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Surgery (partial or radical nephrectomy) is the standard of care for large, high-risk kidney cancers that have not spread outside the kidney. The cancer can come back (recurrence) after nephrectomy in some patients. Adjuvant therapy is additional treatment that is taken after surgery to reduce the risk of the cancer from coming back.
Clinical trials with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) that block the blood supply to the cancer have shown little benefit for patients for stopping the cancer from coming back after surgery.
However, immunotherapy with pembrolizumab has been approved in several countries as an adjuvant therapy to stop the cancer from coming back in other parts of the body.
In the KEYNOTE-564 clinical trial pembrolizumab (given by an infusion into a vein) has been shown to improve cancer-free survival after nephrectomy for kidney cancer patients at high-risk of their cancer returning compared to a dummy infusion (placebo).
994 patients were enrolled in the trial, of which nearly three quarters had intermediate-risk disease and one fifth had high-risk disease. The remaining patients (6%) had metastases that had been removed and they were cancer-free. Patients were followed-up for more than 4 and a half years (57 months).
The average overall survival time was not reached during the follow-up period for both groups of patients. However, more patients survived for 4 years or more when taking pembrolizumab (91.2%) compared to placebo (86%). For patients with kidney cancer that was at high risk of coming back after surgery, there was a 38% reduction in the risk of death with adjuvant pembrolizumab compared to placebo. The cancer-free survival benefit with pembrolizumab continued during the 4.5 years of follow-up: Adjuvant pembrolizumab improves cancer-free survival in all patients with high-risk kidney cancer compared with placebo.
These results further support the use of adjuvant pembrolizumab as a standard treatment for patients with kidney cancer at high-risk of returning after surgery.
However, patients should consider their situation carefully with their doctor and discuss the potential risks and benefits of adjuvant pembrolizumab. Without a test to predict which patients might benefit from treatment or who might suffer serious side effects, some patients may be given treatment they don’t need, and they may suffer from the potentially serious side effects of pembrolizumab unnecessarily. This needs careful consideration in discussion with your doctor.
