Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study
Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study
复制标题
DOI：
10.1038/leu.2012.181
复制
发表时间：
2013-01-01
期刊：
影响因子：
11.4
通讯作者：
Kantarjian, H. M.
中科院分区：
文献类型：
--
作者：
Giles, F. J.;le Coutre, P. D.;Kantarjian, H. M.
尼洛替尼（Tasigna）是一种 BCR-ABL1 酪氨酸激酶抑制剂，被批准用于治疗新诊断或对伊马替尼不耐受或耐药的费城染色体阳性慢性粒细胞白血病慢性期 (CML-CP) 患者。对一项国际 II 期研究中伊马替尼耐药或不耐受后接受尼洛替尼治疗的 CML-CP 患者的 48 个月随访数据进行了分析。总体而言，59% 的患者获得了主要的细胞遗传学缓解； 45% 的人在研究期间实现了完整的细胞遗传学反应。 48 个月时的估计总生存率 (OS) 和无进展生存率 (PFS) 分别为 78% 和 57%。 3 个月和 6 个月时更深层次的分子反应与长期结果高度正相关，包括 48 个月时的 PFS 和 OS。在最初参与该研究的 321 名患者中，98 名 (31%) 接受了至少 48 个月的治疗。停药主要是由于疾病进展（30%）或不良事件（21%）。对于对伊马替尼不耐受或耐药的 CML-CP 患者，长期使用尼罗替尼是安全有效的。对于伊马替尼耐药或不耐受的患者，需要进一步显着改善治疗。白血病 (2013) 27, 107-112; doi:10.1038/leu.2012.181
Nilotinib (Tasigna) is a BCR-ABL1 tyrosine kinase inhibitor approved for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (CML-CP) who are newly diagnosed or intolerant of or resistant to imatinib. The 48-month follow-up data for patients with CML-CP treated with nilotinib after imatinib resistance or intolerance on an international phase II study were analyzed. Overall, 59% of patients achieved major cytogenetic response; 45% achieved complete cytogenetic response while on study. The estimated rate of overall survival (OS) and progression-free survival (PFS) at 48 months was 78% and 57%, respectively. Deeper levels of molecular responses at 3 and 6 months were highly positively correlated with long-term outcomes, including PFS and OS at 48 months. Of the 321 patients initially enrolled in the study, 98 (31%) were treated for at least 48 months. Discontinuations were primarily due to disease progression (30%) or adverse events (21%). Nilotinib is safe and effective for long-term use in responding patients with CML-CP who are intolerant of or resistant to imatinib. Further significant improvements in therapy are required for patients who are resistant or intolerant to imatinib. Leukemia (2013) 27, 107-112; doi:10.1038/leu.2012.181