Observational studyClinical cancer research : an official journal of the American Association for Cancer Research2026
A New CA19-9 Cutoff Value Identifies Lewis Antigen Status and Refines Prognostic Stratification in PDAC.
Observational study in Clinical cancer research : an official journal of the American Association for Cancer Research, 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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Abstract
purposeCarbohydrate antigen 19-9 (CA19-9) has limited utility in the ∼10% of patients with pancreatic ductal adenocarcinoma (PDAC) who are Lewis-negative CA19-9 "nonproducers" (FUT3-null). This study aims to define the prognosis of FUT3-null PDAC and establish a CA19-9 cutoff that can help identify this subgroup in clinical practice. EXPERIMENTAL
designGermline whole-exome sequencing was performed in a multicenter cohort of 615 patients with PDAC to determine FUT2/FUT3 genotypes. Receiver operating characteristic (ROC) analysis identified the optimal CA19-9 cutoff for FUT3-null status. Maximally selected rank statistics were used to derive CA19-9 cutoffs that best stratified overall survival (OS) in a training set (n = 307) and were tested in a validation set (n = 308).
resultsFUT3-null patients had similar demographics except for a lower median baseline CA19-9 level (2.4 vs. 496 U/mL in FUT3-intact patients) and a comparable median OS (13.5 months) to FUT3-intact patients with CA19-9 >200 U/mL (12.9 months). ROC analysis identified 7 U/mL as the optimal CA19-9 cutoff for FUT3-null (positive predictive value 95.1%; accuracy 87.9%). Using CA19-9 cutoffs of 7 and 200 U/mL (without genotyping), patients were stratified into four prognostic groups: >7 to 37 U/mL (median OS, 23.2 months), >37 to 200 U/mL (median OS, 22 months), >200 U/mL (median OS, 12.8 months), and ≤7 U/mL (likely FUT3-null; median OS, 13.5 months; P < 0.001). Findings were consistent in multivariable Cox models.
conclusionsCA19-9 nonproducers whose outcomes are comparable with those with CA19-9 >200 U/mL represent a high-risk subgroup. CA19-9 ≤7 U/mL is a practical surrogate for identifying these patients. When genotyping is unavailable, a dual-threshold model (≤7 and >200 U/mL) improves risk stratification.
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