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接受 tisagenlecleucel CAR-T 细胞治疗的复发/难治性滤泡性淋巴瘤患者的医疗资源利用和住院费用评估:ELARA 研究结果

英文原题:Assessment of Healthcare Resource Utilization and Hospitalization Costs in Patients With Relapsed or Refractory Follicular Lymphoma Undergoing CAR-T Cell Therapy With Tisagenlecleucel: Results From the ELARA Study.

查看英文原题

Assessment of Healthcare Resource Utilization and Hospitalization Costs in Patients With Relapsed or Refractory Follicular Lymphoma Undergoing CAR-T Cell Therapy With Tisagenlecleucel: Results From the ELARA Study.

PubMed 2022/09/28(内容时间) Transplant Cell Ther Q1 · IF 4.7(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

中文摘要

滤泡性淋巴瘤(FL)通常被认为是一种惰性疾病,尽管复发FL患者对二线或后线治疗的反应持续时间逐渐缩短。正在进行的ELARA试验在成人复发/难治性(r/r)FL患者中采用tisagenlecleucel治疗,结果显示总缓解率为86.2%,完全缓解率为69.1%,且无治疗相关死亡。在ELARA中,18%的患者在门诊接受了tisagenlecleucel输注;然而,关于住院与门诊接受tisagenlecleucel输注对r/r FL患者医疗资源利用(HCRU)影响的认识有限。

在此,我们呈现了在II期、单臂、多中心ELARA试验中接受tisagenlecleucel治疗的r/r FL患者的首次HCRU分析。HCRU通过tisagenlecleucel输注后第1天至第2个月的住院数据进行表征。对在门诊或住院接受tisagenlecleucel输注的患者,评估了住院时长、设施使用和出院信息。所有费用均折算为2020年美元。截至2021年8月3日(中位随访20个月),17/97(18%)r/r FL患者在门诊接受输注。门诊输注的患者通常具有较好的东部肿瘤协作组体能状态和滤泡性淋巴瘤国际预后指数评分,以及基线时较少的巨块型病变。

然而,与住院患者相比,门诊患者中3A级FL、原发性难治性疾病以及既往治疗线数>5的患者比例更高。在门诊接受治疗的患者中,41%在输注后30天内不需要住院,而确实需要住院的门诊患者与住院患者相比,平均住院时间更短(5天对13天)。没有门诊患者需要入住ICU,而9%的住院患者入住ICU。输注后平均住院费用在门诊和住院环境中分别为$7477和$40,054。两组之间的疗效相似。Tisagenlecleucel可以安全地给予部分门诊患者,这可能减少r/r FL患者的HCRU。

展开英文摘要原文

Follicular lymphoma (FL) is generally considered an indolent disease, although patients with relapsing FL experience progressively shorter durations of response to second or later lines of therapy. The ongoing ELARA trial in adult patients with relapsed/refractory (r/r) FL treated with tisagenlecleucel demonstrated an overall response rate of 86.

2% and a complete response rate of 69. 1%, with no treatment-related deaths. Tisagenlecleucel was administered in the outpatient setting in 18% of patients in ELARA; however, there is limited knowledge concerning the impact of inpatient versus outpatient tisagenlecleucel administration on healthcare resource utilization (HCRU) among patients with r/r FL.

Here, we present the first HCRU analysis among patients with r/r FL who received tisagenlecleucel in the Phase II, single-arm, multicenter ELARA trial. HCRU was characterized using hospitalization data from day 1 to month 2 after tisagenlecleucel infusion. Information on length of stay, facility use, and discharge was assessed in patients who received tisagenlecleucel in the outpatient or inpatient setting.

All costs were inflated to 2020 US dollars. As of August 3, 2021 (20-month median follow-up), 17/97 (18%) r/r FL patients were infused in an outpatient setting. Patients infused in the outpatient setting generally had favorable Eastern Cooperative Oncology Group performance status and Follicular Lymphoma International Prognostic Index scores, and less bulky disease at baseline.

However, the outpatients had higher proportions of patients with grade 3A FL, primary refractory disease, and >5 lines of prior therapy compared with inpatients. Forty-one percent of patients treated in the outpatient setting did not require hospitalization within 30 days after infusion, and outpatients who did require hospitalization had a shorter average length of stay compared with inpatients (5 versus 13 days).

No outpatients required intensive care unit (ICU) admission, whereas 9% of inpatients were admitted to the ICU. The mean postinfusion hospitalization costs were $7477 and $40,054 in the outpatient and inpatient settings, respectively. Efficacy between both groups was similar. Tisagenlecleucel can be safely administered to some patients in the outpatient setting, which may reduce HCRU for patients with r/r FL.

论文信息

作者
Fowler NH、Dickinson M、Ghosh M、Chen AI、Andreadis C、Tiwari R、Masood A、Ramos R
单位
The University of Texas MD Anderson Cancer Center, Houston, Texas; BostonGene, Waltham, Massachusetts. Electronic address: nfowler@mdanderson.org.United States
文献类型
多中心研究 · 非美国政府资助研究
期刊
Transplantation and cellular therapy2023 Jan
原文标识
PubMed 36182104 · DOI 10.1016/j.jtct.2022.09.022