There’s hope on the horizon for bladder cancer sufferers, according to a recent British clinical trial carried out among more than 1 000 people, where patients given an immunotherapy drug were found to be a third less likely to see disease return and are more likely to survive.
Those 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, said the doctors.
The 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, told Daily Mail: “This is a major breakthrough in the treatment of bladder cancer.
“For many years, survival rates 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 after 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 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 moment, around half of all 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”.
“We had not seen any additional survival benefit in previous trials investigating other treatments in combination with standard of care cisplatin-based chemotherapy before surgery.”
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.”
Study details
Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer
Thomas Powles, James Catto, Matthew Galsky et al.
Published in the New England Journal of Medicine on 15 September 2024
Abstract
Background
Neoadjuvant chemotherapy followed by radical cystectomy is the standard treatment for cisplatin-eligible patients with muscle-invasive bladder cancer. Adding perioperative immunotherapy may improve outcomes.
Methods
In this phase 3, open-label, randomised trial, we assigned, in a 1:1 ratio, cisplatin-eligible patients with muscle-invasive bladder cancer to receive neoadjuvant durvalumab plus gemcitabine–cisplatin every 3 weeks for four cycles, followed by radical cystectomy and adjuvant durvalumab every 4 weeks for eight cycles (durvalumab group), or to receive neoadjuvant gemcitabine–cisplatin followed by radical cystectomy alone (comparison group). Event-free survival was one of two primary end points. Overall survival was the key secondary end point.
Results
In total, 533 patients were assigned to the durvalumab group and 530 to the comparison group. The estimated event-free survival at 24 months was 67.8% (95% confidence interval [CI], 63.6 to 71.7) in the durvalumab group and 59.8% (95% CI, 55.4 to 64.0) in the comparison group (hazard ratio for progression, recurrence, not undergoing radical cystectomy, or death from any cause, 0.68; 95% CI, 0.56 to 0.82; P<0.001 by stratified log-rank test). The estimated overall survival at 24 months was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab group and 75.2% (95% CI, 71.3 to 78.8) in the comparison group (hazard ratio for death, 0.75; 95% CI, 0.59 to 0.93; P=0.01 by stratified log-rank test). Treatment-related adverse events of grade 3 or 4 in severity occurred in 40.6% of the patients in the durvalumab group and in 40.9% of those in the comparison group; treatment-related adverse events leading to death occurred in 0.6% in each group. Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group.
Conclusions
Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival and overall survival as compared with neoadjuvant chemotherapy alone.
See more from MedicalBrief archives:
FDA approves AstraZeneca’s immunotherapy drug for lung cancer
UK launches major study of personalised cancer therapies
US study finds immunotherapy boosts Hodgkin’s survival chances