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https://hdl.handle.net/2440/75914
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dc.contributor.author | Branford, S. | - |
dc.contributor.author | Kim, D. | - |
dc.contributor.author | Soverini, S. | - |
dc.contributor.author | Haque, A. | - |
dc.contributor.author | Shou, Y. | - |
dc.contributor.author | Woodman, R. | - |
dc.contributor.author | Kantarjian, H. | - |
dc.contributor.author | Martinelli, G. | - |
dc.contributor.author | Radich, J. | - |
dc.contributor.author | Saglio, G. | - |
dc.contributor.author | Hochhaus, A. | - |
dc.contributor.author | Hughes, T. | - |
dc.contributor.author | Muller, M. | - |
dc.date.issued | 2012 | - |
dc.identifier.citation | Journal of Clinical Oncology, 2012; 30(35):4323-4329 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.issn | 1527-7755 | - |
dc.identifier.uri | http://hdl.handle.net/2440/75914 | - |
dc.description.abstract | PURPOSE: The association between initial molecular response and longer-term outcomes with nilotinib was examined. PATIENTS AND METHODS: Patients with imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase from the phase II nilotinib registration study with available postbaseline BCR-ABL1 transcript assessments were included (N = 237). RESULTS: BCR-ABL1 transcript levels (International Scale [IS]) at 3 months correlated with complete cytogenetic response (CCyR) by 24 months. Patients with BCR-ABL1 (IS) of > 1% to ≤ 10% at 3 months with nilotinib had higher cumulative incidence of CCyR by 24 months than patients with BCR-ABL1 (IS) of > 10% (53% v 16%). BCR-ABL1 (IS) at 3 months predicted major molecular response (MMR) by 24 months. Cumulative incidence of MMR by 24 months for patients with BCR-ABL1 (IS) of > 0.1% to ≤ 1%, > 1% to ≤ 10%, and > 10% was 65%, 27%, and 9%, respectively. These differences were observed for patients with or without baseline BCR–ABL1 mutations and for those with imatinib resistance or intolerance. Estimated event-free survival (EFS) rates at 24 months decreased with higher transcript levels at 3 months; patients with BCR-ABL1 (IS) of ≤ 1% had an estimated 24-month EFS rate of 82%, compared with 70% for patients with BCR-ABL1 (IS) of > 1% to ≤ 10% and 48% for patients with BCR-ABL1 (IS) of > 10%. CONCLUSION: Patients with BCR-ABL1 (IS) of > 10% at 3 months had a lower cumulative incidence of CCyR and MMR and lower rates of EFS versus patients with BCR-ABL1 (IS) of ≤ 10%. Prospective studies may determine whether close monitoring or alternative therapies are warranted for patients with minimal initial molecular response. | - |
dc.description.statementofresponsibility | Susan Branford, Dong-Wook Kim, Simona Soverini, Ariful Haque, Yaping Shou, Richard C. Woodman, Hagop M. Kantarjian, Giovanni Martinelli, Jerald P. Radich, Giuseppe Saglio, Andreas Hochhaus, Timothy P. Hughes and Martin C. Müller | - |
dc.language.iso | en | - |
dc.publisher | Amer Soc Clinical Oncology | - |
dc.rights | © 2012 by American Society of Clinical Oncology | - |
dc.source.uri | http://dx.doi.org/10.1200/jco.2011.40.5217 | - |
dc.subject | Humans | - |
dc.subject | Benzamides | - |
dc.subject | Piperazines | - |
dc.subject | Pyrimidines | - |
dc.subject | Fusion Proteins, bcr-abl | - |
dc.subject | RNA, Messenger | - |
dc.subject | Antineoplastic Agents | - |
dc.subject | Disease-Free Survival | - |
dc.subject | Treatment Outcome | - |
dc.subject | Remission Induction | - |
dc.subject | Survival Rate | - |
dc.subject | Drug Resistance, Neoplasm | - |
dc.subject | Mutation | - |
dc.subject | Adolescent | - |
dc.subject | Adult | - |
dc.subject | Leukemia, Myelogenous, Chronic, BCR-ABL Positive | - |
dc.subject | Young Adult | - |
dc.subject | Imatinib Mesylate | - |
dc.title | Initial molecular response at 3 months may predict both response and event-free survival at 24 months in Imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with Nilotinib | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1200/JCO.2011.40.5217 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Branford, S. [0000-0002-1964-3626] [0000-0002-5095-7981] | - |
dc.identifier.orcid | Hughes, T. [0000-0002-0910-3730] [0000-0002-7990-4509] | - |
Appears in Collections: | Aurora harvest Molecular and Biomedical Science publications |
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