Single-center phase 2 trial of perioperative mFOLFIRINOX for resectable pancreatic ductal adenocarcinoma

Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignant tumor, and durable disease control is rare with the current standard of care, even for patients who undergo surgical resection. A phase 2 trial at Yale University School of Medicine (New Haven, CT) evaluated perioperative mFOLFIRINOX for resectable PDAC. The trial included 46 patients who received 6 cycles of neoadjuvant mFOLFIRINOX, followed by surgery and 6 cycles of adjuvant mFOLFIRINOX. The 12-months progression-free survival rate was 67%, which met the primary end point of a 12-months PFS rate of 50% or greater. Detectable circulating tumor DNA levels, high tumor keratin 17 expression, and mutational signature SBS15 were associated with decreased survival. The authors conclude that perioperative mFOLFIRINOX was safe and effective, with a clinically meaningful improvement in survival compared with historical controls.