Abstract：
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.
摘要：
滤泡性淋巴瘤（FL）通常被认为是一种惰性疾病，尽管复发性FL患者对第二或更晚的治疗线的反应持续时间逐渐缩短。正在进行的ELARA试验在使用tisagenlecleucel治疗的复发性/难治性（r/r）FL的成年患者中显示出86.2％的总反应率和69.1％的完全反应率。没有治疗相关的死亡。在ELARA中有18％的患者在门诊使用Tisagenlecleucel；然而，在r/rFL患者中,关于住院患者与门诊tisagenlecleucel给药对医疗资源利用(HCRU)的影响的知识有限.这里,我们对在II期接受tisagenlecleucel的r/rFL患者进行了首次HCRU分析，单臂,多中心ELARA试验。使用tisagenlecleucel输注后第1天至第2个月的住院数据对HCRU进行表征。关于逗留时间的信息，设施使用,并对门诊或住院接受tisagenlecleucel治疗的患者进行出院评估。所有成本都膨胀到2020美元。截至2021年8月3日（20个月随访中位数），17/97（18％）r/rFL患者在门诊进行了输注。在门诊注射的患者通常具有良好的东部肿瘤协作组表现状态和滤泡性淋巴瘤国际预后指数评分，基线时体积较小的疾病。然而,门诊患者中有较高比例的3A级FL，原发性难治性疾病，与住院患者相比，既往治疗>5行。在门诊接受治疗的患者中，有41％在输液后30天内不需要住院治疗，与住院患者相比,需要住院治疗的门诊患者的平均住院时间较短(5天对13天).没有门诊病人需要入住重症监护病房(ICU)，而9%的住院患者入住ICU。门诊和住院患者的平均输液后住院费用为7477美元和40,054美元，分别。两组之间的疗效相似。Tisagenlecleucel可以安全地用于门诊的一些患者，这可能会降低r/rFL患者的HCRU。
