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


Journal

Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333

Informations de publication

Date de publication:
10 08 2019
Historique:
pubmed: 14 6 2019
medline: 21 5 2020
entrez: 14 6 2019
Statut: ppublish

Résumé

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. 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-directed 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. 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. 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.

Identifiants

pubmed: 31194611
doi: 10.1200/JCO.18.02218
doi:

Substances chimiques

Antineoplastic Agents, Immunological 0
Nivolumab 31YO63LBSN

Banques de données

ClinicalTrials.gov
['NCT03013335']

Types de publication

Clinical Trial, Phase II Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2008-2016

Commentaires et corrections

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Auteurs

Ronan Flippot (R)

1Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif, France.

Cécile Dalban (C)

2Centre Léon Berard, Lyon, France.

Brigitte Laguerre (B)

3Centre Eugene Marquis, Rennes, France.

Delphine Borchiellini (D)

4Centre Antoine Lacassagne, Université Côte d'Azur, Nice, France.

Gwénaelle Gravis (G)

5Institut Paoli Calmettes, Marseille, France.

Sylvie Négrier (S)

2Centre Léon Berard, Lyon, France.

Christine Chevreau (C)

6Institut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France.

Florence Joly (F)

7Centre François Baclesse, Caen, France.

Lionnel Geoffrois (L)

8Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.

Sylvain Ladoire (S)

9Centre Georges François Leclerc, Dijon, France.

Hakim Mahammedi (H)

10Centre Jean Perrin, Clermont-Ferrand, France.

Frédéric Rolland (F)

11Centre René Gauducheau, Saint Herblain, France.

Marine Gross-Goupil (M)

12Bordeaux University Hospital, Bordeaux, France.

Elise Deluche (E)

13Limoges University Hospital, Limoges, France.

Frank Priou (F)

14Centre Hospitalier de Vendée, La Roche sur Yon, France.

Mathieu Laramas (M)

15Alpes University Hospital, Grenoble, France.

Philippe Barthélémy (P)

16Strasbourg University Hospital, Strasbourg, France.

Bérengère Narciso (B)

17Tours University Hospital, Tours, France.

Nadine Houedé (N)

18Nimes University Hospital, Nimes, France.

Stéphane Culine (S)

19Hôpital Saint Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.

Stéphane Oudard (S)

20Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.

Marina Chenot (M)

21Université Montpellier, Montpellier, France.

Florence Tantot (F)

22GETUG Group, Unicancer, Paris, France.

Sylvie Chabaud (S)

2Centre Léon Berard, Lyon, France.

Bernard Escudier (B)

1Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif, France.

Laurence Albiges (L)

1Gustave Roussy Cancer Campus, Université Paris-Saclay, Villejuif, France.

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Classifications MeSH