PROSPECT: neoadjuvant FOLFOX with selective use of chemoradiotherapy for locally advanced rectal cancer
For rectal cancers of intermediate risk suitable for sphincter-sparing surgery, six cycles of FOLFOX chemotherapy, with radiotherapy only if the tumour did not shrink, was as effective as routine chemoradiation and spared nine in ten patients pelvic radiotherapy.
Overview
Phase 3 non-inferiority trial of 1,194 patients with cT2 node-positive, cT3 node-negative or cT3 node-positive rectal cancer candidates for sphincter-sparing surgery, randomised to neoadjuvant FOLFOX with chemoradiotherapy only for poor response, or standard pelvic chemoradiotherapy.
Five-year disease-free survival was 80.8 versus 78.6 percent (non-inferior), local recurrence 1.8 versus 1.6 percent, and only 9 percent of FOLFOX patients needed chemoradiotherapy; quality of life differed in bowel, sexual and neuropathy domains by arm.
- Five-year disease-free survival 80.8 percent vs 78.6 percent (non-inferior).
- Chemoradiotherapy avoided in 91 percent of the FOLFOX arm.
Selected patients with intermediate-risk rectal cancer can avoid radiotherapy altogether, with chemotherapy alone before surgery, trading neuropathy for better long-term bowel and sexual function.
- Excluded T4 tumours, threatened mesorectal fascia and low tumours needing abdominoperineal resection.
- Non-inferiority margin allowed a modest loss of efficacy.