The standard of care for patients with intermediate/high risk kidney cancer is surgery to remove the entire kidney (radical nephrectomy) or the part of the kidney containing the tumour (partial nephrectomy) followed by surveillance.
In this study, patients with intermediate/high risk kidney cancer were given the immunotherapy, nivolumab before surgery (neoadjuvant nivolumab) followed by nivolumab after surgery (adjuvant nivolumab) to see if this treatment improved recurrence-free survival compared to surgery alone.
Eight hundred and nineteen (819) patients were enrolled in this phase 3 study (PROSPER) from across the US and Canada. All patients had previously untreated kidney cancer and were planned to have a partial or radical nephrectomy. Patients were randomly allocated to have either nivolumab plus surgery, or surgery only, followed by surveillance.
Patients were followed up for and average of 2 and a half years. During this time, the cancer recurred in a third of the patients who had nivolumab and surgery and a third of the patients who had surgery only.
Nearly half of the patients in the nivolumab group and a quarter of patients in the surgery only group had serious or life-threatening side effects, the most common of which were low red blood cells (anaemia), high blood pressure (hypertension), and problems with the pancreas (high lipase levels in the blood). Unfortunately, 1 in 10 patient died during the trial, of which less that 2 in a hundred was related to treatment.
This study show that giving nivolumab before and after surgery did not improve recurrence-free survival compared to surgery only in patients with high-risk kidney cancer.