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美国既往接受共价布鲁顿酪氨酸激酶(BTK)抑制剂和BCL2抑制剂治疗的慢性淋巴细胞白血病(CLL)患者的结局:一项真实世界数据库研究

Outcomes for Patients With Chronic Lymphocytic Leukemia (CLL) Previously Treated With Both a Covalent BTK and BCL2 Inhibitor in the United States: A Real-World Database Study.

作者信息

Mato Anthony R, Hess Lisa M, Chen Yongmei, Abada Paolo B, Konig Heiko, Pagel John M, Walgren Richard A

机构信息

Memorial Sloan Kettering Cancer Center, New York, NY.

Eli Lilly and Company, Indianapolis, IN.

出版信息

Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):57-67. doi: 10.1016/j.clml.2022.09.007. Epub 2022 Oct 7.

Abstract

PURPOSE

This study describes the treatment patterns and outcomes of patients with CLL/SLL in a de-identified real-world oncology electronic health records database.

METHODS

Adult patients with CLL/SLL were eligible if they had received cBTKi therapy, both a cBTKi and a BCL2i, or all 4 drug classes (cBTKi, BCL2i, rituximab, and chemotherapy) at any time during the first 5 lines of therapy. Time-to-event outcomes were evaluated using Kaplan Meier method. No statistical comparisons were conducted; all analyses were descriptive and conducted using SAS Enterprise.

RESULTS

A total of 9578 patients were eligible: 52.0% (n = 4983) received at least one cBTKi, 6.1% (n = 581) received both a cBTKi and BCL2i, and 2.3% (n = 218) received all four therapies (cBTKi, BCL2i, rituximab, and chemotherapy). Of those who discontinued these treatments, only 39.5% (n = 1 206/3 577), 59.7% (n = 228/382), and 55.0% (n = 82/149) received subsequent therapy (post-cBTKi, post-cBTKi/post-BCL2i, and post-all 4 therapies, respectively). Median time from treatment discontinuation of these therapies to the discontinuation of subsequent therapy or death was 9.5 months (all patients who discontinued the cBTKi) 5.6 months (those who discontinued both a cBTKi and BCL2i) and 3.9 months (patients who discontinued all four therapies). The median duration of the next treatment among those who received additional therapy was post-cBTKi treatment duration = 4.1 months; post-cBTKi/post-BCL2i treatment duration = 5.5 months; and median duration of the immediate next therapy after discontinuation of all 4 therapies = 5.1 months.

CONCLUSIONS

The poor outcomes observed across cohorts in this study demonstrate the need for effective treatments that can improve outcomes in patients with CLL/SLL.

摘要

目的

本研究描述了在一个经过去识别处理的真实世界肿瘤电子健康记录数据库中慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)患者的治疗模式和结局。

方法

成年CLL/SLL患者若在治疗的前5线中的任何时间接受过共价布鲁顿酪氨酸激酶抑制剂(cBTKi)治疗、同时接受过cBTKi和BCL2抑制剂(BCL2i)治疗或接受过所有4类药物(cBTKi、BCL2i、利妥昔单抗和化疗)治疗,则符合入选标准。使用Kaplan-Meier方法评估事件发生时间结局。未进行统计学比较;所有分析均为描述性分析,使用SAS Enterprise进行。

结果

共有9578例患者符合入选标准:52.0%(n = 4983)接受过至少一种cBTKi治疗,6.1%(n = 581)同时接受过cBTKi和BCL2i治疗,2.3%(n = 218)接受过所有4种治疗(cBTKi、BCL2i、利妥昔单抗和化疗)。在那些停止这些治疗的患者中,只有39.5%(n = 1206/3577)、59.7%(n = 228/382)和55.0%(n = 82/149)接受了后续治疗(分别为cBTKi治疗后、cBTKi/BCL2i治疗后和所有4种治疗后)。从停止这些治疗到停止后续治疗或死亡的中位时间为9.5个月(所有停止cBTKi治疗的患者)、5.6个月(停止cBTKi和BCL2i治疗的患者)和3.9个月(停止所有4种治疗的患者)。在接受额外治疗的患者中,下一次治疗的中位持续时间为:cBTKi治疗后持续时间 = 4.1个月;cBTKi/BCL2i治疗后持续时间 = 5.5个月;停止所有4种治疗后紧接着的下一次治疗的中位持续时间 = 5.1个月。

结论

本研究中各队列观察到的不良结局表明,需要有能改善CLL/SLL患者结局的有效治疗方法。

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