University of California San Diego Health, San Diego, CA.
Northwestern Medicine, Chicago, IL.
Clin Lymphoma Myeloma Leuk. 2022 Nov;22(11):e959-e971. doi: 10.1016/j.clml.2022.07.004. Epub 2022 Jul 15.
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.
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]).
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).
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.
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。
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。
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)。
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。