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tisagenlecleucel 与 axicabtagene ciloleucel CAR-T 细胞治疗复发/难治性弥漫大 B 细胞淋巴瘤的真实世界比较

英文原题:A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma.

查看英文原题

A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma.

PubMed 2022/09/22(内容时间) Nat Med Q1 · IF 52.5(JCR 2025)

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中文摘要

Axicabtagene ciloleucel(axi-cel)和tisagenlecleucel(tisa-cel)在复发/难治性(R/R)弥漫大B细胞淋巴瘤(DLBCL)中均显示出令人瞩目的临床活性。

在本研究中,我们分析了809例既往接受过两线或以上治疗的R/R DLBCL患者的结局,这些患者曾商业订购axi-cel或tisa-cel的嵌合抗原受体(CAR)T细胞,并登记于回顾性法国DESCAR-T 注册研究(NCT04328298)中。经过1:1倾向性评分匹配后(n = 418),接受axi-cel治疗的患者与接受tisa-cel治疗的患者相比,最佳总缓解率/完全缓解率(ORR/CRR)分别为80%/60%和66%/42%(ORR和CRR比较的P值均 < 0.001)。

中位随访11.7个月后,axi-cel的1年无进展生存率为46.6%,tisa-cel为33.2%(风险比(HR)= 0.61;95%置信区间(CI),0.46-0.79;P = 0.0003)。与tisa-cel输注后相比,axi-cel输注后的总生存期(OS)也显著改善(1年OS 63.5%对48.8%;HR = 0.63;95% CI,0.45-0.88;P = 0.0072)。使用逆概率治疗加权统计方法也观察到类似结果。1-2级细胞因子释放综合征在axi-cel中显著比tisa-cel更常见,但3级未见显著差异。关于免疫效应细胞相关神经毒性综合征(ICANS),1-2级和3级ICANS在axi-cel中均显著比tisa-cel更常见。

总之,我们的匹配比较研究支持在R/R DLBCL的三线或以上治疗中,与tisa-cel相比,axi-cel具有更高的疗效,同时也具有更高的毒性。

展开英文摘要原文

Axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) have both demonstrated impressive clinical activity in relapsed/refractory (R/R) diffuse large B cell lymphoma (DLBCL). In this study, we analyzed the outcome of 809 patients with R/R DLBCL after two or more previous lines of treatment who had a commercial chimeric antigen receptor (CAR) T cells order for axi-cel or tisa-cel and were registered in the retrospective French DESCAR-T registry study ( NCT04328298 ).

After 1:1 propensity score matching (n = 418), the best overall response rate/complete response rate (ORR/CRR) was 80%/60% versus 66%/42% for patients treated with axi-cel compared to tisa-cel, respectively (P < 0. 001 for both ORR and CRR comparisons). After a median follow-up of 11. 7 months, the 1-year progression-free survival was 46. 6% for axi-cel and 33. 2% for tisa-cel (hazard ratio (HR) = 0. 61; 95% confidence interval (CI), 0. 46-0. 79; P = 0. 0003).

Overall survival (OS) was also significantly improved after axi-cel infusion compared to after tisa-cel infusion (1-year OS 63. 5% versus 48. 8%; HR = 0. 63; 95% CI, 0. 45-0. 88; P = 0. 0072). Similar findings were observed using the inverse probability of treatment weighting statistical approach.

Grade 1-2 cytokine release syndrome was significantly more frequent with axi-cel than with tisa-cel, but no significant difference was observed for grade 3. Regarding immune effector cell-associated neurotoxicity syndrome (ICANS), both grade 1-2 and grade 3 ICANS were significantly more frequent with axi-cel than with tisa-cel.

In conclusion, our matched comparison study supports a higher efficacy and also a higher toxicity of axi-cel compared to tisa-cel in the third or more treatment line for R/R DLBCL.

论文信息

作者
Bachy E、Le Gouill S、Di Blasi R、Sesques P、Manson G、Cartron G、Beauvais D、Roulin L
单位
Hematology Department, Hospices Civils de Lyon, Pierre Bénite, Lyon, France. emmanuel.bachy@chu-lyon.fr.France
文献类型
非美国政府资助研究
期刊
Nature medicine2022 Oct
原文标识
PubMed 36138152 · DOI 10.1038/s41591-022-01969-y