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阿基仑赛对比化学免疫疗法在既往接受过 2 线或以上治疗的复发/难治性大 B 细胞淋巴瘤老年患者和/或 ECOG 体能状态较差患者中的获益

英文原题:Benefit of axicabtagene ciloleucel versus chemoimmunotherapy in older patients and/or patients with poor ECOG performance status with relapsed or refractory large B-cell lymphoma after 2 or more lines of prior therapy.

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Benefit of axicabtagene ciloleucel versus chemoimmunotherapy in older patients and/or patients with poor ECOG performance status with relapsed or refractory large B-cell lymphoma after 2 or more lines of prior therapy.

PubMed 2024/03/19(内容时间) Am J Hematol Q1 · IF 9.4(JCR 2025)

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中文摘要

Axicabtagene ciloleucel(axi-cel)在试验中显示,与历史对照相比,在≥2线治疗后治疗复发/难治性(R/R)大B细胞淋巴瘤(LBCL)方面具有良好疗效。

在此,我们将axi-cel的真实世界有效性与化疗免疫治疗(CIT)在年龄≥65岁患者和东部肿瘤协作组体能状态(ECOG PS)为2的患者中的疗效和有效性进行了比较。共纳入1146例接受商业化axi-cel治疗、既往接受≥2线治疗的R/R LBCL患者,来自国际血液和骨髓移植研究中心的前瞻性观察性研究;并纳入469例既往接受≥2线治疗后接受CIT治疗的R/R LBCL患者,来自SCHOLAR-1(一项国际、多队列、回顾性研究)。经过倾向评分匹配后,在接受axi-cel的患者中位随访24个月、接受CIT的患者中位随访60个月时,12个月总生存率分别为62%和28%(风险比,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58%),而接受CIT的患者为28%(CR率16%)。在年龄≥65岁患者中,观察到ORR差异为57%(CR率差异为55%),有利于axi-cel优于CIT。在ECOG PS = 2的患者中,也观察到axi-cel相较于CIT在缓解率方面获益幅度增加。这些发现进一步支持在年龄较大和ECOG PS = 2的R/R LBCL患者中更广泛地使用axi-cel。

展开英文摘要原文

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.

论文信息

作者
Lunning MA、Wang HL、Hu ZH、Locke FL、Siddiqi T、Jacobson CA、Ahmed S、Miklos DB
第一作者单位
University of Nebraska, Omaha, Nebraska, USA.United States
通讯作者单位
CIBMTR, Milwaukee, Wisconsin, USA.United States
文献类型
观察性研究 · 非美国政府资助研究 · 美国 NIH 资助研究
期刊
American journal of hematology2024 May
原文标识
PubMed 38504387 · DOI 10.1002/ajh.27283