876 - Efficacy and safety of sequential usage of everolimus in patients with metastatic renal cell carcinoma (mRCC) previously treated with bevacizumab +/...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer Agents
Renal Cell Cancer
Biological Therapy
Presenter Antoine-Thierry Vuillemin
Authors A. Vuillemin1, C. Theodore2, L. Jacobasch3, J. Schmitz4, A. Guillot5, C. Papandreou6, C. Emmanouilides7, K. Slimane8, M. Ktiouet8, T. Nguyen1
  • 1Medical Oncology, Hôpital Jean Minjoz, 25030 - Besançon/FR
  • 2Medical Oncology, HÔPITAL FOCH, 92151 - Suresnes/FR
  • 3Hematology/oncology, Private practice for Hematology/Oncology, 01307 - Dresden/DE
  • 4Hematology/oncology, Fachklinik Lindenberg/Ried, 88161 - Lindenberg/DE
  • 6Department Of Medical Oncology, University Hospital of Larissa, 41110 - Larissa/GR
  • 7Oncology, Iatriko Diavalkaniko Thessalonikis, 57001 - Thessaloniki/GR
  • 8Oncology, Novartis Pharmaceuticals, 92500 - Rueil-Malmaison/FR



EVE (Afinitor®) has demonstrated activity in the treatment of mRCC after failure of VEGF-targeted tyrosine kinase inhibitors. However, to this date, there is no published data evaluating its activity/safety after failure of first line BEV-based therapy.


Our non-interventional multicenter international study reports retrospective data on EVE in routine use. Eligible patients had mRCC; were given EVE after 1 prior first-line systemic therapy with BEV +/- INF. The data were provided by each center and centralised. The pts were evaluated for differences in baseline characteristics and prognostic factors (PFs) validated in mRCC.


Here are the results from an interim analysis: 20 sites included 43 pts between October 2011 and February 2012. Baseline patient characteristics included median age of 69 [38–90] years old; 64.3% male; 97.5% with prior nephrectomy. First-line therapy was BEV + INF in 69% of patients, only BEV for 31%. Prognostic groups at the time of EVE initiation according to Heng (1) and to MSKCC (2) were respectively: (1): good 25%, intermediate 59.4% and poor prognosis 15.6% and (2) good 28.1%, intermediate 56.3% and poor 15.6%. Median duration of treatment with first line therapy was 7.5 months, it was discontinued for disease progression in 61.9 % of pts. Median EVE treatment duration with was 5 [3.0–7.0] months. Median progression free survival (PFS) has not yet been reached as 15 pts are still receiving EVE. Overall response rate was 9.5 % and disease stabilization rate was 50%. At least one adverse event (AE) occurred in 73.8 % of pts with 13 serious AEs. All grade common AEs were consistent with the toxicity profile of EVE with 31% of stomatitis, 16.7% of pneumonitis, 31% of fatigue.


This study provided encouraging results for the activity and safety profile of EVE in second line mRCC setting and warrants further investigation after 1 prior first-line therapy with bevacizumab-based regimen. Final results with mature PFS data and median overall survival from initiation of first-line therapy will be available in 2013.


A. Vuillemin: Consulting fees : Novartis, Sanofi-Aventis, Ferring Member of Novartis Advisory board Honorarium study Novartis

C. Theodore: Research grant from Novartis Consulting fees from Novartis Honorarium study Novartis

L. Jacobasch: Honorarium study Novartis

A. Guillot: Member of Novartis Advisory board Speaker at Novartis regional meetings Honorarium study Novartis

C. Papandreou: Participated to advisory boards for Novartis

C. Emmanouilides: Research grants : Novartis, Pfizer, GSK

K. Slimane: Novartis employee

M. Ktiouet: Novartis Employee

T. Nguyen: Honorarium study Novartis

All other authors have declared no conflicts of interest.