Abstract

Abstract Importance: CLDN18.2 was a promising therapeutic target in solid tumors, whereas the clinicopathological features of Chinese CLDN18.2-positive cancer patients were rarely elucidated. Objective: This study aimed to explore the association between CLDN18.2 expression and clinicopathological features of Chinese patients with CLDN18.2-positive digestive system cancers. Methods: This retrospective study included digestive system cancer patients from June 2019 to April 2021 who were screened for two clinical trials of CT041 (an anti-CLDN18.2 CAR-T cell, NCT03874897, and NCT04581473), which were initiated at our center. Results: A total of 875 digestive system cancer patients were included. CLDN18.2 expression was observed in 73.1% GC patients, 61.8% pancreatic cancer (PC) patients, 10.6% colorectal cancer (CRC) patients, and 65.6% biliary tract carcinoma (BTC) patients. In GC, CLDN18.2 expression was associated with age, sex, and Lauren phenotype (all P<0.01). CLDN18.2-positive GC patients had a higher incidence of uterine adnexa metastasis (6.4% vs. 20.8%, P<0.001), and a lower incidence of liver metastasis (22.2% vs. 35.7%, P<0.001). In PC, CLDN18.2-positive cases had a higher proportion of tumors with moderate/high differentiation (46.1% vs. 19.0%, P<0.001), compared with CLDN18.2-negative patients. Additionally, compared with CLDN18.2-negative patients, the proportion of right colon cancer was higher in CLDN18.2-positive patients (40% vs. 18.1%, P=0.028). Conclusions: The results of this study suggested that CLDN18.2-positive tumors had unique clinicopathological features, which provided a theoretical basis for the treatment of CLDN18.2 positive tumors. Citation Format: Chong XiaoYi, Changsong Qi, Jifang Gong, Miao Zhang, Mingyang Ma, keren Jia, Ting Zhou, Li Jian, Zhi Peng, Jun Xiao, Xiaohui Peng, Zhen Liu, Zonghai Li, Xiaotian Zhang, Lin Shen. CLDN18.2 expression is associated with clinicopathological features and prognosis of Chinese patients with digestive system cancers: a retrospective analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6482.

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