ASCO PERSPECTIVE
“Even with the current standard of care — surgery with or without pre-surgery chemotherapy —muscle-invasive urothelial carcinoma has a high risk of recurring. These new findings show that treating patients at highest risk of recurrence with an immunotherapy after surgery can help extend the time until the disease returns,” said Robert Dreicer, MD, MS, MACP, FASCO, ASCO expert in genitourinary cancers.
ALEXANDRIA, Va. —Treatment with the immunotherapy nivolumab (Opdivo®) following radical surgery with or without cisplatin-based chemotherapy significantly improved disease-free survival in patients with muscle-invasive urothelial carcinoma, according to a study that will be presented at the 2021 ASCO Genitourinary Cancers Symposium, taking place virtually February 11-13.
The results come from the phase III CheckMate 274 trial of adjuvant nivolumab in patients who underwent radical surgery (surgery intended to remove all diseased tissue) for high-risk muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis.
Study At-a-Glance
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Focus |
Effect of treatment with nivolumab following surgery with or without pre-surgery chemotherapy |
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Population |
709 patients with muscle-invasive urothelial cancer at high risk of relapse despite being treated with surgery with or without pre-surgery chemotherapy |
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Findings |
Among all randomized patients, disease-free survival was improved for those treated with nivolumab after surgery compared with those who received placebo — median 21 months with nivolumab vs. median 10.9 months with placebo. |
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Significance |
Adjuvant nivolumab provides a clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent, irrespective of PD-L1 status. |
Key Findings
Median disease-free survival—the time between the end of primary treatment and the return of signs or symptoms of cancer—was significantly longer for patients who received post-surgery treatment with nivolumab (median 21 months) compared with those who received placebo (median 10.9 months). Disease-free survival for a subset of patients with tumors positive for a certain type of protein (PD-L1) was also improved with nivolumab (median, however, not yet reached by the time of analysis).
“Nivolumab is the first immune therapy to be used in the adjuvant setting that provides a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent, irrespective of PD-L1 status,” said lead author Dean F. Bajorin, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York.
About the Study
The study involved 709 patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or renal pelvis who underwent radical surgery with or without pre-surgery (neoadjuvant) cisplatin-based chemotherapy. There was a high risk for recurrence based on the tumor stage at surgery. Patients were randomized to receive nivolumab or placebo every other week for 1 year.
Nivolumab is an immunotherapy that works by blocking the protein PD-L1 from binding to another protein (PD-1) found on T cells, which are part of the immune system. When PD-L1 and PD-1 bind, T cells are prevented from killing cancer cells. By blocking PD-L1, nivolumab allows T cells to kill cancer cells.
The standard-of-care treatment for muscle-invasive urothelial carcinoma is cisplatin-based neoadjuvant therapy followed by radical surgery — removal of the bladder. However, some patients may be ineligible to receive cisplatin due to factors like inadequate kidney function. Adjuvant nivolumab could provide a treatment option for these patients to reduce the risk of recurrent cancers and death.
More serious treatment-related side effects (grade 3–4) were seen among patients who received nivolumab (17.9%) than those who received placebo (7.2%). The most common grade 3 or higher treatment-related side effects were diarrhea, colitis, and pneumonitis in the nivolumab arm and colitis, diarrhea, gamma-glutamyl transferase (GGT) increase, and hepatitis in the placebo arm.
Next Steps
In order to examine the impact of nivolumab on overall survival and cancer-specific survival, longer follow-up is needed.
Funding
The study received funding from Bristol Myers Squibb in collaboration with ONO Pharmaceutical Company Ltd.
For Your Readers
View abstract author disclosures: https://coi.asco.org/Report/ViewAbstractCOI?id=324057
ATTRIBUTION TO THE GENITOURINARY CANCERS SYMPOSIUM IS REQUESTED IN ALL NEWS COVERAGE
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About ASCO:
Founded in 1964, the American Society of Clinical Oncology, Inc. (the Society) is committed to the principle that knowledge conquers cancer. Together with the Association for Clinical Oncology, ASCO® represents nearly 45,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of high quality and equitable patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. Conquer Cancer, the ASCO Foundation, supports the Society by funding groundbreaking research and education across cancer’s full continuum. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, Instagram, and YouTube.
About the American Society for Radiation Oncology:
The American Society for Radiation Oncology (ASTRO) is the premier radiation oncology society in the world, with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals that specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training live activities as well as online through the ASTRO Academy, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes three medical journals, International Journal of Radiation Oncology, Biology, Physics, Practical Radiation Oncology, and Advances in Radiation Oncology, developed and maintains an extensive patient website; and created the Radiation Oncology Institute, a non-profit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. Learn more about ASTRO.
About the Society of Urologic Oncology:
The Society of Urologic Oncology (SUO) was created in 1984 to enable qualified members primarily interested in the care of patients with malignant genitourinary diseases to meet for the purpose of discussion, development, and implementation of ideas to improve care. The Society and its bylaws conform to the guidelines and bylaws of the American Urological Association (AUA).
The purpose of the SUO is to develop educational and research initiatives and to study issues in urologic oncology and provide physician statements that represent a state-of-the-art assessment of these issues to other organizations.
The Society also provides a forum for identifying the urologic oncologist as a physician with specific expertise in the study and treatment of genitourinary malignancies. In recognition of the multidisciplinary efforts involved in the study and treatment of genitourinary malignancies, the Society seeks to incorporate multiple disciplines in achieving these goals. The Society supports the activities of multiple disciplines in the common objectives of seeking an increased understanding and successful treatment of genitourinary malignancies.
The SUO seeks to improve the care of patients with malignant urologic disease and to provide a forum for the discussion of problems relating to malignant urologic disease. Our objectives include: 1) Stimulating research in and the teaching of urologic oncology, 2) Disseminating the principles of urologic oncology to the medical profession at large, 3) Bringing urologists into a Society whose work is entirely, or principally with malignant disease, 4) Being identified as the most qualified organization on matters relating to urologic oncology, and 5) Standardize fellowship training in urologic oncology.
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