OPRA
OPRA showed that about half of people with rectal cancer who receive all their chemotherapy and radiotherapy before surgery can keep their rectum without any drop in the chance of cure, and that giving the chemotherapy after the radiotherapy preserves more rectums.
Overview
OPRA randomised 324 patients with MRI-staged stage II or III rectal cancer to induction FOLFOX or CAPOX followed by chemoradiation, or to chemoradiation followed by consolidation FOLFOX or CAPOX. Patients with a clinical complete or near-complete response were offered watch and wait rather than total mesorectal excision.
Three-year disease-free survival was 76 percent in both arms, no different from the historical rate with chemoradiation and surgery. Three-year survival without total mesorectal excision was 41 percent with induction chemotherapy and 53 percent with consolidation chemotherapy; regrowth after watch and wait was salvaged by surgery in almost every case without loss of disease control.
OPRA made organ preservation a planned outcome of rectal cancer treatment rather than a chance finding, and the consolidation sequence is now the preferred order when the goal is to avoid surgery.
- 41 vs 53 out of 100 reached this endpoint at 3 years with Induction chemotherapy then chemoradiation compared with Chemoradiation then consolidation chemotherapy; 12 fewer per 100.
- On this measure the first group did worse, not better.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 76 vs 76 out of 100 alive without the cancer coming back at 3 years with Induction chemotherapy then chemoradiation compared with Chemoradiation then consolidation chemotherapy; 0 more per 100.
- No difference between the groups on this measure.
- 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: Stage II or III rectal adenocarcinoma: total neoadjuvant therapy as induction chemotherapy then chemoradiation, or chemoradiation then consolidation chemotherapy, with watch and wait offered to patients whose tumour disappeared. 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.
324 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Survival without total mesorectal excision at 3 yearsprimary | Induction chemotherapy then chemoradiation | 158 | 41% | - | - | link |
| Chemoradiation then consolidation chemotherapy | 166 | 53% | ||||
| Disease-free survival at 3 years | Induction chemotherapy then chemoradiation | 158 | 76% | - | - | link |
| Chemoradiation then consolidation chemotherapy | 166 | 76% |
Similar pages
not linked directly; found by shared links- TrialPROSPECT (Alliance N1048)
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, FOLFOX (5-FU, leucovorin, oxaliplatin).
- Key paperSauer 2004: chemoradiotherapy before rather than after surgery for rectal cancer (CAO/ARO/AIO-94)
Shares Total neoadjuvant therapy (TNT, rectal cancer), Organ preservation (watch-and-wait, bladder-sparing, larynx preservation), Chemoradiation (chemoradiotherapy, CRT), Colorectal cancer.
- PersonAngelita Habr-Gama
Shares Organ preservation (watch-and-wait, bladder-sparing, larynx preservation), Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Colorectal cancer.
- TermAbdominoperineal resection
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Colorectal cancer.
- TrialCAO/ARO/AIO-94 (German Rectal Cancer Study)
Shares Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, IMRT / IGRT (modern external beam), Colorectal cancer.
- TrialAZUR-1
Shares Clinical complete response (cCR), Rectal cancer, Memorial Sloan Kettering Cancer Center, Colorectal cancer.
- TrialPRODIGE 23
Shares Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, IMRT / IGRT (modern external beam), Colorectal cancer.
- TermStoma (colostomy, ileostomy, urostomy)
Shares Organ preservation (watch-and-wait, bladder-sparing, larynx preservation), Rectal cancer, Colorectal cancer.