Below the Belt Award

The majority (80%) of newly diagnosed bladder cancers are limited to superficial layers of the bladder. Patients with these aggressive superficial bladder cancers are commonly treated with an immunotherapy medication called BCG, which is put into the bladder. BCG is the inactivated tuberculosis bacterium (BCG) that stimulates the body’s immune cells to attack the tumour cells and has been used effectively for decades. However, in 30-45% of patients, this BCG treatment will fail, with the cancer progressing into deeper layers or spreading outside the bladder despite treatment. If the cancer progresses to the bladder muscle despite BCG, even curative treatments such as removal of the bladder result in poor outcomes. Yet, currently, there are no biomarkers to identify which patients will not respond to BCG treatment. The funding from the Below the Belt Award in 2022 allowed us to identify that BCG was ineffective in activating immune cells in BCG-unresponsive tumours because these tumours have low levels of inflammatory immune cells, which are exhausted (accepted for ANZUP 2024). Therefore, by staining five immune cell types, we developed a biomarker, BCG-R5, which could predict response to BCG therapy in patients with aggressive superficial bladder cancer. Our proposed study aims to validate the BCG-R5 immune marker combination prospectively. Recent studies also suggest that the chemotherapy combination of Gemcitabine-Docetaxcel (Gem-Doce) is an alternative to BCG, so we aim to evaluate the utility of the BCG-R5 immune marker in patients undergoing Gem-Doce.