The University of Texas MD Anderson Cancer Center, Houston, Texas.
Moffitt Cancer Center, Tampa, Florida.
Clin Cancer Res. 2023 May 15;29(10):1894-1905. doi: 10.1158/1078-0432.CCR-22-3136.
Older patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) may be considered ineligible for curative-intent therapy including high-dose chemotherapy with autologous stem-cell transplantation (HDT-ASCT). Here, we report outcomes of a preplanned subgroup analysis of patients ≥65 years in ZUMA-7.
Patients with LBCL refractory to or relapsed ≤12 months after first-line chemoimmunotherapy were randomized 1:1 to axicabtagene ciloleucel [axi-cel; autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy] or standard of care (SOC; 2-3 cycles of chemoimmunotherapy followed by HDT-ASCT). The primary endpoint was event-free survival (EFS). Secondary endpoints included safety and patient-reported outcomes (PROs).
Fifty-one and 58 patients aged ≥65 years were randomized to axi-cel and SOC, respectively. Median EFS was greater with axi-cel versus SOC (21.5 vs. 2.5 months; median follow-up: 24.3 months; HR, 0.276; descriptive P < 0.0001). Objective response rate was higher with axi-cel versus SOC (88% vs. 52%; OR, 8.81; descriptive P < 0.0001; complete response rate: 75% vs. 33%). Grade ≥3 adverse events occurred in 94% of axi-cel and 82% of SOC patients. No grade 5 cytokine release syndrome or neurologic events occurred. In the quality-of-life analysis, the mean change in PRO scores from baseline at days 100 and 150 favored axi-cel for EORTC QLQ-C30 Global Health, Physical Functioning, and EQ-5D-5L visual analog scale (descriptive P < 0.05). CAR T-cell expansion and baseline serum inflammatory profile were comparable in patients ≥65 and <65 years.
Axi-cel is an effective second-line curative-intent therapy with a manageable safety profile and improved PROs for patients ≥65 years with R/R LBCL.
对于复发/难治性（R/R）大 B 细胞淋巴瘤（LBCL）的老年患者，可能被认为不符合包括大剂量化疗联合自体干细胞移植（HDT-ASCT）在内的治愈性意向治疗。在此，我们报告了 ZUMA-7 中≥65 岁患者的预先计划的亚组分析结果。
在一线化疗免疫治疗后复发或缓解≤12 个月的 LBCL 患者，以 1:1 的比例随机分配至 axi-cel（axicabtagene ciloleucel；自体抗 CD19 嵌合抗原受体（CAR）T 细胞治疗）或标准治疗（SOC；2-3 个周期的化疗免疫治疗后行 HDT-ASCT）。主要终点为无事件生存（EFS）。次要终点包括安全性和患者报告的结局（PROs）。
51 名和 58 名年龄≥65 岁的患者分别被随机分配至 axi-cel 和 SOC 组。与 SOC 相比，axi-cel 组的中位 EFS 更长（21.5 个月 vs. 2.5 个月；中位随访：24.3 个月；HR，0.276；描述性 P＜0.0001）。与 SOC 相比，axi-cel 组的客观缓解率更高（88% vs. 52%；OR，8.81；描述性 P＜0.0001；完全缓解率：75% vs. 33%）。axi-cel 组和 SOC 组分别有 94%和 82%的患者发生≥3 级不良事件。无 5 级细胞因子释放综合征或神经事件发生。在生活质量分析中，100 天和 150 天时，EORTC QLQ-C30 全球健康、身体功能和 EQ-5D-5L 视觉模拟量表的 PRO 评分从基线的平均变化对 axi-cel 有利（描述性 P＜0.05）。≥65 岁和＜65 岁患者的 CAR T 细胞扩增和基线血清炎症特征相似。
对于复发/难治性大 B 细胞淋巴瘤的老年患者，axi-cel 是一种有效的二线治愈性意向治疗方法，具有可管理的安全性和改善的 PROs。
