First randomized trial on adjuvant mitotane in adrenocortical carcinoma patients: The Adjuvo study.

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Published: 21 Feb 2022
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Prof Alfredo Berruti - University Of Brescia, Brescia, Italy

Prof Alfredo Berruti talks to ecancer about his talk at ASCO GU 2022, First randomised trial on adjuvant mitotane in adrenocortical carcinoma patients: The Adjuvo study.

He begins by explaining that adrenocortical carcinoma is an extremely rare and aggressive disease with estimated incidents in western countries being around 0.72 per 1,000,000 per year. Even after surgery, patients are at high risk of relapse, so adjuvant therapy is recommended by international guidelines for patients with high-risk overlap. The ADIUVO study was undertaken to show whether mitotane administered in an adjuvant setting is efficacious in the subset of patients with low intermediate risk of relapse.

Prof Berruti then goes on to explain the most important finding of this study was that patients meeting the eligibility criteria of the trial depicted a relatively good prognosis with a relapse-free survival (RFS) rate after 5 years of 75%. This was unexpected but is good news for the patients. In this patient subset mitotane therapy failed to demonstrate a significant advantage in terms of RFS or overall survival (OS) with respect to observation. However, the number of events were low, as only 19 relapses were observed during a follow-up of 48 months. 7 deaths were recorded.

He concludes by saying it’s important to continue follow-up of these patients because this is the first randomised clinical trial ever conducted in an adjuvant setting for this extremely rare disease.