{"entity":{"id":"paper-moertel-levamisole-fluorouracil-adjuvant-colon-nejm-1990","kind":"paper","name":"Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma","aka":[],"tldr":"The 1990 trial that first showed chemotherapy after a colon cancer operation stops the cancer coming back. It cut recurrences by 41 percent and deaths by a third in node-positive disease.","summary":"Moertel, Fleming, Macdonald and colleagues randomly assigned 1,296 patients with resected colon cancer that was either locally invasive (stage B2) or node-positive (stage C) to observation or to one year of levamisole combined with fluorouracil; stage C patients could also be assigned to levamisole alone. Median follow-up at the time of writing was three years.\n\nToxic effects of levamisole plus fluorouracil were essentially those of fluorouracil alone: nausea, vomiting, stomatitis, diarrhoea, dermatitis and leukopenia, usually not severe. Because most patients were treated by community oncologists, the authors argued the approach would be readily adaptable to conventional practice, and it became the first adjuvant standard in colon cancer.","asOf":"2026-09-24","links":[{"label":"N Engl J Med 1990","url":"https://doi.org/10.1056/NEJM199002083220602"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/2300087/"}],"tags":["colorectal-evidence"],"related":["paper-quasar-adjuvant-chemotherapy-vs-observation-lancet-2007","paper-mosaic-oxaliplatin-adjuvant-colon-nejm-2004"],"cancers":["colorectal","colon-cancer"],"sections":["chemotherapy"],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["fluorouracil","leucovorin"],"companies":[],"institutions":[],"pathways":[],"terms":["neoadjuvant-adjuvant"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":1990,"doi":"10.1056/NEJM199002083220602","pmid":"2300087","authors":"Moertel CG, Fleming TR, Macdonald JS, et al.","paperType":"rct","findings":["In stage C disease, levamisole plus fluorouracil reduced the risk of recurrence by 41 percent (p<0.0001).","The overall death rate was reduced by 33 percent (p approximately 0.006).","Levamisole alone had no detectable effect.","Results in stage B2 disease were equivocal and too preliminary for firm conclusions."],"whatItMeans":"The start of adjuvant treatment for colon cancer. Levamisole was later dropped, but fluorouracil with folinic acid remained the backbone that oxaliplatin was added to in MOSAIC fourteen years later.","caveats":["Three years' median follow-up at publication; the stage B2 question it left open took QUASAR and seventeen more years.","Levamisole, an antihelminthic, was subsequently shown to add nothing and was withdrawn from oncology use."],"changedPractice":true,"participants":1296},"route":"/key-papers/paper-moertel-levamisole-fluorouracil-adjuvant-colon-nejm-1990/","neighbours":{"paper":[{"id":"paper-quasar-adjuvant-chemotherapy-vs-observation-lancet-2007","kind":"paper","name":"Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study (QUASAR)","route":"/key-papers/paper-quasar-adjuvant-chemotherapy-vs-observation-lancet-2007/"},{"id":"paper-mosaic-oxaliplatin-adjuvant-colon-nejm-2004","kind":"paper","name":"Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer (MOSAIC)","route":"/key-papers/paper-mosaic-oxaliplatin-adjuvant-colon-nejm-2004/"}],"cancer":[{"id":"colon-cancer","kind":"cancer","name":"Colon cancer (adenocarcinoma of the colon)","route":"/cancers/colon-cancer/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","route":"/drugs/fluorouracil/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"}],"term":[{"id":"neoadjuvant-adjuvant","kind":"term","name":"Neoadjuvant / adjuvant / perioperative","route":"/terms/neoadjuvant-adjuvant/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}]}}