NAPOLI-3 in Real World Practice: Expert Insights on Data From ASCO GI 2025
Panelists discuss how real-world retrospective data from the Flatiron Health Database showed median overall survival of approximately 9 months for FOLFIRINOX-treated patients, which appears numerically lower than NALIRIFOX results, though these findings require cautious interpretation due to the non-randomized nature of the comparison.
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Dr. Chandana reviews a retrospective study presented at ASCO GI 2025 by Paul Cochram et al., which analyzed real-world outcomes for patients with metastatic pancreatic adenocarcinoma treated with FOLFIRINOX or modified FOLFIRINOX. Using the Flatiron Health Database, researchers examined three cohorts: all adult metastatic pancreatic cancer patients treated with first-line FOLFIRINOX from January 2014 to January 2022; a trial-aligned cohort of patients treated with FOLFIRINOX between January 2020 and July 2022 (coinciding with the NAPOLI-3 study period); and patients who received modified FOLFIRINOX during the same time frame.
The analysis included 3,200 patients in the comprehensive cohort with a median age of 63 years, 42% female representation, and 48.9% having ECOG performance status of 1. The median overall survival for this group was 9 months. The trial-aligned cohort comprised 219 patients with a median survival of 9.1 months (range: 7.8-10.9 months). The third cohort of 154 patients treated with modified FOLFIRINOX during the NAPOLI-3 study period showed a median overall survival of 8.6 months (range: 7.3-10.5 months).
Dr. Chandana emphasizes that while this real-world data suggests NALIRIFOX showed numerically improved overall survival compared to FOLFIRINOX or modified FOLFIRINOX (with median overall survival around 9 months across cohorts), the results should be interpreted cautiously as this was not a randomized comparison. He notes the limitations of retrospective analyses and suggests that further studies adjusting for baseline characteristics are warranted to provide more definitive insights into comparative effectiveness.
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