Trial to improve advanced bladder cancer survival

A major new trial to help improve survival rates of advanced bladder cancer has been launched.

The Genotype of Urothelial cancer: Stratified Treatment and Oncological outcomes (GUSTO) trial is being led by Sheffield Teaching Hospitals NHS Foundation Trust and the Leeds Cancer Research UK Clinical Trials Unit at the University of Leeds in partnership with the University of Sheffield.

In the study, the researchers will examine if treatments for muscle-invasive bladder cancer can be tailored to different genetic subtypes known to cause the disease.

Treatment for advanced cancer of the bladder wall involves chemotherapy before or after surgery to remove the bladder and then other treatments such as radiotherapy.

It has not been possible to say how individuals will respond to the treatment, but new research suggests that different genetic causes of bladder cancers may respond differently to different treatments.

The trial, which is jointly funded by a Medical Research Council (MRC) and National Institute for Health and Care Research (NIHR) partnership, will be the first to test this in a clinical trial in the hope of improving survival rates and boosting quality of life for patients following surgery.

The study’s chief investigator, Professor James Catto, honorary consultant urological surgeon at Sheffield Teaching Hospitals NHS Foundation Trust, said: “We are very excited to be launching this new study, which has been in development for the best part of four years. Recent advances in understanding genetic causes that lead to bladder cancer have opened new possibilities in how we can better treat this awful disease. Survival rates for the disease also remain unchanged.

“By tailoring treatments to genetic markers of the disease, we hope to help patients get the right treatment for their specific disease and boost quality of life following surgery.”

Professor Syed Hussain, lead oncologist for the study and professor and consultant in medical oncology at Sheffield Teaching Hospitals, said while combined treatments have the best cure rates, they also have the most complications, are expensive and affect a person’s wellbeing for many months.

“Recent advances have suggested that treating all individual patients as though they have the same type of bladder cancer, with everyone receiving the same treatment schedules in the same way, may not be best for individual patients. GUSTO trial stratifies treatments for patients based on subtypes of bladder cancer,” he explained.

“This is an exciting trial that may help to improve the outcome for our patients in coming years and change the landscape for patients with muscle invasive bladder cancer. We are very much looking forward to working with our partner sites on this hugely exciting study.”

During the first part of the study, the researchers see if genetic profiling from tumour samples can be turned around fast enough so as not to delay treatment and will also work with an American laboratory with next-generation facilities to undertake the complex processing needed to measure the RNA levels of 200 genes and identify individual cancer subtypes.

It will involve 320 patients at up to 20 UK sites, half of whom will receive treatments based on their genetic sub-type, while the other half will receive the current standard treatment.

Allen Knight, patient trustee at Action Bladder Cancer UK, which helped to design the study, said: “For the first time, GUSTO will let doctors diagnose the subtypes of muscle invasive bladder cancer, enabling them to tailor treatment to each individual patient, rather than the current ‘one size fits all’ approach. This has the potential to give the correct treatment more quickly and avoid unnecessary treatment, thus radically improving patients’ quality of life and saving many lives.”

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