title: Management of adverse events associated with the use of everolimus in patients with advanced renal cell carcinoma.
abstract: OBJECTIVE
  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.
authors.affiliation: IRCCS San Matteo University Hospital Foundation, Pavia, Italy. c.porta@smatteo.pv.it
authors.forename: Camillo
authors.initials: C
authors.lastname: Porta
authors.forename: Susanne
authors.initials: S
authors.lastname: Osanto
authors.forename: Alain
authors.initials: A
authors.lastname: Ravaud
authors.forename: Miguel-Angel
authors.initials: MA
authors.lastname: Climent
authors.forename: Ulka
authors.initials: U
authors.lastname: Vaishampayan
authors.forename: Dorothy A
authors.initials: DA
authors.lastname: White
authors.forename: Patricia
authors.initials: P
authors.lastname: Creel
authors.forename: Brenda
authors.initials: B
authors.lastname: Dickow
authors.forename: Patricia
authors.initials: P
authors.lastname: Fischer
authors.forename: Suzanne Sweeney
authors.initials: SS
authors.lastname: Gornell
authors.forename: Federica
authors.initials: F
authors.lastname: Meloni
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Motzer
mesh_terms: D000368:Aged; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D018450:Disease Progression; D000068338:Everolimus; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010919:Placebos; D011014:Pneumonia / Q000188:drug therapy; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D012306:Risk; D020123:Sirolimus / Q000009:adverse effects / Q000031:analogs & derivatives*; D013280:Stomatitis / Q000139:chemically induced; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010919:Placebos; D000068338:Everolimus; D020123:Sirolimus