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Blood. 2014 Jul 31;124(5):729-36. doi: 10.1182/blood-2013-12-544015. Epub 2014 Jun 19.

Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib.

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South Australian Health and Medical Research Institute, Division of Haematology and Centre for Cancer Biology, South Australia Pathology, University of Adelaide, Adelaide, Australia;
Princess Margaret Hospital, Leukemia Clinic, Blood and Marrow Transplant Centre, Apheresis Unit, Toronto, ON, Canada;
Universidade Federal do Rio de Janeiro, Department of Clinical Medicine, Rio de Janeiro, Brazil;
Hospital Clínic L'Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain;
Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil;
Hospital Das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil;
Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, Hematology Department, São Paulo, Brazil;
Hematology Department, Alfred Hospital, Melbourne, Australia;
Laboratoire d'Hématologie, Centre Hospitalier Universitaire de Bordeaux and Laboratoire Hématopoïèse Leucémique et Cible Thérapeutique, Biothérapies des Maladies Génétiques et Cancers, Inserm U1035, Université Bordeaux Ségalen, Bordeaux, France;
Service des Maladies du Sang et EA3518, Hôpital Saint-Louis, Paris, France;
Centre for Cancer Biology, South Australia Pathology, University of Adelaide, Adelaide, Australia;
Novartis Pharmaceuticals Corporation, East Hanover, NJ; and.
McMaster University and Juravinski Hospital and Cancer Centre, Hamilton, ON, Canada.


Patients in complete cytogenetic response (CCyR) with detectable BCR-ABL1 after ≥2 years on imatinib were randomized to nilotinib (400 mg twice daily, n = 104) or continued imatinib (n = 103) in the Evaluating Nilotinib Efficacy and Safety in clinical Trials-Complete Molecular Response (ENESTcmr) trial. By 1 and 2 years, confirmed undetectable BCR-ABL1 was achieved by 12.5% vs 5.8% (P = .108) and 22.1% vs 8.7% of patients in the nilotinib and imatinib arms, respectively (P = .0087). Among patients without molecular response 4.5 (BCR-ABL1(IS) ≤0.0032%; MR(4.5)) and those without major molecular response at study start, MR(4.5) by 2 years was achieved by 42.9% vs 20.8% and 29.2% vs 3.6% of patients in the nilotinib and imatinib arms, respectively. No patient in the nilotinib arm lost CCyR, vs 3 in the imatinib arm. Adverse events were more common in the nilotinib arm, as expected with the introduction of a new drug vs remaining on a well-tolerated drug. The safety profile of nilotinib was consistent with other reported studies. In summary, switching to nilotinib enabled more patients with chronic myeloid leukemia in chronic phase (CML-CP) to sustain lower levels of disease burden vs remaining on imatinib. This trial was registered at as #NCT00760877.

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