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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.
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.
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 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% |
Shares International Watch & Wait Database, CAO/ARO/AIO-94 (German Rectal Cancer Study), STELLAR (rectal cancer), Randomise organ preservation against surgery in mismatch repair-proficient rectal cancer, with bowel function as a co-primary endpoint and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.
Shares Chemoradiation (chemoradiotherapy, CRT), IMRT / IGRT (modern external beam) and the tag radiation-wave4.