Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma.
Efficacy comparison of tisagenlecleucel vs usual care in patients with relapsed or refractory follicular lymphoma.
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DOI：
10.1182/bloodadvances.2022008150
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发表时间：
2022-11-22
期刊：
影响因子：
7.5
通讯作者：
Link, Brian K.
中科院分区：
文献类型：
--
作者：
Salles, Gilles;Schuster, Stephen J.;Dreyling, Martin;Fischer, Luca;Kuruvilla, John;Patten, Piers E. M.;von Tresckow, Bastian;Smith, Sonali M.;Jimenez-Ubieto, Ana;Davis, Keith L.;Anjos, Carla;Chu, Jufen;Zhang, Jie;Bodoni, Chiara Lobetti;Thieblemont, Catherine;Fowler, Nathan H.;Dickinson, Michael;Martinez-Lopez, Joaquin;Wang, Yucai;Link, Brian K.
Elara试验表明，组织凝集素(TiSA-cel)是治疗复发或难治性滤泡性淋巴瘤(r/rFL)的一种有效的抗CD19嵌合抗原受体T细胞疗法。由于Elara是一项单臂试验，因此本研究将Elara试验的TiSA-cel结果与现实世界队列中的常规护理进行了比较。截至2021年3月29日，Elara纳入了98名患者(中位数随访：从登记之日起15个月)。常规护理数据来自RECORD-FL，这是一项对符合Elara类似资格标准的r/rFL患者进行的全球回顾性研究。数据截止日期为2020年12月31日，有187名≥-2患者纳入了RECORD-FL研究(中位数随访：距三线57个月)。对来自Elara试验的97名患者和来自Record-FL研究的143名患者进行了间接治疗比较，这些患者没有基线因素方面的缺失数据。使用倾向评分模型在队列之间选择或匹配用于评估其结果的治疗路线。通过优势加权调整基线因素后，TISA-CEL的完全缓解率(CRR)为69.1%(59.8%-78.3%)，常规护理为37.3%(26.4%-48.3%)；总缓解率为85.6%(78.7%-92.5%)对63.6%(52.5%-74.7%)。12个月无进展/无事件概率TISA组为70.5%(61.4%~79.7%)，常规治疗组为51.9%(40.6%~63.3%)，危险比(HR)=0.60(0.34~0.86)；12个月总生存率为96.6%(92.9%~100%)vs.71.7%(61.2%~82.2%)，HR=0.2(0.02~0.38)。总而言之，与常规护理相比，TiSA-cel的完全应答率提高1.9倍，进展或无事件发生率提高1.4倍，死亡风险降低80%。这一发现为≥-2治疗后的r/rFL患者使用TISA-CEL的益处提供了进一步的证据。这项试验在www.Clinicaltrials.gov上注册为NCT03568461。我们的研究通过提供临床相似患者在常规护理中的历史对照数据，对单臂Elara试验进行了背景分析。Tisagenlecucel被证明在多发性复发或难治性滤泡性淋巴瘤患者中的疗效优于常规治疗。
The ELARA trial indicates tisagenlecleucel (tisa-cel) is an effective anti-CD19 chimeric antigen receptor T-cell therapy for relapsed or refractory follicular lymphoma (r/r FL). As ELARA is a single-arm trial, this study compares tisa-cel outcomes from the ELARA trial with usual care from a real-world cohort. ELARA enrolled 98 patients as of 29 March 2021 (median follow-up: 15 months from enrollment). Usual care data were obtained from ReCORD-FL, a global retrospective study of patients with r/r FL, who met similar eligibility criteria to ELARA. With a data cutoff date of 31 December 2020, 187 patients with ≥2 preceding treatment lines were included in the ReCORD-FL (median follow-up: 57 months from third-line) study. An indirect treatment comparison was performed for 97 patients from the ELARA trial and 143 patients from the ReCORD-FL study with no missing data on baseline factors. The line of therapy for which outcomes were assessed was selected or matched between cohorts using propensity score modeling. After baseline factor adjustment via weighting by odds, complete response rate (CRR; 95% confidence interval) was 69.1% (59.8%-78.3%) for tisa-cel vs. 37.3% (26.4%-48.3%) for usual care; overall response rate was 85.6% (78.7%-92.5%) vs. 63.6% (52.5%-74.7%). Kaplan-Meier probability of being progression/event-free at 12 months was 70.5% (61.4%-79.7%) for tisa-cel vs. 51.9% (40.6%-63.3%) for usual care, with hazard ratio (HR)=0.60 (0.34-0.86); 12-month overall survival was 96.6% (92.9%-100%) vs. 71.7% (61.2%-82.2%), with HR=0.2 (0.02-0.38). In conclusion, tisa-cel was associated with a 1.9-fold higher complete response rate and a 1.4-fold higher rate of being progression or event free at 12 months vs usual care, as well as a death risk reduction of 80%. The findings provide additional evidence on the benefit of tisa-cel in patients with r/r FL after ≥2 treatment lines. This trial was registered at www.clinicaltrials.gov as NCT03568461 Our study contextualizes the single-arm ELARA trial by providing historical control data from clinically similar patients on usual care. Tisagenlecleucel was shown to have superior efficacy than usual care in patients with multiply relapsed or refractory follicular lymphoma.
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影响因子：
12.8
作者：
Maurer, Matthew J.;Bachy, Emmanuel;Ghesquieres, Herve;Ansell, Stephen M.;Nowakowski, Grzegorz S.;Thompson, Carrie A.;Inwards, David J.;Allmer, Cristine;Chassagne-Clement, Catherine;Nicolas-Virelizier, Emmanuelle;Sebban, Catherine;Lebras, Laure;Sarkozy, Clementine;Macon, William R.;Feldman, Andrew L.;Syrbu, Sergei I.;Traverse-Glehan, Alexandra;Coiffier, Bertrand;Slager, Susan L.;Weiner, George J.;Witzig, Thomas E.;Habermann, Thomas M.;Salles, Gilles;Cerhan, James R.;Link, Brian K.
通讯作者：
Link, Brian K.
影响因子：
7.2
作者：
Stuart, Elizabeth A.;Lee, Brian K.;Leacy, Finbarr P.
通讯作者：
Leacy, Finbarr P.
影响因子：
6.6
作者：
Salles, Gilles;Schuster, Stephen J.;Fischer, Luca;Kuruvilla, John;Patten, Piers Em;von Tresckow, Bastian;Smith, Sonali M.;Ubieto, Ana Isabel Jiminez;Davis, Keith L.;Nagar, Saurabh P.;Zhang, Jie;Bollu, Vamsi;Jousseaume, Etienne;Ramos, Roberto;Wang, Yucai;Link, Brian K.
通讯作者：
Link, Brian K.
影响因子：
82.9
作者：
Fowler, Nathan Hale;Dickinson, Michael;Thieblemont, Catherine
通讯作者：
Thieblemont, Catherine
影响因子：
7
作者：
Harder, Valerie S.;Stuart, Elizabeth A.;Anthony, James C.
通讯作者：
Anthony, James C.