PRODIGE-23 original
Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial UNICANCER-PRODIGE 23, page 1
Publication information
Lancet, 2021 5 French hospitals (comprehensive cancer centres, university hospitals, private hospitals, and public hospital
Hypothesis:
Methods
Design
Inclusion
Staged cT3 (at risk of local recurrence + MDT recommended preoperative chemoradiotherapy) or cT4.
Primary outcome
DFS 3y
Procedure
FOLFIRINOX + LCCR + TME + FOLFOX3m vs LCCR + TME + FOLFOX6m
Outcome
Results
Population
461, 231 exp, 230 standard
Primary endpoint
DFS - Exp 76% vs Standarf 69% Metastasis-free survival 78.8% vs 71.7% OS 90.8% vs 87.7%
Take home
Improved DFS
PRODIGE-23 7years
Oral abstract only: PRODIGE-23 7 years, page 1
DFS - The absolute increase in 5-year survival were 7.6% for Disease-Free Survival (DFS), 6.9% for Overall Survival (OS), 9.9% for Metastasis-Free Survival (MFS), and 5.7% for Cancer Specific Survival (CSS). 7-year cumulative incidence of locoregional relapses are 5.3% in Exp vs 8.1% Standard of care (p= 0.38)
Double pCR in Exp group 12.1 to 27.8%
Take home:
Improved DFS, OS, MFS, CSS. No difference in local relapse.