A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma.
A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma.
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DOI：
10.1038/s41591-022-01969-y
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发表时间：
2022-10
期刊：
影响因子：
82.9
通讯作者：
Morschhauser, Franck
中科院分区：
文献类型：
--
作者：
Bachy, Emmanuel;Le Gouill, Steven;Di Blasi, Roberta;Sesques, Pierre;Manson, Guillaume;Cartron, Guillaume;Beauvais, David;Roulin, Louise;Gros, Francois Xavier;Rubio, Marie Therese;Bories, Pierre;Bay, Jacques Olivier;Llorente, Cristina Castilla;Choquet, Sylvain;Casasnovas, Rene-Olivier;Mohty, Mohamad;Guidez, Stephanie;Joris, Magalie;Loschi, Michael;Carras, Sylvain;Abraham, Julie;Chauchet, Adrien;La Rochelle, Laurianne Drieu;Deau-Fischer, Benedicte;Hermine, Olivier;Gastinne, Thomas;Tudesq, Jean Jacques;Gat, Elodie;Broussais, Florence;Thieblemont, Catherine;Houot, Roch;Morschhauser, Franck
Axicabtagene ciloleucel（axi-cel）和tisagenlecleucel（tisa-cel）在复发/难治性（R/R）弥漫性大B细胞淋巴瘤（DLBCL）中均表现出令人印象深刻的临床活性。在这项研究中，我们分析了809例既往接受过两种或两种以上治疗的R/R DLBCL患者的结局，这些患者接受了axi-cel或tisa-cel的商业嵌合抗原受体（CAR）T细胞订单，并在回顾性法国DESCAR-T登记研究（NCT 04328298）中登记。1：1倾向评分匹配后（n = 418），axi-cel治疗患者的最佳总缓解率/完全缓解率（ORR/CRR）分别为80%/60%和66%/42%（ORR和CRR比较均P < 0.001）。中位随访11.7个月后，axi-cel组1年无进展生存率为46.6%，tisa-cel组为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% vs 48.8%; HR = 0.63; 95% CI，0.45-0.88; P = 0.0072）。使用治疗加权统计方法的逆概率观察到类似结果。axi-cel组1-2级细胞因子释放综合征的发生率显著高于tisa-cel组，但≥3级无显著差异。关于免疫效应细胞相关神经毒性综合征（ICANS），axi-cel组1-2级和≥3级ICANS的发生率显著高于tisa-cel组。总之，我们的匹配比较研究支持axi-cel在R/R DLBCL的三线或三线以上治疗中的疗效高于tisa-cel，毒性也高于tisa-cel。对800多例复发性/难治性弥漫性大B细胞淋巴瘤患者（采用市售CAR T细胞疗法治疗）的结局进行分析，结果支持与tisagenlecleucel相比，axicabtagene ciloleucel作为此类肿瘤的第三种或更多种治疗线具有更高的疗效和更高的毒性。
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. Analysis of outcomes of over 800 patients with relapsed/refractory diffuse large B cell lymphoma, treated with commercially available CAR T cell therapy, supports higher efficacy and also a higher toxicity of axicabtagene ciloleucel compared to tisagenlecleucel as the third or more treatment line for this type of tumor.
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影响因子：
7.5
作者：
Pasquini, Marcelo C.;Hu, Zhen-Huan;Grupp, Stephan
通讯作者：
Grupp, Stephan
DOI：
10.1056/nejmoa1707447
发表时间：
2017-12-28
期刊：
The New England journal of medicine
影响因子：
--
作者：
Neelapu SS;Locke FL;Bartlett NL;Lekakis LJ;Miklos DB;Jacobson CA;Braunschweig I;Oluwole OO;Siddiqi T;Lin Y;Timmerman JM;Stiff PJ;Friedberg JW;Flinn IW;Goy A;Hill BT;Smith MR;Deol A;Farooq U;McSweeney P;Munoz J;Avivi I;Castro JE;Westin JR;Chavez JC;Ghobadi A;Komanduri KV;Levy R;Jacobsen ED;Witzig TE;Reagan P;Bot A;Rossi J;Navale L;Jiang Y;Aycock J;Elias M;Chang D;Wiezorek J;Go WY
通讯作者：
Go WY
DOI：
10.1038/nrclinonc.2017.148
发表时间：
2018-01
期刊：
Nature reviews. Clinical oncology
影响因子：
--
作者：
Neelapu SS;Tummala S;Kebriaei P;Wierda W;Gutierrez C;Locke FL;Komanduri KV;Lin Y;Jain N;Daver N;Westin J;Gulbis AM;Loghin ME;de Groot JF;Adkins S;Davis SE;Rezvani K;Hwu P;Shpall EJ
通讯作者：
Shpall EJ
影响因子：
7.5
作者：
Pinnix, Chelsea C.;Gunther, Jillian R.;Nastoupil, Loretta J.
通讯作者：
Nastoupil, Loretta J.
影响因子：
158.5
作者：
Locke, F. L.;Miklos, D. B.;Westin, J. R.
通讯作者：
Westin, J. R.