After surgery, immunotherapy helps high-risk bladder cancer patients live longer without cancer
September 16, 2024
Press release
Monday, September 16, 2020
Results from NIH-sponsored clinical trials are expanding the treatment options available for this condition.
With pembrolizumab, people with muscle-invasive bladder cancer can stay cancer-free longer. National Cancer Institute
Results from a large trial suggest an immunotherapy drug could nearly double the time it takes for people to be cancer-free after their bladder is removed. The FDA-approved drug pembrolizumab, also known as Keytruda, is superior to observation in terms of post-surgery treatment. Researchers at the National Institutes of Health led the study. It was published on September 15, 2024. New England Journal of Medicine.
Andrea B. Apolo, principal investigator of the National Cancer Institute Research Center at the National Cancer Institute (NCI), said: "This study suggests that pembrolizumab may offer patients an additional treatment option to prevent their cancer from coming back." Cancer Research Center. The quality of life of cancer patients is significantly improved by extending the time they are disease-free.
Muscle-invasive bladder carcinoma is a diagnosis that means the cancer has spread into the muscle layer surrounding the bladder. This form of bladder carcinoma is treated by surgically removing the bladder. Patients are given chemotherapy with cisplatin before or after surgery to improve the chances of a successful operation and to kill any cancer cells that may have escaped from the tumor.
Many people with muscle-invasive bladder carcinoma cannot or will not have neoadjuvant cisplatin-based therapy. Some people cannot tolerate adjuvant cisplatin-based chemotherapy. Others, despite neoadjuvant cisplatin-based therapy, have persistent, muscle-invasive disease but cannot be treated with adjuvant cisplatin-based chemotherapy. In the past, patients in this group were closely monitored for signs of relapse.
Researchers have studied giving immunotherapy drugs to patients after surgery as an alternative to observation to see if it can extend their lives without their cancer coming back.
The FDA will approve nivolumab, also known as Opdivo, in 2021 for patients with high-risk, muscle-invasive bladder cancer. A clinical trial found that the immune checkpoint inhibitor, a form of immunotherapy that unleashes T cells to attack and recognize tumors, doubled the length of time cancer-free patients were able to stay compared with a placebo. In this setting, adjuvant nivolumab is the current standard of care.
The researchers in the current trial examined whether immune checkpoint inhibitors, such as pembrolizumab, would be as effective when used as an adjuvant. The researchers randomly assigned 702 high-risk patients who were diagnosed with high-risk, muscle-invasive bladder cancer after undergoing bladder removal surgery to either receive adjuvant treatment with pembrolizumab given every three weeks for a year or to observe the patient for that same period. About two-thirds of the patients received neoadjuvant treatment with cisplatin.
Patients in the pembrolizumab group were cancer-free after a median follow-up of four years, while the outcome group remained cancer-free for only 14.2 months. Pembrolizumab is well tolerated. The most common side effects are fatigue, itchy diarrhea, and an underactive thyroid.
Pembrolizumab, an immune checkpoint blocker, is more effective in some cancers whose tumors are PDL1-positive. This means that the tumor cells produce a lot of PDL1 on their surface. Dr. Apolo’s colleagues then tested whether the effects of pembrolizumab varied depending on PD-L1 status.
Among 404 patients with PD-L1-positive tumors, pembrolizumab-treated patients remained cancer-free for a median of 36.9 months, compared with 21 months in the observation group. Among 298 patients with PDL1-negative tumors, pembrolizumab-treated patients remained cancer-free for a median of 17.3 months, compared with nine months in the observation group. The researchers concluded that PDL1 status should not be used as a factor in selecting patients to receive pembrolizumab treatment, since both groups benefited.
Preliminary data show that at three years, about 61% of patients in the pembrolizumab groups were still alive, compared with about 62% in the observation group. The researchers noted that patients in the observation group either started taking nivolumab after it was approved or withdrew. This may have affected the data and made survival rates difficult to interpret.
Researchers are already exploring adjuvant treatments using different combinations of immune checkpoint inhibitors. Researchers have also tested biomarkers to determine which patients are at high risk of developing muscle-invasive bladder carcinoma and who would benefit from adjuvant treatments.
The NCI is sponsoring the study, known as AMBASSADOR. The Alliance for Clinical Trials in Oncology is leading and conducting the study, which includes Merck's cooperative research and development agreement with the NCI.
The National Cancer Institute: NCI leads the National Cancer Program, the NIH, and its efforts to reduce the prevalence of cancer and improve the lives of cancer patients. NCI provides extramural support for a variety of cancer training and research through contracts and grants. NCI’s intramural research program conducts innovative, transdisciplinary basic, translational, and clinical research, as well as epidemiologic and early detection and treatment research. This includes research conducted at the NIH Clinic Center, the world’s largest research hospital. To learn more about intramural cancer research, visit the NCI website. cancer.govCall the NCI Contact Center at 1-800-422-6237 (1-800-422 6237). The National Institutes of Health: The NIH is the medical research agency of the U.S. Department of Health and Human Services. It consists of 27 institutes and centers. The NIH, the nation's medical research agency, is a component of the U.S. Department of Health and Human Services. It is responsible for conducting basic, translational, clinical, and other medical research. Visit the NIH website for more information about its programs.
www.nih.gov . NIH…Transforming Discovery into Health(r)
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