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Abstract：
BACKGROUND: Although anti-CD19 chimeric antigen receptor (CAR) T cell therapy was approved as a very effective salvage strategy in relapsed/refractory (R/R) B cell lymphoma, the experience in R/R gastrointestinal (GI) lymphoma is still insufficient.
METHODS: We summarized the efficacy and side effects of anti-CD19 CAR T-cell therapy in 12 patients with R/R GI lymphoma. Based on literature, the R/R GI lymphoma patients were divided into subgroups with different characteristics: Bulky/No bulky disease, Gastric/Gastrointestinal involvement, Gastrointestinal/Combined extra-gastrointestinal lesions, Ulcer/Lumps or nodules type, With/without gastrointestinal bleeding.
RESULTS: The objective response rate (ORR) was 66.67% in these 12 patients. The ORR was 83.33% in no bulky disease group, 80.00% in gastric involvement group, 100.00% in ulcer type group, and 80.00% in no gastrointestinal bleeding group. The CR rate was 33.33% in these 12 patients. The CR was 50.0% in no bulky disease group, 60.00% in gastric involvement group, and 80.00% in ulcer type group. The PFS and OS rate of the 12 patients at 6 months after infusion were 54.55% and 58.33%, respectively. The overall survival (OS) at 6 months was higher in no bulky disease group. There was no difference of the OS or the progression free survival (PFS) at 6 months between the other groups. The mean peak of CAR-T cells and Cytokine Release Syndrome (CRS) grade were higher in gastrointestinal lesions group. The mean peak of IFN-γ and CRS grade were higher in gastrointestinal bleeding group. Four out of six patients in group of gastrointestinal lesions group were patient with high tumor burden. Patients with gastrointestinal involvement only were at higher risk for gastrointestinal bleeding.
CONCLUSIONS: The ORR and CR of high tumor load, gastrointestinal involvement, lumps or nodules type and gastrointestinal bleeding group were lower. The CRS grade was higher in gastrointestinal lesions group and in gastrointestinal bleeding group. Patients with gastrointestinal involvement only were at higher risk for gastrointestinal bleeding.
METHODS: We summarized the efficacy and side effects of anti-CD19 CAR T-cell therapy in 12 patients with R/R GI lymphoma. Based on literature, the R/R GI lymphoma patients were divided into subgroups with different characteristics: Bulky/No bulky disease, Gastric/Gastrointestinal involvement, Gastrointestinal/Combined extra-gastrointestinal lesions, Ulcer/Lumps or nodules type, With/without gastrointestinal bleeding.
RESULTS: The objective response rate (ORR) was 66.67% in these 12 patients. The ORR was 83.33% in no bulky disease group, 80.00% in gastric involvement group, 100.00% in ulcer type group, and 80.00% in no gastrointestinal bleeding group. The CR rate was 33.33% in these 12 patients. The CR was 50.0% in no bulky disease group, 60.00% in gastric involvement group, and 80.00% in ulcer type group. The PFS and OS rate of the 12 patients at 6 months after infusion were 54.55% and 58.33%, respectively. The overall survival (OS) at 6 months was higher in no bulky disease group. There was no difference of the OS or the progression free survival (PFS) at 6 months between the other groups. The mean peak of CAR-T cells and Cytokine Release Syndrome (CRS) grade were higher in gastrointestinal lesions group. The mean peak of IFN-γ and CRS grade were higher in gastrointestinal bleeding group. Four out of six patients in group of gastrointestinal lesions group were patient with high tumor burden. Patients with gastrointestinal involvement only were at higher risk for gastrointestinal bleeding.
CONCLUSIONS: The ORR and CR of high tumor load, gastrointestinal involvement, lumps or nodules type and gastrointestinal bleeding group were lower. The CRS grade was higher in gastrointestinal lesions group and in gastrointestinal bleeding group. Patients with gastrointestinal involvement only were at higher risk for gastrointestinal bleeding.
摘要：
背景：尽管抗CD19嵌合抗原受体（CAR）T细胞疗法被批准为复发性/难治性（R/R）B细胞淋巴瘤的非常有效的补救策略，在R/R胃肠道（GI）淋巴瘤的经验仍然不足。
方法：我们总结了抗CD19CART细胞治疗12例R/RGI淋巴瘤患者的疗效和副作用。根据文献,将R/R胃肠道淋巴瘤患者分为具有不同特征的亚组：大体积/无大体积疾病，胃/胃肠道受累，胃肠/合并胃肠外病变,溃疡/肿块或结节类型，有/无消化道出血。
结果：这12例患者的客观缓解率（ORR）为66.67%。无大病组ORR为83.33%,胃受累组80.00%,溃疡型组100.00%,无消化道出血组为80.00%。12例患者的CR率为33.33%。无大病组的CR为50.0%，胃受累组60.00%,溃疡型组80.00%。12例患者输液后6个月的PFS和OS分别为54.55%和58.33%,分别。6个月时的总生存期（OS）在无大体积疾病组中较高。其他组之间在6个月时的OS或无进展生存期（PFS）没有差异。胃肠道病变组的CAR-T细胞平均峰值和细胞因子释放综合征（CRS）分级较高。消化道出血组IFN-γ平均峰值和CRS分级较高。胃肠道病变组6例患者中有4例为肿瘤负荷高的患者。仅胃肠道受累的患者发生胃肠道出血的风险较高。
结论：高肿瘤负荷的ORR和CR，胃肠道受累,肿块或结节类型和消化道出血组较低。消化道病变组和消化道出血组CRS分级较高。仅胃肠道受累的患者发生胃肠道出血的风险较高。
方法：我们总结了抗CD19CART细胞治疗12例R/RGI淋巴瘤患者的疗效和副作用。根据文献,将R/R胃肠道淋巴瘤患者分为具有不同特征的亚组：大体积/无大体积疾病，胃/胃肠道受累，胃肠/合并胃肠外病变,溃疡/肿块或结节类型，有/无消化道出血。
结果：这12例患者的客观缓解率（ORR）为66.67%。无大病组ORR为83.33%,胃受累组80.00%,溃疡型组100.00%,无消化道出血组为80.00%。12例患者的CR率为33.33%。无大病组的CR为50.0%，胃受累组60.00%,溃疡型组80.00%。12例患者输液后6个月的PFS和OS分别为54.55%和58.33%,分别。6个月时的总生存期（OS）在无大体积疾病组中较高。其他组之间在6个月时的OS或无进展生存期（PFS）没有差异。胃肠道病变组的CAR-T细胞平均峰值和细胞因子释放综合征（CRS）分级较高。消化道出血组IFN-γ平均峰值和CRS分级较高。胃肠道病变组6例患者中有4例为肿瘤负荷高的患者。仅胃肠道受累的患者发生胃肠道出血的风险较高。
结论：高肿瘤负荷的ORR和CR，胃肠道受累,肿块或结节类型和消化道出血组较低。消化道病变组和消化道出血组CRS分级较高。仅胃肠道受累的患者发生胃肠道出血的风险较高。
