Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study
An erratum to this article was published (Lancet Diabetes Endocrinol, Dec 2023 ↗)
- Discontinued prematurely due to slow recruitment
Authors' conclusion
Adjuvant mitotane might not be indicated in patients with low-grade, localised adrenocortical carcinoma considering the relatively good prognosis of these patients, and no significant improvement in recurrence-free survival and treatment-associated toxicity in the mitotane group. However, the study was discontinued prematurely due to slow recruitment and cannot rule out an efficacy of treatment.
Study context
- Population
- Adults ≥18 years with adrenocortical carcinoma at low to intermediate risk of recurrence (R0, stage I–III, Ki67 ≤10%) after complete resection; 23 centres in seven countriesrandomised
- Participants
- 45 vs 46
- Comparison
- Adjuvant mitotane vs surveillance alone after complete resection
- Mitotanen = 45
- Surveillancen = 46reference
- Primary endpoint
- Recurrence-free survival (time from randomisation to first radiological recurrence or death from any cause), ITT
Methodological detailsinternational, multicentre, open-label, parallel, phase 3, with observational study
- International
- Multicentre
- Open-label
- Parallel
- Phase 3
- With observational study
Primary result
5-year recurrence-free survival · 5 years
HR for recurrence or death
0.74
95% CI 0.30–1.85
By group
Mitotanevs Surveillance
HR for recurrence or death 0.74 (95% CI 0.30–1.85)
As reported in the abstract
Secondary outcomes
| Outcome | Mitotane | Surveillance |
|---|---|---|
| 5-year overall survival · events = deaths | 95% (95% CI 89–100) | 86% (95% CI 74–100) |
5-year overall survival
- 5-year OS not significantly different
Safety
- Patients receiving mitotane with adverse events
- All 42
- Discontinued mitotane
- eight (19%)
- Grade 4 adverse events or treatment-related deaths
- 0
Original publication
Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study. Lancet Diabetes Endocrinol. Published 21 August 2023. doi:10.
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