PRODIGE 23
In locally advanced rectal cancer, does neoadjuvant mFOLFIRINOX-based total treatment improve outcomes compared with standard preoperative chemoradiotherapy?
Trial design and population
Key results
At 3 years, DFS was 76% with the intensified neoadjuvant strategy vs 69% with standard treatment (HR 0.69, 95% CI 0.49–0.97; P=.034). Pathological complete response was about 27.8% vs 12.1%.
Source-reported outcome visualization
3-year disease-free survival · 3 years
Bars are scaled to the larger reported group value; endpoint, unit and horizon are labelled. Values are source-reported, not estimated from medians.
Absolute Effect
Absolute 3-year DFS gain 7 percentage points; NNT 15 based on 3-year DFS.
NNT: 15 based on 3-year DFS. Use only at the stated endpoint/time horizon; median survival differences are not converted into NNT.
NNH: Not quantifiable. Grade 3–4 neutropenia, diarrhoea, neuropathy and other triplet chemotherapy toxicities increase treatment burden; irinotecan diarrhoea and oxaliplatin neuropathy require active management.
Time-to-event hazard ratios and median survival are not treated as absolute risk differences. Where no defensible fixed-time NNT/NNH is available, the source-reported endpoint is visualized instead.
Safety and treatment burden
Grade 3–4 neutropenia, diarrhoea, neuropathy and other triplet chemotherapy toxicities increase treatment burden; irinotecan diarrhoea and oxaliplatin neuropathy require active management.
Follow-up, maturity and limitations
Follow-up: Primary report median follow-up approximately 46 months; long-term updates have followed.
Requires fitness for triplet chemotherapy. Control strategy predates some modern total-neoadjuvant options; MRI risk assessment and patient selection matter.
Clinical interpretation
Current-practice context · reviewed 20 October 2026
This page separates the original trial findings from contemporary treatment sequencing. Confirm current guidelines, local regulatory status, biomarker requirements, prior treatment exposure and patient-specific contraindications before applying the evidence. Historical comparators may no longer represent the current standard; subgroup findings and immature endpoints are labelled rather than generalized.