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

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. UROLOGY 81: 143-149, 2013. (c) 2013 Elsevier Inc.