Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma Journal Article
| Authors: | Porta, C.; Osanto, S.; Ravaud, A.; Climent, M. A.; Vaishampayan, U.; White, D. A.; Creel, P.; Dickow, B.; Fischer, P.; Gornell, S. S.; Meloni, F.; Motzer, R. J. |
| Article Title: | Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma |
| 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. 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. © 2011 Elsevier Ltd. All rights reserved. |
| Keywords: | vasculotropin; cancer survival; treatment outcome; aged; middle aged; antibiotic agent; prednisone; fatigue; review; sorafenib; placebo; sunitinib; advanced cancer; diarrhea; drug dose reduction; drug safety; drug withdrawal; side effect; clinical trials as topic; liver neoplasms; drug targeting; research design; outcome assessment; treatment indication; progression free survival; anemia; mucosa inflammation; nausea; stomatitis; thrombocytopenia; randomized controlled trials as topic; aciclovir; antifungal agent; creatinine blood level; practice guideline; renal cell carcinoma; kidney carcinoma; time factors; risk; asthenia; dyspnea; hyperglycemia; lymphocytopenia; pneumonia; rash; adverse outcome; drug mechanism; carcinoma, renal cell; disease progression; mammalian target of rapamycin; neoplasm metastasis; peripheral edema; interstitial lung disease; methylprednisolone; safety; antivirus agent; diet therapy; virus infection; hypercholesterolemia; corticosteroid; lifestyle modification; double blind procedure; bacterial infection; atorvastatin; fibric acid derivative; simvastatin; kidney metastasis; fatty acid; metabolic disorder; everolimus; hyperlipidemia; fluconazole; mycosis; sirolimus; immunosuppressive agents; hypertriglyceridemia; placebos; nicotinic acid; lamivudine; mouthwash; randomized controlled trial (topic); pravastatin; phase 3 clinical trial (topic); acute respiratory failure; adverse events; multicenter study (topic); patient management; entecavir; nystatin; tenofovir |
| Journal Title: | European Journal of Cancer |
| Volume: | 47 |
| Issue: | 9 |
| ISSN: | 0959-8049 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2011-06-01 |
| Start Page: | 1287 |
| End Page: | 1298 |
| Language: | English |
| DOI: | 10.1016/j.ejca.2011.02.014 |
| PROVIDER: | scopus |
| PUBMED: | 21481584 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 3 October 2011" - "CODEN: EJCAE" - "Source: Scopus" |
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