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Poster Discussion session - Genitourinary tumours, non prostate

4306 - Brain metastases response to nivolumab in patients with renal cell carcinoma (RCC): prospective analysis from the GETUG-AFU 26 (NIVOREN) trial


20 Oct 2018


Poster Discussion session - Genitourinary tumours, non prostate



Tumour Site

Renal Cell Cancer


Ronan Flippot


Annals of Oncology (2018) 29 (suppl_8): viii303-viii331. 10.1093/annonc/mdy283


R. Flippot1, C. Dalban2, B. Laguerre3, D. Borchiellini4, G. Gravis5, S. Negrier2, C.M. Chevreau6, F. Joly7, L. Geoffrois8, S. Ladoire9, H. Mahammedi10, F. Tantot11, B. Escudier12, L. Albiges13

Author affiliations

  • 1 Medical Oncology, Gustave Roussy, 94800 - Villejuif/FR
  • 2 Medical Oncology, Centre Léon Bérard, 69008 - Lyon/FR
  • 3 Medical Oncology, Centre Eugene - Marquis, 35042 - Rennes/FR
  • 4 Medical Oncology, CENTRE ANTOINE LACASSAGNE, 06189 - NICE CEDEX /FR
  • 5 Medical Oncology, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 6 31, Institut Universitaire du Cancer -Toulouse- Oncopole, 31059 - Toulouse/FR
  • 7 Medical Oncology, Centre Francois Baclesse Caen, 14000 - Caen/FR
  • 8 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 9 Medical Oncology, Centre Georges-François Leclerc (Dijon), 21000 - Dijon/FR
  • 10 Medical Oncology, Centre Jean Perrin, 63011 - Clermont-Ferrand/FR
  • 11 Clinical research, Unicancer, Paris/FR
  • 12 Medical Oncology, Gustave Roussy Institut de Cancérologie, 94805 - Villejuif/FR
  • 13 Medical Oncology, Institut Gustave Roussy, 94800 - Villejuif/FR


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Abstract 4306


Nivolumab (N) is a standard of care in patients (pts) with metastatic RCC after failure of 1 or 2 TKIs. Efficacy of N on brain metastases (BM) from RCC is still unknown.


GETUG-AFU 26 (NIVOREN) is a prospective phase 2 trial assessing safety and efficacy of N in real-world mRCC pts population. This trial included pts with BM not requiring steroids. Herein, we report BM response to N and clinical outcomes in this subpopulation.


Overall, 81/709 (11%) pts had active BM or history of BM. Among them, 72 with visible BM at baseline and treated with N were included for analysis. IMDC risk groups were: favorable in 13 pts (18%), intermediate in 34 (48%), poor in 24 (34%). N was given in 2nd or 3rd line in 74% of pts. Median follow up was 16.1 months (m). Among 72 pts, 33 (46%) had no prior local therapy for BM, and 39 (54%) had prior local therapy: 29 had radiation therapy (RT) including 25 pts with stereotactic and 4 with whole brain RT, and 10 had prior surgery plus RT. Number of BM at baseline was 1 in 45 pts (62.5%), 2 or 3 in 17 (23.6%), >3 in 10 (13.9%). Median PFS was 2.8m [CI95% 2.5-4.2], 12m-OS was 61.7% [CI95% 48.5-72.5]. Response assessment on BM was available in 64 pts, among which 11 (17.2%) had objective response (Table 1). Under N, neurologic deterioration was observed in 29 pts (41%) and 28 (39%) required steroids. Overall, 35/72 (49%) pts required focal treatment: 27/33 (82%) in untreated pts and 8/39 (20.5%) in previously treated pts. 6m-brain PFS was 24.5% in untreated pts vs 44.8% in previously treated pts. Correlation between systemic RECIST and brain RECIST will be reported.Table: 868PD Brain objective response (modified RECIST).

Untreated (N = 33)Prior focal treatment (N = 39)Overall (N = 72)
CR4* (13.3%)3 (8.8%)7 (10.9%)
PR0 (0.0%)4 (11.8%)4 (6.3%)
SD12 (40.0%)16 (47.1%)28 (43.8%)
PD14 (46.7%)11 (32.4%)25 (39.1%)

2/4 pts developed new BM on subsequent brain imaging


not assessed due to early clinical progression.


This is the first study to report activity of N in pts with and without prior focal treatment of BM from RCC. In pts without prior BM focal therapy, N efficacy was poor, and most pts required local treatment for brain progression.

Clinical trial identification


Legal entity responsible for the study




Editorial Acknowledgement


R. Flippot: Travel grants: Pfizer, Novartis B. Laguerre: Honoraria: Bristol-Myers Squibb, Bristol-Myers Squibb, Novartis, Pfizer, Sanofi; Travel, accommodations, expenses: Bristol-Myers Squibb, Bristol-Myers Squibb, Janssen Oncology, Novartis; Pfizer. D. Borchiellini, C.M. Chevreau: Consulting or advisory role: Bristol-Myers Squibb, Ipsen, Novartis, Pfizer, G. Gravis: Travel, accommodations, expenses: Astellas Pharma, Bristol-Myers Squibb, Janssen, Oncology, Novartis, Sanofi, Takeda. S. Negrier: Honoraria: Bristol-Myers Squibb, EUSA Pharma, Ipsen, Novartis, Pfizer Consulting; Advisory role: Bristol-Myers Squibb, EUSA Pharma; Research funding: Novartis (Inst), Pfizer (Inst); Travel, accommodations, expenses: Bristol-Myers Squibb, Pfizer. F. Joly: Consulting or advisory role: AstraZeneca, BMS Brazil, Janssen, Novartis, Roche, Sanofi, Tesaro; Research funding: Astellas Pharma, Janssen; Travel, accommodations, expenses: AstraZeneca, Janssen, Roche, Tesaro. B. Escudier: Honoraria: Bayer, Bristol-Myers Squibb, Exelixis, Ipsen, Novartis, Pfizer, Roche/Genentech; Consulting or advisory role: Bayer, Bristol-Myers Squibb, EUSA Pharma, Exelixis, Ipsen, Novartis, Pfizer; Travel, accommodations, expenses: Bristol-Myers Squibb, Novartis, Pfizer. L. Albiges: Consulting or advisory role: Amgen, Bayer, Bristol-Myers Squibb, Bristol-Myers Squibb (Inst), Ipsen (Inst), Novartis, Pfizer, Sanofi; Research funding: (Inst): Bristol-Myers Squibb, Novartis, Pfizer. All other authors have declared no conflicts of interest.

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