Researchers from the University of Edinburgh and University of Texas MD Anderson Cancer Center carried out a randomised clinical trial involving 260 women from the UK and USA with low serous grade ovarian cancer. As part of the study, 130 women received trametinib and 130 received standard care of either hormone therapy or chemotherapy. Each study participant and clinician knew what was being prescribed. The effect on the tumours were then assessed using CT or MRI scans every eight weeks for the first 15 months of treatment and every three months after. Study participants also completed questionnaires on quality of life throughout the study and had pathology tests conducted on tissue samples.
The team found that trametinib reduced the risk of disease progression or death by 52 per cent compared with hormonal treatment or chemotherapy. The progression of the cancer was slowed by 13 months for patients on trametinib compared with seven months for those on standard care. Trametinib was also associated with a fourfold increase in response to treatment compared with those who received standard care.
Ovarian cancer patients who received trametinib reported side effects that included fatigue, skin rash and gastrointestinal problems. This is similar to those who receive trametinib for other cancers. Those who received trametinib reported having a slightly lower quality of life at 12 weeks compared with those on standard care. There were minimal differences between both groups at all other time points.