- A phase 3 clinical trial has shown that patients were 32 per cent less likely to experience cancer recurrence when treated with the immunotherapy drug durvalumab before and after surgery
- Led by researchers from the University of Sheffield, and Barts Cancer Institute at Queen Mary University of London, results of the trial also showed that overall survival rates were 25 per cent higher among patients treated with durvalumab
- The groundbreaking study, which involved 1,063 patients with operable bladder cancer, compared the outcomes of patients who received standard chemotherapy (cisplatin and gemcitabine) and surgery, to those who received chemotherapy plus durvalumab before surgery, followed by eight cycles of durvalumab after surgery
- Bladder cancer is the 9th most common form of cancer in the UK, with 17,000 new cases and 5,000 deaths in England each year, however survival rates for bladder cancer have not improved in the UK for many years
Survival rates for patients with operable bladder cancer are significantly improved by adding an immunotherapy drug to before and after surgery, a major clinical trial has revealed.
Results of the phase 3 clinical trial, led by researchers at the University of Sheffield and Barts Cancer Institute at Queen Mary University of London, found that patients were 32 per cent less likely to experience disease progression, recurrence, not undergoing surgery, or death when treated with the drug durvalumab, in addition to routine chemotherapy and surgery, compared to those treated with chemotherapy and surgery alone.
Overall survival rates were also 25 per cent higher among those treated with durvalumab.
Bladder cancer is the 9th most common form of cancer in the UK, with 17,000 new cases and 5,000 deaths in England each year, however survival rates for bladder cancer have not improved in the UK for many years.
Bladder cancer has the highest lifetime treatment costs per patient of all cancers. This is due to the high recurrence rate and ongoing invasive monitoring.
Professor 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: “This is a major breakthrough in the treatment of bladder cancer. For many years survival rates for advanced bladder cancer have remained stagnant, but our findings offer hope to thousands of patients who face this devastating diagnosis.
“Patients treated with durvalumab before and after surgery had both significantly higher survival rates and lower risks of the cancer returning and didn’t face any additional serious side effects. This is important for patients undergoing chemotherapy and its numerous and often debilitating side effects.
“Our hope is that this treatment can be made available for NHS patients as soon as possible following regulatory approval by the MHRA, and that it becomes the new standard of care.”
He added: “Recent research suggests that cases of bladder cancer will increase by 50 per cent over the next two decades, but yet the level of awareness about bladder cancer in the UK remains low.
“We are extremely grateful to the 1,063 patients who took part in the phase three clinical trial not only for themselves, but to help others facing the disease in the future.”
Ian Flower, 63, from Sheffield took part in the NIAGARA trial which was run at Sheffield Teaching Hospitals NHS Foundation Trust after being diagnosed with operable bladder cancer.
“I was happy to help with the trial, not just for myself but in the hope that it could help other patients,” said Ian.
“The staff at Weston Park were brilliant. It is nice to hear the trial received positive results and I hope it can become available for other patients.”
The international NIAGARA phase 3 clinical trial was funded and led by AstraZeneca. The trial was conducted across the globe including Weston Park Cancer Centre, based at Sheffield Teaching Hospitals NHS Foundation Trust, in Sheffield. The results are published in the New England Journal of Medicine.
Professor Syed Hussain, Professor and Honorary Consultant of Medical Oncology at the University of Sheffield and Sheffield Hospitals NHS Foundation Trust and Principal investigator of the trial said: "These are exciting times in the management of muscle invasive bladder cancer. We had not seen any additional survival benefit in previous trials investigating additional treatments in combination with standard of care cisplatin-based chemotherapy before surgery.
“This clinical trial combining immune checkpoint inhibitor durvalumab with standard of care chemotherapy was one of the largest perioperative chemotherapy trials done so far and with the magnitude of survival benefit seen will certainly be a game changer. By bringing these exciting new treatments earlier in the disease pathway we will continue to see more patients being cured of muscle invasive bladder cancer.”
Lead author of the study, Professor Thomas Powles, Professor of Genitourinary Oncology at Queen Mary University of London’s Barts Cancer Institute, said: “Treating aggressive bladder cancer before it spreads is perhaps our best chance of a cure. In NIAGARA, we showed for the first time that the addition of immunotherapy to chemotherapy increases the rate of overall survival. This is a major step forward for these patients.”
Durvalumab was generally well tolerated and no new safety signals were observed in this study. Grade 3 and 4 adverse events due to any cause occurred in 69 per cent of patients treated with durvalumab and 68 per cent of patients in the comparator arm.
The Sheffield team now want to understand which patients benefit most from this type of treatment. For this they are running a new trial - the National Institute for Health and Care Research (NIHR) GUSTO trial led by Sheffield Teaching Hospitals NHS Foundation Trust, which uses genomic subtypes to direct a more personalised treatment approach.
This research supports the University of Sheffield's cancer research strategy. Through the strategy, the University aims to prevent cancer-related deaths by undertaking high quality research, leading to more effective treatments, as well as methods to better prevent and detect cancer and improve quality of life.
For more information about the University of Sheffield’s cancer research strategy, please visit: https://www.sheffield.ac.uk/cancer
