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酪氨酸激酶抑制剂治疗慢性髓性白血病患者的不良事件:一项健康计划参保者的真实世界分析。

Adverse events among chronic myelogenous leukemia patients treated with tyrosine kinase inhibitors: a real-world analysis of health plan enrollees.

机构信息

Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.

Department of Pediatrics, University of Washington, Seattle Children's Hospital, Seattle, WA, USA.

出版信息

Leuk Lymphoma. 2021 May;62(5):1203-1210. doi: 10.1080/10428194.2020.1855340. Epub 2020 Dec 7.

Abstract

With tyrosine kinase inhibitor (TKI) therapy, chronic myelogenous leukemia (CML) is now a chronic disease. CML patients treated with TKIs ( = 1200) were identified from the OptumLabs Data Warehouse (de-identified claims and electronic health records) between 2000 and 2016 and compared with a non-cancer cohort ( = 7635). The 5-year cumulative incidence of all organ system outcomes was significantly greater for the TKI versus non-cancer group. In the first year, compared with imatinib, later generation TKIs were associated with primary infections (hazard ratios [HR] 1.43, 95% CI 1.02-2.00), circulatory events (HR 1.15, 95% CI 1.01-1.31), and skin issues (HR 1.43, 95% CI 1.13-1.80); musculoskeletal and nervous system/sensory issues were less common (HRs 0.83-0.84,  < 0.05). Increased risk of infections, cardiopulmonary and skin issues associated with later generation TKIs persisted in subsequent years. In this real-world population, TKI therapy was associated with a high burden of adverse events. Later generation TKIs may have greater toxicity than imatinib.

摘要

随着酪氨酸激酶抑制剂(TKI)治疗的出现,慢性髓细胞白血病(CML)现在已成为一种慢性疾病。从 2000 年到 2016 年,通过 OptumLabs 数据仓库(去识别索赔和电子健康记录)确定了 1200 名接受 TKI 治疗的 CML 患者,并与非癌症队列(7635 名)进行了比较。与非癌症组相比,TKI 组所有器官系统结局的 5 年累积发生率显著更高。在第一年,与伊马替尼相比,后一代 TKI 与原发性感染(危险比 [HR] 1.43,95%置信区间 [CI] 1.02-2.00)、循环系统事件(HR 1.15,95%CI 1.01-1.31)和皮肤问题(HR 1.43,95%CI 1.13-1.80)相关;肌肉骨骼和神经系统/感觉问题则不太常见(HRs 0.83-0.84, < 0.05)。与后一代 TKI 相关的感染、心肺和皮肤问题的风险增加在随后的几年中持续存在。在这个真实世界的人群中,TKI 治疗与不良事件负担高有关。与伊马替尼相比,后一代 TKI 可能具有更大的毒性。

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