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 nation’s leading integrated academic health systems and one of the largest in the New York metropolitan area. Its comprehensive system includes seven hospitals, more than 400 outpatient practices, over 600 research and clinical laboratories, the Icahn School of Medicine at Mount Sinai, the Graduate School of Biomedical Sciences, and the Mount Sinai Phillips School of Nursing. Together, the Health System comprises approximately 48,000 employees, more than 9,000 physicians, and 8,600 nurses.
As a leading learning health system, Mount Sinai combines clinical expertise with scientific discovery to improve patient care while training the next generation of health care and biomedical leaders. The Health System provides care across every stage of life, from prenatal care through geriatrics, while advancing personalized medicine through artificial intelligence, data science, and biomedical research.
Mount Sinai is consistently recognized among the nation’s leading academic health systems for patient care, research, and education. The Mount Sinai Hospital is ranked No. 1 in New York by Newsweek and No. 5 on the magazine’s World’s Best Hospitals list. The Icahn School of Medicine at Mount Sinai ranks No. 11 among U.S. medical schools and No. 1 among freestanding medical schools for National Institutes of Health funding, reflecting the strength of its scientific enterprise and leadership in biomedical research.
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