Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study - Université de Montpellier Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2019

Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study

1 Département de médecine oncologique [Gustave Roussy]
2 Centre Léon Bérard [Lyon]
3 CRLCC - CRLCC Eugène Marquis
4 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
5 CRCM - Centre de Recherche en Cancérologie de Marseille
6 IUCT Oncopole - UMR 1037 - Institut Universitaire du Cancer de Toulouse - Oncopole
7 ANTICIPE - Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers
8 UNICANCER/CRLC - Centre Régional de Lutte contre le Cancer François Baclesse [Caen]
9 UNICANCER
10 UNICANCER/ICL - Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy]
11 Département de Biologie et pathologie des tumeurs [Centre Georges-François Leclerc]
12 UFR des Sciences de Santé (Université de Bourgogne)
13 Département d'oncologie médicale [Centre Georges-François Leclerc]
14 LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
15 UNICANCER/CJP - Centre Jean Perrin [Clermont-Ferrand]
16 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
17 Département d'oncologie médicale
18 Service d'Oncologie médicale [CHU Limoges]
19 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
20 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
21 Voies de Signalisation du Développement et du Stress Cellulaire dans les Cancers Digestifs et Urologiques
22 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
23 IRCM - U1194 Inserm - UM - Institut de Recherche en Cancérologie de Montpellier
24 AP-HP - Hopital Saint-Louis [AP-HP]
25 HEGP - Hôpital Européen Georges Pompidou [APHP]
26 UNICANCER/CRCL - Centre de Recherche en Cancérologie de Lyon
27 IGR - Institut Gustave Roussy
Hakim Mahammedi
Bérengère Narciso
  • Fonction : Auteur
Stéphane Culine
Marina Chenot
  • Fonction : Auteur
Florence Tantot
  • Fonction : Auteur

Résumé

PURPOSE Nivolumab is standard of care for patients with metastatic clear cell renal cell carcinoma (ccRCC) after failure of antiangiogenic therapies, but its activity on brain metastases from ccRCC remains unknown, because these patients were excluded from pivotal studies. We aimed to assess the activity of nivolumab in this population. METHODS The GETUG-AFU 26 NIVOREN phase II trial assessed the activity and safety of nivolumab in patients with metastatic ccRCC who failed vascular endothelial growth factor\textendashdirected therapies ( ClinicalTrials.gov identifier: NCT03013335 ). Patients with asymptomatic brain metastases were prospectively identified and underwent dedicated brain evaluation. Two cohorts were constituted: cohort A comprised patients with previously untreated brain metastases, and cohort B comprised patients whose brain metastases underwent prior therapy. The primary end point was intracranial response rate in cohort A. RESULTS Seventy-three patients with brain metastases were included: 39 in cohort A and 34 in cohort B. Intracranial response rate was 12% in cohort A; no objective response was reported in patients with brain lesions that were multiple or larger than 1 cm. Median intracranial progression-free survival was 2.7 months (95% CI, 2.3 to 4.6 months) in cohort A and 4.8 months (95% CI, 3.0 to 8.0 months) in cohort B, with adjusted hazard ratio of 2.04 (95% CI, 1.08 to 3.83). Overall survival rate at 12 months was 67% (95% CI, 49.6% to 79.1%) in cohort A and 59% (95% CI, 40.6% to 73.2%) in cohort B. Most patients in cohort A (72%) needed subsequent focal brain therapy. Nivolumab was well tolerated, with no unexpected toxicity. CONCLUSION Nivolumab activity is limited in patients with untreated brain metastases from ccRCC. Brain imaging and focal therapy should be considered before immune checkpoint inhibitors in patients with metastatic ccRCC.

Dates et versions

hal-02931819 , version 1 (07-09-2020)

Identifiants

Citer

Ronan Flippot, Cécile Dalban, Brigitte Laguerre, Delphine Borchiellini, Gwénaelle Gravis, et al.. Safety and Efficacy of Nivolumab in Brain Metastases From Renal Cell Carcinoma: Results of the GETUG-AFU 26 NIVOREN Multicenter Phase II Study. Journal of Clinical Oncology, 2019, 37 (23), pp.2008--2016. ⟨10.1200/JCO.18.02218⟩. ⟨hal-02931819⟩
107 Consultations
0 Téléchargements

Altmetric

Partager

Gmail Facebook X LinkedIn More