{"entity":{"id":"paper-prospect-nejm-2023","kind":"paper","name":"PROSPECT: neoadjuvant FOLFOX with selective use of chemoradiotherapy for locally advanced rectal cancer","aka":[],"tldr":"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.","summary":"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.\n\nFive-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.","asOf":"2026-09-17","links":[{"label":"N Engl J Med 2023","url":"https://doi.org/10.1056/NEJMoa2303269"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37272534/"}],"tags":[],"related":[],"cancers":["rectal-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["prospect"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2023,"doi":"10.1056/NEJMoa2303269","pmid":"37272534","authors":"Schrag D, Shi Q, Weiser MR, et al.","paperType":"rct","findings":["Five-year disease-free survival 80.8 percent vs 78.6 percent (non-inferior).","Chemoradiotherapy avoided in 91 percent of the FOLFOX arm."],"whatItMeans":"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.","caveats":["Excluded T4 tumours, threatened mesorectal fascia and low tumours needing abdominoperineal resection.","Non-inferiority margin allowed a modest loss of efficacy."],"changedPractice":true,"participants":1194},"route":"/key-papers/paper-prospect-nejm-2023/","neighbours":{"cancer":[{"id":"rectal-cancer","kind":"cancer","name":"Rectal cancer","route":"/cancers/rectal-cancer/"}],"trial":[{"id":"prospect","kind":"trial","name":"PROSPECT (Alliance N1048)","route":"/trials/prospect/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}]}}