Merck & Co, Inc, Rahway, NJ.
COVIA Health Solutions, Lansdale, PA.
Clin Lymphoma Myeloma Leuk. 2024 Oct;24(10):e350-e358.e1. doi: 10.1016/j.clml.2024.05.023. Epub 2024 Jun 4.
While covalent Bruton's tyrosine kinase inhibitors (cBTKis) have become a standard of care treatment for relapsed/refractory mantle cell lymphoma (R/R MCL), response duration is limited and resistance to BTKi and/or adverse events develop in a subset of patients. However, little real-world evidence on post-cBTKi clinical and economic outcomes exists for these patients.
This retrospective study used 2010 to 2019 U.S. Medicare claims, to identify elderly (≥ 66 years) patients with newly-diagnosed MCL who received third-line (3L) treatment and had evidence of cBTKi use in a prior line of therapy. Outcomes were assessed ≥ 12-months post 3L-treatment initiation and included treatment patterns, all-cause and MCL-related HRU and costs, and overall survival.
The final sample contained 230 elderly patients with R/R MCL receiving 3L treatment who had cBTKi use in a prior line of therapy (mean age 75.0, 21.7% age > 80 years; 67.4% male; 93.9% White). Common 3L treatments included chemotherapy (26.1%), lenalidomide (18.7%), and bortezomib (18.3%); 1-quarter (25.7%) of patients received a cBTKi (17.8% ibrutinib; 7.8% acalabrutinib). Overall survival was poor from 3L treatment initiation (median OS = 9.4 months; 1-years survival rate = 43.7%). Patients exhibited high rates of HRU (73.6% experienced hospitalization) and substantial costs ($145,726) in the 12-months after 3L initiation.
A large unmet need exists in this patient subpopulation, highlighting the importance of ongoing development of novel therapeutics.
虽然共价布鲁顿酪氨酸激酶抑制剂(cBTKi)已成为复发/难治性套细胞淋巴瘤(R/R MCL)的标准治疗方法,但在一部分患者中,其反应持续时间有限,并且会对 BTKi 产生耐药性和/或出现不良反应。然而,对于这些患者,关于 cBTKi 后临床和经济结果的真实世界证据很少。
本回顾性研究使用了 2010 年至 2019 年美国医疗保险索赔数据,以确定新诊断为 MCL 的老年(≥66 岁)患者,这些患者接受了三线(3L)治疗,并在前一线治疗中使用了 cBTKi。结果在 3L 治疗开始后≥12 个月进行评估,包括治疗模式、全因和 MCL 相关的 HRU 和费用以及总生存。
最终样本包含 230 名接受 3L 治疗的 R/R MCL 老年患者,他们在前一线治疗中使用了 cBTKi(平均年龄 75.0 岁,21.7%年龄>80 岁;67.4%男性;93.9%为白人)。常见的 3L 治疗包括化疗(26.1%)、来那度胺(18.7%)和硼替佐米(18.3%);1/4(25.7%)的患者接受了 cBTKi(17.8%伊布替尼;7.8%阿卡替尼)。从 3L 治疗开始,总生存情况较差(中位 OS=9.4 个月;1 年生存率=43.7%)。在 3L 治疗开始后 12 个月内,患者的 HRU 发生率很高(73.6%患者经历住院),且费用巨大(145726 美元)。
在这一患者亚群中存在巨大的未满足需求,突出了开发新型治疗药物的重要性。