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idecabtagene vicleucel (ide-cel, bb2121) 治疗前后患者体验:KarMMa 试验中患者访谈的定性分析

英文原题:Patient experience before and after treatment with idecabtagene vicleucel (ide-cel, bb2121): qualitative analysis of patient interviews in the KarMMa trial.

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Patient experience before and after treatment with idecabtagene vicleucel (ide-cel, bb2121): qualitative analysis of patient interviews in the KarMMa trial.

PubMed 2022/07/21(内容时间) Leuk Res Q2 · IF 2.4(JCR 2025)

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研究概要

ide-cel 治疗前的患者访谈显示,三类药物暴露的 RRMM 存在未被满足的需求。

中文摘要

了解复发/难治性多发性骨髓瘤(RRMM)患者在关键性Ⅱ期KarMMa试验中接受idecabtagene vicleucel(ide-cel)治疗的体验;ide-cel是一种靶向B细胞成熟抗原的CAR-T 细胞疗法。

在白细胞单采前(治疗前)开展可选的半结构式访谈,了解患者预期;在ide-cel输注后1、2和3个月访谈,评估治疗体验、ide-cel的利弊及健康与幸福感。混合方法分析按临床应答状态、健康与幸福感,以及患者自述输注后恢复情况对治疗体验分类。

治疗前访谈显示患者存在未满足的治疗需求。治疗后访谈中,多数患者认为ide-cel的益处超过缺点(69%,27/39)。最常提及的优点为疗效(18%~64%)、副作用特征较好(46%~68%)及恢复时间(13%~18%);最常见缺点与副作用有关(13%~20%)。按临床应答分析,患者最常达到严格完全缓解或非常好的部分缓解,健康和幸福感改善,且输注后恢复程度不一(27/58,47%)。多数临床应答较弱的患者报告输注后轻度恢复(5/6,83%)。

ide-cel治疗前访谈显示,既往接受三类药物治疗的RRMM患者仍有未满足需求。治疗后患者总体上认为ide-cel体验优于既往疗法。

展开英文摘要原文

To understand the experience of patients with relapsed and refractory multiple myeloma (RRMM) receiving idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in the pivotal, phase 2 KarMMa trial.

Optional semi-structured interviews before leukapheresis (pre-treatment) captured expectations and after ide-cel infusion (1, 2, and 3 months post-treatment), assessed treatment experience, ide-cel advantages/disadvantages, and health and well-being. In a mixed-method analysis, treatment experiences were categorized by clinical response status, health and well-being, and self-reported recovery after infusion.

Pre-treatment interviews indicated unmet treatment needs. In post-treatment interviews, most patients reported the positives of ide-cel outweighed negatives (69%, n = 27/39). Most common advantages of ide-cel were efficacy (18-64%), favorable side-effect profile (46-68%), and recovery time (13-18%); most common disadvantages were related to side effects (13-20%). When analyzed by clinical response, patients most often had stringent complete or very good partial response and improved health and well-being with mild or severe recovery from the infusion (27/58, 47%). Most patients with minimal clinical response reported mild infusion recovery (5/6, 83%).

Patient interviews before ide-cel treatment showed unmet needs in triple-class exposed RRMM. Post-treatment experiences generally favored ide-cel versus previously received treatments.

论文信息

作者
Shah N、Delforge M、San-Miguel J、Moshkovich O、Braverman J、Dhanda DS、Lanar S、Miera M
单位
University of California San Francisco, San Francisco, CA, USA. Electronic address: Nina.Shah@ucsf.edu.United States
文献类型
非美国政府资助研究
期刊
Leukemia research2022 Sep
原文标识
PubMed 35930999 · DOI 10.1016/j.leukres.2022.106921