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Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study

Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study
Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study
The Evaluating Nilotinib Efficacy and Safety in Clinical Trials as First-Line Treatment (ENEST1st) study included 1089 patients with newly diagnosed chronic myeloid leukemia in chronic phase. The rate of deep molecular response (MR4 (BCR-ABL1less than or equal to0.01% on the International Scale or undetectable BCR-ABL1 with greater than or equal to10?000 ABL1 transcripts)) at 18 months was evaluated as the primary end point, with molecular responses monitored by the European Treatment and Outcome Study network of standardized laboratories. This analysis was conducted after all patients had completed 24 months of study treatment (80.9% of patients) or discontinued early. In patients with typical BCR-ABL1 transcripts and less than or equal to3 months of prior imatinib therapy, 38.4% (404/1052) achieved MR4 at 18 months. Six patients (0.6%) developed accelerated or blastic phase, and 13 (1.2%) died. The safety profile of nilotinib was consistent with that of previous studies, although the frequencies of some nilotinib-associated adverse events were lower (for example, rash, 21.4%). Ischemic cardiovascular events occurred in 6.0% of patients. Routine monitoring of lipid and glucose levels was not mandated in the protocol. These results support the use of frontline nilotinib, particularly when achievement of a deep molecular response (a prerequisite for attempting treatment-free remission in clinical trials) is a treatment goal.
0887-6924
57-64
Hochhaus, A.
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Rosti, G.
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Cross, N.C.P.
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Masszi, T.
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Hellmann, A.
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Griskevicius, L.
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Saglio, G.
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Masszi, T.
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Hellmann, A.
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Rea, D.
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Coriu, D.
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Brümmendorf, T.H.
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Porkka, K.
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Saglio, G.
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Müller, M.C.
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Schuld, P.
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Di Matteo, P.
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Pellegrino, A.
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Dezzani, L.
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Mahon, F-X.
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Baccarani, M.
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Giles, F.J.
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Hochhaus, A., Rosti, G., Cross, N.C.P., Steegmann, J.L., le Coutre, P., Ossenkoppele, G., Petrov, L., Masszi, T., Hellmann, A., Griskevicius, L., Wiktor-Jedrzejczak, W., Rea, D., Coriu, D., Brümmendorf, T.H., Porkka, K., Saglio, G., Gastl, G., Müller, M.C., Schuld, P., Di Matteo, P., Pellegrino, A., Dezzani, L., Mahon, F-X., Baccarani, M. and Giles, F.J. (2016) Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study. Leukemia, 30 (1), 57-64. (doi:10.1038/leu.2015.270). (PMID:26437782)

Record type: Article

Abstract

The Evaluating Nilotinib Efficacy and Safety in Clinical Trials as First-Line Treatment (ENEST1st) study included 1089 patients with newly diagnosed chronic myeloid leukemia in chronic phase. The rate of deep molecular response (MR4 (BCR-ABL1less than or equal to0.01% on the International Scale or undetectable BCR-ABL1 with greater than or equal to10?000 ABL1 transcripts)) at 18 months was evaluated as the primary end point, with molecular responses monitored by the European Treatment and Outcome Study network of standardized laboratories. This analysis was conducted after all patients had completed 24 months of study treatment (80.9% of patients) or discontinued early. In patients with typical BCR-ABL1 transcripts and less than or equal to3 months of prior imatinib therapy, 38.4% (404/1052) achieved MR4 at 18 months. Six patients (0.6%) developed accelerated or blastic phase, and 13 (1.2%) died. The safety profile of nilotinib was consistent with that of previous studies, although the frequencies of some nilotinib-associated adverse events were lower (for example, rash, 21.4%). Ischemic cardiovascular events occurred in 6.0% of patients. Routine monitoring of lipid and glucose levels was not mandated in the protocol. These results support the use of frontline nilotinib, particularly when achievement of a deep molecular response (a prerequisite for attempting treatment-free remission in clinical trials) is a treatment goal.

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Accepted/In Press date: 18 September 2015
e-pub ahead of print date: 6 October 2015
Published date: January 2016
Organisations: Human Development & Health

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Local EPrints ID: 382697
URI: http://eprints.soton.ac.uk/id/eprint/382697
ISSN: 0887-6924
PURE UUID: 68667e31-ebb6-4774-a459-e3d28cbacb66
ORCID for N.C.P. Cross: ORCID iD orcid.org/0000-0001-5481-2555

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Date deposited: 03 Nov 2015 14:48
Last modified: 17 Dec 2019 01:51

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Contributors

Author: A. Hochhaus
Author: G. Rosti
Author: N.C.P. Cross ORCID iD
Author: J.L. Steegmann
Author: P. le Coutre
Author: G. Ossenkoppele
Author: L. Petrov
Author: T. Masszi
Author: A. Hellmann
Author: L. Griskevicius
Author: W. Wiktor-Jedrzejczak
Author: D. Rea
Author: D. Coriu
Author: T.H. Brümmendorf
Author: K. Porkka
Author: G. Saglio
Author: G. Gastl
Author: M.C. Müller
Author: P. Schuld
Author: P. Di Matteo
Author: A. Pellegrino
Author: L. Dezzani
Author: F-X. Mahon
Author: M. Baccarani
Author: F.J. Giles

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