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Random Allocated Study of Wrapping Oblate for Prevention of Everolimus-associated Stomatitis in Patients With Metastatic Renal Cell Carcinoma

Background: The study aim was to evaluate the efficacy of wrapping oblate for prevention of everolimus-associated stomatitis in metastatic renal cell carcinoma (mRCC). Patients and Methods: Patients with mRCC prescribed everolimus after failure of vascular endothelial growth factor–tyrosine kinase inhibitor were enrolled. Patients were consecutively assigned to take everolimus covered with or without oblate. The primary end-points were the incidence of and time to grade 2 or more stomatitis. Additionally, we assessed whether grade 2 or more stomatitis that occurred in the non-oblate group could be prevented with crossover application of oblate. Results: This study included 79 patients [oblate group: 42(53%); non-oblate group: 37(47%)]. Thirty (38%) patients developed grade 2 or more stomatitis [incidence: oblate group, 31% (13/42); non-oblate group, 46% (17/37), p=0.245; median time to grade 2 or more stomatitis: oblate group, not reached; non-oblate group, 6.0 months, p=0.251]. Among 10 patients who developed grade 2 or more stomatitis in the non-oblate group and received oblate-covered everolimus, nine (90%) showed complete recovery or improved to grade 1, which persisted until discontinuation of everolimus. Conclusion: Oblate-covered everolimus improved the incidence of and time to grade 2 or more stomatitis, although it was not statistically significantly different compared to the non-oblate group. Oblate wrapping prevented recurrence of grade 2 or more stomatitis in patients who took uncovered everolimus and developed significant stomatitis.