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Bladder cancer patients given an immunotherapy drug are a third less likely to see disease come back and are more likely to survive, according to a “game-changer” study.
Patients with advanced (muscle-invasive) bladder cancer had significantly less risk of cancer progressing or returning when treated with durvalumab, and were more likely to still be alive two years after treatment.
Experts from the University of Sheffield and Barts Cancer Institute at Queen Mary University of London included 1,063 patients with operable bladder cancer in their study.
Patients were given either standard chemotherapy (cisplatin and gemcitabine) and surgery (530 people), or chemotherapy plus durvalumab before surgery and eight cycles of durvalumab after surgery (533).
The final-stage phase 3 clinical trial found patients were 32% less likely to experience cancer recurrence or progression if they had immunotherapy, and were more likely to still be alive after two years.
Overall survival at two years was 82.2% in the durvalumab group and 75.2% in the comparator group.
Durvalumab (brand name Imfinzi) is a treatment for non small cell lung cancer (NSCLC) but is also being trialled in other cancers.
James Catto, professor of urology at the University of Sheffield and honorary consultant urological surgeon, who co-led 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 Medicines and Healthcare products Regulatory Agency, and that it becomes the new standard of care.
“Recent research suggests that cases of bladder cancer will increase by 50% over the next two decades, but yet the level of awareness about bladder cancer in the UK remains low.”
The trial was funded by AstraZeneca, with the results published in the New England Journal of Medicine.
At the the moment, around half of patients with muscle-invasive bladder cancer experience recurrence within three years.
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 the “magnitude of survival benefit seen will certainly be a game changer”.
He added: “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.
“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, Thomas Powles, professor of genitourinary oncology at Queen Mary University of London’s Barts Cancer Institute, said: “In (the) NIAGARA (trial), 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.”
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,” he said.
“It is nice to hear the trial received positive results and I hope it can become available for other patients.”
