Axicabtagene ciloleucel (axi-cel) in trials has demonstrated favorable efficacy compared with historical controls after ≥2 lines of therapy for the treatment of relapsed or refractory (R/R) large B cell lymphoma (LBCL). Herein, we compared the real-world effectiveness of axi-cel with efficacy and effectiveness of chemoimmunotherapy (CIT) in patients aged ≥65 years and patients with Eastern Cooperative Oncology Group performance status (ECOG PS) of 2. A total of 1146 patients treated with commercial axi-cel for R/R LBCL with ≥2 lines of prior therapy were included from the Center for International Blood and Marrow Transplantation Research prospective observational study, and 469 patients treated with CIT for R/R LBCL after ≥2 lines of prior therapy were included from SCHOLAR-1 (an international, multicohort, retrospective study). After propensity score matching, at a median follow-up of 24 months for patients receiving axi-cel and 60 months for patients receiving CIT, 12-month overall survival rates were 62% and 28%, respectively (hazard ratio, 0.30 [95% CI, 0.24–0.37]). Objective response rate (ORR) was 76% (complete response [CR] rate 58%) in patients receiving axi-cel versus 28% (CR rate 16%) for those receiving CIT. A 57% difference in ORR (55% difference in CR rate) favoring axi-cel over CIT was observed among patients aged ≥65 years. Increased magnitude of benefit in response rates for axi-cel versus CIT was also observed among patients with ECOG PS = 2. These findings further support the broader use of axi-cel in older patients and patients with ECOG PS = 2 with R/R LBCL.

中文翻译：

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axicabtagene ciloleucel 与化学免疫治疗相比，对于老年患者和/或经 2 线或以上治疗后 ECOG 表现状态不佳的复发性或难治性大 B 细胞淋巴瘤患者的益处

试验中的 Axicabtagene ciloleucel (axi-cel) 在治疗复发或难治性 (R/R) 大 B 细胞淋巴瘤 (LBCL) 的≥2 线治疗后，与历史对照相比显示出良好的疗效。在此，我们比较了 axi-cel 的实际疗效与化学免疫疗法 (CIT) 在年龄 ≥ 65 岁的患者以及东部肿瘤合作组体能状态 (ECOG PS) 为 2 的患者中的疗效和有效性。总共治疗了 1146 名患者国际血液和骨髓移植研究中心的前瞻性观察研究纳入了使用商业 axi-cel 治疗 R/R LBCL 且接受过 ≥2 行既往治疗的患者，469 名患者在接受过 ≥2 行既往治疗后接受 CIT 治疗 R/R LBCL治疗包含在 SCHOLAR-1（一项国际多队列回顾性研究）中。倾向评分匹配后，接受 axi-cel 的患者中位随访 24 个月，接受 CIT 的患者中位随访 60 个月，12 个月总生存率分别为 62% 和 28%（风险比为 0.30 [95%] CI，0.24–0.37]）。接受 axi-cel 的患者的客观缓解率 (ORR) 为 76%（完全缓解 [CR] 率为 58%），而接受 CIT 的患者为 28%（CR 率为 16%）。在年龄≥65 岁的患者中，axi-cel 与 CIT 相比，ORR 存在 57% 的差异（CR 率差异为 55%）。在 ECOG PS = 2 的患者中，还观察到 axi-cel 与 CIT 的反应率获益程度有所增加。这些发现进一步支持 axi-cel 在老年患者和 ECOG PS = 2 的 R/R LBCL 患者中的更广泛使用。