"…the mechanism of action and the favorable safety profile of everolimus might suggest the possibility of an earlier administration." Everolimus treatment in advanced solid tumors: a personal view

Everolimus is currently approved in four settings: progressive well differentiated pancreatic neuroendocrine tumors (pNETs), metastatic renal cell carcinoma (mRCC), in patients who failed a treatment with tyrosine kinase inhibitor; advanced hormone receptor positive HER-2 negative breast carcinoma in combination with exemestane; and astrocytoma associated with tuberous sclerosis [1]. The approval of everolimus was based on the results of three Phase III, randomized, placebo-controlled trials: RADIANT-3, RECORD 1 and BOLERO 2 [2–4], which included patients with pNET, mRCC and breast carcinoma, respectively. Overall, everolimus was shown to increase the median progression-free survival, the primary endpoint of each study. The safety profile of everolimus was satisfactory: most adverse events were of mild-to-moderate severity and were successfully managed