Ma Lixia, Dou Yimeng, Liu Rui, Xu Teng, Yang Fan, Zheng Peihao, Feng Shaomei, Guo Yuelu, Shi Hui, Xue Fei, Deng Biping, Ke Xiaoyan, Hu Kai
Department of Adult Lymphoma, Beijing Boren Hospital, Beijing, China.
Cytology Laboratory, Beijing Boren Hospital, Beijing, China.
Cancer Rep (Hoboken). 2025 Jan;8(1):e70083. doi: 10.1002/cnr2.70083.
Currently, chimeric antigen receptor T-cell (CART) therapy represents a highly effective approach for relapsed/refractory B-cell lymphomas. However, it also carries treatment-related risks. Limited data are available on the risks associated with CART therapy in patients with gastrointestinal involvement in B-cell lymphomas. Therefore, we conducted a retrospective cohort study to address this gap in knowledge.
During the period from May 2019 to August 2022, a total of 26 patients recurrent/refractory with recurrent/refractory B-cell lymphoma involving the gastrointestinal tract enrolled. Pathology confirmed CD19 antigen expression in tumor tissues. The disease status of patients who failed multiple lines of therapy was progressive disease (PD). Before CART cell infusion, patients received an FC regimen (fludarabine and cyclophosphamide) lymphodepletion. Quantitative PCR and flow cytometry were adopted for monitoring CART cell kinetics and function, with a focus on gastrointestinal AEs during treatment. The overall response rate (ORR) of the 26 patients was 61.5% (16/26), while the complete response rate (CR) was 23.1% (6/26). Their median follow-up time was 22.49 months, while the medians of overall survival (OS) and progression-free survival (PFS) were 10.88 and 5.47 months, respectively. The 1-year OS and PFS rates were 45% and 42.3%, respectively. The prevalence of gastrointestinal complications was 21/26 (80.7%), including gastrointestinal hemorrhage in 11/26 (42.3%), emesis and diarrhea in 9/26 (34.6%), as well as intestinal obstruction in 2/26 (7.7%). A total of three patients (3/26, 11.5%) died of gastrointestinal hemorrhage. The gastrointestinal hemorrhage group exhibited markedly lower ORR and inferior OS compared to the non-hemorrhage group.
Generally, the CART cell therapy is valid in relapsed/refractory B-cell lymphoma with gastrointestinal involvement, but gastrointestinal bleeding is a unique risk factor that requires special attention, particularly in patients with high gastrointestinal tumor burden, as it is associated with poor efficacy and survival.
目前，嵌合抗原受体T细胞（CART）疗法是复发/难治性B细胞淋巴瘤的一种高效治疗方法。然而，它也存在与治疗相关的风险。关于B细胞淋巴瘤累及胃肠道患者接受CART疗法相关风险的数据有限。因此，我们开展了一项回顾性队列研究以填补这一知识空白。
在2019年5月至2022年8月期间，共有26例复发/难治性B细胞淋巴瘤累及胃肠道的患者入组。病理证实肿瘤组织中CD19抗原表达。经过多线治疗失败的患者疾病状态为疾病进展（PD）。在输注CART细胞前，患者接受氟达拉滨和环磷酰胺（FC）方案进行淋巴细胞清除。采用定量PCR和流式细胞术监测CART细胞动力学和功能，重点关注治疗期间的胃肠道不良事件。26例患者的总缓解率（ORR）为61.5%（16/26），而完全缓解率（CR）为23.1%（6/26）。他们的中位随访时间为22.49个月，总生存期（OS）和无进展生存期（PFS）的中位数分别为10.88个月和5.47个月。1年OS率和PFS率分别为45%和42.3%。胃肠道并发症的发生率为21/26（80.7%），包括胃肠道出血11/26（42.3%）、呕吐和腹泻9/26（34.6%）以及肠梗阻2/26（7.7%）。共有3例患者（3/26，11.5%）死于胃肠道出血。与非出血组相比，胃肠道出血组的ORR明显更低，OS更差。
总体而言，CART细胞疗法对复发/难治性累及胃肠道的B细胞淋巴瘤有效，但胃肠道出血是一个需要特别关注的独特风险因素，尤其是在胃肠道肿瘤负荷高的患者中，因为它与疗效和生存率差有关。
