Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma
Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma
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DOI：
10.1182/bloodadvances.2019001026
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发表时间：
2020-02-25
期刊：
影响因子：
7.5
通讯作者：
Tam, Constantine S.
中科院分区：
文献类型：
--
作者：
Maziarz, Richard T.;Waller, Edmund K.;Tam, Constantine S.
JULIET 2期试验评估了单次输注tisagenlecleucel治疗复发/难治性（r/r）弥漫性大b细胞淋巴瘤（DLBCL）的成人患者。当前分析的目的是评估患者报告的健康相关生活质量（HRQoL），中位随访时间为19.3个月，患者输注单剂量tisagenlecleucel。入选的患者年龄为>= 18岁，接受>= 2线治疗后患有r/r DLBCL，要么接受了失败的自体干细胞移植，要么不符合手术条件。两种经过验证的HRQoL工具，肿瘤治疗-淋巴瘤功能评估（FACT-Lym）和简短表格-36 （SF-36）健康调查，用于测量基线和第3、6、12和18个月的HRQoL。截至数据截止（2018年5月21日），115例患者接受了tisagenleclelear输注。在评估的99例患者中，总缓解率为54%，40%的患者达到完全缓解（CR）。最初，108名患者在基线时完成了HRQoL评估，其中57名患者最终达到CR或部分缓解（PR）。此外，30名和21名在基线完成评估的临床反应患者也分别在12个月和18个月完成了评估。达到CR或PR的患者在所有时间点的所有FACT评分均持续改善HRQoL。SF-36仪器在8个亚量表中的5个显示出高于最小临床重要差异的改善。2期JULIET研究的长期随访表明，对tisagenlecucel治疗有反应的r/r DLBCL患者在HRQoL方面有持续的、有临床意义的改善。
The JULIET phase 2 trial evaluated a single infusion of tisagenlecleucel in adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The objective of the current analysis was to evaluate patient-reported health-related quality of life (HRQoL) with a median follow-up of 19.3 months among patients infused with a single dose of tisagenlecleucel. Patients enrolled were >= 18 years of age with r/r DLBCL after >= 2 lines of therapy and had either undergone a failed autologous stem cell transplant or were ineligible for the procedure. Two validated HRQoL instruments, Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and Short Form-36 (SF-36) Health Survey, were used to measure HRQoL at baseline and months 3, 6, 12, and 18. At data cutoff (21 May 2018), 115 patients had received tisagenlecleucel infusion. Among the 99 patients evaluated, overall response rate was 54%, and 40% of patients achieved complete response (CR). Initially, 108 patients completed the HRQoL assessments at baseline, including 57 patients who eventually achieved CR or partial response (PR). Further, 30 and 21 patients in clinical response who completed assessments at baseline also completed assessments at months 12 and 18, respectively. Patients who achieved CR or PR sustained HRQoL improvement in all FACT scores at all time points. SF-36 instruments showed improvement above the minimal clinically important differences on 5 of 8 subscales. Long-term follow-up in the phase 2 JULIET study demonstrated that patients with r/r DLBCL who respond to tisagenlecleucel therapy had sustained, clinically meaningful improvements in HRQoL.