Background:The long-term follow-up of clinical trials of novel first-line (1L) therapies for chronic lymphocytic leukemia (CLL) demonstrates 6–10-year progression-free survival. We describe the effectiveness of 1L CLL treatments in real-world settings, with an emphasis on the important real-world outcome of time to next treatment or death (TTNT-D).Methods:This retrospective, observational study utilized de-identified electronic health records from the ConcertAI RWD360™ database with linked administrative open claims. Adults with CLL who initiated an approved 1L CLL therapy (June 2019–March 2023) were included. Duration of therapy (DoT), TTNT-D, and overall survival were assessed.Results:At 1L, 39.8% of 1843 patients received first-generation covalent Bruton tyrosine kinase inhibitors (cBTKis), 23.0% second-generation cBTKis, 12.4% venetoclax-obinutuzumab (VenO), 7.4% chemotherapy/chemoimmunotherapy (CT/CIT), and 17.4% anti-CD20 monotherapy. Median (range) follow-up in months was 24.9 (13.1–36.6) for first-generation cBTKis, 13.4 (7.3–21.7) for second-generation cBTKis, 16.0 (8.4–27.8) for VenO, 21.8 (11.2–32.7) for CT/CIT, and 19.7 (10.0–33.4) for anti-CD20 monotherapy. Median (range) DoT was 11.5 (4.2–25.0) and 8.6 (3.0–16.1), 9.1 (5.9–12.2), 5.6 (3.2–5.8), and 1.6 (1.6–4.5) months for first- and second-generation cBTKis, VenO, CT/CIT, and anti-CD20 monotherapy, respectively. Regarding TTNT-D, at 2 years’ follow-up, 69.1%, 82.5%, 86.3%, 79.1%, and 53.0% of patients treated with first- and second-generation cBTKis, VenO, CT/CIT, and anti-CD20 monotherapy, respectively, had not initiated subsequent treatment or experienced death.Conclusions:TTNT-D is an important real-world outcome in CLL. Our findings demonstrated the utility of time-limited VenO, with potentially more time off treatment, relative to continuous 1L cBTKi therapies.
背景：针对慢性淋巴细胞白血病（CLL）新型一线疗法的临床试验长期随访数据显示，患者可获得6至10年的无进展生存期。本研究旨在描述真实世界环境中CLL一线治疗的有效性，重点关注至下次治疗或死亡时间这一重要的真实世界结局指标。 方法：本回顾性观察性研究利用ConcertAI RWD360™数据库中经去标识化处理的电子健康记录及关联的行政公开理赔数据。纳入2019年6月至2023年3月期间开始接受已获批CLL一线治疗的成年患者。评估指标包括治疗持续时间、至下次治疗或死亡时间以及总生存期。 结果：在1843例接受一线治疗的患者中，39.8%使用第一代共价布鲁顿酪氨酸激酶抑制剂，23.0%使用第二代共价布鲁顿酪氨酸激酶抑制剂，12.4%使用维奈克拉-奥妥珠单抗联合方案，7.4%接受化疗/化学免疫治疗，17.4%接受抗CD20单药治疗。中位随访时间分别为：第一代共价布鲁顿酪氨酸激酶抑制剂24.9个月（范围13.1-36.6），第二代13.4个月（7.3-21.7），维奈克拉-奥妥珠单抗16.0个月（8.4-27.8），化疗/化学免疫治疗21.8个月（11.2-32.7），抗CD20单药治疗19.7个月（10.0-33.4）。治疗持续时间中位数分别为：第一代与第二代共价布鲁顿酪氨酸激酶抑制剂11.5个月（4.2-25.0）和8.6个月（3.0-16.1），维奈克拉-奥妥珠单抗9.1个月（5.9-12.2），化疗/化学免疫治疗5.6个月（3.2-5.8），抗CD20单药治疗1.6个月（1.6-4.5）。在至下次治疗或死亡时间方面，随访2年时，接受第一代与第二代共价布鲁顿酪氨酸激酶抑制剂、维奈克拉-奥妥珠单抗、化疗/化学免疫治疗及抗CD20单药治疗的患者中，分别有69.1%、82.5%、86.3%、79.1%和53.0%未开始后续治疗或发生死亡事件。 结论：至下次治疗或死亡时间是CLL治疗中重要的真实世界结局指标。本研究结果表明，相较于持续给药的一线共价布鲁顿酪氨酸激酶抑制剂疗法，限时治疗的维奈克拉-奥妥珠单抗方案具有临床实用性，可能为患者提供更长的无治疗间隔期。
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