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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.
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.
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 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% |
Shares International Watch & Wait Database, CAO/ARO/AIO-12, Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU).
Shares Dutch TME trial, CAO/ARO/AIO-12, Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU).
Shares International Watch & Wait Database, CAO/ARO/AIO-12, Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT).
Shares Dutch TME trial, International Watch & Wait Database, Capecitabine, Rectal cancer.
Shares Alliance for Clinical Trials in Oncology, FOLFOX (5-FU, leucovorin, oxaliplatin), Fluorouracil (5-FU), Capecitabine.
Shares Dutch TME trial, Rectal cancer, IMRT / IGRT (modern external beam), Colorectal cancer.
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), Fluorouracil (5-FU), Rectal cancer.
Shares Total mesorectal excision (TME), Chemoradiation (chemoradiotherapy, CRT), FOLFOX (5-FU, leucovorin, oxaliplatin), Capecitabine.