食管鳞状细胞癌PD-L1不同抗体免疫组织化学检测的一致性分析

陈丽君; 王怡晨; 郑强; 王悦; 金燕; 李媛

doi:10.19401/j.cnki.1007-3639.2023.05.007

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食管鳞状细胞癌PD-L1不同抗体免疫组织化学检测的一致性分析

论著 | 更新时间：2025-12-31

- 食管鳞状细胞癌PD-L1不同抗体免疫组织化学检测的一致性分析
- Consistency analysis of PD-L1 immunohistochemistry antibodies in esophageal squamous cell carcinoma
- 中国癌症杂志 2023年33卷第5期页码：469-477
- 作者机构：
  
  复旦大学附属肿瘤医院病理科，复旦大学上海医学院肿瘤学系，上海 200032
- 作者简介：
  
  [ "陈丽君（ORCID: 0000-0002-7139-0515），硕士，医师。" ]
  李媛（ORCID: 0000-0001-5651-819X），博士，主任医师，复旦大学附属肿瘤医院病理科副主任.
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2023.05.007
  中图分类号： R735.1
- 收稿：2022-10-17，
  
  修回：2023-03-21，
  
  纸质出版：2023-05-30
- 稿件说明：
移动端阅览
陈丽君, 王怡晨, 郑强, 等. 食管鳞状细胞癌PD-L1不同抗体免疫组织化学检测的一致性分析[J]. 中国癌症杂志, 2023,33(5):469-477.

Lijun CHEN, Yichen WANG, Qiang ZHENG, et al. Consistency analysis of PD-L1 immunohistochemistry antibodies in esophageal squamous cell carcinoma[J]. China Oncology, 2023, 33(5): 469-477.
陈丽君, 王怡晨, 郑强, 等. 食管鳞状细胞癌PD-L1不同抗体免疫组织化学检测的一致性分析[J]. 中国癌症杂志, 2023,33(5):469-477. DOI： 10.19401/j.cnki.1007-3639.2023.05.007.

Lijun CHEN, Yichen WANG, Qiang ZHENG, et al. Consistency analysis of PD-L1 immunohistochemistry antibodies in esophageal squamous cell carcinoma[J]. China Oncology, 2023, 33(5): 469-477. DOI： 10.19401/j.cnki.1007-3639.2023.05.007.

摘要

背景与目的：

程序性死亡[蛋白

]

配体-1（programmed death ligand-1，PD-L1）是食

管癌免疫治疗应用最广泛的疗效预测生物标志物，准确可靠的PD-L1检测对于筛查免疫治疗的潜在受益者至关重要。本研究旨在探讨食管鳞状细胞癌（esophageal squamous cell carcinoma，ESCC）患者PD-L1的表达情况以及7种不同克隆号PD-L1抗体免疫组织化学（immunohistochemistry，IHC）检测的一致性，为规范食管癌PD-L1 IHC检测及后续临床研究提供参考。

方法：

收集2020年1月—2021年12月复旦大学附属肿瘤医院的146例ESCC手术切除标本，用PD-L1 22C3、SP263、28-8、E1L3N XP、CST E1L3N、BP6099和MXR006 7种克隆号抗体进行染色，并采用联合阳性评分（comprehensive positive score，CPS）、肿瘤细胞比例评分（tumor proportion score，TPS）和免疫细胞评分（immune cell proportion score，IPS）3种评分标准，在不同临界值下对抗体的一致性进行统计学分析。

