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Title: TIDEL-II: first-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets.
Austin Authors: Yeung, David T;Osborn, Michael P;White, Deborah L;Branford, Susan;Braley, Jodi A;Herschtal, Alan;Kornhauser, Michael;Issa, Samar;Hiwase, Devendra K;Hertzberg, Mark;Schwarer, Anthony P ;Filshie, Robin;Arthur, Christopher K;Kwan, Yiu Lam;Trotman, Judith;Forsyth, Cecily J;Taper, John;Ross, David M;Beresford, Jennifer;Tam, Constantine;Mills, Anthony K;Grigg, Andrew P ;Hughes, Timothy P
Institutional Author: Australasian Leukaemia and Lymphoma Group
Affiliation: Department of Haematology, and Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia
Nepean Hospital, Penrith, Australia
Concord Hospital, Sydney, Australia
School of Molecular and Biomedical Science, and School of Pharmacy and Medical Science, University of South Australia, Adelaide, Australia
Department of Genetics and Molecular Pathology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia
Middlemore Hospital, Auckland, New Zealand;
Cancer Theme, South Australia Health and Medical Research Institute, Adelaide, Australia
Peter MacCallum Cancer Centre, Melbourne, Australia
Princess Alexandra Hospital, Brisbane, Australia
Discipline of Medicine, School of Medicine, University of Adelaide, Adelaide, Australia
Department of Haematology, and Department of Genetics and Molecular Pathology and Centre for Cancer Biology, SA Pathology, Adelaide, Australia
Royal North Shore Hospital, Sydney, Australia
Gosford Hospital, Gosford, Australia
Department of Clinical Haematology, Austin Hospital and University of Melbourne, Melbourne, Australia
Australasian Leukemia and Lymphoma Group, Melbourne, Australia
Box Hill Hospital, Melbourne, Australia
School of Medicine, University of Sydney, Sydney, Australia
Prince of Wales Hospital, Sydney, Australia
Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Australia
St. Vincent's Hospital Melbourne, Melbourne, Australia
Issue Date: 17-Dec-2014
Publication information: Blood 2014; 125(6): 915-23
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 as #12607000325404.
Gov't Doc #: 25519749
DOI: 10.1182/blood-2014-07-590315
Journal: Blood
Type: Journal Article
Subjects: Adolescent
Aged, 80 and over
Benzamides.administration & dosage.adverse effects.therapeutic use
Fusion Proteins, bcr-abl.analysis
Leukemia, Myelogenous, Chronic, BCR-ABL Positive.drug therapy
Middle Aged
Piperazines.administration & dosage.adverse effects.therapeutic use
Protein Kinase Inhibitors.administration & dosage.adverse effects.therapeutic use
Pyrimidines.administration & dosage.adverse effects.therapeutic use
Survival Analysis
Treatment Outcome
Young Adult
Appears in Collections:Journal articles

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