Advanced Bladder Cancer Patients Could Keep Their Bladder Under New Treatment Regime, Clinical Trial Shows

Mount Sinai investigators have developed a new approach for treating invasive bladder cancer without the need for surgical removal of the bladder, according to a study published in Nature Medicine in September. Removing the bladder is currently a standard approach when cancer has invaded the muscle layer of the bladder.

In a phase 2 clinical trial that was the first of its kind, doctors found that some patients could be treated with a combination of chemotherapy and immunotherapy without the need to remove their bladder. Surgical removal of the bladder can be curative in muscle-invasive bladder cancer, but the procedure can have profound effects on a patient’s quality of life.

“Treatment for muscle-invasive bladder cancer is in need of major improvements from both a quality-of-life and an effectiveness standpoint,” said Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute, a part of the Tisch Cancer Center at Mount Sinai. “If additional research confirms our findings, this may lead to a new paradigm in the treatment of muscle-invasive bladder cancer.”

Seventy-six patients participated in this clinical trial, and approximately 43 percent achieved a complete response—no detectable cancer—when treated with the combination of chemotherapy and immunotherapy. Patients with a clinical complete response were offered the opportunity to proceed with additional immunotherapy, without surgical removal of the bladder. Among patients opting to proceed without surgical removal of the bladder, about 70 percent had no evidence of recurrent cancer after two years. Based on the results of this trial, two follow-up studies were launched to build on this approach; one is ongoing, and another will open in the next six months.

Colleagues at City of Hope, the University of Pennsylvania, the University of Wisconsin, the University of Southern California, the University of Utah, and Oregon Health and Sciences University also participated in this research. This study was funded by Bristol Myers-Squibb, the Foundation for the NIH/Partnership for Accelerating Cancer Therapies, and the V Foundation.