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真实世界中伊布替尼治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤患者的持续时间和下次治疗时间,包括有发生心房颤动或中风高风险的患者。

Real-World Persistence and Time to Next Treatment With Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Including Patients at High Risk for Atrial Fibrillation or Stroke.

机构信息

University of California San Diego Health, San Diego, CA.

Northwestern Medicine, Chicago, IL.

出版信息

Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):e959-e971. doi: 10.1016/j.clml.2022.07.004. Epub 2022 Jul 15.

DOI:10.1016/j.clml.2022.07.004
PMID:35973891
Abstract

BACKGROUND

Atrial fibrillation (AF) is a recognized adverse consequence associated with all Bruton's tyrosine kinase inhibitors used to treat chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL); however, real-world time to discontinuation (TTD) and time to next treatment (TTNT) of CLL/SLL patients with a high baseline AF/stroke risk remain unknown.

MATERIALS AND METHODS

Patients with CLL/SLL from a nationwide electronic health record-derived database (February 12, 2013-January 31, 2021) initiating first-line (1L) or second or later-line (2L+) treatment with ibrutinib or other regimens on or after February 12, 2014 (index date) were analyzed. Kaplan-Meier survival analysis was used to assess TTD and TTNT among all patients, patients with high AF risk (CHARGE-AF risk score ≥10.0%), and patients at high risk of stroke (CHADS-VASc risk score ≥3 [females] or ≥2 [males]).

RESULTS

In 1L/2L+, 2190/1851 patients received ibrutinib and 4388/4135, were treated with other regimens. Median TTD for ibrutinib was similar regardless of AF/stroke-related risk (1L: all patients, 15.7 months; high AF risk, 11.7 months; high stroke risk, 13.7 months; similar results in 2L+). Median TTNT was significantly longer for ibrutinib vs. other regimens (1L: not reached vs. 45.9 months; 2L+: not reached vs. 23.6 months; both P < .05), including among those with high AF/stroke risk. TTNT was similar between all patients and high-risk cohorts in 1L and 2L+ (all P > .05).

CONCLUSION

This study highlights that elevated baseline AF/stroke-related risk does not adversely impact TTD and TTNT outcomes associated with ibrutinib use. Additionally, TTNT was significantly longer for patients treated with ibrutinib vs. other regimens.

摘要

背景

心房颤动(AF)是与所有用于治疗慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)的布鲁顿酪氨酸激酶抑制剂相关的公认不良后果;然而,具有高基线 AF/中风风险的 CLL/SLL 患者的停药时间(TTD)和下一次治疗时间(TTNT)的真实世界数据仍不清楚。

材料和方法

从全国性的电子健康记录数据库中(2013 年 2 月 12 日至 2021 年 1 月 31 日)分析了 2014 年 2 月 12 日(索引日期)后开始接受伊布替尼或其他方案一线(1L)或二线或以上(2L+)治疗的 CLL/SLL 患者。使用 Kaplan-Meier 生存分析评估所有患者、高 AF 风险(CHARGE-AF 风险评分≥10.0%)和高中风风险(CHADS-VASc 风险评分≥3[女性]或≥2[男性])患者的 TTD 和 TTNT。

结果

在 1L/2L+中,2190/1851 例患者接受伊布替尼治疗,4388/4135 例患者接受其他方案治疗。伊布替尼的中位 TTD 与 AF/中风相关风险无关(1L:所有患者,15.7 个月;高 AF 风险,11.7 个月;高中风风险,13.7 个月;2L+ 中相似结果)。与其他方案相比,伊布替尼的中位 TTNT 显著更长(1L:未达到 vs. 45.9 个月;2L+:未达到 vs. 23.6 个月;均 P <.05),包括高 AF/中风风险患者。在 1L 和 2L+中,所有患者和高危队列的 TTNT 相似(均 P >.05)。

结论

本研究强调,基线 AF/中风相关风险升高不会对伊布替尼使用相关的 TTD 和 TTNT 结局产生不利影响。此外,与其他方案相比,伊布替尼治疗的患者 TTNT 显著更长。

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