Results of a ground-breaking trial investigating the injection of a new type of cancer therapy directly into the bladder are promising good news for future treatment of the disease.
Professor of Urology at The University of Western Australia Dickon Hayne led the world first SUBDUE-1 trial, which saw the immune-stimulating cancer drug durvalumab injected directly into patients' bladder tissue, rather than a vein, for the first time.
Developed with the Australian and New Zealand Urogenital and Prostrate Cancer Trials Group (ANZUP), and supported by an ANZUP 'Below the Belt' grant, the SUBDUE-1 findings were presented at the recent Genitourinary Cancers Symposium held by the American Society of Clinical Oncology in San Francisco.
Professor Hayne, a consultant urological surgeon and Head of Urology for the South Metropolitan Health Service in WA, said the innovative treatment followed the growing success of immuno-oncology agents, where the body's own immune system was stimulated, as a novel approach to cancer treatment.
"Immune checkpoint inhibitors have had remarkable success across multiple malignancies," Professor Hayne said. "This trial is the first time any of this class of drugs have been injected directly into the bladder and the results are exciting."
Working with nine patients recruited from WA's Fiona Stanley Hospital, all with aggressive bladder cancer, three doses of durvalumab at different predetermined doses were injected into the bladder at least two weeks before bladder surgery.
"We looked at the bladder tissue before and after the injection to see if the drug was effectively treating the cancer. After durvalumab injection, immune cells in the bladder increased, suggesting the immune system had been activated, "Professor Hayne said.
"In one patient there was a 'complete response' with the cancer in the bladder no longer detectable after the durvalumab injection.
"SUBDUE-1 outperformed expectations, demonstrating it is feasible and safe without immune-related adverse events and we now plan to carry out further trials. All nine patients involved proceeded to their bladder surgery as scheduled and recovered well without any evidence of disease recurrence," he said.
Professor Hayne said bladder cancer was a major public health problem with more than 2,500 Australians diagnosed each year and yet it remains one of the most under-researched cancers.
"Bladder cancer is the only major cancer in Australia with a five-year survival rate that has declined in the past 20 years. Trials like SUBDUE-1 are an important part of establishing how we can improve these outcomes by determining the best possible treatment," he said.
