阿西卡布他啶-西洛ucel和tisagenlleucel CAR T细胞疗法治疗复发或难治性滤泡性淋巴瘤的疗效、安全性和成本最小化分析。

IF 3 3区 医学 Q2 ONCOLOGY Investigational New Drugs Pub Date : 2023-10-01 Epub Date: 2023-08-12 DOI:10.1007/s10637-023-01389-w
Buthainah Ghanem
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引用次数: 0

摘要

Axicabtagene ciloleucel(axi-cel)和tisagenleucel(tisa-cel)是嵌合抗原受体(CAR)T细胞疗法,用于治疗两种或多种系统治疗后复发或难治性滤泡性淋巴瘤(rrFL)的成年患者。在缺乏头对头临床试验的情况下,本研究旨在比较axi-cel和tisa-cel在至少两种治疗方法后治疗rrFL的疗效、安全性和成本。使用报告比值比(ROR)和95%置信区间(CI)对总有效率(ORR)和安全信号进行比较  0.05)  1,p
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Efficacy, safety, and cost-minimization analysis of axicabtagene ciloleucel and tisagenlecleucel CAR T-Cell therapies for treatment of relapsed or refractory follicular lymphoma.

Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) are chimeric antigen receptor (CAR) T-cell therapies used to treat adult patients with relapsed or refractory follicular lymphoma (rrFL) after two or more lines of systemic therapy. In the absence of head-to-head clinical trials, this study aimed to compare the efficacy, safety, and cost of axi-cel and tisa-cel in the treatment of rrFL after at least two lines of treatment. Overall response rate (ORR) and safety signals were compared using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at p < 0.05. Progression-free survival (PFS), duration of response (DoR), and overall survival (OS) were compared using the Kaplan?Meier method with a log-rank test. Cost and cost-minimization analyses of drug acquisition, drug administration, serious adverse events (AEs), and relapsed management were calculated. Costs were extracted from the IBM-Micromedex Red Book, Centers for Medicare and Medicaid Services, and existing literature. Statistical analyses were conducted using Microsoft Excel and R version 4.0.5. No statistically significant differences were observed between axi-cel and tisa-cel in terms of ORR, DoR, and OS (p > 0.05). PFS was significantly better with tisa-cel (p < 0.05). Axi-cel was significantly associated with higher incidences of CRS, neurologic events, and grade 3-4 AEs than tisa-cel (ROR > 1, p < 0.05). Axi-cel and tisa-cel cost $512,021 and $450,885 per patient, respectively, resulting in savings of US$61,136 with tisa-cel over axi-cel. Tisa-cel appears to have a better safety profile, fewer serious AEs, lower mortality rate, and lower cost than axi-cel.

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来源期刊
CiteScore
7.60
自引率
0.00%
发文量
121
审稿时长
1 months
期刊介绍: The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.
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