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:T-cell fitness, metabolic tumor volume, and serum LDH levels are associated with response to axicabtagene ciloleucel.
T-cell fitness, metabolic tumor volume, and serum LDH levels are associated with response to axicabtagene ciloleucel.
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Axicabtagene ciloleucel(axi-cel)已在复发/难治性大B细胞淋巴瘤(r/r LBCL)中显示出疗效和安全性。
然而,来自亚洲人群的证据仍然有限。本研究评估了2023年4月至2025年12月期间因axi-cel接受白细胞采集的r/r LBCL患者。55例患者可进行安全性评估,其中38例在二线(2L)治疗。CRS发生于53例(96%),≥3级6例(10%)。ICANS发生于17例(31%),≥3级6例(11%)。与接受三线或更后线(3L+)治疗的患者相比,2L患者的≥3级CRS发生率更高(13% vs. 6%),任何级别ICANS发生率也更高(37% vs. 18%)。在55例患者中,ORR为91%。中位随访14.5个月后,1.5年PFS率和OS率分别为63.1%和83.1%。2L的PFS在数值上高于3L+(1.5年PFS:64.9% vs. 57.0%;HR:1.75;p = 0.248)。多因素分析确定了三个独立的PFS危险因素:白细胞采集时外周血CD8+初始T细胞计数低、高代谢肿瘤体积,以及开始淋巴细胞清除性化疗时LDH水平升高。Axi-cel在日本r/r LBCL患者中显示出显著疗效。2L治疗与更高的毒性和数值上更高的PFS相关。
Axicabtagene ciloleucel (axi-cel) has demonstrated efficacy and safety in relapsed/refractory large B cell lymphoma (r/r LBCL).
However, evidence from Asian populations remains limited. This study evaluated patients with r/r LBCL who underwent leukapheresis for axi-cel between April 2023 and December 2025. Fifty-five patients were evaluable for safety, including 38 treated in the second-line setting (2L). CRS occurred in 53 (96%), with grade ≥ 3 in 6 (10%). ICANS occurred in 17 (31%), with grade ≥ 3 in 6 (11%). Compared with patients receiving third-line or later (3L +) treatment, 2L patients experienced higher rates of grade ≥ 3 CRS (13% vs. 6%) and any-grade ICANS (37% vs. 18%). Among the 55 patients, the overall response rate was 91%.
After a median follow-up of 14. 5 months, the 1. 5-year PFS and OS rates were 63. 1% and 83. 1%, respectively. 2L showed numerically higher PFS than 3L + (1. 5-year PFS: 64. 9% vs. 57. 0%; HR: 1. 75; p = 0. 248).
Multivariate analysis identified three independent risk factors for PFS: low peripheral blood CD8 + naive T-cell count at leukapheresis, high metabolic tumor volume, and elevated LDH level at initiation of lymphodepleting chemotherapy. Axi-cel demonstrated substantial efficacy in Japanese patients with r/r LBCL. The 2L setting was associated with higher toxicity and numerically higher PFS.
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