Comparison of 2-year outcomes with CAR T cells (ZUMA-1) vs salvage chemotherapy in refractory large B-cell lymphoma.
Comparison of 2-year outcomes with CAR T cells (ZUMA-1) vs salvage chemotherapy in refractory large B-cell lymphoma.
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DOI：
10.1182/bloodadvances.2020003848
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发表时间：
2021-10-26
期刊：
影响因子：
7.5
通讯作者：
Gisselbrecht C
中科院分区：
文献类型：
--
作者：
Neelapu SS;Locke FL;Bartlett NL;Lekakis LJ;Reagan PM;Miklos DB;Jacobson CA;Braunschweig I;Oluwole OO;Siddiqi T;Lin Y;Crump M;Kuruvilla J;Van Den Neste E;Farooq U;Navale L;DePuy V;Kim JJ;Gisselbrecht C
倾向性分析证实，与标准挽救方案相比，axi-cel的ORR显著更高，死亡风险降低73%。这项2年分析表明，axi-cel与难治性LBCL患者的持久临床获益相关。SCHOLAR-1国际回顾性研究强调了接受常规化疗的难治性大B细胞淋巴瘤（LBCL）患者的临床结局和生存率较差。Axicabtagene ciloleucel（axi-cel）是一种自体抗CD 19嵌合抗原受体（CAR）T细胞疗法，在关键I/II期ZUMA-1研究（NCT 02348216）中，在难治性LBCL患者中显示出持久的应答。在这里，我们比较了SCHOLAR-1与ZUMA-1的2年结局。在比较临床结局之前，使用倾向评分（基于一组广泛的预后协变量）在ZUMA-1和SCHOLAR-1患者之间建立平衡。在ZUMA-1的关键II期部分，101例患者接受了axi-cel治疗，可评价缓解和生存期。在SCHOLAR-1中，分别有434例和424例患者可评价缓解和生存。ZUMA-1患者比SCHOLAR-1患者接受了更多的预治疗。ZUMA-1的中位随访时间为27.1个月。ZUMA-1的客观缓解率（ORR）和完全缓解率分别为83%和54%，SCHOLAR-1为34%和12%。ZUMA-1的2年生存率为54%，SCHOLAR-1为20%，ZUMA-1与SCHOLAR-1相比，死亡风险降低了73%。这些结果与额外标准化分析的结果一致，其中分层仅限于2个预后因素（难治性分类和化疗难治性后有/无干细胞移植），以保留样本量。尽管非随机化分析存在局限性，但这些结果表明，与非CAR T细胞挽救方案相比，Axi-cel对难治性LBCL患者产生了持久的反应和显著的生存益处。
Propensity analysis confirmed substantially higher ORR and a 73% reduction in risk for death with axi-cel vs standard salvage regimens. This 2-year analysis indicates that axi-cel is associated with durable clinical benefit for patients with refractory LBCL. The SCHOLAR-1 international retrospective study highlighted poor clinical outcomes and survival among patients with refractory large B-cell lymphoma (LBCL) treated with conventional chemotherapy. Axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated durable responses in patients with refractory LBCL in the pivotal phase 1/2 ZUMA-1 study (NCT02348216). Here, we compared SCHOLAR-1 with the 2-year outcomes of ZUMA-1. Prior to comparison of clinical outcomes, propensity scoring (based on a broad set of prognostic covariates) was used to create balance between ZUMA-1 and SCHOLAR-1 patients. In the pivotal phase 2 portion of ZUMA-1, 101 patients received axi-cel and were evaluable for response and survival. In SCHOLAR-1, 434 and 424 patients were evaluable for response and survival, respectively. ZUMA-1 patients were more heavily pretreated than were SCHOLAR-1 patients. The median follow-up was 27.1 months in ZUMA-1. The objective response rate (ORR) and complete response rate were 83% and 54% in ZUMA-1 vs 34% and 12% in SCHOLAR-1, respectively. The 2-year survival rate was 54% in ZUMA-1 and 20% in SCHOLAR-1, and a 73% reduction in the risk of death was observed in ZUMA-1 vs SCHOLAR-1. These results were consistent with those of an additional standardization analysis in which strata were limited to 2 prognostic factors (refractory categorization and presence/absence of stem cell transplant after refractoriness to chemotherapy) to conserve sample size. Despite the limitations of a nonrandomized analysis, these results indicate that axi-cel produces durable responses and a substantial survival benefit vs non–CAR T-cell salvage regimens for patients with refractory LBCL.
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影响因子：
1.9
作者：
Bai X;Tsiatis AA;O'Brien SM
通讯作者：
O'Brien SM
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
影响因子：
45.3
作者：
Maurer, Matthew J.;Ghesquieres, Herve;Cerhan, James R.
通讯作者：
Cerhan, James R.
影响因子：
254.7
作者：
Teras, Lauren R.;DeSantis, Carol E.;Flowers, Christopher R.
通讯作者：
Flowers, Christopher R.
影响因子：
2
作者：
Li, Fan;Zaslavsky, Alan M.;Landrum, Mary Beth
通讯作者：
Landrum, Mary Beth