UNLABELLED: The European Association of Urology Renal Cell Carcinoma (RCC) guidelines panel updated their recommendation on adjuvant therapy in unfavourable, clinically nonmetastatic RCC following the recently reported results of a second randomised controlled phase 3 trial comparing 1-yr sunitinib to placebo for high-risk RCC after nephrectomy (S-TRAC). On the basis of conflicting results from the two available studies, the panel rated the quality of the evidence, the harm-to-benefit ratio, patient preferences, and costs. Finally, the panel, including representatives from a patient advocate group (International Kidney Cancer Coalition) voted and reached a consensus to not recommend adjuvant therapy with sunitinib for patients with high-risk RCC after nephrectomy. PATIENT SUMMARY: In two studies, sunitinib was given for 1 yr and compared to no active treatment (placebo) in patients who had their kidney tumour removed and who had a high risk of cancer coming back after surgery. Although one study demonstrated that 1 yr of sunitinib therapy resulted in a 1.2-yr longer time before the disease recurred, the other study did not show a benefit and it has not been shown that patients live longer. Despite having been diagnosed with high-risk disease, many patients remain without recurrence, and the side effects of sunitinib are high. Therefore, the panel members, including patient representatives, do not recommend sunitinib after tumour removal in these patients.

Department of Cancer Medicine Institut Gustave Roussy Villejuif France

Department of Surgical and Perioperative Sciences Urology and Andrology Umeå University Umeå Sweden

Department of Urology Aberdeen Royal Infirmary Aberdeen UK; Academic Urology Unit University of Aberdeen Aberdeen UK

Department of Urology and Urologic Oncology Hannover Medical School Hannover Germany

Department of Urology Coimbra University Hospital Coimbra Portugal

Department of Urology Faculty Hospital and Faculty of Medicine in Pilsen Charles University Prague Prague Czech Republic

Department of Urology Ludwig Maximilians University Munich Germany

Department of Urology Skåne University Hospital Malmö Sweden

Department of Urology Sunderby Hospital Sunderby Sweden

Department of Urology The Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital Amsterdam The Netherlands

Department of Urology University Hospital Schleswig Holstein Lübeck Germany

Department of Urology University of Rennes Rennes France

Division of Urology Maggiore della Carità Hospital University of Eastern Piedmont Novara Italy

Patient Advocacy International Kidney Cancer Coalition Duivendrecht The Netherlands; University Medical Centre Utrecht Nephrology Department Utrecht The Netherlands

The Royal Free NHS Trust and Barts Cancer Institute Queen Mary University of London London UK

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