ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma
In the first randomised trial of the adrenal-toxic drug mitotane after surgery, patients whose adrenocortical carcinoma had been fully removed and had a low proliferation rate did no better with two years of mitotane than with observation.
Overview
International open-label randomised phase 3 trial of 91 patients with completely resected stage I to III adrenocortical carcinoma and Ki-67 of 10 percent or less, assigned to adjuvant mitotane for two years or active surveillance, with a parallel observational cohort of patients who declined randomisation.
Five-year recurrence-free survival was similar (about 79 percent with mitotane and 75 percent with surveillance) and overall survival did not differ, while mitotane caused frequent adverse effects. The trial supports omitting mitotane in this low-risk group.
- Five-year recurrence-free survival about 79 percent with mitotane versus 75 percent with surveillance; no significant difference.
- No difference in overall survival; mitotane caused frequent adverse events.
Patients with completely resected, low-proliferation adrenocortical carcinoma can be spared adjuvant mitotane; it remains recommended for higher-risk disease on retrospective evidence.
- Slow accrual left the trial underpowered and it closed with 91 of 200 planned patients.
- Applies only to the low-recurrence-risk group defined by complete resection and Ki-67 of 10 percent or less.
Similar pages
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