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ESMO 2016 | CABOSUN trial of cabozantinib – could it change how we treat frontline RCC?

Toni Choueiri, MD of the Dana-Farber Cancer Institute, Boston, MA gives an overview of the CABOSUN trial of cabozantinib compared to sunitinib in treatment naive poor and intermediate risk renal-cell carcinoma (RCC) patients (NCT01835158) presented at the 2016 annual meeting of the European Society of Medical Oncology (ESMO), held in Copenhagen, Denmark. Dr Choueiri first talks about the METEOR trial of cabozantinib in second-line (NCT01865747), which was presented at ESMO last year and published. It showed that cabozantinib provided an improved progression-free survival (PFS) and response rate over everolimus in the second-line setting. Later on they reported at ASCO that cabozantinib in second-line or later is associated with an overall survival (OS) benefit. He explains that the CABOSUN study was sponsored by the National Cancer Institute (NCI) and the Alliance for Clinical Trials in Oncology. It was a smaller study with 157 patients, powered for PFS and for patients who did not have systemic treatment with a focus on intermediate or poor metastatic RCC. PFS was the primary endpoint and they saw a PFS benefit that is clinically relevant and statistically significant. Further, there was a 31% decrease in risk of progression of death. Also, the secondary endpoint, response rate, was higher and more significant with cabozantinib. They had an early look at OS which is not significant yet but trending in the right direction. According to Dr Choueiri, the side effects were similar in both arms. Therefore, the question is if cabozantinib could become the next first-line option after sunitinib, which was the standard and most used first-line agent for 10 years. He believes that cabozantinib could become the next first-line option and therefore CABOSUN could change how we treat frontline RCC.