# ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma

Source: https://onco.cc/key-papers/paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023/  
OnCo record `paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

Five-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.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Journal: The Lancet Diabetes and Endocrinology
- Year: 2023
- DOI: 10.1016/S2213-8587(23)00193-6
- Authors: Terzolo M, Fassnacht M, Perotti P, et al.
- 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.
- What it means: 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.

## Sources

- Lancet Diabetes Endocrinol 2023: https://doi.org/10.1016/S2213-8587(23)00193-6
- PubMed: https://pubmed.ncbi.nlm.nih.gov/37619579/

## Connected records

- cancers: [Adrenocortical carcinoma](https://onco.cc/cancers/adrenocortical/), [Localised adrenocortical carcinoma (ENSAT stage I to III, resectable)](https://onco.cc/cancers/localised-adrenocortical-carcinoma/)
- drugs: [Mitotane](https://onco.cc/drugs/mitotane/)
- trials: [ADIUVO](https://onco.cc/trials/adiuvo/)

---
JSON: https://onco.cc/api/v1/entities/paper-adiuvo-adjuvant-mitotane-low-grade-acc-terzolo-lancet-diabetes-endocrinol-2023.json