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Leukemia. 2016 Jan;30(1):57-64. doi: 10.1038/leu.2015.270. Epub 2015 Oct 6.

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

Author information

1
Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
2
Department of Hematology and Oncology, University of Bologna, Bologna, Italy.
3
Faculty of Medicine, University of Southampton, Southampton, UK.
4
Hospital Universitario de la Princesa, IIS-IP, Madrid, Spain.
5
Charité-Universitätsmedizin Berlin, Berlin, Germany.
6
VU University Medical Center, Amsterdam, The Netherlands.
7
Ion Chiricuta Institute of Oncology, Cluj, Romania.
8
Department of Haematology and Stem Cell Transplantation, St István and St László Hospital, Budapest, Hungary.
9
Medical University of Gdańsk, Gdańsk, Poland.
10
Vilnius University Hospital Santariskiu Klinikos, Vilnius University, Vilnius, Lithuania.
11
Department of Hematology, Medical University of Warsaw, Warsaw, Poland.
12
Service d'Hématologie Adulte et INSERM UMR1160, Hôpital Saint-Louis, Paris, France.
13
Fundeni Clinical Institute, Bucharest, Romania.
14
Universitätsklinikum RWTH Aachen, Aachen, Germany.
15
Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
16
Division of Internal Medicine & Hematology, University of Turin, Orbassano, Italy.
17
Innere Medizin, Medizinische Universität Innsbruck, Innsbruck, Austria.
18
Universitätsmedizin Mannheim, University of Heidelberg, Mannheim, Germany.
19
Novartis Pharma AG, Basel, Switzerland.
20
Novartis Oncology Region Europe, Origgio, Italy.
21
Laboratoire Hématopoïèse Leucémique et Cible Thérapeutique, Université Victor Ségalen, Bordeaux, France.
22
Northwestern Medicine Developmental Therapeutics Institute, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA.

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 (MR(4) (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 MR(4) 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.

PMID:
26437782
PMCID:
PMC4705425
DOI:
10.1038/leu.2015.270
[Indexed for MEDLINE]
Free PMC Article

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