Nilotinib has a higher binding affinity and selectivity for BCR-ABL with respect to imatinib and is an effective treatment of chronic myeloid leukemia (CML) after imatinib failure. In a phase 2 study, 73 early chronic-phase, untreated, Ph+ CML patients, received nilotinib at a dose of 400 mg twice daily. The primary endpoint was the complete cytogenetic response (CCgR) rate at 1 year. With a median follow-up of 15 months, the CCgR rate at 1 year was 96%, and the major molecular response rate 85%. Responses were rapid, with 78% CCgR and 52% major molecular response at 3 months. During the first year, the treatment was interrupted at least once in 38 patients (52%). The mean daily dose ranged between 600 and 800 mg in 74% of patients, 400 and 599 mg in 18% of patients, and was less than 400 mg in 8% of patients. Dose interruptions were mainly due to nonhematologic and biochemical side effects. Myelosuppression was irrelevant. One patient progressed to blastic crisis after 6 months; one went off-treatment for lipase increase grade 4 (no pancreatitis). Nilotinib is safe and very active in early chronic-phase CML. These data support a role for nilotinib for the frontline treatment of CML. This study was registered at ClinicalTrials. gov as NCT00481052. © 2009 by The American Society of Hematology.
Rosti, G., Palandri, F., Castagnetti, F., Breccia, M., Levato, L., Gugliotta, G., et al. (2009). Nilotinib for the frontline treatment of Ph+ chronic myeloid leukemia. BLOOD, 114(24), 4933-4938.
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|Titolo:||Nilotinib for the frontline treatment of Ph+ chronic myeloid leukemia|
|Citazione:||Rosti, G., Palandri, F., Castagnetti, F., Breccia, M., Levato, L., Gugliotta, G., et al. (2009). Nilotinib for the frontline treatment of Ph+ chronic myeloid leukemia. BLOOD, 114(24), 4933-4938.|
|Appare nelle tipologie:||1.1 Articolo in rivista|
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