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J Cancer Res Clin Oncol. 2017 Aug;143(8):1585-1596. doi: 10.1007/s00432-017-2402-x. Epub 2017 Mar 31.

Impact of age on efficacy and toxicity of nilotinib in patients with chronic myeloid leukemia in chronic phase: ENEST1st subanalysis.

Author information

1
Division of Hematology Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. frankgiles@aol.com.
2
Service d'Hématologie Adulte, Hôpital Saint-Louis, Paris, France.
3
Department of Experimental, Diagnostic and Specialty Medicine, "Seràgnoli" Institute of Hematology, "S. Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
4
Faculty of Medicine, University of Southampton, Southampton, UK.
5
Hematology Department, IIS-IP, Hospital Universitario de la Princesa, Madrid, Spain.
6
Vilnius University Hospital Santariskiu Clinics, Vilnius University, Vilnius, Lithuania.
7
Charité - Universitätsmedizin Berlin Campus Virchow, Berlin, Germany.
8
Fundeni Clinical Institute, University of Medicine "Carol Davila" Bucharest, Bucharest, Romania.
9
Ion Chiricuta Instititute of Oncology, Cluj-Napoca, Romania.
10
Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.
11
Hematology Laboratory, Bordeaux University, Bordeaux, France.
12
Universitätsmedizin Mannheim, Universität Heidelberg, Mannheim, Germany.
13
Department of Hematology, Medical University of Gdansk, Gdansk, Poland.
14
Helsinki University Hospital Comprehensive Cancer Center, Department of Hematology and Hematology Research Unit Helsinki, University of Helsinki, Helsinki, Finland.
15
Department of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, University Hospital of the RWTH Aachen, Aachen, Germany.
16
Internal Medicine V, Hematology and Oncology, Medical University Innsbruck, Innsbruck, Austria.
17
Novartis Oncology Italy, Origgio, VA, Italy.
18
Novartis Pharma GmbH, Nuremberg, Germany.
19
Klinik für Innere Medizin II/Hämatologie, Onkologie, Universitätsklinikum Jena, Jena, Germany.

Abstract

PURPOSE:

Achievement of deep molecular response with a tyrosine kinase inhibitor in patients with chronic myeloid leukemia (CML) is required to attempt discontinuation of therapy in these patients. The current subanalysis from the Evaluating Nilotinib Efficacy and Safety in Clinical Trials as First-Line Treatment (ENEST1st) study evaluated whether age has an impact on the achievement of deeper molecular responses or safety with frontline nilotinib in patients with CML.

METHODS:

ENEST1st is an open-label, multicenter, single-arm, prospective study of nilotinib 300 mg twice daily in patients with newly diagnosed CML in chronic phase. The patients were stratified into the following 4 groups based on age: young (18-39 years), middle age (40-59 years), elderly (60-74 years), and old (≥75 years). The primary end point was the rate of molecular response 4 ([MR4] BCR-ABL1 ≤0.01% on the international scale) at 18 months from the initiation of nilotinib.

RESULTS:

Of the 1091 patients enrolled, 1089 were considered in the analysis, of whom, 23% (n = 243), 45% (n = 494), 27% (n = 300), and 5% (n = 52) were categorized as young, middle age, elderly, and old, respectively. At 18 months, the rates of MR4 were 33.9% (95% confidence interval [CI], 27.8-40.0%) in the young, 39.6% (95% CI, 35.3-44.0%) in the middle-aged, 40.5% (95% CI, 34.8-46.1%) in the elderly, and 35.4% (95% CI, 21.9-48.9%) in the old patients. Although the incidence of adverse events was slightly different, no new specific safety signals were observed across the 4 age groups.

CONCLUSIONS:

This subanalysis of the ENEST1st study showed that age did not have a relevant impact on the deep molecular response rates associated with nilotinib therapy in newly diagnosed patients with CML and eventually on the eligibility of the patients to attempt treatment discontinuation.

KEYWORDS:

Chronic myeloid leukemia; Clinical trial; Frontline; Impact of age; Molecular response; Nilotinib

PMID:
28364360
PMCID:
PMC5504128
DOI:
10.1007/s00432-017-2402-x
[Indexed for MEDLINE]
Free PMC Article

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