Nilotinib As Front-Line Treatment for Patients With Chronic Myeloid Leukemia in Early Chronic Phase
Nilotinib As Front-Line Treatment for Patients With Chronic Myeloid Leukemia in Early Chronic Phase
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DOI：
10.1200/jco.2009.25.4896
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发表时间：
2010-01-20
影响因子：
45.3
通讯作者：
Kantarjian, Hagop
中科院分区：
文献类型：
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作者：
Cortes, Jorge E.;Jones, Dan;Kantarjian, Hagop
目的：虽然大多数慢性髓系白血病（CML）慢性期患者对伊马替尼一线治疗反应良好，但部分患者未能达到预期终点，其他患者可能最终失去反应或产生不耐受。患者和方法新诊断的慢性粒细胞白血病（CML）慢慢期患者初始治疗为尼罗替尼400mg，每日2次，空腹。结果在51例观察至少3个月的慢性期患者中，50例（98%）达到完全细胞遗传学缓解（CCyR）， 39例（76%）达到主要分子缓解（MMR）。反应发生迅速，96%的患者在3个月达到CCyR， 98%的患者在6个月达到CCyR。预计24个月无事件生存率为90%，中位随访时间为17个月后，所有患者均存活。12%的患者发生>= 3级中性粒细胞减少，11%的患者发生血小板减少。非血液学毒性通常为1至2级，可控制。12个月时的实际中位剂量为800毫克（范围200至800毫克）。结论尼洛替尼是早期慢性粒细胞白血病（CML）初始治疗的有效选择，可产生较高的CCyR和MMR率，大多数患者在治疗早期达到这些反应。
PurposeAlthough most patients with chronic myeloid leukemia (CML) in chronic phase respond well to front-line therapy with imatinib, some patients do not achieve the desirable end point, and others may eventually lose response or are intolerant.Patients and MethodsPatients with newly diagnosed CML in chronic phase were treated with nilotinib 400 mg twice daily on an empty stomach as initial therapy.ResultsAmong 51 patients in chronic phase observed for at least 3 months, 50 (98%) achieved a complete cytogenetic remission (CCyR), and 39 (76%) achieved a major molecular response (MMR). Responses occurred rapidly, with 96% of patients achieving CCyR by 3 months and 98% achieving CCyR by 6 months. The projected event-free survival at 24 months is 90%, and all patients are alive after a median follow-up time of 17 months. Grade >= 3 neutropenia occurred in 12% of patients, and thrombocytopenia in occurred 11%. Nonhematologic toxicity was usually grade 1 to 2 and manageable. The actual median dose at 12 months was 800 mg (range, 200 to 800 mg).ConclusionNilotinib is an effective option for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR, with most patients reaching these responses early during their therapy.