Clinical trial research from Prof Sarah Blagden, Department of Oncology, was recently published in Lancet Oncology. This work was conducted as part of the larger ICON8 ovarian cancer study and found that ovarian cancer patients placed on a more-frequent chemotherapy treatment plan have the same survival rates but poorer quality of life than those receiving the standard, less-frequent treatment.
Chemotherapy can cause significant side effects which can impact on the day-to-day functioning of patients. Some of these are not necessarily definable symptoms but manifest in changes to their Quality of Life (QOL) – such as the ability to work or take part in family life.
QOL is of particular importance to cancer patients, especially those with advanced or terminal cancers. Investigators are increasingly encouraged to include measures of QOL, via specific questionnaires, into their clinical studies but it is often measured poorly (using the wrong questions or too infrequently).
ICON8 was a phase III clinical trial that randomised 1,540 patients with advanced epithelial ovarian cancer to three different chemotherapy regimens. Those in one arm received chemotherapy once every three weeks (the current standard treatment), whilst patients in the other two arms received chemotherapy weekly.
Although the study showed patients in the thee arms had the same survival outcome, suggesting the weekly or 3-weekly treatments were equivocal, the QOL analysis gave a very different picture. It showed that patients who on the weekly treatments had more fatigue and longer-lasting nerve damage. Sarah’s research concluded that the 3 weekly (standard) treatment was more tolerable for ovarian cancer patients and the different treatments were not equivocal after all.
To me, this study highlights how important it is to include the patients’ experience as a readout in clinical trials. The patients and study centres were fantastic at ensuring the QOL questionnaires were filled in and collected, and the data were carefully analysed by the MRC Trials team at UCL. The results completely changed our interpretation of the data. Not only that, but we can now confidently tell patients starting this treatment in the future what their experience is likely to be.
- Sarah Blagden, Associate Professor
Whilst survival rates are often prioritised over QOL when interpreting study results, QOL is an important factor to consider when weighing up the benefits of one treatment over another. Patients and their wellbeing need to be at the forefront of this decision-making process.
To read more about this paper see here.
This research was funded by Cancer Research UK, Medical Research Council, Health Research Board Ireland, Irish Cancer Society and Cancer Australia.