PROSPECT (Alliance N1048)
PROSPECT showed that most people with intermediate-risk rectal cancer can skip pelvic radiotherapy altogether: chemotherapy alone before surgery, with radiotherapy held back for the few whose tumours did not shrink, cured just as many.
Overview
PROSPECT randomised 1,194 patients with rectal cancer that was locally advanced but not threatening the mesorectal fascia or the sphincter to six cycles of neoadjuvant FOLFOX, with chemoradiation given only if the tumour shrank by less than 20 percent, or to standard fluoropyrimidine chemoradiation. Both groups then had total mesorectal excision and adjuvant chemotherapy.
Five-year disease-free survival was 80.8 percent with FOLFOX and 78.6 percent with chemoradiation, meeting the non-inferiority margin; only 9 percent of the FOLFOX group needed chemoradiation. Local recurrence and overall survival were no different, and patient-reported bowel, sexual and neuropathy outcomes favoured different arms at different times.
The trial removed radiotherapy from the default pathway for a large group of rectal cancer patients and, with RAPIDO, PRODIGE 23 and OPRA, made the treatment of rectal cancer a choice of sequences tailored to risk and to the goal of organ preservation.
- 80.8 vs 78.6 out of 100 alive without the cancer coming back at 5 years with FOLFOX with selective chemoradiation compared with Chemoradiation; 2.2 more per 100.
- Roughly one extra person helped for every 45 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 8 percent lower chance of the event at any given time (hazard ratio 0.92).
- 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: cT2 node-positive, cT3 node-negative or cT3 node-positive rectal cancer suitable for sphincter-sparing surgery: FOLFOX with chemoradiation only for poor responders, versus standard pelvic chemoradiation before surgery. 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.
1,194 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 5 yearsprimary | FOLFOX with selective chemoradiation | 585 | 80.8% | 0.92 | - | link |
| Chemoradiation | 543 | 78.6% |
Similar pages
not linked directly; found by shared links- TrialPRODIGE 23
Shares Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Fluorouracil (5-FU), Capecitabine.
- TrialCAO/ARO/AIO-94 (German Rectal Cancer Study)
Shares Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Fluorouracil (5-FU), IMRT / IGRT (modern external beam).
- TermAbdominoperineal resection
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Colorectal cancer.
- TrialOPRA
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, FOLFOX (5-FU, leucovorin, oxaliplatin).
- TrialRAPIDO
Shares Rectal cancer, Capecitabine, IMRT / IGRT (modern external beam), Colorectal cancer.
- TermTotal neoadjuvant therapy (TNT, rectal cancer)
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Colorectal cancer.
- PersonAngelita Habr-Gama
Shares Chemoradiation (chemoradiotherapy, CRT), Rectal cancer, Colorectal cancer.
- TrialINT-0116 (Macdonald trial)
Shares Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), IMRT / IGRT (modern external beam).