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达沙替尼与伊马替尼治疗新诊断慢性髓性白血病患者的真实世界疗效比较。

Real-World Effectiveness of Dasatinib Versus Imatinib in Newly Diagnosed Patients With Chronic Myeloid Leukemia.

机构信息

Cardinal Health Specialty Solutions, Dublin, OH.

Bristol Myers Squibb, Princeton, NJ.

出版信息

Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):149-157. doi: 10.1016/j.clml.2023.10.005. Epub 2023 Oct 20.

Abstract

INTRODUCTION

Limited data exist comparing dasatinib with imatinib in clinical practice. This study assessed real-world outcomes associated with first-line (1L) dasatinib or imatinib treatment of chronic myeloid leukemia (CML).

PATIENTS AND METHODS

This retrospective, observational, United States multisite cohort study analyzed electronic medical record data from adults with Philadelphia chromosome-positive (Ph+) CML in the chronic phase (CML-CP) after 1L dasatinib or imatinib between January 2014 and September 2018. Rates of and times to major molecular response (MMR) and deep molecular response (DMR) were assessed overall and in subgroups (low vs. intermediate/high risk, aged <65 vs. ≥65 years, low/normal vs. high body mass index [BMI]).

RESULTS

The dasatinib cohort (n = 309) experienced higher rates of MMR (n = 304, 79% vs. 65%, P < .001) and DMR (44% vs. 25%, P < .001) vs. the imatinib cohort with shorter median times to MMR (11.9 vs. 14.7 months, P < .001) and DMR (30.3 vs. 66.1 months, P < .001). Patients with intermediate-/high-risk disease and those aged <65 years had higher MMR and DMR rates and achieved response earlier with dasatinib (P < .01). Patients with low-risk disease treated with dasatinib had higher rates of DMR (60% vs. 32%, P = .01). Across BMI strata, rates of MMR and DMR were higher with dasatinib (P < .05).

CONCLUSIONS

Patients with CML-CP treated with 1L dasatinib achieved higher rates of, with shorter times to, MMR and DMR versus 1L imatinib. These clinically meaningful improvements were observed across subgroups.

摘要

简介

在临床实践中,比较达沙替尼和伊马替尼的数据有限。本研究评估了一线(1L)达沙替尼或伊马替尼治疗慢性髓性白血病(CML)的真实世界结局。

患者和方法

这是一项回顾性、观察性、美国多地点队列研究,分析了 2014 年 1 月至 2018 年 9 月期间接受 1L 达沙替尼或伊马替尼治疗的费城染色体阳性(Ph+)慢性期(CML-CP)CML 成年患者的电子病历数据。总体上以及在亚组(低危与中高危、年龄<65 岁与≥65 岁、低/正常体重指数[BMI]与高 BMI)中评估主要分子反应(MMR)和深度分子反应(DMR)的发生率和时间。

结果

达沙替尼组(n=309)的 MMR(n=304,79% vs. 65%,P<.001)和 DMR(44% vs. 25%,P<.001)发生率更高,且达到 MMR(11.9 个月 vs. 14.7 个月,P<.001)和 DMR(30.3 个月 vs. 66.1 个月,P<.001)的时间更短。中高危疾病和年龄<65 岁的患者接受达沙替尼治疗时 MMR 和 DMR 发生率更高,且更早达到缓解(P<.01)。低危疾病患者接受达沙替尼治疗时 DMR 发生率更高(60% vs. 32%,P=.01)。在 BMI 各层中,达沙替尼的 MMR 和 DMR 发生率更高(P<.05)。

结论

CML-CP 患者接受 1L 达沙替尼治疗时,与 1L 伊马替尼相比,MMR 和 DMR 的发生率更高,达到 MMR 和 DMR 的时间更短。这些具有临床意义的改善在各个亚组中均观察到。

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