Preventive Treatment After Kidney Cancer Surgery Receives FDA Approval for the First Time
On 16 November 2017, the United States Food and Drug Administration FDA approved sunitinib malate (trade name Sutent) for adjuvant (preventive) treatment of adult patients with renal cell carcinoma, the most common type of kidney cancer, at high risk of recurrence after surgical kidney removal (nephrectomy).
Sunitinib malate is a kinase inhibitor that works by blocking several enzymes enabling cancer cells to multiply. Sunitinib malate was first approved for certain gastrointestinal stromal tumors and stage 4 renal cell carcinomas, as well as certain pancreatic cancer types, in 2006.
Adjuvant treatment is given after the main treatment (such as surgery) to reduce the likelihood of cancer recurrence. It aims to kill micrometastases and cancer cells too small to detect through imaging.
Approval of sunitinib for adjuvant use was based on a study involving 615 patients with kidney cancer at high risk of recurrence after nephrectomy: a multicenter, international, double-blind, placebo-controlled clinical trial (S-TRAC). Patients received sunitinib malate or placebo (a medicine without an active ingredient) once daily for 4 weeks, followed by a 2-week treatment break.
Comparing patients receiving sunitinib malate with those receiving placebo, median disease-free survival was 6.8 years in the sunitinib arm and 5.6 years in the placebo arm. Overall survival data were immature at the time of the disease-free survival analysis. The most common side effects were weakness, fatigue, diarrhea, mouth sores, nausea, loss of appetite, severe weight loss, vomiting, abdominal pain, rashes on the hands and feet, high blood pressure, bleeding, altered taste, indigestion and low platelet counts. The medicine’s label also warns healthcare professionals and patients that it may cause severe liver injury leading to liver failure or death.
After surgery for renal cell carcinoma, sunitinib’s dose is 50 mg once daily, with or without food. Treatment continues for 4 weeks, followed by a 2-week break. A 6-week cycle is one course, and total treatment lasts 9 courses.
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Sources
fda.gov
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