PRODIGE 23
PRODIGE 23 showed that six cycles of intensive chemotherapy before chemoradiation improves disease-free survival in rectal cancer and, on longer follow-up, overall survival, the second pillar of total neoadjuvant therapy.
Overview
PRODIGE 23 randomised 461 patients with cT3 or cT4 rectal cancer to standard capecitabine chemoradiation followed by surgery and six months of adjuvant chemotherapy, or to six cycles of induction mFOLFIRINOX before the same sequence. Three-year disease-free survival was 76 percent with induction chemotherapy versus 69 percent (hazard ratio 0.69), pathological complete response rose from 12 to 28 percent (Conroy and colleagues, Lancet Oncology 2021), and seven-year results showed an overall survival gain.
- 76 vs 69 out of 100 alive without the cancer coming back at 3 years with Induction mFOLFIRINOX then chemoradiation compared with Chemoradiation first; 7 more per 100.
- Roughly one extra person helped for every 14 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Locally advanced rectal cancer: induction mFOLFIRINOX then chemoradiation, surgery and adjuvant chemotherapy, versus chemoradiation, surgery and adjuvant chemotherapy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
461 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 3 yearsprimary | Induction mFOLFIRINOX then chemoradiation | 231 | 76% | - | - | - |
| Chemoradiation first | 230 | 69% |
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