Trial reportESMO open2026
Perioperative NALIRIFOX in patients with resectable pancreatic ductal adenocarcinoma: updated analysis of survival and circulating and genetic biomarkers from the phase II nITRO trial.
Trial report in ESMO open, 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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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
13 authors.
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Abstract
backgroundThe optimal perioperative strategy for resectable pancreatic ductal adenocarcinoma (PDAC) remains undefined, and predictive biomarkers to guide treatment selection are lacking. The phase II nanoliposomal IrinoTecan with 5-fluorouracil, levofolinic acid and oxaliplatin in patients with Resectable pancreatic cancer (nITRO) trial showed the activity of perioperative NALIRIFOX in patients with resectable PDAC. Here, we report updated survival outcomes and translational analyses of this trial. PATIENTS AND
methodsPlasma levels of 25 cytokines were quantified via multiplex bead-based immunoassay. Germline whole-exome sequencing assessed variants in tumor suppression, DNA damage repair (DDR), and drug metabolism pathways. Five in silico tools re-evaluated variants of uncertain significance. Statistical correlations between circulating cytokines or germline pathogenic variants and clinical outcomes were determined.
resultsAfter a median follow-up of 50.2 months, the median overall survival (mOS) was 32 months in the intention-to-treat population and 48 months in patients who underwent resection. High baseline tumor necrosis factor-alpha (TNF-α) levels were consistently associated with reduced treatment response (P = 0.022), lower resection probability (P = 0.007), and shorter survival (P = 0.014). Germline pathogenic/predicted damaging variants in DDR or tumor suppressor genes (g.Deficient) were detected in 36.2% of patients and correlated with improved outcomes. Patients with combined g.Deficient/TNF-α-low status achieved the most favorable prognosis, with an mOS of 55 months and a 100% resection rate. DPYD c.496A>G predicted both severe gastrointestinal toxicity and chemotherapy dose reductions.
conclusionsLong-term results from the nITRO trial confirm the activity of perioperative NALIRIFOX in resectable PDAC. Inflammatory, genomic, and pharmacogenomic biomarkers strongly influenced treatment response, surgical eligibility, survival, and toxicity. Biomarker integration could enable more precise patient stratification and guide personalized perioperative strategies in PDAC.
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