Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia.

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Abstract

Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase.

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Characterization of AMN107, a selective inhibitor of native and mutant Bcr-Abl.

Ellen Weisberg, Paul W. Manley, Werner Breitenstein … (2005)

The Bcr-Abl tyrosine kinase oncogene causes chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). We describe a novel selective inhibitor of Bcr-Abl, AMN107 (IC50 <30 nM), which is significantly more potent than imatinib, and active against a number of imatinib-resistant Bcr-Abl mutants. Crystallographic analysis of Abl-AMN107 complexes provides a structural explanation for the differential activity of AMN107 and imatinib against imatinib-resistant Bcr-Abl. Consistent with its in vitro and pharmacokinetic profile, AMN107 prolonged survival of mice injected with Bcr-Abl-transformed hematopoietic cell lines or primary marrow cells, and prolonged survival in imatinib-resistant CML mouse models. AMN107 is a promising new inhibitor for the therapy of CML and Ph+ ALL.

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Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet.

Michele Baccarani, Jorge Cortés, Fabrizio Pane … (2009)

To review and update the European LeukemiaNet (ELN) recommendations for the management of chronic myeloid leukemia with imatinib and second-generation tyrosine kinase inhibitors (TKIs), including monitoring, response definition, and first- and second-line therapy. These recommendations are based on a critical and comprehensive review of the relevant papers up to February 2009 and the results of four consensus conferences held by the panel of experts appointed by ELN in 2008. Cytogenetic monitoring was required at 3, 6, 12, and 18 months. Molecular monitoring was required every 3 months. On the basis of the degree and the timing of hematologic, cytogenetic, and molecular results, the response to first-line imatinib was defined as optimal, suboptimal, or failure, and the response to second-generation TKIs was defined as suboptimal or failure. Initial treatment was confirmed as imatinib 400 mg daily. Imatinib should be continued indefinitely in optimal responders. Suboptimal responders may continue on imatinb, at the same or higher dose, or may be eligible for investigational therapy with second-generation TKIs. In instances of imatinib failure, second-generation TKIs are recommended, followed by allogeneic hematopoietic stem-cell transplantation only in instances of failure and, sometimes, suboptimal response, depending on transplantation risk.

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Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia.

A Hochhaus, S O'Brien, F Guilhot … (2009)

Imatinib mesylate is considered standard of care for first-line treatment of chronic phase chronic myeloid leukemia (CML-CP). In the phase III, randomized, open-label International Randomized Study of Interferon vs STI571 (IRIS) trial, previously untreated CML-CP patients were randomized to imatinib (n=553) or interferon-alpha (IFN) plus cytarabine (n=553). This 6-year update focuses on patients randomized to receive imatinib as first-line therapy for newly diagnosed CML-CP. During the sixth year of study treatment, there were no reports of disease progression to accelerated phase (AP) or blast crisis (BC). The toxicity profile was unchanged. The cumulative best complete cytogenetic response (CCyR) rate was 82%; 63% of all patients randomized to receive imatinib and still on study treatment showed CCyR at last assessment. The estimated event-free survival at 6 years was 83%, and the estimated rate of freedom from progression to AP and BC was 93%. The estimated overall survival was 88% -- or 95% when only CML-related deaths were considered. This 6-year update of IRIS underscores the efficacy and safety of imatinib as first-line therapy for patients with CML.

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Author and article information

Journal

Journal ID (iso-abbrev): N Engl J Med

Title: The New England journal of medicine

Publisher: Massachusetts Medical Society

ISSN (Electronic): 1533-4406

ISSN (Print): 0028-4793

Publication date (Electronic): Jun 17 2010

Volume: 362

Issue: 24

Affiliations

[1 ] University of Turin, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy. giuseppe.saglio@unito.it

Article

Publisher Item ID: NEJMoa0912614

DOI: 10.1056/NEJMoa0912614

PubMed ID: 20525993

SO-VID: bcfa3f95-3063-408a-86c5-1f5cf2537b95

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Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia.

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Most cited references 18

Characterization of AMN107, a selective inhibitor of native and mutant Bcr-Abl.

Chronic myeloid leukemia: an update of concepts and management recommendations of European LeukemiaNet.

Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia.

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