Department of Internal Medicine, Section of Hematology, Yale University School of Medicine, New Haven, CT, USA.
Merck & Co., Inc., Rahway, NJ, USA.
Leuk Lymphoma. 2023 Dec;64(14):2286-2295. doi: 10.1080/10428194.2023.2256911. Epub 2023 Dec 25.
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.
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。