PRODIGE 23: induction FOLFIRINOX before chemoradiotherapy and surgery for locally advanced rectal cancer
Six cycles of FOLFIRINOX chemotherapy before standard chemoradiation and surgery reduced metastases and improved disease-free survival in locally advanced rectal cancer, and longer follow-up showed a survival benefit.
Overview
Phase 3 trial of 461 patients with cT3 or cT4 rectal adenocarcinoma randomised to induction mFOLFIRINOX followed by chemoradiotherapy, surgery and three months of adjuvant chemotherapy, or chemoradiotherapy, surgery and six months of adjuvant chemotherapy.
Three-year disease-free survival was 76 versus 69 percent (hazard ratio 0.69), pathological complete response 28 versus 12 percent, and the seven-year update showed improved overall survival (81.9 versus 76.1 percent).
- Three-year disease-free survival 76 percent vs 69 percent; hazard ratio 0.69.
- Seven-year overall survival 81.9 percent vs 76.1 percent.
Induction FOLFIRINOX-based total neoadjuvant therapy is a preferred strategy for locally advanced rectal cancer, and the first to show a survival gain.
- Total treatment burden is high; FOLFIRINOX toxicity requires fit patients.
- Compared against a control arm receiving six months of adjuvant chemotherapy, which many patients do not complete.