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患者对 ciltacabtagene autoleucel 治疗的看法:来自 CARTITUDE-1 研究中复发/难治性多发性骨髓瘤患者访谈的定性证据

英文原题:Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study.

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Patient Perceptions Regarding Ciltacabtagene Autoleucel Treatment: Qualitative Evidence From Interviews With Patients With Relapsed/Refractory Multiple Myeloma in the CARTITUDE-1 Study.

PubMed 2022/10/11(内容时间) Clin Lymphoma Myeloma Leuk Q1 · IF 4.1(JCR 2025)

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研究概要

总体 HRQoL 改善和定性访谈显示,cilta-cel 满足了患者对治疗的期望,并提示较长的无治疗期也对积极情绪有所贡献。

研究思路结论见上方概要

西达基奥仑赛(cilta-cel)是一种新型CAR-T(CAR-T)细胞疗法,在既往接受过大量治疗的复发/难治性多发性骨髓瘤(RRMM)患者中已显示出早期、深度且持久的临床缓解,并在CARTITUDE-1(NCT03548207)中改善了健康相关生活质量(HRQoL)。患者对治疗的看法为疗效结局提供了背景,并且是治疗评估的一个重要方面。

在CARTITUDE-1研究的一个亚组患者(n = 36)中,于筛选时、cilta-cel治疗后第100天和第184天进行了定性访谈,内容涉及与MM共存、治疗期望以及研究期间的治疗体验。

患者最希望看到对HRQoL影响最大的症状改善:疼痛(85.2%)和疲乏(74.1%)。主要治疗期望是实现缓解(40.7%),其次是延长预期寿命(14.8%)。患者最常将有意义的改变定义为症状改善(70.4%)和恢复正常(40.7%)。报告症状(疼痛、疲乏、骨折、胃肠道、神经病变和乏力)的患者百分比从基线时各症状类型的85.2%至22.2%降至cilta-cel后第184天的29.2%至0%。症状改善和积极情绪分别与整体健康状况感知改善和疼痛程度降低相对应。大多数患者报告,在第184天时,他们对cilta-cel治疗的期望已达到(70.8%)或超出(20.8%),并且70.8%的患者认为cilta-cel治疗优于其既往治疗。

展开英文摘要原文

Qualitative interviews were conducted in a subset of CARTITUDE-1 patients (n = 36) at screening, Day 100, and Day 184 post cilta-cel on living with MM, therapy expectations, and treatment experiences during the study.

Patients most wanted to see change in symptoms with the greatest impact on HRQoL: pain (85.2%) and fatigue (74.1%). The primary treatment expectation was achieving remission (40.7%), followed by extended life expectancy (14.8%). Patients most often defined meaningful change as improvement in symptoms (70.4%) and return to normalcy (40.7%). The percentage of patients reporting symptoms (pain, fatigue, bone fracture, gastrointestinal, neuropathy, and weakness) decreased from 85.2% to 22.2% across symptom types at baseline to 29.2% to 0% on Day 184 after cilta-cel. Improved symptoms and positive sentiments corresponded with improved perception of overall health status and reduced pain level, respectively. Most patients reported that their expectations of cilta-cel treatment had been met (70.8%) or exceeded (20.8%) at Day 184, and 70.8% of patients considered cilta-cel therapy better than their previous treatments.

Overall HRQoL improvements and qualitative interviews showed cilta-cel met patient expectations of treatment and suggest the long treatment-free period also contributed to positive sentiments.

论文信息

作者
Cohen AD、Hari P、Htut M、Berdeja JG、Usmani SZ、Madduri D、Olyslager Y、Goldberg JD
第一作者单位
Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.United States
通讯作者单位
Mount Sinai Medical Center, New York, NY. Electronic address: sundar.jagannath@mountsinai.com.United States
文献类型
非美国政府资助研究
期刊
Clinical lymphoma, myeloma & leukemia2023 Jan
原文标识
PubMed 36357295 · DOI 10.1016/j.clml.2022.10.001