CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：Applying the EHA/EBMT grading for ICAHT after CAR-T: comparative incidence and association with infections and mortality.
Applying the EHA/EBMT grading for ICAHT after CAR-T: comparative incidence and association with infections and mortality.
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血细胞减少是 CAR-T 细胞治疗最常见的副作用，并可能增加严重感染并发症的风险。当前的评级系统，如不良事件通用术语标准（CTCAE），既不能反映 CAR-T 后中性粒细胞恢复的独特特征，也不能反映因持续性中性粒细胞减少导致的固有感染风险。为此，最近针对免疫效应细胞相关血液毒性（ICAHT）制定了新的 EHA/EBMT 共识评级。在这项多中心观察性研究中，我们将该评级系统应用于一个大型真实世界队列，该队列包含 549 例接受 BCMA 或 CD19 靶向 CAR-T 治疗难治性 B 细胞恶性肿瘤的患者（112 例多发性骨髓瘤 [MM]，334 例大 B 细胞淋巴瘤 [LBCL]，103 例套细胞淋巴瘤 [MCL]），并检查了重度（3 级）ICAHT 的临床后遗症。ICAHT 评级与重度中性粒细胞减少的累积持续时间（r = 0.92，P < .0001）、多系血细胞减少的存在以及血小板和红细胞输注的使用强烈相关。
我们注意到，与 LBCL 和 MM 患者相比，MCL 患者重度 ICAHT 的发生率更高（28% vs 23% vs 15%）。重度 ICAHT 与更高的严重感染率（49% vs 13%，P < .0001）、增加的非复发死亡率（14% vs 4%，P < .0001）以及更差的生存结局相关（1 年无进展生存率：35% vs 51%，1 年总生存率：52% vs 73%，均 P < .0001）。
重要的是，与 CTCAE 评级相比，ICAHT 评级在预测严重感染方面表现出更优的能力（c-index 0.73 vs 0.55，P < .0001 vs 无显著性）。
综上所述，这些数据凸显了新型分级系统的临床相关性，并支持在评估CAR-T 疗法的临床试验中报告ICAHT严重程度。
Cytopenias represent the most common side effect of CAR T-cell therapy (CAR-T) and can predispose for severe infectious complications. Current grading systems, such as the Common Terminology Criteria for Adverse Events (CTCAE), neither reflect the unique quality of post-CAR-T neutrophil recovery, nor do they reflect the inherent risk of infections due to protracted neutropenia. For this reason, a novel EHA/EBMT consensus grading was recently developed for Immune Effector Cell-Associated HematoToxicity (ICAHT).
In this multicenter, observational study, we applied the grading system to a large real-world cohort of 549 patients treated with BCMA- or CD19-directed CAR-T for refractory B-cell malignancies (112 multiple myeloma [MM], 334 large B-cell lymphoma [LBCL], 103 mantle cell lymphoma [MCL]) and examined the clinical sequelae of severe ( 3 ) ICAHT.
The ICAHT grading was strongly associated with the cumulative duration of severe neutropenia (r = 0. 92, P < . 0001), the presence of multilineage cytopenias, and the use of platelet and red blood cell transfusions.
We noted an increased rate of severe ICAHT in patients with MCL vs those with LBCL and MM (28% vs 23% vs 15%). Severe ICAHT was associated with a higher rate of severe infections (49% vs 13%, P < . 0001), increased nonrelapse mortality (14% vs 4%, P < . 0001), and inferior survival outcomes (1-year progression-free survival: 35% vs 51%, 1-year overall survival: 52% vs 73%, both P < . 0001).
Importantly, the ICAHT grading demonstrated superior capacity to predict severe infections compared with the CTCAE grading (c-index 0. 73 vs 0. 55, P < . 0001 vs nonsignificant). Taken together, these data highlight the clinical relevance of the novel grading system and support the reporting of ICAHT severity in clinical trials evaluating CAR-T therapies.
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