结果：

PD-L1 22C3与两种伴随诊断抗体（SP263、28-8）对比结果显示：CPS临界值为10时，3种抗体之间均一致性较好（Kappa：0.66 ~ 0.80）；CPS临界值为1时，28-8与22C3、SP263抗体一致性较好（Kappa=0.80、0.65），22C3与SP263一致性一般（Kappa=0.49）；TPS临界值为10%和1%时，3种抗体之间均具有很高的一致性（Kappa：0.79 ~ 0.89，0.71 ~ 0.91）。PD-L1 22C3与4种国产抗体（E1L3N XP、CST E1L3N、BP6099、MXR006）对比结果显示：CPS临界值为10和TPS临界值为10%时，5种抗体之间均一致性较好（Kappa：0.67 ~ 0.88，0.65 ~ 0.79）；CPS临界值为1时，5种抗体之间一致性较好或一般（Kappa：0.58 ~ 0.88）；TPS临界值为1%时，5种抗体之间均一致性很好（Kappa：0.85 ~ 0.92）；IPS临界值为1%和10%时，5种抗体之间一致性一般或较差（Kappa：0.46 ~ 0.66，0.30 ~ 0.62）。

结论：

PD-L1 22C3与两种伴随诊断抗体（SP263、28-8）在CPS和TPS中一致性较好；PD-L1 22C3与4种国产抗体（E1L3N XP、CST E1L3N、BP6099、MXR006）在CPS和TPS中一致性较好，而采用IPS时不同克隆号抗体的一致性较差。这些抗体之间具有一定的可互换性，可为食管鳞状细胞癌PD-L1临床检测提供更多选择。

Abstract

Background and purpose:

Immunohistochemistry (IHC) expression of programmed death ligand-1 (PD-L1) is the most widely used biomarker for predicting the efficacy of esophageal cancer immunotherapy

and accurate and reliable PD-L1 testing is crucial for screening potential beneficiaries of immunotherapy. This study aimed to investigate the expression of PD-L1 in patients with esophageal squamous cell carcinoma (ESCC) and the consistency and correlation of IHC detection of seven different clones of PD-L1 antibody

and to provide reference for the gradual standardization of PD-L1 IHC detection and follow-up clinical research of esophageal cancer.

Methods:

This study collected surgically resected and pathologically confirmed specimens from 146 ESC

C patients in Fudan University Shanghai Cancer Center from January 2020 to December 2021

and specimens were stained with seven antibodies: PD-L1 22C3

SP263

28-8

E1L3N XP

CST E1L3N

BP6099 and MXR006

respectively. The consistency of the antibodies was statistically analyzed in different cut-off values using three scoring criteria: comprehensive positive score (CPS)

tumor cell proportional score (TPS) and immune cell score (IPS).

Results:

The results of PD-L1 22C3

SP263 and 28-8 antibodies demonstrated that the consistency between the three antibodies was substantial (Kappa: 0.66-0.80) when CPS cut-off was 10

and the consistency of PD-L1 28-8 with 22C3 and SP263 antibodies was substantial (Kappa=0.80

0.65) whereas the consistency between PD-L1 22C3 and SP263 was moderate (Kappa=0.49) when CPS cut-off was 1. The three antibodies showed a high consistency when TPS cut-off was 10% and 1% (Kappa: 0.79-0.89

0.71-0.91). The companion diagnostic PD-L1 22C3 clone antibody and the four domestic clone antibodies E1L3N XP

CST E1L3N

BP6099 and MXR006 consistency study showed that the consistency between the five antibodies was substantial (Kappa: 0.67-0.88

0.65-0.79) when CPS cut-off was 10 and TPS cut-off was 10%

and the consistency between the five antibodies was substantial or moderate when CPS cut-off was 1 (Kappa: 0.58-0.88). When TPS cut-off was 1%

there was an excellent consistency between the five antibodies (Kappa: 0.85-0.92). Using IPS cut-off of 1% or 10%

the five antibodies showed moderate or poor consistency (Kappa: 0.30-0.62).

Conclusion:

PD-L1 22C3

SP263 and 28-8 antibodies showed high consistency. PD-L1 22C3 and four domestic antibodies PD-L1 E1L3N XP

CST E1L3N

BP6099 and MXR006 antibodies showed moderate consistency in CPS and TPS

while the consistency was poor in IPS. These antibodies are interchangeable with each other

providing more selectivity for clinical testing needs.

关键词

Keywords

references

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