Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib
Date
2014
Authors
Hughes, T.
Lipton, J.
Spector, N.
Cervantes, F.
Pasquini, R.
Clementino, N.
Dorlhiac Llacer, P.
Schwarer, A.
Mahon, F.
Rea, D.
Editors
Advisors
Journal Title
Journal ISSN
Volume Title
Type:
Journal article
Citation
Blood, 2014; 124(5):729-736
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
Conference Name
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.
School/Discipline
Dissertation Note
Provenance
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).
Access Status
Rights
© 2014 by The American Society of Hematology