Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/83386
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dc.contributor.author | Stein, A. | - |
dc.contributor.author | Martinelli, G. | - |
dc.contributor.author | Hughes, T. | - |
dc.contributor.author | Muller, M. | - |
dc.contributor.author | Beppu, L. | - |
dc.contributor.author | Gottardi, E. | - |
dc.contributor.author | Branford, S. | - |
dc.contributor.author | Soverini, S. | - |
dc.contributor.author | Woodman, R. | - |
dc.contributor.author | Hochhaus, A. | - |
dc.contributor.author | Kim, D. | - |
dc.contributor.author | Saglio, G. | - |
dc.contributor.author | Radich, J. | - |
dc.date.issued | 2013 | - |
dc.identifier.citation | BMC Cancer, 2013; 13(1):1-10 | - |
dc.identifier.issn | 1471-2407 | - |
dc.identifier.issn | 1471-2407 | - |
dc.identifier.uri | http://hdl.handle.net/2440/83386 | - |
dc.description.abstract | BACKGROUND We evaluated BCR-ABL1 kinetics in patients treated with nilotinib and analyzed whether a dynamic model of changes in BCR-ABL1 levels over time could be used to predict long-term responses. METHODS Patients from the nilotinib registration trial (CAMN107A2101; registered at http://www.clinicaltrials.gov webcite as NCT00109707) who had imatinib-resistant or -intolerant Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) or accelerated phase with BCR-ABL1 > 10% (on the international scale [IS]) at baseline and, in the first 6 months, had at least three BCR-ABL1 transcript measurements and an average daily dose of at least 720 mg were included in this analysis (N = 123). RESULTS More than half of patients (65/123; 53%) had a slow monophasic response and the remainder (58/123; 47%) had a biphasic response, in which patients had a rapid initial decrease in BCR-ABL1 transcripts followed by a more gradual response. The biphasic response type strongly correlated with improved event-free survival (EFS). Data in the first 6 months of follow-up were sufficient to predict EFS at 24 months. CONCLUSIONS Unlike newly diagnosed patients with Ph+ CML-CP—in whom the majority had a biphasic response—approximately half of patients with imatinib-resistant or -intolerant CML had a slower, monophasic response. Second-line patients who did have a biphasic response had an EFS outlook similar to that of newly diagnosed patients treated with imatinib. Our model was comparable to using BCR-ABL1 (IS) ≤ 10% at 6 months as a threshold for predicting EFS. | - |
dc.description.statementofresponsibility | Andrew M Stein, Giovanni Martinelli, Timothy P Hughes, Martin C Müller, Lan Beppu, Enrico Gottardi, Susan Branford, Simona Soverini, Richard C Woodman, Andreas Hochhaus, Dong-Wook Kim, Giuseppe Saglio and Jerald P Radich | - |
dc.language.iso | en | - |
dc.publisher | BioMed Central Ltd. | - |
dc.rights | © 2013 Stein et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. | - |
dc.source.uri | http://dx.doi.org/10.1186/1471-2407-13-173 | - |
dc.subject | Chronic myeloid leukemia | - |
dc.subject | Nilotinib | - |
dc.subject | Mathematical modeling | - |
dc.subject | BCR-ABL | - |
dc.subject | Molecular response | - |
dc.title | Rapid initial decline in BCR-ABL1 is associated with superior responses to second-line nilotinib in patients with chronic-phase chronic myeloid leukemia | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1186/1471-2407-13-173 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Hughes, T. [0000-0002-0910-3730] [0000-0002-7990-4509] | - |
dc.identifier.orcid | Branford, S. [0000-0002-1964-3626] [0000-0002-5095-7981] | - |
Appears in Collections: | Aurora harvest 4 Medicine publications |
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