Journal article
Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd
TP Hughes, E Munhoz, M Aurelio Salvino, TC Ong, A Elhaddad, J Shortt, H Quach, C Pavlovsky, VJ Louw, LY Shih, AG Turkina, L Meillon, Y Jin, S Acharya, D Dalal, JH Lipton
British Journal of Haematology | WILEY | Published : 2017
DOI: 10.1111/bjh.14829
Abstract
The Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Extending Molecular Responses (ENESTxtnd) study was conducted to evaluate the kinetics of molecular response to nilotinib in patients with newly diagnosed chronic myeloid leukaemia in chronic phase and the impact of novel dose-optimization strategies on patient outcomes. The ENESTxtnd protocol allowed nilotinib dose escalation (from 300 to 400 mg twice daily) in the case of suboptimal response or treatment failure as well as dose re-escalation for patients with nilotinib dose reductions due to adverse events. Among 421 patients enrolled in ENESTxtnd, 70·8% (95% confidence interval, 66·2–75·1%) achieved major molecular response (..
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Funding Acknowledgements
The ENESTxtnd study and work presented here were sponsored and funded by Novartis Pharmaceuticals Corporation.