Head-to-head comparison of FOLFIRINOX versus gemcitabine plus nab-paclitaxel in advanced pancreatic cancer: a target trial emulation using real-world data

Purpose: To emulate a hypothetical target trial assessing the effect of initiating 5-fluorouracil, folinic acid, irinotecan, and oxaliplatin (FOLFIRINOX) versus gemcitabine plus nab-paclitaxel (GN) within 8 weeks of diagnosis on overall survival.Methods: An observational cohort study was conducted using population-level data from Alberta, Canada. Individuals diagnosed with advanced pancreatic cancer between April 2015 and December 2019 were identified through the provincial cancer registry and followed until March 2021. Records were linked to other administrative databases containing information on relevant variables. Individuals were excluded if they did not have adequate hemoglobin, platelet, white blood cell, and serum creatinine measures or if they received prior therapy. The observational analog of the per-protocol effect was estimated using inverse probability weighted Kaplan-Meier curves with bootstrapped 95% confidence intervals.Results: Four hundred seven individuals were eligible. The weighted median overall survival was 8.3 months (95% CI, 5.7-11.9) for FOLFIRINOX and 5.1 months (95% CI: 4.3 to 5.8) for GN. The adjusted difference in median overall survival was 3.2 months (95% CI, 1.1-7.4) and the mortality hazard ratio was 0.78 (95% CI, 0.61-0.97). Conclusions: Our estimates favored the initiation of FOLFIRINOX over GN with respect to overall survival. (c) 2022 Elsevier Inc. All rights reserved.

Automated summary

This study aimed to simulate a hypothetical target trial to assess the effect of initiating FOLFIRINOX versus GN within 8 weeks of diagnosis on overall survival in advanced pancreatic cancer patients. The observational cohort study used population-level data from Alberta, Canada. The results showed that FOLFIRINOX had a longer median overall survival compared to GN, with an adjusted difference of 3.2 months and a mortality hazard ratio of 0.78. These findings support the initiation of FOLFIRINOX for improved overall survival in patients with advanced pancreatic cancer.