Combination regimen may spare patients' bladders
CANCER DIGEST – Oct. 7, 2023 – Bladder cancer patients were able to keep their bladders following a new treatment approach using chemotherapy and immunotherapy, an early clinical trial shows. The results were published in the Oct. 2, 2023 Nature Medicine.
Cancer that has invaded the bladder muscle is often treated with surgical removal of the bladder and the installation of a tube to divert the urine to a bag outside the body. While such treatment is effective in treating the cancer it reduces the quality of life for the patient.
In the new approach being tested at Mount Sinai Cancer Center, New York, a research team led by Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute, patients were treated with a combination of chemotherapy and immunotherapy.
The phase 2 trial involved 76 patients with muscle-invasive bladder cancer who received four cycles of a combination chemotherapy regimen using cisplatin and gemcitabine followed by administration of the immunotherapy drug nivolumab (Opdivo®).
Of the 76 patients, 33 (43 percent) achieved a complete response, meaning MRI and/or CT scans and other tests showed no signs of cancer following therapy. Of those 33 patients, 32 opted to forgo surgical removal of the bladder and instead underwent continued doses of nivolumab every two weeks.
After two years of follow-up 70 percent of those patients continued to show no signs of recurrent cancer.
“If additional research confirms our findings, this may lead to a new paradigm in the treatment of muscle-invasive bladder cancer,” Glassy said in a press release.
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. The study was funded by Bristol Myers-Squibb, the Foundation for NIH/Partnership for Accelerating Cancer Therapies, and the V Foundation.