845P - Everolimus for patients with metastatic renal cell carcinoma (mRCC) refractory to anti-VEGF therapy: Updated results of a pooled analysis of nonint...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Renal Cell Cancer
Therapy
Biological therapy
Presenter Laurence Albiges
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors L. Albiges1, U. Kube2, J. Eymard3, M. Schmidinger4, A. Bamias5, N. Kelkouli6, B. Mraz6, S. Florini7, C. Rose8, A. Cattaneo9, L. Bergmann10
  • 1Dept. Of Medicine, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif/FR
  • 2Urology, Private practice, Chemnitz/DE
  • 3Oncology, Institut Jean Godinot, Reims/FR
  • 4Department Of Medicine I, Clinical Division Of Oncology And Comprehensive Cancer Center, Medical University of Vienna, Vienna/AT
  • 5Department Of Clinical Therapeutics, University of Athens, Athends/GR
  • 6Oncology, NOVARTIS PHARMA, 92500 - RUEIL MALMAISON/FR
  • 7Oncology, Novartis Hellas S.A.C.I., Athens Greece, Athens/GR
  • 8Department Is Clinical Development Of Solid Tumors, NOvartis Pharma GMBH, Nuremberg/DE
  • 9Department Is Clinical Development Of Solid Tumors, NOVARTIS PHARMA, Origgio/IT
  • 10Department Is Medical Clinic Ii, University Hospital Frankfurt, Tumor Center Rhein-Main,, Frankfurt/DE

Abstract

Aim

The pivotal RECORD-1 trial showed that the oral mTOR inhibitor everolimus significantly improved PFS compared with placebo in patients with mRCC refractory to 1 or 2 prior VEGFr-TKIs. Because clinical trial results may differ from clinical practice, it is important to evaluate routine clinical use of everolimus in patients with mRCC.

Methods

Pooled data from 4 prospective, noninterventional studies conducted in Germany, France, Greece, and Austria were evaluated to assess the safety and efficacy of everolimus after 1 or 2 anti-VEGF therapies.

Results

Data from 632 patients were included in this analysis. At baseline, median time since mRCC diagnosis was 1.7 years, 91% of patients were of favorable or intermediate MSKCC risk prognosis, clear cell histology was predominant (89%), and majority of patients had prior nephrectomy (89%). Median time to progression was 6.3 months (95%CI, 5.9–6.8); median progression free survival was 5.6 months (95% CI, 5.0–6.1). Data on tumor response was available for 436 patients: 11% had partial response; 58%, stable disease; 31%, progressive disease. Adverse events (AEs) of any grade and of any cause occurred in 78% of patients; serious AEs (SAEs), in 36%. AEs that occurred in >5% of patients included stomatitis (25%), anemia (15%), asthenia (11%), pneumonitis (10%), rash (10%), fatigue (10%), dyspnea (9%), decreased appetite (8%), cough (7%), diarrhea (7%), peripheral edema (7%), nausea (7%), and hypertriglyceridemia (6%). The most common SAEs were anemia (5%), dyspnea (5%), stomatitis (4%), general health deterioration (4%), and pneumonitis (4%). Karnofsky performance status (KPS) was largely stable through the study period: 86% of patients had a KPS ≥70 at baseline, compared with 81% at end of analysis. The presentation will also include additional updated data.

Conclusions

This pooled analysis of 4 European prospective, noninterventional studies provides evidence for the safety and effectiveness of everolimus in routine clinical use. The results support the use of everolimus as a standard of care for VEGF-refractory patients with mRCC.

Disclosure

L. Albiges Sauvin: I have been an advisory board member for Novartis, Pfizer, Amgen, and sanofi, and have received a research grant from Pfizer and Novartis;J. Eymard: I have been an advisory board member for Novartis, sanofi, Janssen, and Astellas; M. Schmidinger: I have served as an advisory board member for Pfizer, GSK, Novartis, Roche, Astellas, Bayer; have peformd corporate-sponsored research for Pfizer, GSK, Novartis, Roche; and received honoraria for lectures from Pfizer, GSK, Novartis, Roche, and Astellas; A. Bamias: I have served as an advisory board member for and have received honoraria from Novartis; N. Kelkouli: Novartis full-time employee with salary; B. Mraz: Employee of Novartis Pharma GmbH, Austria; S. Florini and C. Rose: Full-time employee of Novartis Pharma GmbH; A. Cattaneo: Employee of Novartis Pharma SPA; L. Bergmann: Advisory board member (company not specified). All other authors have declared no conflicts of interest.