在复发/难治套细胞淋巴瘤中,对Acalabrutinib和Ibrutinib进行匹配调整后的间接比较。

IF 2.9 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES
Journal of Medical Economics Pub Date : 2024-01-01 Epub Date: 2024-12-05 DOI:10.1080/13696998.2024.2422227
Ling Cai, Jack Roos, Paulo A P Miranda, Bengt Liljas, Simon Rule, Michael Wang
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引用次数: 0

摘要

目的:在缺乏头对头临床试验的情况下,匹配调整间接比较(MAIC)被用来比较两种被批准用于治疗复发/难治(R/R)套细胞淋巴瘤(MCL)的布鲁顿酪氨酸激酶抑制剂(BTKis)。与之前发表的MAIC相比,本分析采用了更成熟的数据集,比较了阿卡布替尼与伊布替尼的疗效和安全性:对一项2期研究中接受阿卡鲁替尼治疗的122名患者的个体数据进行加权,以匹配从3项独立的伊布替尼试验中汇集的患者总体基线特征。患者的东方合作肿瘤学组表现状态、简化套细胞淋巴瘤国际预后指数、乳酸脱氢酶、既往治疗方案、肿瘤负荷和类囊组织学均匹配。评估结果包括无进展生存期(PFS)、总生存期(OS)和不良事件:匹配后,阿卡布替尼(中位 17.8 个月)与伊布替尼(中位 12.8 个月)的 PFS 差异无统计学意义(危险比 [HR],0.92;95% 置信区间 [CI],0.74-1.15;P = 0.48)。同样,在匹配后,阿卡布替尼(中位36.5个月)与伊布替尼(中位27.9个月)的OS差异也未达到统计学意义(HR,0.87;95% CI,0.64-1.17;P = 0.35)。与伊布替尼相比,Acalabrutinib的安全性更好,≥3级心房颤动和血小板减少的发生率显著低于伊布替尼:对用于治疗R/R MCL的两种BTKis进行的比较显示,两种治疗方法的PFS和OS风险在统计学上没有差异;然而,与伊布替尼相比,阿卡鲁替尼的安全性更好。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Matching-adjusted indirect comparison of acalabrutinib versus ibrutinib in relapsed/refractory mantle cell lymphoma.

Objective: In the absence of head-to-head clinical trials, matching-adjusted indirect comparison (MAIC) was used to compare two Bruton tyrosine kinase inhibitors (BTKis) approved for the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL). This analysis compares the efficacy and safety of acalabrutinib versus ibrutinib using a more mature dataset than a previously published MAIC.

Methods: Individual patient data from 122 patients treated with acalabrutinib in a phase 2 study were weighted to match aggregate baseline characteristics of patients pooled from three separate trials of ibrutinib. Patients were matched on Eastern Cooperative Oncology Group performance status, simplified Mantle Cell Lymphoma International Prognostic Index, lactate dehydrogenase, prior lines of therapy, tumor burden, and blastoid histology. Outcomes assessed included progression-free survival (PFS), overall survival (OS), and adverse events.

Results: After matching, differences in PFS between acalabrutinib (median = 17.8 months) and ibrutinib (median = 12.8 months) were not statistically significant (hazard ratio [HR] = 0.92; 95% confidence interval [CI] = 0.74-1.15; p = 0.48). Similarly, after matching, OS differences between acalabrutinib (median = 36.5 months) and ibrutinib (median = 27.9 months) did not reach statistical significance (HR = 0.87; 95% CI = 0.64-1.17; p = 0.35). Acalabrutinib was associated with an improved safety profile compared with ibrutinib, with statistically significantly lower rates of grade ≥3 atrial fibrillation and thrombocytopenia.

Conclusions: This comparison of two BTKis used in the treatment of R/R MCL showed that PFS and OS risk was not statistically different between the treatments; however, acalabrutinib had an improved safety profile compared with ibrutinib.

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来源期刊
Journal of Medical Economics
Journal of Medical Economics HEALTH CARE SCIENCES & SERVICES-MEDICINE, GENERAL & INTERNAL
CiteScore
4.50
自引率
4.20%
发文量
122
期刊介绍: Journal of Medical Economics'' mission is to provide ethical, unbiased and rapid publication of quality content that is validated by rigorous peer review. The aim of Journal of Medical Economics is to serve the information needs of the pharmacoeconomics and healthcare research community, to help translate research advances into patient care and be a leader in transparency/disclosure by facilitating a collaborative and honest approach to publication. Journal of Medical Economics publishes high-quality economic assessments of novel therapeutic and device interventions for an international audience
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