{"entity":{"id":"paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023","kind":"paper","name":"ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma","aka":[],"tldr":"After complete removal of a low-grade adrenal cancer, two years of mitotane did not significantly reduce recurrence or improve survival compared with surveillance, and every patient on it had side effects.","summary":"International multicentre open-label randomised phase 3 trial with a parallel observational study: 91 patients with completely resected low- to intermediate-risk adrenocortical carcinoma were randomised to adjuvant mitotane (45) or surveillance (46) between 2008 and 2018, when the trial closed for slow recruitment.\n\nFive-year recurrence-free survival was 79 percent with mitotane against 75 percent with surveillance (hazard ratio 0.74, 95% CI 0.30 to 1.85); five-year overall survival 95 against 86 percent with two and five deaths. All 42 treated patients had adverse events and 19 percent discontinued.","asOf":"2026-09-22","links":[{"label":"Lancet Diabetes Endocrinol 2023","url":"https://doi.org/10.1016/S2213-8587(23)00193-6"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/37619579/"}],"tags":[],"related":[],"cancers":["localised-adrenocortical-carcinoma","adrenocortical"],"sections":[],"technologies":[],"targets":[],"drugs":["mitotane"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["adiuvo"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"The Lancet Diabetes and Endocrinology","year":2023,"doi":"10.1016/S2213-8587(23)00193-6","pmid":"37619579","authors":"Terzolo M, Fassnacht M, Perotti P, et al.","paperType":"rct","findings":["Five-year recurrence-free survival 79 percent (95% CI 67 to 94) versus 75 percent (63 to 90); hazard ratio 0.74 (0.30 to 1.85).","Five-year overall survival 95 percent (89 to 100) versus 86 percent (74 to 100), not significant.","Adverse events in all 42 treated patients; 19 percent discontinued mitotane."],"whatItMeans":"Adjuvant mitotane may be withheld in low-grade localised adrenocortical carcinoma, given the good prognosis and the drug's toxicity.","caveats":["Underpowered after early closure, so a treatment effect cannot be excluded."],"changedPractice":true,"participants":91},"route":"/key-papers/paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023/","neighbours":{"cancer":[{"id":"adrenocortical","kind":"cancer","name":"Adrenocortical carcinoma","route":"/cancers/adrenocortical/"},{"id":"localised-adrenocortical-carcinoma","kind":"cancer","name":"Localised adrenocortical carcinoma (ENSAT stage I to III, resectable)","route":"/cancers/localised-adrenocortical-carcinoma/"}],"drug":[{"id":"mitotane","kind":"drug","name":"Mitotane","route":"/drugs/mitotane/"}],"trial":[{"id":"adiuvo","kind":"trial","name":"ADIUVO","route":"/trials/adiuvo/"}]}}