Everolimus-induced stomatitis did not negatively affect progression-free survival in patients with various types of cancer, such as breast cancer and renal cell carcinoma, a study published online ahead of print in the journal Annals of Oncology has shown.1

Stomatitis, an inflammation of the oral mucous membranes is a common adverse event associated with mammalian target of rapamycin (mTOR) inhibitors, including everolimus, which is used to treat solid tumors. Therefore, researchers sought to conduct a meta-analysis to determine the clinical impact of everolimus-related stomatitis on efficacy and safety.

For the study, investigators pooled data from everolimus breast cancer studies, BOLERO-2 and -3, the renal cell carcinoma RECORD-1 study, the RADIANT-2 carcinoid tumors study, and the RADIANT-3 pancreatic neuroendocrine tumors study.

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Results showed that 67% of the 1455 patients with solid tumors experienced stomatitis. Most stomatitis events were grade 1 or 2, with grade 3 or 4 events reported in only 9% of cases.

Researchers found that 89% of first stomatitis episodes occurred within 8 weeks of initiating everolimus therapy, and patients with stomatitis occurring during that period had long progression-free survival compared with everolimus-treated patients without stomatitis in the BOLERO-2 and RADIANT-3 studies. A similar trend was observed in the RECORD-1 and RADIANT-2 studies, but not in BOLERO-3.

The results ultimately support the administration of everolimus in accordance with standard management guidelines.

“The findings suggest that with early follow-up (within 2 weeks), proactive management, and dose adjustments according to approved prescribing information in patients who experience stomatitis, everolimus can be administered with confidence regarding patient comfort, compliance, and safety,” the authors conclude.


1. Rugo HS, Hortobagyi GN, Yao J, et al. Meta-analysis of stomatitis in clinical studies of everolimus: incidence and relationship with efficacy [published online ahead of print January 11, 2016]. Ann Oncol. doi:10.1093/annonc/mdv595.