Gemcitabine plus nab-paclitaxel versus FOLFIRINOX for unresected pancreatic cancer: Comparative effectiveness and evaluation of tumor growth in Veterans.

Advanced, unresectable pancreatic cancer is often treated with either gemcitabine plus nab-paclitaxel (Gem/NabP) or FOLFIRINOX, although these regimens have never been compared in a head-to-head trial. In this study, we compared these two regimens using Veterans Administration (VA) data and evaluated the use of a novel tumor growth formula to predict outcomes. We identified 670 Veterans from national VA data with unresected stage II-IV pancreatic adenocarcinoma diagnosed between 2003 and 2016 who were treated with either first-line Gem/NabP or FOLFIRINOX. We compared overall survival (OS) and adverse events by treatment using propensity scores (PS) to account for allocation bias. Using longitudinal CA19-9 biomarker information we then fit the data to a novel tumor growth equation, comparing growth with OS. We found no difference in PS-adjusted (hazard ratio [HR] 1.00; 95% confidence interval [95% CI] 0.84-1.20) or PS-matched (HR: 0.93; 95% CI: 0.76-1.13) OS between the two treatment groups. Tumor growth analysis revealed similar growth parameter values for Gem/NabP and FOLFIRINOX (P = .074 for difference). Gem/NabP appeared noninferior to FOLFIRINOX for survival outcomes for advanced pancreatic adenocarcinoma based on national VA data. Biomarker-based growth equations may be useful for monitoring treatment response and predicting prognosis for pancreatic cancer.

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Copyright © 2021. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Conflicts of interest Dr. Wisnivesky has received consulting honorarium from GSK, Sanofi and Banook and a research grant from Sanofi. Dr. Bates has received consulting honoraria from Pegascy, Inc., and research funding from Pancreatic Cancer Action Network. Dr. Nadkarni receives financial compensation as consultant and advisory board member for RenalytixAI, and owns equity in RenalytixAI and Pensieve Health. He is a scientific co-founder of RenalytixAI and Pensieve Health. Dr. Nadkarni has also received operational funding from Goldfinch Bio and consulting fees from BioVie Inc, AstraZeneca, Reata, Variant Bio and GLG consulting in the past three years.