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.
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.
European urology. 2016 Dec 13 [Epub ahead of print]
Axel Bex, Laurence Albiges, Börje Ljungberg, Karim Bensalah, Saeed Dabestani, Rachel H Giles, Fabian Hofmann, Milan Hora, Markus A Kuczyk, Thomas B Lam, Lorenzo Marconi, Axel S Merseburger, Michael Staehler, Alessandro Volpe, Thomas Powles
Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. Electronic address: ., 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, University of Rennes, Rennes, France., Department of Urology, Skåne University Hospital, Malmö, Sweden., Patient Advocacy, International Kidney Cancer Coalition, Duivendrecht, The Netherlands; University Medical Centre Utrecht, Nephrology Department, Utrecht, The Netherlands., Department of Urology, Sunderby Hospital, Sunderby, Sweden., Department of Urology, Faculty Hospital and Faculty of Medicine in Pilsen, Charles University in Prague, Prague, Czech Republic., Department of Urology and Urologic Oncology, Hannover Medical School, Hannover, Germany., Department of Urology, Aberdeen Royal Infirmary, Aberdeen, UK; Academic Urology Unit, University of Aberdeen, Aberdeen, UK., Department of Urology, Coimbra University Hospital, Coimbra, Portugal., Department of Urology, University Hospital Schleswig-Holstein, Lübeck, Germany., Department of Urology, Ludwig-Maximilians University, Munich, Germany., Division of Urology, Maggiore della Carità Hospital, University of Eastern Piedmont, Novara, Italy., The Royal Free NHS Trust and Barts Cancer Institute, Queen Mary University of London, London, UK.