Bone metastases (BM) in renal cell carcinoma (RCC) are associated with a poor prognosis based on retrospective studies evaluating antiangiogenic agents. Few data are available regarding immune checkpoint inhibitors (ICI) in patients with bone metastatic RCC. NIVOREN is a multicentre prospective study in which patients were treated with nivolumab after the failure of antiangiogenic agents. We aim to assess the impact of BM on prognosis, and the efficacy and safety of nivolumab in patients enrolled in the NIVOREN trial.
All patients with BM at inclusion were included in our study. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), objective response rate (ORR), safety, and skeletal-related events (SRE).
Among 720 patients treated with nivolumab, 194 presented BM at inclusion. The median follow-up was 23.9 months. Median OS was 17.9 months in patients with BM versus 26.1 months in patients without BM (p = 0.0023). The difference was not statistically significant after adjustment (p = 0.0707). The median PFS was shorter in patients with BM even after adjustment (2.8 versus 4.6 months, p = 0.0045), as well as the ORR (14.8% versus 23.3%). SRE occurred for 36% of patients with BM. A post-hoc analysis evaluating the impact of bone-targeting agents (BTA) on SRE incidence showed a significant benefit of BTA on the incidence of SRE (OR = 0.367, CI95% [0.151-0.895]).
Nivolumab is associated with shorter PFS, and lower ORR in RCC patients with BM. Our study suggests that BTA in association with immunotherapy decreases the incidence of SRE.
European journal of cancer (Oxford, England : 1990). 2023 Jan 13 [Epub ahead of print]
Maud Velev, Cécile Dalban, Christine Chevreau, Gwenaelle Gravis, Sylvie Negrier, Brigitte Laguerre, Marine Gross-Goupil, Sylvain Ladoire, Delphine Borchiellini, Lionnel Geoffrois, Florence Joly, Frank Priou, Philippe Barthelemy, Mathieu Laramas, Berangère Narciso, Antoine Thiery-Vuillemin, Jean-François Berdah, Victoria Ferrari, Quentin Dominique Thomas, Cécile Mione, Hubert Curcio, Stephane Oudard, Florence Tantot, Bernard Escudier, Sylvie Chabaud, Laurence Albiges, Constance Thibault
Departement of Medical Oncology, Hôpital Européen Georges Pompidou, Institut du Cancer Paris CARPEM, APHP-Centre, Service d'oncologie médicale, Université Paris Cité, 20 rue Leblanc, 75015, Paris, France. Electronic address: ., Centre Léon Bérard Direction de la Recherche Clinique et de l'Innovation, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France. Electronic address: ., Institut Universitaire du Cancer Toulouse-Oncopole, Service d'oncologie médicale, 1 Av. Irène Joliot-Curie, 31100, Toulouse, France. Electronic address: ., Institut Paoli Calmettes, Service d'oncologie médicale, 232 Bd de Sainte-Marguerite, 13009, Marseille, France. Electronic address: ., Centre Léon Bérard, université Lyon I, Service oncologie médicale, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France. Electronic address: ., Centre Eugene Marquis, Service d'oncologie médicale, Av. de la Bataille Flandres-Dunkerque CS 44229, 35000, Rennes, France. Electronic address: ., Bordeaux University Hospital, Service d'oncologie medicale, Hôpital Pellegrin, Pl. Amélie Raba Léon, 33000, Bordeaux, France. Electronic address: ., Centre Georges François Leclerc, Service d'oncologie médicale, 1 Rue du Professeur Marion, 21000, Dijon, France. Electronic address: ., Centre Antoine Lacassagne, Université Côte d'Azur, Service d'oncologie médicale, 33 Av. de Valombrose, 06100, Nice, France. Electronic address: ., Institut de Cancérologie de Lorraine, Service d'oncologie médicale,6 Av. de Bourgogne, Institut de Cancérologie de Lorraine, 54519, Vandoeuvre-lès-Nancy, France. Electronic address: ., Centre François Baclesse, Service d'oncologie médicale, 3 Av. du Général Harris, 14000, Caen, France. Electronic address: ., Centre Hospitalier de Vendée, Service d'oncologie médicale, Bd Stéphane Moreau, 85000, La Roche sur Yon, France. Electronic address: ., Institut de Cancérologie Strasbourg Europe, Service d'oncologie médicale, 17 Rue Albert Calmette, 67200, Strasbourg, France. Electronic address: ., Grenoble Alpes University Hospital, Grenoble, Service d'oncologie médicale, Av. des Maquis du Grésivaudan, 38700 La Tronche, France. Electronic address: ., Tours University Hospital, Service d'oncologie médicale, 2 Bd Tonnellé, 37000, Tours, France. Electronic address: ., Hôpital Jean-Minjoz, Service d'oncologie médicale, 3 Bd Alexandre Fleming, 25000, Besançon, France. Electronic address: ., Centre Hospitalier de Hyères, Service d'oncologie médicale, Centre hospitalier d'Ajaccio, 27 Av. Impératrice Eugénie, 20000 Ajaccio, France. Electronic address: ., Centre Antoine Lacassagne, Université Côte d'Azur, Service d'oncologie médicale, 33 Av. de Valombrose, 06100, Nice, France. Electronic address: ., Departement of Medical Oncology, Institut du Cancer de Montpellier, Montpellier University, Service d'oncologie médicale, Parc Euromédecine, 208 Av. des Apothicaires, 34090, Montpellier, France. Electronic address: ., Université Clermont-Ferrand, 28 Pl. Henri Dunant, 63000, Clermont-Ferrand, France. Electronic address: ., Centre François Baclesse, Service d'oncologie médicale, 3 Av. du Général Harris, 14000, Caen, France., Departement of Medical Oncology, Hôpital Européen Georges Pompidou, Institut du Cancer Paris CARPEM, APHP-Centre, Université Paris Cité, Service d'oncologie médicale, 20 rue Leblanc, 75015, Paris, France. Electronic address: ., GETUG Group, Unicancer, 101 rue de Tolbiac, Paris, France. Electronic address: ., Gustave Roussy Cancer Campus, Université Paris-Saclay, Service d'oncologie médicale, 114 Rue Edouard Vaillant, 94805, Villejuif, France. Electronic address: ., Centre Léon Bérard, Lyon, France., Gustave Roussy Cancer Campus, Université Paris-Saclay, Service d'oncologie médicale, 114 Rue Edouard Vaillant, 94805, Villejuif, France. Electronic address: ., Departement of Medical Oncology, Hôpital Européen Georges Pompidou, Institut du Cancer Paris CARPEM, APHP-Centre, Université Paris Cité, Service d'oncologie médicale, 20 rue Leblanc, 75015, Paris, France. Electronic address: .