Multinational randomized phase 2 trial of neoadjuvant FOLFIRINOX versus upfront surgery for resectable PDAC

In patients undergoing resection for pancreatic cancer, adjuvant FOLFIRINOX improves overall survival compared with alternative chemotherapy regimens. The randomized phase 2 NORPACT-1 trial, at 12 centers in Denmark, Finland, Norway, and Sweden, compared outcomes after neoadjuvant FOLFIRINOX followed by surgery and adjuvant chemotherapy versus outcomes after upfront surgery and adjuvant chemotherapy for resectable PDAC. In the per protocol analysis, percentage of patients alive at 18 months was 57% with neoadjuvant FOLFIRINOX versus 70% with upfront surgery (p=0.14), while the median overall survival was 23.0 months versus 34.4 months (HR 1.46; p=0.058). At least one grade 3 or higher treatment-related adverse event was seen in 58% of patients in the neoadjuvant FOLFIRINOX group and 40% of patients in the upfront surgery group. The authors conclude that the trial did not show a survival benefit from neoadjuvant FOLFIRINOX in resectable PDAC when compared with upfront surgery.