Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: A large unmet need exists in this patient subpopulation, highlighting the importance of ongoing development of novel therapeutics.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: A large unmet need exists in this patient subpopulation, highlighting the importance of ongoing development of novel therapeutics.
摘要：
背景：虽然共价Bruton的酪氨酸激酶抑制剂（cBTKis）已成为复发性/难治性套细胞淋巴瘤（R/RMCL）的标准治疗方法，反应持续时间有限,并且在部分患者中出现对BTKi的抵抗和/或不良事件.然而,关于这些患者cBTKi术后临床和经济结局的真实世界证据很少.
方法：这项回顾性研究使用了2010年至2019年的美国医疗保险索赔，确定接受三线(3L)治疗且有证据表明在之前的治疗中使用cBTKi的老年(≥66岁)新诊断MCL患者.结果在3L治疗开始后≥12个月进行评估，并包括治疗模式，所有原因和MCL相关的HRU和成本，和总体生存率。
结果：最终样本包含230名接受3L治疗的R/RMCL老年患者，他们在先前的治疗路线中使用了cBTKi（平均年龄75.0，21.7％年龄>80岁；67.4％男性；93.9％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cBTKi(17.8%伊布替尼;7.8%阿卡拉布替尼).从3L治疗开始，总生存率较差（中位OS=9.4个月；1年生存率=43.7％）。在3L开始后的12个月中，患者表现出很高的HRU率（73.6％的住院经历）和可观的费用（$145,726）。
结论：该患者亚群存在大量未满足的需求，强调正在开发的新型疗法的重要性。
方法：这项回顾性研究使用了2010年至2019年的美国医疗保险索赔，确定接受三线(3L)治疗且有证据表明在之前的治疗中使用cBTKi的老年(≥66岁)新诊断MCL患者.结果在3L治疗开始后≥12个月进行评估，并包括治疗模式，所有原因和MCL相关的HRU和成本，和总体生存率。
结果：最终样本包含230名接受3L治疗的R/RMCL老年患者，他们在先前的治疗路线中使用了cBTKi（平均年龄75.0，21.7％年龄>80岁；67.4％男性；93.9％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cBTKi(17.8%伊布替尼;7.8%阿卡拉布替尼).从3L治疗开始，总生存率较差（中位OS=9.4个月；1年生存率=43.7％）。在3L开始后的12个月中，患者表现出很高的HRU率（73.6％的住院经历）和可观的费用（$145,726）。
结论：该患者亚群存在大量未满足的需求，强调正在开发的新型疗法的重要性。
