不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
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.
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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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。
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.
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