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 Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
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.