Long-term follow-up of MRD-guided ibrutinib plus venetoclax in relapsed CLL: phase 2 VISION/HO141 trial.

Although continuous treatment may lead to cumulative toxicity or resistance, fixed-duration treatment may lead to undertreatment and early relapse.

尽管持续治疗可能导致累积毒性或耐药性，但固定疗程治疗可能导致治疗不足和早期复发。

Efficacy and safety of minimal residual disease (MRD)-guided treatment cessation of ibrutinib + venetoclax (I+V) with reinitiated I+V upon MRD conversion was evaluated in the randomized VISION/HO41 phase 2 study.

在随机的VISION/HO41 II期研究中，评估了基于最小残留病灶（MRD）指导的伊布替尼+维奈克拉（I+V）治疗停药，并在MRD转换时重新开始I+V治疗的疗效和安全性。

Four-year follow-up including long-term toxicity and MRD kinetics are reported.

报告了包括长期毒性和MRD动力学在内的四年随访结果。

Patients received ibrutinib for 2 (28-day) cycles followed by 13 cycles of I+V.

患者接受了两个28天周期的伊布替尼治疗，随后接受了13个周期的伊布替尼加伏立诺他治疗。

Patients reaching undetectable MRD at 4 years (<10-4, flow cytometry) in the blood and bone marrow at cycle 15 (C15) were randomized 2:1 between treatment cessation with reinitiated I+V upon detectable MRD2 (dMRD2; sensitivity of ≥10-2 by flow cytometry) and ibrutinib maintenance.

在第15个治疗周期（C15）时，血液和骨髓中未检测到微小残留病灶（MRD）的患者（<10^-4，流式细胞术），在4年内被随机分为2:1，一组停止治疗并在检测到MRD2（dMRD2；流式细胞术的敏感度≥10^-2）时重新开始伊布替尼加伏立诺他治疗，另一组继续使用伊布替尼维持治疗。

MRD4-positive patients at C15 remained on ibrutinib (dMRD4 arm, defined by MRD sensitivity of ≥10-4 by flow cytometry).

C15时MRD4阳性患者继续使用伊布替尼（dMRD4组，通过流式细胞术定义的MRD敏感性≥10^-4）。

With a median of 51.7 months, the estimated 4-year overall survival(OS) was 88%, progression free survival (PFS) was 81%; 14% of patients required next-line treatment (NT).

中位随访时间为51.7个月，估计4年总生存（OS）为88%，无进展生存（PFS）为81%；14%的患者需要接受后续治疗（NT）。

For patients randomized to treatment cessation, 40% had reinitiated therapy per protocol because of dMRD2.

对于被随机分配到治疗终止组的患者，有40%的患者因dMRD2而按照方案重新开始治疗。

No difference between treatment cessation, ibrutinib maintenance, or the dMRD4 arm continuing ibrutinib was seen for OS, PFS, or NT in landmark analysis from C15 time of randomization.

在从C15随机化时间点的里程碑分析中，治疗终止、伊布替尼维持治疗或继续使用伊布替尼的dMRD4组在总生存期（OS）、无进展生存期（PFS）或中性粒细胞减少症（NT）方面没有差异。

Lower toxicity was demonstrated for the treatment-cessation arm.

治疗停止组显示出较低的毒性。

MRD-guided cessation and reinitiation of I+V for R/R CLL is feasible, reduces toxicity compared with indefinite BTK inhibitor, while providing comparable PFS rates.

基于最小残留病（MRD）指导的复发/难治性慢性淋巴细胞白血病（CLL）患者的伊布替尼（I）和维奈克拉（V）的停药和重新开始是可行的，与无限期使用BTK抑制剂相比，可以减少毒性，同时提供可比的无进展生存（PFS）率。

This trial was registered at www.clinicaltrials.gov as #NCT03226301.

该试验已在www.clinicaltrials.gov上注册，注册号为#NCT03226301。