# PANOPTIMOX-PRODIGE 35

Source: https://onco.cc/trials/panoptimox-prodige-35/  
OnCo record `panoptimox-prodige-35` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

PANOPTIMOX showed that people whose pancreatic cancer is controlled after four months of FOLFIRINOX can drop to a gentler fluorouracil maintenance without losing survival, living longer before their quality of life fell; the alternating gemcitabine strategy did worse.

## Summary

PANOPTIMOX-PRODIGE 35 randomised 276 patients (mean age 63) between January 2015 and November 2016: arm A six months of FOLFIRINOX (91), arm B four months of FOLFIRINOX then leucovorin plus fluorouracil maintenance in controlled patients (92), arm C sequential gemcitabine and FOLFIRI.3 alternating every two months (90). Six-month progression-free survival was 47.1, 42.9 and 34.1 percent and median overall survival 10.1, 11.2 and 7.3 months. Median survival without deterioration in quality-of-life scores was 11.4 months in the maintenance arm against 7.2 and 7.5 months, but grade 3 or 4 neurotoxicity was higher with maintenance (19.8 against 10.2 percent), probably because more oxaliplatin was delivered (92 against 83 percent of the target dose). The maintenance strategy became an accepted way to give FOLFIRINOX and the platform on which POLO-style maintenance questions sit for patients without a BRCA mutation.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-24
- Also known as: PRODIGE 35; PANOPTIMOX
- Registry id: NCT02352337
- Phase: 2
- Setting: Untreated metastatic pancreatic cancer in France: six months of FOLFIRINOX, against four months of FOLFIRINOX then leucovorin and fluorouracil maintenance with oxaliplatin reintroduced on progression, against alternating gemcitabine and FOLFIRI.3 every two months, with six-month progression-free survival as the primary endpoint
- Sponsor: Federation Francophone de Cancerologie Digestive (FFCD)
- Enrolled: 276
- Result: Six-month progression-free survival 47.1 percent (six months of FOLFIRINOX), 42.9 percent (four months then fluorouracil maintenance) and 34.1 percent (alternating gemcitabine and FOLFIRI.3); median overall survival 10.1, 11.2 and 7.3 months.
- Outcomes: Progression-free survival at 6 months: FOLFIRINOX 6 months 47.1% vs FOLFIRINOX 4 months then LV5FU2 maintenance 42.9% vs Alternating gemcitabine and FOLFIRI.3 34.1%; Overall survival: FOLFIRINOX 6 months 10.1 months vs FOLFIRINOX 4 months then LV5FU2 maintenance 11.2 months vs Alternating gemcitabine and FOLFIRI.3 7.3 months

## Sources

- ClinicalTrials.gov NCT02352337: https://clinicaltrials.gov/study/NCT02352337
- Dahan et al., PANOPTIMOX-PRODIGE 35 (JCO 2021): https://doi.org/10.1200/JCO.20.03329

## Connected records

- cancers: [Metastatic pancreatic ductal adenocarcinoma](https://onco.cc/cancers/metastatic-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [FOLFIRINOX / mFOLFIRINOX](https://onco.cc/drugs/folfirinox/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/)
- terms: [Maintenance therapy](https://onco.cc/terms/maintenance-therapy/), [Peripheral neuropathy (chemotherapy-induced)](https://onco.cc/terms/peripheral-neuropathy/), [Quality of life](https://onco.cc/terms/quality-of-life/)
- trials: [POLO](https://onco.cc/trials/polo/)

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