TIDEL-II: first-line use of imatinib in CML with early switch to nilotinib for failure to achieve time-dependent molecular targets
Date
2015
Authors
Yeung, D.
Osborn, M.
White, D.
Branford, S.
Braley, J.
Herschtal, A.
Kornhauser, M.
Issa, S.
Hiwase, D.
Hertzberg, M.
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Journal article
Citation
Blood, 2015; 125(6):915-923
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.
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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.
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© 2015 by The American Society of Hematology