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在常规临床实践中评估维奈托克逐步递增治疗慢性淋巴细胞白血病期间监测肿瘤溶解的影响

Evaluation of the Impact of Monitoring for Tumor Lysis During Venetoclax Ramp-Up in Chronic Lymphocytic Leukemia in Routine Clinical Practice.

作者信息

Ghosh Nilanjan, Matusz-Fisher Ashley, Bose Rupali, Boselli Danielle, Magee Gray, Chen Tommy, Hu Bei, Moyo Tamara, Soni Amy, Park Steven, Copelan Edward, Avalos Belinda, Symanowski James, Raghavan Derek, Jacobs Ryan

机构信息

Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Wake Forest University School of Medicine, Charlotte, NC.

Department of Biostatistics and Data Sciences, Levine Cancer Institute, Atrium Health, Charlotte, NC.

出版信息

JCO Oncol Pract. 2025 May;21(5):677-682. doi: 10.1200/OP.24.00417. Epub 2024 Nov 18.

Abstract

PURPOSE

Venetoclax has made a significant impact in the treatment of chronic lymphocytic leukemia (CLL) due to its ability to induce deep and durable remissions with a finite duration of oral therapy. However, it can lead to tumor lysis syndrome (TLS) which is mitigated with dose escalation strategies. Patients who initiate venetoclax need to follow rigorous, and potentially burdensome, TLS monitoring during dose ramp-up. The frequency with which this rigorous monitoring leads to therapeutic interventions in clinical practice has not been well described. We conducted a study to assess the incidence of TLS and interventions needed after initiation of venetoclax in patients with CLL.

METHODS

Adult patients with CLL who started treatment with venetoclax between July 2017 and March 2021 at Levine Cancer Institute were included in this study. Adherence to the venetoclax package insert (PI) for tumor lysis monitoring, incidence of laboratory as well as clinical TLS, and interventions resulting from the monitoring of TLS were collected.

RESULTS

We report outcomes on 73 consecutive patients with CLL who initiated venetoclax. The majority of patients had low (49%) or medium (44%) tumor burden. During venetoclax ramp-up, 66% of patients adhered strictly to TLS monitoring as per the venetoclax PI. One patient developed laboratory TLS, and no patients developed clinical TLS. Six patients received unplanned interventions to treat TLS; all had medium or high tumor burden. There were no unplanned interventions in patients with low tumor burden.

CONCLUSION

In patients with low and medium tumor burden CLL who start venetoclax, the incidence of TLS is very low, and interventions are uncommonly needed.

摘要

目的

维奈克拉因其能够通过有限疗程的口服治疗诱导深度且持久的缓解,在慢性淋巴细胞白血病(CLL)治疗中产生了重大影响。然而,它可导致肿瘤溶解综合征(TLS),而剂量递增策略可减轻该综合征。开始使用维奈克拉的患者在剂量递增期间需要遵循严格且可能繁琐的TLS监测。在临床实践中,这种严格监测导致治疗干预的频率尚未得到充分描述。我们开展了一项研究,以评估CLL患者开始使用维奈克拉后TLS的发生率以及所需的干预措施。

方法

本研究纳入了2017年7月至2021年3月在莱文癌症研究所开始使用维奈克拉治疗的成年CLL患者。收集了对维奈克拉药品说明书(PI)中肿瘤溶解监测的依从性、实验室及临床TLS的发生率,以及TLS监测导致的干预措施。

结果

我们报告了73例连续开始使用维奈克拉的CLL患者的结果。大多数患者肿瘤负荷低(49%)或中等(44%)。在维奈克拉剂量递增期间,66%的患者严格按照维奈克拉PI进行TLS监测。1例患者发生实验室TLS,无患者发生临床TLS。6例患者接受了治疗TLS的非计划干预;所有患者肿瘤负荷均为中等或高。肿瘤负荷低的患者未进行非计划干预。

结论

在开始使用维奈克拉的低和中等肿瘤负荷CLL患者中,TLS的发生率非常低,通常不需要进行干预。

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