Dasatinib in imatinib-resistant or imatinib-intolerant chronic myeloid leukemia in blast phase after 2 years of follow-up in a phase 3 study: efficacy and tolerability of 140 milligrams once daily and 70 milligrams twice daily.
Dasatinib in imatinib-resistant or imatinib-intolerant chronic myeloid leukemia in blast phase after 2 years of follow-up in a phase 3 study: efficacy and tolerability of 140 milligrams once daily and 70 milligrams twice daily.
复制标题
DOI：
10.1002/cncr.25123
复制
发表时间：
2010-08-15
期刊：
影响因子：
6.2
通讯作者：
Dombret H
中科院分区：
文献类型：
--
作者：
Saglio G;Hochhaus A;Goh YT;Masszi T;Pasquini R;Maloisel F;Erben P;Cortes J;Paquette R;Bradley-Garelik MB;Zhu C;Dombret H
在一项3期研究中，作者评估了达沙替尼对晚期慢性髓性白血病（CML）或费城染色体阳性急性淋巴细胞白血病耐药或不耐受的患者的疗效，剂量分别为140 mg每日1次和70 mg每日2次。在目前的报告中，报告了CML患者在2年随访后的结果。根据患者是否患有髓细胞母细胞期（MBP-CML）或淋巴细胞母细胞期（LBP-CML）的CML进行分层，并在每个层中随机（1:1）接受口服达沙替尼140 mg每日一次或70 mg每日两次。在MBP-CML患者中，两种方案的主要血液学反应率均为28%；在LBP-CML患者中，每日一次达沙替尼的主要血液学反应率为42%，每日两次达沙替尼的主要血液学反应率为32%。在MBP-CML患者中，每日一次达沙替尼的主要细胞遗传学反应率为25%，每日两次达沙替尼的主要细胞遗传学反应率为28%，LBP-CML患者的主要细胞遗传学反应率分别为50%和40%。在MBP-CML患者中，每日一次达沙替尼的24个月总生存率为24%，每日两次达沙替尼的总生存率为28%，LBP-CML患者的总生存率分别为21%和16%。不良事件表明每日一次治疗的耐受性有改善的趋势。目前的结果表明，对于伊马替尼耐药的blast期CML患者，140mg每日一次的达沙替尼与70mg每日两次的方案具有相似的疗效和改善的耐受性。
In a phase 3 study, the authors assessed the effects of dasatinib at doses of 140 mg once daily and 70 mg twice daily in patients who had either chronic myeloid leukemia (CML) in advanced phases or Philadelphia chromosome-positive acute lymphoblastic leukemia and were resistant or intolerant to imatinib. In the current report, the results for patients with CML in blast phase after 2 years of follow-up are reported. Patients were stratified according to whether they had CML in myeloid blast phase (MBP-CML) or in lymphoid blast phase (LBP-CML) and were randomized (1:1) within each stratum to receive either oral dasatinib 140 mg once daily or 70 mg twice daily. In patients with MBP-CML, the major hematologic response rate was 28% for both regimens; and, in patients with LBP-CML, the major hematologic response rate was 42% for once-daily dasatinib and 32% for twice-daily dasatinib. The major cytogenetic response rates were 25% for once-daily dasatinib and 28% for twice-daily dasatinib in patients with MBP-CML, and the respective rates in patients with LBP-CML were 50% and 40%. The overall survival rate at 24 months was 24% for once-daily dasatinib and 28% for twice-daily dasatinib in patients with MBP-CML, and the respective values in patients with LBP-CML were 21% and 16%. Adverse events indicated a trend toward improved tolerability for the once-daily regimen. The current results suggested that dasatinib 140 mg once daily had similar efficacy and improved tolerability relative to the 70-mg twice-daily regimen in patients with imatinib-resistant, blast phase CML.