Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006).
Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006).
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DOI：
10.1111/ejh.12423
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发表时间：
2015-03
影响因子：
3.1
通讯作者：
Nordic CML Study Group
中科院分区：
文献类型：
--
作者：
Hjorth-Hansen H;Stenke L;Söderlund S;Dreimane A;Ehrencrona H;Gedde-Dahl T;Gjertsen BT;Höglund M;Koskenvesa P;Lotfi K;Majeed W;Markevärn B;Ohm L;Olsson-Strömberg U;Remes K;Suominen M;Simonsson B;Porkka K;Mustjoki S;Richter J;Nordic CML Study Group
我们随机选择了46例新诊断的慢性髓性白血病患者（中位年龄56岁）接受达沙替尼100mg QD或伊马替尼400mg QD治疗，并通过36个月的随访报告了意向治疗分析结果。早期细胞遗传学和分子反应在达沙替尼组是优越的，伊马替尼患者有赶上时间的趋势。例如，两组患者在3个月时达到MR3.0的比例为36%比8% (P = 0.02)，在12个月时达到MR3.0的比例为81%比46% (P = 0.02)，在18个月时达到MR3.0的比例为73%比65% （n.s）。相比之下，达沙替尼组在6个月后的所有时间点MR4.5始终优于达沙替尼组，在36个月时达到61%比21% （P < 0.05）。达沙替尼组和伊马替尼组分别有64%和71%的患者继续使用指定药物。达沙替尼的剂量经常减少，但仍保持良好的效果。1例伊马替尼患者进展至母细胞期，但未发生cml相关死亡。总之，我们的数据优于达沙替尼注册研究DASISION的数据。与伊马替尼相比，达沙替尼诱导的快速和深度分子反应可能被用来增加停药后可以实现无治疗缓解的患者比例。
We randomised 46 newly diagnosed patients with chronic myeloid leukaemia (median age 56) to receive dasatinib 100 mg QD or imatinib 400 mg QD and report outcome as an intention-to-treat analysis with 36 months follow-up. Early cytogenetic and molecular responses were superior in the dasatinib group, with a tendency that imatinib patients caught up with time. For instance, MR3.0 was reached at 3 months in 36% vs. 8% (P = 0.02), at 12 months in 81% vs. 46% (P = 0.02) and at 18 months in 73% vs. 65% (n.s.) of the patients in the two groups. In contrast, MR4.5 was consistently superior in the dasatinib group at all time points from 6 months onwards, reaching 61% vs. 21% (P < 0.05) at 36 months. Sixty-four vs. 71% of the patients in the dasatinib and imatinib arms, respectively, remained on assigned drug. Dasatinib dose was frequently reduced, but with maintained excellent effect. One imatinib patient progressed to blastic phase, but no CML-related deaths occurred. In conclusion, our data compare favourably with those of the dasatinib registration study, DASISION. The fast and deep molecular responses induced by dasatinib compared with imatinib may be exploited to increase the proportion of patients who can achieve a treatment-free remission after treatment discontinuation.
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影响因子：
11.4
作者：
Mustjoki, S.;Richter, J.;Hjorth-Hansen, H.
通讯作者：
Hjorth-Hansen, H.
影响因子：
11.4
作者：
Hochhaus, A.;O'Brien, S. G.;Larson, R. A.
通讯作者：
Larson, R. A.
影响因子：
6.2
作者：
Porkka, Kimmo;Khoury, H. Jean;Paquette, Ronald L.;Matloub, Yousif;Sinha, Ritwik;Cortes, Jorge E.
通讯作者：
Cortes, Jorge E.
影响因子：
6.5
作者：
Santos FP;Kantarjian H;Fava C;O'Brien S;Garcia-Manero G;Ravandi F;Wierda W;Thomas D;Shan J;Cortes J
通讯作者：
Cortes J
影响因子：
45.3
作者：
Hehlmann, Ruediger;Lauseker, Michael;Saussele, Susanne
通讯作者：
Saussele, Susanne