Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/89685
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Type: Journal article
Title: Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib
Author: Hughes, T.
Lipton, J.
Spector, N.
Cervantes, F.
Pasquini, R.
Clementino, N.
Dorlhiac Llacer, P.
Schwarer, A.
Mahon, F.
Rea, D.
Branford, S.
Purkayastha, D.
Collins, L.
Szczudlo, T.
Leber, B.
Citation: Blood, 2014; 124(5):729-736
Publisher: American Society of Hematology
Issue Date: 2014
ISSN: 0006-4971
1528-0020
Statement of
Responsibility: 
Timothy P. Hughes, Jeffrey H. Lipton, Nelson Spector, Francisco Cervantes, Ricardo Pasquini, Nelma Cristina D. Clementino, Pedro Enrique Dorlhiac Llacer, Anthony P. Schwarer, Francois-Xavier Mahon, Delphine Rea, Susan Branford, Das Purkayastha, LaTonya Collins, Tomasz Szczudlo and Brian Leber
Abstract: 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 www.clinicaltrials.gov as #NCT00760877.
Keywords: Benzamides; Piperazines; Pyrimidines; Fusion Proteins, bcr-abl; Protein Kinase Inhibitors
Description: Presented at the 53rd, 54th, and 55th annual meetings of the American Society of Hematology (San Diego, CA, December 10-13, 2011; Atlanta, GA, December 8-11, 2012; and New Orleans, LA, December 7-10, 2013), the 2012 and 2013 annual meetings of the American Society of Clinical Oncology (Chicago, IL, June 1-5, 2012, and May 31 to June 4, 2013), and at the 17th and 18th congresses of the European Hematology Association (Amsterdam, The Netherlands, June 14-17, 2012, and Stockholm, Sweden, June 13-16, 2013).
Rights: © 2014 by The American Society of Hematology
RMID: 0030018382
DOI: 10.1182/blood-2013-12-544015
Appears in Collections:Medicine publications

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