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Leukemia. 2016 May;30(5):1044-54. doi: 10.1038/leu.2016.5. Epub 2016 Feb 3.

Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial.

Author information

1
Abteilung Hämatologie/Onkologie, Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.
2
Division of Internal Medicine & Hematology, University of Turin, Orbassano, Italy.
3
South Australian Health and Medical Research Institute (SAHMRI), University of Adelaide, SA Pathology, Adelaide, South Australia, Australia.
4
Department of Medicine, The University of Chicago, Chicago, IL, USA.
5
Leukemia Research Institute, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
6
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
7
Charité-Universitätsmedizin Berlin, Berlin, Germany.
8
Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest, Institut Bergonié, Département d'Oncologie Médicale, Bordeaux, France.
9
Hospital das Clinicas FMUSP, São Paulo, Brazil.
10
Royal Liverpool University Hospital, Liverpool, UK.
11
Sarah Cannon Research Institute, Nashville, TN, USA.
12
Department of Hematology, Osaka City University, Osaka, Japan.
13
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
14
Novartis Pharma AG, Basel, Switzerland.
15
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Abstract

In the phase 3 Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd) study, nilotinib resulted in earlier and higher response rates and a lower risk of progression to accelerated phase/blast crisis (AP/BC) than imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Here, patients' long-term outcomes in ENESTnd are evaluated after a minimum follow-up of 5 years. By 5 years, more than half of all patients in each nilotinib arm (300 mg twice daily, 54%; 400 mg twice daily, 52%) achieved a molecular response 4.5 (MR(4.5); BCR-ABL⩽0.0032% on the International Scale) compared with 31% of patients in the imatinib arm. A benefit of nilotinib was observed across all Sokal risk groups. Overall, safety results remained consistent with those from previous reports. Numerically more cardiovascular events (CVEs) occurred in patients receiving nilotinib vs imatinib, and elevations in blood cholesterol and glucose levels were also more frequent with nilotinib. In contrast to the high mortality rate associated with CML progression, few deaths in any arm were associated with CVEs, infections or pulmonary diseases. These long-term results support the positive benefit-risk profile of frontline nilotinib 300 mg twice daily in patients with CML-CP.

PMID:
26837842
PMCID:
PMC4858585
DOI:
10.1038/leu.2016.5
[Indexed for MEDLINE]
Free PMC Article

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