Thomas Powles1, Laurence Albiges2, Michael Staehler3, Karim Bensalah4, Saeed Dabestani5, Rachel H Giles6, Fabian Hofmann7, Milan Hora8, Markus A Kuczyk9, Thomas B Lam10, Lorenzo Marconi11, Axel S Merseburger12, Sergio Fernández-Pello13, Rana Tahbaz14, Alessandro Volpe15, Börje Ljungberg16, Axel Bex17. 1. The Royal Free NHS Trust and Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: Thomas.Powles@bartshealth.nhs.uk. 2. Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France. 3. Department of Urology, Ludwig-Maximilians University, Munich, Germany. 4. Department of Urology, University of Rennes, Rennes, France. 5. Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden. 6. Patient Advocacy, International Kidney Cancer Coalition, Duivendrecht, The Netherlands; University Medical Center Utrecht, Department of Nephrology and Hypertension, Regenerative Medicine Center Utrecht, University of Utrecht, The Netherlands. 7. Department of Urology, Sunderby Hospital, Sunderby, Sweden. 8. Faculty Hospital Plzeň and Faculty of Medicine in Plzeň, Charles University, Czech Republic. 9. Department of Urology and Urologic Oncology, Hannover Medical School, Hannover, Germany. 10. Department of Urology, Aberdeen Royal Infirmary, Aberdeen, UK; Academic Urology Unit, University of Aberdeen, Aberdeen, UK. 11. Department of Urology, Coimbra University Hospital, Coimbra, Portugal. 12. Department of Urology, University Hospital Schleswig-Holstein, Lübeck, Germany. 13. Department of Urology, Cabueñes Hospital, Gijón, Spain. 14. Department of Urology, University Hospital Hamburg Eppendorf, Hamburg, Germany. 15. Division of Urology, Maggiore Della Carità Hospital, University of Eastern Piedmont, Novara, Italy. 16. Department of Surgical and Perioperative Sciences, Urology and Andrology, Umeå University, Umeå, Sweden. 17. Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Abstract
The randomised phase III clinical trial Checkmate-214 showed a survival superiority for the combination of ipilimumab and nivolumab when compared with the previous standard of care in first-line metastatic/advanced clear cell renal cell carcinoma (RCC) (Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. LBA5, ESMO 2017, 2017). These results change the frontline standard of care for this disease and have implications for the selection of subsequent therapies. For this reason the European Association of Urology RCC guidelines have been updated. PATIENT SUMMARY: The European Association of Urology guidelines will be updated based on the results of the phase III Checkmate-214 clinical trial. The trial showed superior survival for a combination of ipilimumab and nivolumab (IN), compared with the previous standard of care, in intermediate- and poor-risk patients with metastatic clear cell renal cell carcinoma. When IN is not safe or feasible, alternative agents such as sunitinib, pazopanib, and cabozantinib should be considered. Furthermore, at present, the data from the trial are immature in favourable-risk patients. Therefore, sunitinib or pazopanib remains the favoured agent for this subgroup of patients.
RCT Entities:
The randomised phase III clinical trial Checkmate-214 showed a survival superiority for the combination of ipilimumab and nivolumab when compared with the previous standard of care in first-line metastatic/advanced clear cell renal cell carcinoma (RCC) (Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. LBA5, ESMO 2017, 2017). These results change the frontline standard of care for this disease and have implications for the selection of subsequent therapies. For this reason the European Association of Urology RCC guidelines have been updated. PATIENT SUMMARY: The European Association of Urology guidelines will be updated based on the results of the phase III Checkmate-214 clinical trial. The trial showed superior survival for a combination of ipilimumab and nivolumab (IN), compared with the previous standard of care, in intermediate- and poor-risk patients with metastatic clear cell renal cell carcinoma. When IN is not safe or feasible, alternative agents such as sunitinib, pazopanib, and cabozantinib should be considered. Furthermore, at present, the data from the trial are immature in favourable-risk patients. Therefore, sunitinib or pazopanib remains the favoured agent for this subgroup of patients.
Authors: Sebastien J Hotte; Anil Kapoor; Naveen S Basappa; Georg Bjarnason; Christina Canil; Henry J Conter; Piotr Czaykowski; Jeffrey Graham; Samantha Gray; Daniel Y C Heng; Pierre I Karakiewicz; Christian Kollmannsberger; Aly-Khan A Lalani; Scott A North; François Patenaude; Denis Soulières; Phillippe Violette; Eric Winquist; Lori A Wood; Shaan Dudani; Ranjena Maloni; M Neil Reaume Journal: Can Urol Assoc J Date: 2019-10 Impact factor: 1.862
Authors: John K Chan; William Brady; Bradley J Monk; Jubilee Brown; Mark S Shahin; Peter G Rose; Jae-Hoon Kim; Angeles Alvarez Secord; Joan L Walker; David M Gershenson Journal: Gynecol Oncol Date: 2018-06-18 Impact factor: 5.482