Author: Yeung, D.
Osborn, M.
White, D.
Branford, S.
Braley, J.
Herschtal, A.
Kornhauser, M.
Issa, S.
Hiwase, D.
Hertzberg, M.
Schwarer, A.
Filshie, R.
Arthur, C.
Kwan, Y.
Trotman, J.
Forsyth, C.
Taper, J.
Ross, D.
Beresford, J.
Tam, C.
et al.
Citation: Blood, 2015; 125(6):915-923
Publisher: American Society of Hematology
Issue Date: 2015
ISSN: 0006-4971
1528-0020
Statement of
Responsibility: 
David T. Yeung, Michael P. Osborn, Deborah L. White, Susan Branford, Jodi Braley, Alan Herschtal, Michael Kornhauser, Samar Issa, Devendra K. Hiwase, Mark Hertzberg, Anthony P. Schwarer, Robin Filshie, Christopher K. Arthur, Yiu Lam Kwan, Judith Trotman, Cecily J. Forsyth, John Taper, David M. Ross, Jennifer Beresford, Constantine Tam, Anthony K. Mills, Andrew P. Grigg, and Timothy P. Hughes, for the Australasian Leukaemia and Lymphoma Group.
Abstract: The Therapeutic Intensification in De Novo Leukaemia (TIDEL)-II study enrolled 210 patients with chronic phase chronic myeloid leukemia (CML) in two equal, sequential cohorts. All started treatment with imatinib 600 mg/day. Imatinib plasma trough level was performed at day 22 and if <1000 ng/mL, imatinib 800 mg/day was given. Patients were then assessed against molecular targets: BCR-ABL1 ≤10%, ≤1%, and ≤0.1% at 3, 6, and 12 months, respectively. Cohort 1 patients failing any target escalated to imatinib 800 mg/day, and subsequently switched to nilotinib 400 mg twice daily for failing the same target 3 months later. Cohort 2 patients failing any target switched to nilotinib directly, as did patients with intolerance or loss of response in either cohort. At 2 years, 55% of patients remained on imatinib, and 30% on nilotinib. Only 12% were >10% BCR-ABL1 at 3 months. Confirmed major molecular response was achieved in 64% at 12 months and 73% at 24 months. MR4.5 (BCR-ABL1 ≤0.0032%) at 24 months was 34%. Overall survival was 96% and transformation-free survival was 95% at 3 years. This trial supports the feasibility and efficacy of an imatinib-based approach with selective, early switching to nilotinib. This trial was registered at www.anzctr.org.au as #12607000325404.
Keywords: Australasian Leukaemia and Lymphoma Group; Humans; Benzamides; Piperazines; Pyrimidines; Fusion Proteins, bcr-abl; Protein Kinase Inhibitors; Treatment Outcome; Survival Analysis; Adolescent; Adult; Aged; Aged, 80 and over; Middle Aged; Female; Male; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Young Adult; Imatinib Mesylate
Rights: © 2015 by The American Society of Hematology
RMID: 0030018378
DOI: 10.1182/blood-2014-07-590315
Appears in Collections:Medicine publications

Files in This Item:
There are no files associated with this item.


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.