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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.
Authors: 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.L.;Trotman, J.;Forsyth, Cecily J ;Taper, J.;Ross, D.M.;Beresford, J.;Tam, C.;Mills, A.K.;Grigg, A.;Hughes, T.
Issue Date: Feb-2015
Source: Volume 125, Issue 6, pp. 915 - 923
Journal title: Blood
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.
DOI: 10.1182/blood-2014-07-590315
ISSN: 1528-0020
Publicaton type: Journal Article
Keywords: Cancer
Drug Therapy
Study or Trial: Clinical Trial
Appears in Collections:Haematology

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