Incidence of a common adverse event should not be considered a hindrance to the administration of everolimus for patients with cancer, according to a recent study.
Everolimus is an oral mammalian target of rapamycin (mTOR) inhibitor and is used to treat solid tumors and tuberous sclerosis complex (TSC). Use of everolimus and other mTOR inhibitors is often associated with stomatitis, an inflammation of the mucous membranes of the mouth.
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Using data from clinical trials of everolimus, researchers led by Hope S. Rugo, MD, University of California, San Francisco, evaluated the impact of stomatitis on clinical outcomes with everolimus. For their analysis, researchers looked at seven phase 3, double blind, randomized clinical trials of everolimus use in patients with breast cancer (BOLERO-2 and BOLERO-3), renal cell carcinoma (RECORD-1), carcinoid tumors (RADIANT-2), pancreatic neuroendocrine tumors (RADIANT-3) and TSC (EXIST-1 and EXIST-2).
From these trials, 1455 patients were identified who received everolimus for solid tumors, and 157 patients were identified for TSC. The two cohorts were evaluated separately. Overall, 67% of patients (973) in the solid tumor trials and 70% of patients (110) in the TSC trials experienced stomatitis, but the majority of these cases were not severe. Grade 3 or 4 events occurred in only 9% and 8% of patients in the solid tumor and TSC groups, respectively.
A lack of TSC patients available for analysis prevented researchers from making an in-depth evaluation of stomatitis and response. However, in the solid tumor trials, researchers determined that most episodes of stomatitis (89% [870]) occurred within 8 weeks after initiating treatment. In addition, these patients seemed to have a longer progression-free survival than patients treated with everolimus who did not experience stomatitis in the BOLERO-2 (8.5 versus 6.9 months, respectively) and RADIANT-3 [13.9 versus 8.3 months, respectively) trials.
Thus, researchers concluded that the incidence of stomatitis did not adversely affect progression-free survival, supporting the administration of everolimus in accordance with standard management guidelines.
