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Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized
Thorsten O Goetze1,2,3, Alexander Reichart4, Ulli S Bankstahl4
1Krankenhaus Nordwest, Institut für Klinisch Onkologische Forschchung IKF, University Cancer Center (UCT) Frankfurt, Frankfurt, Germany. Goetze.thortsen@ikf-khnw.de.
Annals of Surgical Oncology
|March 8, 2024
Summary
Perioperative FOLFIRINOX shows potential for resectable pancreatic cancer, with improved progression-free survival but comparable overall survival. Patient selection is key for this treatment approach.
Area of Science:
- Oncology
- Gastroenterology
- Surgical Oncology
Background:
- Pancreatic cancer prognosis remains poor despite adjuvant chemotherapy.
- The NEPAFOX trial investigated perioperative FOLFIRINOX for resectable pancreatic cancer.
Purpose of the Study:
- To evaluate the efficacy and safety of perioperative FOLFIRINOX compared to upfront surgery plus adjuvant gemcitabine in resectable pancreatic cancer.
- To assess overall survival as the primary endpoint.
Main Methods:
- A multicenter phase II trial randomized patients with resectable or borderline resectable pancreatic cancer.
- Arm A: upfront surgery plus adjuvant gemcitabine. Arm B: perioperative FOLFIRINOX.
- Recruitment was stopped early due to poor accrual (40 of 126 planned patients).
Main Results:
- Median progression-free survival was nearly doubled in the perioperative FOLFIRINOX arm (14.1 months) versus adjuvant gemcitabine (8.4 months) in surgically resected patients.
- R0-resection rates were similar (77% vs 71%).
- Perioperative morbidity was lower in the FOLFIRINOX arm (46%) compared to the adjuvant gemcitabine arm (72%).
Conclusions:
- Perioperative FOLFIRINOX appears feasible and potentially effective in selected pancreatic cancer patients, despite small study numbers.
- No significant safety concerns regarding surgical complications were noted with perioperative FOLFIRINOX.
- Careful patient selection for neoadjuvant therapy is critical in pancreatic cancer management.
