Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib
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Citações na Scopus
82
Tipo de produção
article
Data de publicação
2014
Editora
AMER SOC HEMATOLOGY
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Autores
HUGHES, Timothy P.
LIPTON, Jeffrey H.
SPECTOR, Nelson
CERVANTES, Francisco
PASQUINI, Ricardo
CLEMENTINO, Nelma Cristina D.
SCHWARER, Anthony P.
MAHON, Francois-Xavier
REA, Delphine
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Citação
BLOOD, v.124, n.5, p.729-736, 2014
Resumo
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%; MR4.5) and those without major molecular response at study start, MR4.5 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.
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Referências
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