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.
journal_name
Urologyjournal_title
Urologyauthors
van den Eertwegh AJ,Karakiewicz P,Bavbek S,Rha SY,Bracarda S,Bahl A,Ou YC,Kim D,Panneerselvam A,Anak O,Grünwald Vdoi
10.1016/j.urology.2012.09.019subject
Has Abstractpub_date
2013-01-01 00:00:00pages
143-9issue
1eissn
0090-4295issn
1527-9995pii
S0090-4295(12)01110-7journal_volume
81pub_type
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