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The US Food and Drug Administration (FDA) has approved sunitinib (Sutent) for adjuvant treatment of adults who have had their kidney cancer removed, but who are at high risk of the cancer returning.
Sunitinib is a tyrosine kinase inhibitor (TKI) that works by blocking several enzymes that promote cell growth and the formation of new blood vessels (angiogenesis). It first became available within the NHS in 2009 for the treatment of patients with advanced renal cell carcinoma (RCC).
The approval of adjuvant sunitinib by the FDA was based on the S-TRAC study, which involved 615 patients with a high risk of recurrent RCC following nephrectomy. The results from S-TRAC showed that five years after one year of treatment with either sunitinib or placebo, 59.3% of patients treated with sunitinib remained disease-free compared with 51.3% of those receiving placebo. Median disease-free survival in the sunitinib arm was 6.8 years, versus 5.6 years for placebo; an improvement of more than a year.
However, it is important to highlight that the S-TRAC study is still ongoing and patients continue to be followed for overall survival data. It is, therefore, not known whether sunitinib can prevent recurrence of RCC completely. The S-TRAC data show that sunitinib can delay recurrence of RCC compared to placebo.
As with most cancer drugs, there are side effects to taking sunitinib, and healthcare professionals and patients are warned about the risk of severe liver damage (hepatoxicity), which may result in liver failure or death. Other potential serious side effects include heart failure, heart attack, hypertension, metabolic abnormalities, and osteonecrosis.
Ongoing study of the data will help healthcare professionals determine which patients will truly benefit from this treatment, and frank, detailed conversations need to occur between patients and doctors regarding the risks and benefits of taking adjuvant sunitinib.
The European Medicines Agency (EMA) has not yet approved a marketing authorisation for sunitinib for the adjuvant treatment of advanced RCC. And adjuvant sunitinib will also need to be appraised by the National Institute for Health and Care Excellence (NICE) for cost:effectiveness before becoming available for use within the NHS. We expect the NICE appraisal to take place early-mid 2018.