Ongoing Trial: The INSPIRE research study is testing a new treatment approach for patients with advanced bladder cancerJanuary 5, 2023
Video: The Patient VoiceJanuary 5, 2023
Bladder cancer is the fifth most common cancer in the United States. It begins in the cells in the lining of the bladder. About 70% of patients are diagnosed with early-stage disease, in which the cancer has not yet spread beyond the bladder to the muscle layer.
However, some of these patients are at higher risk than others of the cancer growing, spreading, or returning after treatment. Aggressive (high-grade) cancer often recurs (comes back) after treatment and can spread into the muscle layer of the bladder, to other parts of the body, and to lymph nodes in the pelvis. Almost all deaths from bladder cancer are due to high-grade disease.
The usual treatment approach for early-stage, high-risk bladder cancer is surgery through the urinary tract to remove tumors (it is less invasive than open surgery and spares the bladder itself). After surgery, patients receive immune system therapy with the Bacillus Calmette-Guerin (BCG) vaccine. BCG is given directly into the bladder through a catheter. It works by stimulating the body’s immune system to destroy cancer cells.
Although this approach can be effective in many people, the cancer returns in about 40-60% of patients within two years.
The BRIDGE clinical trial (EA8212) is exploring a different treatment strategy that could potentially improve results for patients, leading to fewer relapses. The study is comparing BCG immunotherapy to chemotherapy that consists of gemcitabine (jem-SITE-a-been) and docetaxel (DOH-seh-TAK-sil). Gemcitabine and docetaxel are also given directly into the bladder through a catheter. They work by stopping cell growth and division. Study researchers are looking to see if chemotherapy is better than the usual approach to prevent bladder cancer recurrences.
To be eligible for this trial, patients must be at least 18 years old and have early-stage bladder cancer that has not invaded the muscle layer. In addition, the cancer must be high-grade. They must have completed surgery to remove their cancer, but not yet received any post-surgical treatment given directly into the bladder. Learn more about tumor stages and grades at cancer.gov.
About 870 patients will take part in the study. They will be randomly assigned by a computer to one of two groups. The first group will receive the study drugs gemcitabine and docetaxel. The second group will receive the usual treatment.
This study is led by Max Kates, MD, of Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center.
Learn more about EA8212/BRIDGE at ecog-acrin.org.