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Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma.
- Source :
-
European journal of cancer (Oxford, England : 1990) [Eur J Cancer] 2011 Jun; Vol. 47 (9), pp. 1287-98. Date of Electronic Publication: 2011 Apr 08. - Publication Year :
- 2011
-
Abstract
- Purpose: In April 2009, an expert group of 11 physicians and clinical nurses met to discuss the management of selected adverse events associated with the use of everolimus for the treatment of metastatic renal cell carcinoma (mRCC). Everolimus is an orally administered inhibitor of the mammalian target of rapamycin that recently received approval from the European Medicines Agency for the treatment of advanced RCC that has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy, and from the United States Food and Drug Administration for treatment of advanced RCC after failure of sorafenib or sunitinib. Before the approval of everolimus, no standard therapy existed for the treatment of mRCC after failure of VEGF-targeted therapy. RECORD-1 (Renal Cell cancer treatment with Oral RAD001 given Daily) was the pivotal multicenter, phase III, randomised, double-blind, placebo-controlled trial of everolimus that led to approval for patients with disease progression on or after treatment with VEGF-targeted agents. Safety data from RECORD-1 were reviewed by these clinicians, all of whom had experience using everolimus in patients with mRCC. Adverse events discussed were non-infectious pneumonitis, infections, stomatitis and metabolic abnormalities.<br />Results: The outcome of this discussion is summarised here. Guidance for management of these adverse events is provided. Both clinicians and patients should be aware of the potential side-effects of everolimus and understand that these side-effects are manageable with standard care to optimise patient benefit.<br /> (Copyright © 2011 Elsevier Ltd. All rights reserved.)
- Subjects :
- Aged
Clinical Trials as Topic
Disease Progression
Everolimus
Humans
Immunosuppressive Agents therapeutic use
Male
Middle Aged
Neoplasm Metastasis
Placebos
Pneumonia drug therapy
Randomized Controlled Trials as Topic
Research Design
Risk
Sirolimus adverse effects
Stomatitis chemically induced
Time Factors
Treatment Outcome
Carcinoma, Renal Cell drug therapy
Liver Neoplasms drug therapy
Sirolimus analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1879-0852
- Volume :
- 47
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- European journal of cancer (Oxford, England : 1990)
- Publication Type :
- Academic Journal
- Accession number :
- 21481584
- Full Text :
- https://doi.org/10.1016/j.ejca.2011.02.014