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

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

Urology. 2013 Jan;81(1):143-9

Authors: van den Eertwegh AJ, Karakiewicz P, Bavbek S, Rha SY, Bracarda S, Bahl A, Ou YC, Kim D, Panneerselvam A, Anak O, Gr�nwald V

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.

PMID: 23273080 [PubMed - in process]

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