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伊布替尼停药及相关因素分析:一项真实世界、全美老年医疗保险受益人群中慢性淋巴细胞白血病患者的国家抽样调查。

Ibrutinib discontinuation and associated factors in a real-world national sample of elderly Medicare beneficiaries with chronic lymphocytic leukemia.

机构信息

Department of Internal Medicine, Section of Hematology, Yale University School of Medicine, New Haven, CT, USA.

Merck & Co., Inc., Rahway, NJ, USA.

出版信息

Leuk Lymphoma. 2023 Dec;64(14):2286-2295. doi: 10.1080/10428194.2023.2256911. Epub 2023 Dec 25.

Abstract

Prior studies evaluating ibrutinib discontinuation are limited to clinical trials and selected medical centers and hence may not reflect real-world practice. This study used Medicare claims (2013-2019) to examine ibrutinib discontinuation and associated factors among elderly patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Over a median follow-up of 2.1 years, two-thirds (65.2%) of the 11,870 new ibrutinib initiators were discontinued, with half (45.1%) of patients discontinuing within 12 months of initiation. Factors such as advanced age, lack of Part D low-income subsidy, evidence of prior CLL/SLL treatment, and cardiovascular comorbidities (e.g. atrial fibrillation) were associated with higher risk of discontinuation. Over a median of 1.2 years from discontinuation, 40% of discontinuers initiated another CLL/SLL treatment after ibrutinib discontinuation; 25% of patients restarted ibrutinib treatment at some point over follow-up. Our findings point to a large unmet need with the widely used BTKi ibrutinib and underscore the importance of ongoing development of efficacious and well-tolerated CLL/SLL therapies.

摘要

先前评估伊布替尼停药的研究仅限于临床试验和选定的医疗中心,因此可能无法反映实际情况。本研究使用医疗保险索赔数据(2013-2019 年),调查了老年慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)患者中伊布替尼停药的情况及相关因素。在中位随访 2.1 年期间,新开始伊布替尼治疗的 11870 名患者中有三分之二(65.2%)停药,其中一半(45.1%)的患者在开始治疗后 12 个月内停药。年龄较大、缺乏 Part D 低收入补贴、有 CLL/SLL 治疗史以及心血管合并症(如心房颤动)等因素与较高的停药风险相关。从停药开始的中位时间为 1.2 年,40%的停药患者在伊布替尼停药后开始接受另一种 CLL/SLL 治疗;在随访期间,25%的患者在某个时间重新开始伊布替尼治疗。我们的研究结果表明,广泛使用的 BTKi 伊布替尼存在大量未满足的需求,突出了开发有效且耐受良好的 CLL/SLL 治疗方法的重要性。

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