Department of Hematology Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Eli Lilly Japan K.K, Kobe, Japan.
J Clin Exp Hematop. 2023;63(4):219-229. doi: 10.3960/jslrt.23032.
Standard treatment has not been established for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after discontinuation of covalent Bruton tyrosine kinase inhibitor (cBTKi) therapy. This retrospective, administrative database (Medical Data Vision) study described the patient characteristics, treatment patterns, and factors associated with receiving post-first-cBTKi treatment in Japanese patients with CLL/SLL. Patients aged ≥18 years with confirmed CLL/SLL diagnosis and treated with anti-neoplastic drugs indicated for CLL/SLL between March 2013 and February 2022 were included. Patient characteristics at baseline (first line), first cBTKi exposure (first-cBTKi), post-first-cBTKi treatment received, and the treatment sequence of CLL drugs received first line through third line, were described. Time-to-event analyses used the Kaplan-Meier method. Multivariable logistic regression analysis was used to explore factors associated with receiving post-first-cBTKi treatment among patients who discontinued first-cBTKi treatment. Among 2,424 eligible patients (median age: 72.0 years, 61.9% male), 450 (18.6%) received cBTKi in any treatment line. Among patients treated with cBTKi, 273 (60.7%) discontinued treatment; 56.0% of them (n = 153/273) received subsequent treatment. Median duration of post-first-cBTKi treatment was 2.2 months (95% confidence interval [CI]: 1.8, 3.5). The most common regimens post-first-cBTKi were cBTKi therapy (47.7%), bendamustine-based therapy (17.0%), and venetoclax-based therapy (13.1%). Patients aged <75 years (odds ratio [OR] [95% CI]: 2.0 [1.2, 3.4]) and those who did not receive blood transfusion during cBTKi treatment (OR [95% CI]: 2.3 [1.3, 4.1]) were more likely to receive post-first-cBTKi treatment. In conclusion, Japanese patients with CLL/SLL received various treatments for short duration after first-cBTKi discontinuation.
对于已停止使用共价布鲁顿酪氨酸激酶抑制剂(cBTKi)治疗的慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)患者,目前尚未确立标准治疗方法。本项回顾性、行政数据库(Medical Data Vision)研究描述了日本 CLL/SLL 患者在停止 cBTKi 治疗后的患者特征、治疗模式以及与接受首次 cBTKi 治疗后治疗相关的因素。纳入了年龄≥18 岁且确诊为 CLL/SLL 并在 2013 年 3 月至 2022 年 2 月期间接受了 CLL/SLL 适应证的抗肿瘤药物治疗的患者。描述了基线(一线治疗)、首次 cBTKi 暴露(首次 cBTKi)、接受首次 cBTKi 治疗后以及接受 CLL 药物一线至三线治疗的治疗顺序等患者特征。使用 Kaplan-Meier 方法进行时间事件分析。使用多变量逻辑回归分析来探索首次 cBTKi 治疗停药患者中与接受首次 cBTKi 治疗后治疗相关的因素。在 2424 名符合条件的患者中(中位年龄:72.0 岁,61.9%为男性),450 名(18.6%)在任何治疗线中接受了 cBTKi 治疗。在接受 cBTKi 治疗的患者中,有 273 名(60.7%)停止治疗;其中 56.0%(n=153/273)接受了后续治疗。首次 cBTKi 治疗后的中位治疗时间为 2.2 个月(95%置信区间 [CI]:1.8,3.5)。首次 cBTKi 治疗后最常见的方案为 cBTKi 治疗(47.7%)、苯达莫司汀为基础的治疗(17.0%)和维奈妥拉为基础的治疗(13.1%)。年龄<75 岁的患者(比值比 [OR] [95%CI]:2.0 [1.2,3.4])和在 cBTKi 治疗期间未接受输血的患者(OR [95%CI]:2.3 [1.3,4.1])更有可能接受首次 cBTKi 治疗后治疗。总之,日本 CLL/SLL 患者在首次 cBTKi 停药后接受了各种短期治疗。