SUTENT Clinical Trial Results
SUTENT was studied in a clinical trial involving 615 adult patients who were at high risk of RCC coming back after kidney cancer surgery. For approximately 1 year after kidney cancer surgery, 309 patients took SUTENT, while 306 took a placebo, or sugar pill.
The main objective of the trial was to measure disease-free survival (DFS). DFS is the length of time after cancer treatment that a patient lives without the signs or symptoms of cancer. This is one way to check how effective treatment is.
Along with DFS, the study also looked at overall survival (OS). This is the total time patients remain alive after treatment. By the end of the study, 141 out of 615 people (23%) who participated had died. At the time data was collected, there was not enough information available to predict SUTENT’s impact on OS.
Understanding clinical trial results
Patients taking SUTENT experienced a median DFS of 6.8 years compared with 5.6 years for those taking placebo. That means SUTENT was shown to:
Give patients more time without evidence of cancer.
Patients taking SUTENT showed no evidence of cancer for, on average, 1.2 years longer than those taking placebo.
Lower the risk of cancer recurrence.
Patients taking SUTENT were 24% less likely to have a recurrence compared to those taking placebo.
At 5 years, 113 patients taking SUTENT had experienced a DFS event compared with 144 patients taking placebo. That means:
Patients taking SUTENT experienced about 22% fewer DFS events. DFS events included recurrence of cancer or death.
Patients taking SUTENT experienced a 5-year DFS rate of 59.3% compared with 51.3%
for those taking placebo. That means:
Patients taking SUTENT were more likely to be disease-free after 5 years.
SUTENT is not a cure, and not all patients will experience the same results.
In the clinical trial, patients taking SUTENT as adjuvant therapy started within 3 to 12 weeks after surgery.
Talk to your doctor before or soon after surgery to determine if SUTENT is an option for you.