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Neoadjuvant FOLF(IRIN)OX Chemotherapy for Resectable Pancreatic Adenocarcinoma: A Multicenter Randomized
Lilian Schwarz1,2, Jean-Baptiste Bachet3, Aurelia Meurisse4,5
1Department of Digestive Surgery, Rouen University Hospital, Rouen, France.
Summary
Neoadjuvant chemotherapy (NAC) with mFOLFIRINOX is feasible and effective for resectable pancreatic cancer, improving treatment completion and survival. This supports its use in ongoing clinical trials for pancreatic adenocarcinoma.
Area of Science:
- Oncology
- Gastroenterology
- Clinical Trials
Background:
- Neoadjuvant chemotherapy (NAC) shows promise for resectable pancreatic adenocarcinoma (rPAC).
- Limited prospective data exist on completing NAC and its oncologic outcomes.
- The PANACHE01-PRODIGE48 trial investigated NAC regimens for rPAC.
Purpose of the Study:
- To evaluate the feasibility and efficacy of neoadjuvant chemotherapy (NAC) regimens in resectable pancreatic adenocarcinoma (rPAC).
- To assess 1-year overall survival (OS) and therapeutic sequence completion rates.
- To compare event-free survival (EFS) between NAC arms and upfront surgery.
Main Methods:
- Phase II trial with 153 patients randomized to mFOLFIRINOX, FOLFOX, or upfront surgery.
- Primary endpoints: 1-year OS and completion of the full therapeutic sequence.
- Secondary endpoint: Event-free survival (EFS) including progression, unresectable disease, recurrence, or death.
Main Results:
- Modified FOLFIRINOX (mFOLFIRINOX) achieved primary objectives; 70.8% completed therapy, with 84.3% alive at 1 year.
- FOLFOX arm showed lack of efficacy and was stopped early.
- One-year EFS rates: 51.4% (mFOLFIRINOX), 43.1% (FOLFOX), and 38.7% (control).
Conclusions:
- Neoadjuvant mFOLFIRINOX is feasible and effective in the perioperative setting for rPAC.
- Results support ongoing trials investigating NAC for pancreatic cancer.
- Further research is needed to identify optimal patient selection for NAC.
