Patients who did not undergo cytoreductive nephrectomy in the GETUG-AFU 26 NIVOREN trial, and for whom the primary tumor was evaluated as a target lesion, were included in this analysis:
Patients received nivolumab after the failure of one or more previous treatments, and radiological evaluation was performed every 8-12 weeks (RECIST v1.1). Response rate (ORR), progression-free survival (PFS), and overall survival (OS) were prospectively assessed. Best response in primary tumor size from baseline was considered as a partial response (shrinkage > 30%), stable disease (between -30% and +20%) and progressive disease (growth >20%).
Among 720 patients treated with nivolumab in the NIVOREN GETUG-AFU -26 study, 111 did not undergo cytoreductive nephrectomy, including 67 patients evaluable for response on their primary tumor. This population was predominantly male (76.1%), with a median age of 64 years (min: 33, max: 82), and included 47% poor-risk by IMDC criteria. IMDC risk was favorable in 1.5% of patients and intermediate-risk in 51.5%. Nivolumab was used in 2nd line for 62% of patients and 3rd line or more in 38%. With a median follow-up of 26.9 months (95% CI 22.3-28.5), the ORR was 6.0% (4/67) patients), median PFS was 2.8 months (95% CI 2.6-4.2), and OS 16.6 months:
The median size of the primary renal tumor at nivolumab start was 80mm and consisted of>50% of the measured tumor burden (median sum of target lesion diameters 147mm). The median best change in primary tumor size was 5% (range: -51% to +68%). Four patients experienced primary tumor partial response (6.0%), 11 primary tumor progressive disease (16.4%), and 52 primary tumor stabile disease (77.6%). A comparison between the response of the primary and other lesions showed a linear correlation at first, which became uncertain with successive evaluations.
Dr. Courcier concluded his presentation with the following take-home messages:
- Patients who did not undergo cytoreductive nephrectomy had adverse baseline characteristics but most achieved primary tumor stabile disease or partial response, as well as prolonged primary tumor control with nivolumab
- Study of exceptional responders may provide insights on subsets of patients who may benefit from delayed cytoreductive nephrectomy
Presented by: Jean Courcier, Urology, Hôpital Henri Mondor, APHP, Haute-Garonne, France
Co-Authors: C. Dalban,2 B. Laguerre,3 S. Ladoire,4 P. Barthélémy,5 S. Oudard,6 F. Joly,7 G. Gravis Mescam,8 C.M. Chevreau,9 L. Geoffrois,10 E. Deluche,11 F. Rolland,12 D. Topart,13 S. Culine,14 S. Négrier,15 H. Mahammedi,16 F. Tantot,17 B. Escudier,18 R. Flippot,19 L. Albiges20
Affiliations: 2 Clinical Research Department, Centre Léon Bérard, Lyon, France, 3 Medical Oncology Department, Centre Eugene - Marquis, Rennes, France, 4 Oncology, Centre Georges-François Leclerc (Dijon), Dijon, France, 5 Department of Medical Oncology, Les Hôpitaux Universitaires de Strasbourg/ Institut de Cancérologie Strasbourg Europe, Strasbourg, France, 6 Medical Oncology, Hopital Européen Georges Pompidou, AP-HP.Centre – Université de Paris, Paris, France, 7 Medical Oncology Department, Centre François Baclesse, Caen, France, 8 Medical Oncology Department, Institute Paoli Calmettes, Marseille, France, 9 IUCT-Oncopôle Institut Claudius Regaud, Toulouse, HauteGaronne, France, 10 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, Vandoeuvre Les Nancy, France, 11 Medical Oncology Department, CHU Limoges - Hopital Dupuytren, Limoges, France, 12 Medical Oncology Department, ICO Institut de Cancerologie de l'Ouest René Gauducheau, Saint-Herblain, France, 13 CHU Montpellier, CHU Montpellier, Montpellier, France, 14 Medical Oncology, Hôpital Saint-Louis, Paris, France, 15 Oncologie Urologique, Centre Léon Bérard, Lyon, France, 16 Oncology, Centre Jean Perrin, Clermont Ferrand, Clermont-Ferrand, France, 17 Research & Development Department, Unicancer, Le Kremlin Bicêtre, France, 18 Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France, 19 Medical Oncology, Institut Gustave Roussy, Villejuif, France 20 Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France
Written by: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia Twitter: @zklaassen_md at the 2020 European Society for Medical Oncology Virtual Congress (#ESMO20), September 19th-September 21st, 2020.
- Mejean A, Ravaud A, Thezenas S, et al. Sunitinib alone or after nephrectomy in metastatic renal cell carcinoma. N Engl J Med 2018 Aug 2;379(5):417-427.
EAU 2020: Cytoreductive Nephrectomy: What Do We Know? Cytoreductive Nephrectomy May Be an Option Only After Response