| Safety of Everolimus by Treatment Duration in Patients With Advanced Renal Cell Cancer in an Expanded Access Program. | |
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MedLine Citation:
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PMID: 23273080 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article |
Journal Detail:
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Title: Urology Volume: 81 ISSN: 1527-9995 ISO Abbreviation: Urology Publication Date: 2013 Jan |
Date Detail:
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Created Date: 2012-12-31 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0366151 Medline TA: Urology Country: United States |
Other Details:
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Languages: eng Pagination: 143-9 Citation Subset: IM |
Copyright Information:
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Copyright © 2013 Elsevier Inc. All rights reserved. |
Affiliation:
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VU University Medical Center, Amsterdam, The Netherlands. Electronic address: vandeneertwegh@vumc.nl. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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