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Safety of Everolimus by Treatment Duration in Patients With Advanced Renal Cell Cancer in an Expanded Access Program

Authors
 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 
Citation
 UROLOGY, Vol.81(1) : 143-149, 2013 
Journal Title
 UROLOGY 
ISSN
 0090-4295 
Issue Date
2013
MeSH
Aged ; Anemia/chemically induced ; Antineoplastic Agents/adverse effects* ; Antineoplastic Agents/therapeutic use ; Carcinoma, Renal Cell/drug therapy* ; Carcinoma, Renal Cell/secondary ; Disease Progression ; Dyspnea/chemically induced ; Everolimus ; Fatigue/chemically induced ; Female ; Humans ; Hyperglycemia/chemically induced ; Kidney Neoplasms/drug therapy* ; Kidney Neoplasms/pathology ; Male ; Middle Aged ; Pneumonia/chemically induced ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives* ; Sirolimus/therapeutic use ; Stomatitis/chemically induced ; Time Factors ; Treatment Outcome
Keywords
Aged ; Anemia/chemically induced ; Antineoplastic Agents/adverse effects* ; Antineoplastic Agents/therapeutic use ; Carcinoma, Renal Cell/drug therapy* ; Carcinoma, Renal Cell/secondary ; Disease Progression ; Dyspnea/chemically induced ; Everolimus ; Fatigue/chemically induced ; Female ; Humans ; Hyperglycemia/chemically induced ; Kidney Neoplasms/drug therapy* ; Kidney Neoplasms/pathology ; Male ; Middle Aged ; Pneumonia/chemically induced ; Sirolimus/adverse effects ; Sirolimus/analogs & derivatives* ; Sirolimus/therapeutic use ; Stomatitis/chemically induced ; Time Factors ; Treatment Outcome
Abstract
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.
Full Text
http://www.sciencedirect.com/science/article/pii/S0090429512011107
DOI
10.1016/j.urology.2012.09.019
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/86583
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