Document Detail

Safety of Everolimus by Treatment Duration in Patients With Advanced Renal Cell Cancer in an Expanded Access Program.
MedLine Citation:
PMID:  23273080     Owner:  NLM     Status:  In-Data-Review    
OBJECTIVE: To retrospectively analyze the effects of treatment duration on outcomes of everolimus treatment of patients in the RAD001 Expanded-Access Clinical Trial in RCC (REACT) program.
METHODS: Patients with metastatic renal cell carcinoma refractory to vascular endothelial growth factor receptor-tyrosine kinase inhibitor received everolimus (10 mg once daily), with dosing interruption or modifications allowed for toxicity. All serious and grade 3/4 adverse events and grade 1/2 adverse events leading to a change in drug administration were reported. Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors.
RESULTS: The study stratified 1367 evaluable patients into treatment duration groups of <3 months, ≥3 and <6 months, ≥6 months and <1 year, and ≥1 year. Pneumonia, noninfectious pneumonitis, and hyperglycemia occurred more frequently in patients receiving everolimus for ≥1 year but did not result in treatment discontinuations. First occurrence of adverse events presented early in the treatment course for most patients. Treatment duration of ≥6 months was associated with improved disease control rates.
CONCLUSION: Everolimus is well tolerated in patients with metastatic renal cell carcinoma for treatment durations ≥1 year and not associated with cumulative toxicity.
Alfonsus J M van den Eertwegh; Pierre Karakiewicz; Sevil Bavbek; Sun Young Rha; Sergio Bracarda; Amit Bahl; Yen-Chuan Ou; Dennis Kim; Ashok Panneerselvam; Oezlem Anak; Viktor Grünwald
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Urology     Volume:  81     ISSN:  1527-9995     ISO Abbreviation:  Urology     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2012-12-31     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0366151     Medline TA:  Urology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  143-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 Elsevier Inc. All rights reserved.
VU University Medical Center, Amsterdam, The Netherlands. Electronic address:
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