A trial looking at mitotane for adrenal gland cancer (ADIUVO)

Trial design
This trial was for people with adrenal gland cancer who had:

• already had surgery to remove the cancer
• a low or medium chance that their cancer would come back

Some people had mitotane after their operation. They took mitotane tablets 3 times a day for up to 2 years.

Some people didn’t have mitotane after their operation. 

Everyone taking part had regular appointments and scans to check for any signs that their cancer had come back. The research team compared the results for the 2 groups.

Results
There were 91 people in this trial:

• 45 people had mitotane
• 46 people didn’t have mitotane

The research team looked at how many people’s cancer started to grow again. They found it was similar in the two groups:

• 8 out of 45 people who had mitotane
• 11 out of 46 people who didn’t have mitotane 

They also looked at how many people had died. They found it was low in both groups:

• 2 out of 45 people who had mitotane
• 5 out of 46 people who didn’t have mitotane

Side effects
We have been unable to find information about the side effects that the people who took part in this trial had.

We have general information about mitotane, including details of the usual side effects, in our Cancer drugs section. The most common side effects are:

• loss of appetite
• feeling or being sick
• diarrhoea
• extreme tiredness (fatigue)

Conclusion
The trial team found that a small number of people with adrenal gland cancer have a low or medium risk that their cancer will come back. They also found that these people tend to do better than they expected. And that there is no benefit in them having mitotane.

The trial team don’t recommend that mitotane is used as a treatment for this group of people. But even when a trial shows a treatment isn’t useful for a particular cancer, it adds to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below. 

Please note, this article may not be in plain English. It has been written for health care professionals and researchers.

First randomized trial on adjuvant mitotane in adrenocortical carcinoma patients: The Adiuvo study.
A Berruti and others
Journal of Clinical Oncology, 2022. Volume 40, Issue 6.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed ) and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.