JEAN MINJOZ HOSPITAL, Besançon, France
Antoine Thiery-Vuillemin , Christine Theodore , Lutz Jacobasch , Jorg Schmitz , Aline Guillot , Christos Papandreou , Christos E. Emmanouilides , Stefano Chong Hun Kim , Meryem Ktiouet , Nadia Kelkouli , Thierry Nguyen
Background: 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. Methods: 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 centralized. Results: Here are the final results: 20 sites included 43 pts between 2011 and 2012, with 42 evaluable patients. 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, BEV only 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, and it was discontinuated for disease progression in 61.9 % of pts. From initiation of first line therapy 53.3 % of patients were alive at 32 months. Median OS was not reached for the second line; with 52.3% patients who had not progressed 8 months after the start of everolimus. 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. Conclusions: This study provided encouraging results for the activity and safety profile of EVE in this second line mRCC setting after 1 prior first-line therapy with bevacizumab-based regimen. Further studies with larger numbers of pts are planned based on these novel findings.
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