# Conroy 2011: FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer (PRODIGE 4/ACCORD 11)

Source: https://onco.cc/key-papers/paper-conroy-folfirinox-pancreatic-nejm-2011/  
OnCo record `paper-conroy-folfirinox-pancreatic-nejm-2011` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A four-drug chemotherapy combination gave fit patients with metastatic pancreatic cancer clearly longer survival than the standard gemcitabine, the first real improvement in the disease in over a decade, at the cost of more side effects.

## Summary

This French phase 2-3 trial randomised 342 patients with metastatic pancreatic adenocarcinoma and good performance status to FOLFIRINOX (oxaliplatin, irinotecan, leucovorin and fluorouracil) or gemcitabine. FOLFIRINOX improved overall survival, progression-free survival and response rate, and delayed the decline in quality of life despite more grade 3 and 4 toxicity, particularly neutropenia, febrile neutropenia, diarrhoea and sensory neuropathy. It made FOLFIRINOX a first-line standard for fit patients and the backbone later moved into the adjuvant setting.

## Fields

- Kind: Key paper
- Last checked: 2026-09-08
- Journal: New England Journal of Medicine
- Year: 2011
- DOI: 10.1056/NEJMoa1011923
- Authors: Conroy T, Desseigne F, Ychou M, et al.
- Findings: 342 patients with metastatic pancreatic cancer and ECOG performance status 0 or 1; FOLFIRINOX vs gemcitabine.; Median overall survival 11.1 vs 6.8 months, hazard ratio 0.57.; Median progression-free survival 6.4 vs 3.3 months, hazard ratio 0.47; response rate 31.6% vs 9.4%.; Grade 3 or 4 neutropenia 45.7% vs 21.0%, febrile neutropenia 5.4% vs 1.2%, sensory neuropathy 9.0% vs 0%.
- What it means: FOLFIRINOX and, soon after, gemcitabine plus nab-paclitaxel ended the era of single-agent gemcitabine for metastatic pancreatic cancer. The regimen's modified form later improved survival after surgery in PRODIGE 24, and its toxicity is why fitness, not just stage, decides which treatment a patient is offered.
- Caveats: Restricted to fit patients under 76 with good performance status; most patients with pancreatic cancer are not eligible.; Toxicity is substantial and needs experienced supportive care.; Open-label design.

## Sources

- Full text (DOI): https://doi.org/10.1056/NEJMoa1011923
- ClinicalTrials.gov NCT00112658: https://clinicaltrials.gov/study/NCT00112658

## Connected records

- key papers: [Burris 1997: gemcitabine becomes the first standard treatment for advanced pancreatic cancer](https://onco.cc/key-papers/paper-burris-gemcitabine-pancreatic-jco-1997/), [MPACT (Von Hoff 2013): nab-paclitaxel plus gemcitabine for metastatic pancreatic cancer](https://onco.cc/key-papers/paper-mpact-nab-paclitaxel-gemcitabine-nejm-2013/), [Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial](https://onco.cc/key-papers/paper-napoli-1-nanoliposomal-irinotecan-lancet-2016/), [Pancreatic cancer](https://onco.cc/key-papers/paper-hidalgo-pancreatic-cancer-review-nejm-2010/)
- cancers: [Borderline resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/borderline-resectable-pdac/), [Locally advanced unresectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/locally-advanced-pdac/), [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Irinotecan (and liposomal irinotecan)](https://onco.cc/drugs/irinotecan/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- terms: [Febrile neutropenia](https://onco.cc/terms/febrile-neutropenia/), [Overall survival (OS)](https://onco.cc/terms/os/), [Progression-free survival (PFS)](https://onco.cc/terms/pfs/)
- trials: [PRODIGE 24 / CCTG PA6](https://onco.cc/trials/prodige-24/)
- people: [Thierry Conroy](https://onco.cc/people/thierry-conroy/)
- roadmaps: [Pancreatic cancer roadmap: from Whipple's operation to gemcitabine, FOLFIRINOX, adjuvant chemotherapy, PARP inhibition, KRAS inhibition, vaccines and the surveillance question](https://onco.cc/roadmaps/pancreatic-roadmap/)

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