NORPACT-1: neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer
Giving FOLFIRINOX before surgery did not help people with clearly resectable pancreatic head cancer: fewer were alive at 18 months than those who went straight to surgery.
Overview
Nordic multicentre randomised phase 2 trial: 140 patients with resectable pancreatic head cancer were assigned to four cycles of neoadjuvant FOLFIRINOX then surgery and adjuvant chemotherapy (77) or upfront surgery and adjuvant chemotherapy (63). The primary endpoint was survival at 18 months by intention to treat.
60 percent of the neoadjuvant group were alive at 18 months against 73 percent of the upfront surgery group (p 0.032); median overall survival was 25.1 against 38.5 months (hazard ratio 1.52). Resection rates were 82 and 89 percent; grade 3 or worse adverse events occurred in 58 and 40 percent.
- Alive at 18 months: 60 percent (95% CI 49 to 71) versus 73 percent (62 to 84), p 0.032.
- Median overall survival 25.1 versus 38.5 months; hazard ratio 1.52 (1.00 to 2.33), p 0.050.
- Only 61 of 77 (79 percent) neoadjuvant patients received neoadjuvant therapy.
Upfront surgery followed by adjuvant chemotherapy remains standard for clearly resectable pancreatic cancer; neoadjuvant treatment belongs in trials or borderline disease.
- Phase 2 with a small sample; a fifth of the neoadjuvant arm never received the assigned treatment.
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