作者：温杰1，王斌2，杨壮壮3，熊建琪3，韩安家4，陈创奇5，包勇3，牛绍清3

单位：1.中山大学附属第一医院肿瘤介入科，广东 广州 510080；2.山东省滕州市中心人民医院两腺外科，山东 滕州 277500；3.中山大学附属第一医院放射治疗科，广东 广州 510080；4.中山大学附属第一医院病理科，广东 广州 510080；5.中山大学附属第一医院胃肠外科中心，广东 广州 510080

Authors: Wen Jie1, Wang Bin2, Yang Zhuangzhuang3, Xiong Jianqi3, Han Anjia4, Chen Chuangqi5, Bao Yong3, Niu Shaoqing3

Unit：1.Department of Interventional Oncology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China；2.Department of Breast and Thyroid Surgery, Tengzhou Central People’s Hospital, Tengzhou 277500, Shandong, China；3.Department of Radiotherapy, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China；4.Department of Pathology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China；5.Gastrointestinal Surgery Center, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, Guangdong, China

摘要：

目的 探讨肛管鳞状细胞癌（anal squamous cell carcinoma，ASCC）患者中程序性死亡受体配体1（programmed death-ligand 1, PD-L1）的表达水平及其对患者预后的影响，以期为免疫治疗在ASCC患者中的临床应用提供依据。方法  本研究为一项回顾性研究，收集了2016年5月至2024年1月在中山大学附属第一医院确诊并接受根治性放化疗的Ⅱ~Ⅲ期ASCC患者（n=20）的临床病理资料。利用免疫组织化学方法检测患者（n=14）肿瘤样本中PD-L1的表达水平，采用综合阳性评分（combined positive score, CPS）评价PD-L1染色强度。PD-L1阳性判读标准为CPS≥1，根据所有患者CPS值的中位数将患者分为PD-L1 高表达组（CPS≥20，n=7）和低表达组（CPS＜20，n=7），并采用Log-rank生存分析比较PD-L1高表达组和低表达组患者的生存预后。结果  20例患者的中位随访时间为33.4个月。所有患者的3年总生存率、无进展生存率、无局部复发生存率和无远处转移生存率分别为83.9%、78.6%、92.9%和85.7%。14例患者的肿瘤样本PD-L1免疫组织化学检测均为阳性（CPS≥1）。生存分析结果显示，PD-L1高表达组和PD-L1 低表达组患者的3年总生存率分别为80.0%和100%（P=0.371），3年无进展生存率分别为60.0%和100%（P=0.134），3 年无局部复发生存率分别为100%和100%（P=1.000），3 年无远处转移生存率分别为60.0%和100%（P=0.134）。结论  ASCC患者中PD-L1表达阳性率高，PD-L1高表达和低表达患者生存预后无显著差异。

关键词：程序性死亡受体配体1；肛管鳞状细胞癌；综合阳性评分；生存预后 

Abstract：

Objective The purpose of this study is to explore programmed death-ligand 1 (PD-L1) expression and its effect on prognosis of anal squamous cell carcinoma (ASCC) patients, so as to provide clinical basis for immunotherapy in ASCC patients. Method  This is a retrospective study, and the clinical data of patients (n =20) who were diagnosed as stage Ⅱ- Ⅲ ASCC and received curative chemoradiotherapy in the First Affiliated Hospital of Sun Yat-sen University between May 2016 and January 2024 were collected. PD-L1 expression levels in tumor samples (n=14) were tested by immunohistochemistry technique. PD-L1 expression intensity was evaluated by combined positive score (CPS). PD-L1 positive criterion was CPS≥1, and patients were divided into PD-L1 high-expression group (CPS≥20, n=7) and low -expression group (CPS＜20, n =7) according to the median value of CPS. The comparison of survival between PD-L1 high-expression group and low-expression group was calculated with the Log-rank test. Result  The median follow-up time of 20 patients was 33.4 months. The 3-year overall survival (OS) rate, progression -free survival (PFS) rate, local-regional recurrence free survival (LRFS) rate and distance-metastasis free survival (DMFS) rate for all patients were 83.9%, 78.6%, 92.9% and 85.7%, respectively. Immunohistochemistry results of PD-L1 in 14 patients' tumor samples were all positive (CPS≥1). In survival analysis, the 3-year OS rate of patients with PD-L1 high-expression and PD-L1 low-expression were 80.0% and 100% (P=0.371), 3-year PFS rate were 60.0% and 100% (P=0.134), 3-year LRFS rate were 100% and 100% (P=1.000), and 3-year DMFS rate were 60.0% and 100% (P=0.134), respectively. Conclusion  PD -L1 was highly expressed in ASCC patients, and there was no significant difference in survival prognosis between PD-L1 high-expression and PD-L1 low-expression groups.

Key Words:  Programmed death-ligand 1; Anal squamous cell carcinoma; Combined positive score; Prognosis

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