Format

Send to

Choose Destination
Eur J Cancer. 2015 Nov;51(16):2368-74. doi: 10.1016/j.ejca.2015.07.030. Epub 2015 Aug 11.

Everolimus for patients with metastatic renal cell carcinoma refractory to anti-VEGF therapy: results of a pooled analysis of non-interventional studies.

Author information

1
Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France. Electronic address: laurence.albiges@gustaveroussy.fr.
2
Private Practice Urology, Chemnitz, Germany.
3
Institut Jean Godinot, Reims, France.
4
Department of Medicine I, Clinical Division of Oncology, Medical University of Vienna, Vienna, Austria.
5
Department of Clinical Therapeutics, Athens University, Medical School, Athens, Greece.
6
Novartis Pharma SAS, Paris, France.
7
Novartis Pharma GmbH, Vienna, Austria.
8
Novartis Hellas S.A.C.I., Athens, Greece.
9
Novartis Pharma GmbH, Nuremberg, Germany.
10
Novartis Pharma, Origgio, Italy.
11
University Hospital Frankfurt, Tumor Center Rhein-Main, Frankfurt/Main, Germany.

Abstract

AIM:

To assess the efficacy and safety of everolimus in patients with metastatic renal cell carcinoma (mRCC) who failed one or two anti-VEGF therapies.

PATIENTS AND METHODS:

Data from four prospective, non-interventional studies conducted in Germany, France, Greece and Austria were pooled for this analysis. Patients with mRCC of any histology (clear cell or non-clear cell) were included. VEGF-refractory patients received everolimus 10mg/day until disease progression or unacceptable toxicity. The primary objective was to determine everolimus efficacy as measured by time to progression (TTP; from baseline to progression).

RESULTS:

The overall population comprised 632 patients; 493 patients received everolimus in the second-line setting. Most patients were of favourable/intermediate MSKCC risk (91%), had clear cell mRCC (89%), and had undergone nephrectomy (89%). Median TTP was 6.3months (95% confidence interval [CI], 5.9-6.8) for the overall population and 6.4months (95% CI, 5.8-6.9) for the second-line everolimus population. Similarly, median progression-free survival was 5.5months (95% CI, 5.0-6.1) for the overall population and 5.8months (95% CI, 5.0-6.4) for second-line everolimus population. Best tumour response (n=349) was complete or partial remission in 12% of patients and stable disease in 59% of patients. Overall population median overall survival (OS) was 11.2months (95% CI, 9.0-not reached). Commonly reported adverse events (AEs) (any grade) were stomatitis (25%), anaemia (15%) and asthenia (11%).

CONCLUSIONS:

Results of this pooled analysis provide evidence of safety and effectiveness of second-line everolimus in routine clinical use and support everolimus as a standard of care for VEGF-refractory patients with mRCC.

KEYWORDS:

Everolimus; Metastatic renal cell carcinoma; Non-interventional; Sequential targeted therapy

PMID:
26276039
DOI:
10.1016/j.ejca.2015.07.030
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center