ADIUVO: adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma
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.
Overview
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.
- 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.
Adjuvant mitotane may be withheld in low-grade localised adrenocortical carcinoma, given the good prognosis and the drug's toxicity.
- Underpowered after early closure, so a treatment effect cannot be excluded.
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