The Centre for Statistics in Medicine (CSM) provides statistics support for two large randomised clinical trials on Barrett’s Oesophagus. The condition is a precursor to aggressive, difficult-to-treat oesophageal cancer. Both trials aim to improve how we diagnose, monitor and treat Barrett’s Oesophagus to prevent progression to cancer, and improving the care of over half a million UK patients.
I work in clinical trials because I feel that I can make a difference in the global fight against cancer and improve outcomes for cancer patients using my statistical expertise. New treatments must have the evidence behind them before being introduced into clinical practice.
- CSM Medical Statistician
Oesophageal cancer attacks the food pipe connecting the mouth to the stomach. It is the fastest rising cancer in the developed world, with over 8,000 diagnoses in the UK each year. As this cancer has a 5-year survival of only 15%, with 60% of patients dying within one year of diagnosis, early diagnosis is critical. Barrett’s Oesophagus is one signal we can use to identify those at-risk.
In Barrett’s Oesophagus, the cells lining the oesophagus change, becoming more like intestinal lining cells. Patients with Barrett’s Oesophagus have a higher risk of oesophageal cancer than the general population, as their altered oesophageal cells are prone to developing further abnormalities. These patients are closely monitored and given early interventions to combat the progression to cancer. Any improvements in how these patients are monitored and the treatments used to prevent the development of their disease are helpful.
BOSS is an NHS-HTA-funded randomised trial of 3,453 Barrett’s Oesophagus patients, run throughout the UK. Currently, patients with Barrett’s Oesophagus are given an endoscopy every 2-3 years as a screening measure. A camera is used to check the inside of their oesophagus for any worrying changes. It may be more helpful to instead perform an endoscopy when the patient appears to need one, to spare patients unnecessary invasive tests and reduce costs. The BOSS study will follow trial participants for 10 years to see which of the two approaches works better for them. Trial results are due to be released around 2022.
AspECT, funded by Cancer Research UK, focuses on improving the drug treatment used in Barrett’s Oesophagus to decrease progression to cancer. The drug esomeprazole reduces stomach acid, which can cause the cell abnormalities that characterise the disease. Aspirin can prevent both colorectal and oesophageal cancer. AspECT is investigating which doses of the two drugs together best prevent oesophageal cancer from developing. The final results of AspECT are expected in 2018.
The results from these two trials will offer improved care for over half a million UK patients with Barrett’s Oesophagus. Although it will be a couple of years before we know the primary results, the trials also offer a more immediate benefit. Both trials are gathering information about the characteristics of the patients who suffer from the condition, which will help clinicians to improve diagnosis. The medical community is eagerly awaiting the imminent release of this information, which may inform UK-wide guidelines.
This news item is part of a series on the cancer research conducted and supported by the Centre for Statistics in Medicine, in commemoration of World Cancer Day on 4 February 2016. Read the introduction to the series here, about a little-used trial design that will improve the efficiency of phase I trials here, and about a new trial on pancreatic cancer here.
