Efficacy and safety of nilotinib in Japanese patients with imatinib-resistant or -intolerant Ph+ CML or relapsed/refractory Ph+ ALL: A 36-month analysis of a phase i and II study

Kensuke Usuki, Arinobu Tojo, Yasuhiro Maeda, Yukio Kobayashi, Akira Matsuda, Kazuma Ohyashiki, Chiaki Nakaseko, Tatsuya Kawaguchi, Hideo Tanaka, Tadashi Nagai, Yasushi Miyazaki, Shinichiro Okamoto, Taro Amagasaki, Kenji Oritani, Aira Wanajo, Masaya Okada, Tomoki Naoe, Koichi Miyamura, Noriko Usui

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12 Citations (Scopus)

Abstract

Although the tyrosine kinase inhibitor (TKI) imatinib is often used as first-line therapy for newly diagnosed chronic myelogenous leukemia (CML), some patients fail to respond, or become intolerant to imatinib. Nilotinib is a potent and selective second-generation TKI, with confirmed efficacy and tolerability in patients with imatinib-resistant or -intolerant CML. A phase I/II study was conducted in Japanese patients with imatinib-resistant or -intolerant CML or relapsed/refractory Phfl acute lymphoblastic leukemia. Thirty-four patients were treated with nilotinib for up to 36 months. Major cytogenetic response was achieved in 15/16 patients (93.8%) with chronic-phase CML within a median of approximately 3 months. Major molecular response was achieved in 13/16 patients (81.3%). These responses were sustained at the time of the most recent evaluation in 13 patients and 11 patients, respectively. Hematologic and cytogenetic responses were also observed in patients with advanced CML. The BCR-ABL mutation associated with the most resistance to available TKIs, T315I, was observed in three patients. Common adverse events included rash, nasopharyngitis, leukopenia, neutropenia, thrombocytopenia, nausea, headache and vomiting. Most adverse events resolved following nilotinib dose interruptions/reductions. These results support the favorable longterm efficacy and tolerability of nilotinib in Japanese patients with imatinib-resistant or -intolerant chronic-phase chronic myeloid leukemia.

Original languageEnglish
Pages (from-to)409-419
Number of pages11
JournalInternational journal of hematology
Volume95
Issue number4
DOIs
Publication statusPublished - 2012 Apr

Keywords

  • Acute lymphoblastic leukemia
  • Chronic myeloid leukemia
  • Nilotinib
  • Tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Hematology

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    Usuki, K., Tojo, A., Maeda, Y., Kobayashi, Y., Matsuda, A., Ohyashiki, K., Nakaseko, C., Kawaguchi, T., Tanaka, H., Nagai, T., Miyazaki, Y., Okamoto, S., Amagasaki, T., Oritani, K., Wanajo, A., Okada, M., Naoe, T., Miyamura, K., & Usui, N. (2012). Efficacy and safety of nilotinib in Japanese patients with imatinib-resistant or -intolerant Ph+ CML or relapsed/refractory Ph+ ALL: A 36-month analysis of a phase i and II study. International journal of hematology, 95(4), 409-419. https://doi.org/10.1007/s12185-012-1026-9