ArticleCancers2026
Claudin 18.2 Positivity Thresholds and Candidate Populations for Targeted Therapy in Pancreatic Ductal Adenocarcinoma: A Real-World Retrospective Cohort.
Article in Cancers, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
BACKGROUND/
objectivesClaudin 18.2 (CLDN18.2) is expressed in a substantial proportion of pancreatic ductal adenocarcinoma (PDAC) and has emerged as a promising therapeutic target. However, the positivity threshold for enrollment in CLDN18.2-directed trials remains undefined, and ongoing studies use different criteria. We quantified how different CLDN18.2 thresholds influence the size of the candidate population within the same PDAC cohort.
methodsIn this retrospective single-center study, CLDN18.2 was assessed by immunohistochemistry (43-14A clone, Ventana BenchMark) in 99 PDAC patients (metastatic,
resultsThe candidate proportion was 40.4% (40/99) at ≥75%, 43.4% (43/99) at ≥40%, and 64.6% (64/99) at ≥5%; among metastatic patients, it was 36.6%, 38.0%, and 59.2%, respectively. Lowering the threshold from ≥75% to ≥40% caused virtually no reclassification (1/71 metastatic, 1.4%; McNemar
conclusionsThe stringent thresholds used in current drug development identified nearly identical candidate populations, whereas relaxation to any detectable expression substantially enlarged the pool; CLDN18.2 behaved as a targetable rather than a prognostic biomarker. Our findings highlight the need for a PDAC-specific, response-based CLDN18.2 threshold.
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