作者
Jorge E Cortes, D-W Kim, J l Pinilla-Ibarz, P Le Coutre, R Paquette, C Chuah, FE Nicolini, JF Apperley, HJ Khoury, M Talpaz, J DiPersio, DJ DeAngelo, E Abruzzese, D Rea, M Baccarani, MC Müller, C Gambacorti-Passerini, S Wong, S Lustgarten, VM Rivera, T Clackson, CD Turner, FG Haluska, F Guilhot, MW Deininger, A Hochhaus, T Hughes, JM Goldman, NP Shah, H Kantarjian
发表日期
2013/11/7
期刊
New England Journal of Medicine
卷号
369
期号
19
页码范围
1783-1796
出版商
Massachusetts Medical Society
简介
Background
Ponatinib is a potent oral tyrosine kinase inhibitor of unmutated and mutated BCR-ABL, including BCR-ABL with the tyrosine kinase inhibitor–refractory threonine-to-isoleucine mutation at position 315 (T315I). We conducted a phase 2 trial of ponatinib in patients with chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph-positive ALL).
Methods
We enrolled 449 heavily pretreated patients who had CML or Ph-positive ALL with resistance to or unacceptable side effects from dasatinib or nilotinib or who had the BCR-ABL T315I mutation. Ponatinib was administered at an initial dose of 45 mg once daily. The median follow-up was 15 months.
Results
Among 267 patients with chronic-phase CML, 56% had a major cytogenetic response (51% of patients with resistance to or unacceptable side effects from dasatinib or nilotinib and 70% of patients with the …
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JE Cortes, DW Kim, J Pinilla-Ibarz, P Le Coutre… - New England Journal of Medicine, 2013