Immunotherapy After Surgery Is Shown to Reduce Deadly Relapse Risk in Advanced Bladder Cancer
Clinical trial results point to change in care of patients with high risk of metastatic recurrence
A phase 3 clinical trial co-led by Mount Sinai researchers is the first to show that immunotherapy after surgery to remove bladder cancer can reduce the risk of relapse for patients who are at high risk of their cancer returning in a deadly metastatic form, according to results published in The New England Journal of Medicine. The immunotherapy nivolumab was used as an adjuvant therapy, which is given after surgery in the hopes of maximizing its effectiveness.
The randomized trial, named ”Checkmate 274,” showed that using nivolumab increased these patients’ chance of staying cancer free after surgery compared to patients who received a placebo. The average length of time before relapse nearly doubled in patients who received nivolumab, which is a monoclonal antibody immune checkpoint inhibitor that harnesses the immune system to fight cancer.
Surgery that removes the bladder or kidney and ureter is currently the standard of care for patients with urothelial cancer that has entered surrounding muscle or lymph nodes, though half of these patients later relapse with lethal metastatic cancer. Unfortunately for these patients, no consensus has emerged regarding treatments after surgery that might reduce the risk of cancer recurrence.
“These clinical trial results promise to impact standard treatment of patients with urothelial cancer of the kidney, ureter, or bladder by reducing the risk of metastatic recurrence after surgery,” said Matthew Galsky, MD, senior author of the study and Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, Associate Director of Translational Research, and Co-Leader of the Cancer Clinical Investigation Program at The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai. “Almost 200,000 people die each year of urothelial cancer worldwide, so advances like immunotherapy being used in this manner bring hope.”
A total of 709 patients were part of the trial; half received nivolumab and the other half received placebo every two weeks for one year. The vast majority of patients who received nivolumab had no impact on their quality of life. This trial was conducted with support from Bristol Myers Squibb, the maker of the immunotherapy, in collaboration with ONO Pharmaceutical Company Ltd.
About the Mount Sinai Health System
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in 4 out of 10 pediatric specialties. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: It is consistently ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and top 20 in the nation for National Institutes of Health funding and top 5 in the nation for numerous basic and clinical research areas. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.