A major new trial has been launched which could transform outcomes for patients with bladder cancer by matching treatments to genetic information found within their individual cancer.
The GUSTO trial is jointly led by the University of Southampton, Sheffield Teaching Hospitals NHS Foundation Trust and the University of Leeds.
It will seek to establish if treatments for muscle-invasive bladder cancer, one of the most common and most expensive-to-treat cancers, can be tailored to different genetic subtypes known to cause the disease.
"GUSTO is attempting to fundamentally change our approach to the treatment of bladder cancer," says Simon Crabb, Professor of Experimental Cancer Therapeutics at the University of Southampton, Honorary Consultant at University Hospital Southampton NHS Foundation Trust, and co-chief investigator of the study.
"We hope to utilise the biological characteristics of each cancer to tailor the correct treatment choices. The aim is to provide the right treatment to the right patient and so improve outcomes as well as avoid unnecessary side effects."
Current standard treatments for patients with cancer of the bladder wall involve chemotherapy before either surgery to remove the bladder or radiotherapy.
Until now, it has not been possible to say how individuals will respond to this treatment. However, new research suggests that different genetic causes of bladder cancers may respond differently to different treatments – meaning some patients may respond best to chemotherapy. Other subtypes of the cancer may respond better to immunotherapy and so need this treatment alone or as a boost to chemotherapy. Finally, some cancers may not respond to either chemotherapy or immunotherapy and so need immediate surgery.
The trial, which is jointly funded by an NIHR and MRC partnership, will be the first to test this in a clinical trial. Researchers hope the study will improve survival rates, and boost the quality of life for patients following surgery.
James Catto, Professor of Urology at the University of Sheffield, Honorary Consultant Urological Surgeon at Sheffield Teaching Hospitals NHS Foundation Trust, and co-chief investigator of the study, 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."
Muscle-invasive bladder cancer is an advanced type of cancer that occurs when the cancer invades the muscle layer of the bladder. As soon as this happens, the likelihood of the cancer spreading to other organs is much higher.
During the first part of the study, the team of researchers will look to establish if genetic profiling from tumour samples can be turned around fast enough so as not to delay treatment. The team will also work with an American laboratory with the 'next generation' facilities to undertake the complex processing needed to measure the RNA levels of 200 genes and identify individual cancer subtypes.
A total of 320 patients will be involved in the study, which is set to run in up to 20 UK sites including University Hospital Southampton. Half of the patients in the study will receive treatments based on their genetic subtype, whilst the other half will receive the current standard treatment.