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<p>Claudin 18.2 (CLDN18.2) is a protein overexpressed in primary cancers of a few sites, including pancreatic ductal adenocarcinoma (PDAC). Recent clinical trials demonstrated prolonged progression-free survival and overall survival with an anti-CLDN18.2 agent plus chemotherapy in gastric or gastroesophageal adenocarcinoma patients. Recognizing the potential for efficacy in PDAC, which is also a morphologically and immunophenotypically similar malignancy, we investigated the prevalence and clinicopathologic features of CLDN18.2 immunohistochemical expression in a large cohort of PDAC cases and paired metastases. Two-hundred eighty (83.1%) of the included 337 cases had some degree of expression of CLDN18.2 (any staining intensity), and 90 (26.7%, 95% confidence interval [CI]: 22.3%-31.7%) would be classified as CLDN18.2-positive using the previously defined criteria used in clinical trials for gastroesophageal adenocarcinoma (moderate or strong membranous CLDN18.2 staining in ≥ 75% of tumor cells). Most cases (78 of 102, 76.5%) showed agreement for CLDN18.2 status based on the primary tumor compared to metastatic tissue. CLDN18.2-positive cases had lower tumor grade (<i>p</i> = 0.009), lower pre-operative carcinoembryonic antigen (<i>p</i> = 0.04) and carbohydrate antigen 19 − 9 levels (<i>p</i> = 0.002), and were less likely to have received neoadjuvant chemoradiation (<i>p</i> &lt; 0.001) than CLDN18.2-negative cases. Outcome data showed CLDN18.2 positivity had a slightly protective effect among patients with neoadjuvant therapy (HR = 0.66, 95% CI: 0.43–0.99, <i>p</i> = 0.04). Our findings suggest value in the development of biomarker and morphology-driven clinical trials of anti-CLDN18.2 agents in PDAC, representing the potential for a novel therapeutic avenue for patients.</p>

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Real world clinical characteristics of Claudin 18.2 expression in patients with pancreatic adenocarcinoma

  • 期刊论文

  • 发表日期：

    2026年5月4日

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  • Allison L. Kerper,
  • Haukur Einarsson,
  • Liz Waugh,
  • Adriana Delgado,
  • Carin Smith,
  • Sarah Jenkins,
  • Marie Passow,
  • Shounak Majumder,
  • Rondell P. Graham

摘要

Claudin 18.2 (CLDN18.2) is a protein overexpressed in primary cancers of a few sites, including pancreatic ductal adenocarcinoma (PDAC). Recent clinical trials demonstrated prolonged progression-free survival and overall survival with an anti-CLDN18.2 agent plus chemotherapy in gastric or gastroesophageal adenocarcinoma patients. Recognizing the potential for efficacy in PDAC, which is also a morphologically and immunophenotypically similar malignancy, we investigated the prevalence and clinicopathologic features of CLDN18.2 immunohistochemical expression in a large cohort of PDAC cases and paired metastases. Two-hundred eighty (83.1%) of the included 337 cases had some degree of expression of CLDN18.2 (any staining intensity), and 90 (26.7%, 95% confidence interval [CI]: 22.3%-31.7%) would be classified as CLDN18.2-positive using the previously defined criteria used in clinical trials for gastroesophageal adenocarcinoma (moderate or strong membranous CLDN18.2 staining in ≥ 75% of tumor cells). Most cases (78 of 102, 76.5%) showed agreement for CLDN18.2 status based on the primary tumor compared to metastatic tissue. CLDN18.2-positive cases had lower tumor grade (p = 0.009), lower pre-operative carcinoembryonic antigen (p = 0.04) and carbohydrate antigen 19 − 9 levels (p = 0.002), and were less likely to have received neoadjuvant chemoradiation (p < 0.001) than CLDN18.2-negative cases. Outcome data showed CLDN18.2 positivity had a slightly protective effect among patients with neoadjuvant therapy (HR = 0.66, 95% CI: 0.43–0.99, p = 0.04). Our findings suggest value in the development of biomarker and morphology-driven clinical trials of anti-CLDN18.2 agents in PDAC, representing the potential for a novel therapeutic avenue for patients.