Multinational phase 3 trial of adjuvant mitotane versus surveillance in low-grade, localized adrenocortical carcinoma

Adjuvant treatment with mitotane is commonly used after resection of adrenocortical carcinoma (ACC); however, treatment remains controversial, particularly if risk of recurrence is not high. The phase 3 ADIUVO trial, at 23 centers across seven countries, randomized ACC patients with low or intermediate risk of recurrence after resection to adjuvant mitotane or surveillance. Adjuvant mitotane did not significantly improve recurrence-free or overall survival. All patients in the mitotane group had adverse events, resulting in discontinuation in 19% of patients. The authors conclude that adjuvant mitotane might not be indicated for this patient population.