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

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

Research output: Article

55 Citations (Scopus)

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-ABL1≤0.01% on the International Scale or undetectable BCR-ABL1 with ≥10 000 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 ≤3 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.

Original languageEnglish
Pages (from-to)57-64
Number of pages8
JournalLeukemia
Volume30
Issue number1
DOIs
Publication statusPublished - jan. 1 2016

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Leukemia, Myeloid, Chronic Phase
Clinical Trials
Therapeutics
Safety
Exanthema
4-methyl-N-(3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-pyridin-3-ylpyrimidin-2-yl)amino)benzamide
Outcome Assessment (Health Care)
Lipids
Glucose

ASJC Scopus subject areas

  • Hematology
  • Cancer Research
  • Anesthesiology and Pain Medicine

Cite this

Hochhaus, A., Rosti, G., Cross, N. C. P., Steegmann, J. L., Le Coutre, P., Ossenkoppele, G., ... 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. https://doi.org/10.1038/leu.2015.270

Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase : Results from the European ENEST1st study. / 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.; Giles, F. J.

In: Leukemia, Vol. 30, No. 1, 01.01.2016, p. 57-64.

Research output: Article

Hochhaus, A, Rosti, G, Cross, NCP, Steegmann, JL, Le Coutre, P, Ossenkoppele, G, Petrov, L, Masszi, T, Hellmann, A, Griskevicius, L, Wiktor-Jedrzejczak, W, Rea, D, Coriu, D, Brümmendorf, TH, Porkka, K, Saglio, G, Gastl, G, Müller, MC, Schuld, P, Di Matteo, P, Pellegrino, A, Dezzani, L, Mahon, FX, Baccarani, M & Giles, FJ 2016, 'Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: Results from the European ENEST1st study', Leukemia, vol. 30, no. 1, pp. 57-64. https://doi.org/10.1038/leu.2015.270
Hochhaus A, Rosti G, Cross NCP, Steegmann JL, Le Coutre P, Ossenkoppele G et al. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: Results from the European ENEST1st study. Leukemia. 2016 jan. 1;30(1):57-64. https://doi.org/10.1038/leu.2015.270
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. ; Giles, F. J. / Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase : Results from the European ENEST1st study. In: Leukemia. 2016 ; Vol. 30, No. 1. pp. 57-64.
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AU - Steegmann, J. L.

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AU - Ossenkoppele, G.

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AU - Masszi, T.

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AU - Porkka, K.

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AU - Müller, M. C.

AU - Schuld, P.

AU - Di Matteo, P.

AU - Pellegrino, A.

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AU - Mahon, F. X.

AU - Baccarani, M.

AU - Giles, F. J.

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