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Results from the latest adjuvant study with a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), axitinib (Inlyta), were presented at the European Society of Medical Oncology (ESMO) 2018 conference in Munich over the weekend.
Results of clinical trials assessing adjuvant therapy for intermediate- and high-risk renal cell carcinoma (RCC) with VEGF TKIs have been mixed. Adjuvant therapy remains an unmet need for people at risk of RCC recurrence following surgery. Current standard of care in the UK is surveillance.
Three randomised controlled trials (RCTs) have been published to date, and none have proven conclusively the benefits of adjuvant VEGF TKI treatment in RCC patients. The three published trials are the ASSURE (sunitinib and sorafenib), S-TRAC (sunitinib) and PROTECT (pazopanib). Only S-TRAC was positive for disease-free survival benefit. Based on this, sunitinib has FDA approval for adjuvant therapy, but has not been approved in Europe.
In this latest adjuvant study (ATLAS), axinitib was assessed as an adjuvant treatment for people with clear cell RCC who had been through surgery, and did not have metastatic disease.
There was no significant difference between axitinib and placebo with respect to disease-free survival. However, there was a trend towards benefit in patients at high-risk of recurrence, although this was not significant.
Adverse events were similar to those reported previously for axitinib.
Unfortunately, this was another negative study of adjuvant therapy for people with localised RCC.