Abstract OT1-03-02: Evaluation of the use of oral care to prevent oral mucositis in estrogen receptor positive metastatic breast cancer patients treated with everolimus: Phase III randomized control trial

Abstract

Abstract Background: In patients with estrogen receptor (ER)-positive advanced breast cancer, everolimus plus exemestane prolongs progression-free survival compared to exemestane monotherapy. However, as an adverse event from everolimus, oral mucositis (all grades) has been reported in 58% of all patients and 81% of Asian patients. Although no established prevention method is available, a previous study reported that professional oral care might prevent oral mucositis, and dentists have hypothesized that such care can reduce the occurrence of oral mucositis induced by everolimus. To evaluate this hypothesis, we compare the incidence of oral mucositis with and without professional oral care. Method: This is a randomized, multi-center, open-label, phase III study to evaluate the efficacy of professional oral care in preventing oral mucositis induced by everolimus in postmenopausal ER-positive metastatic breast cancer (MBC). Patients will be randomized into professional oral care and control groups (1:1 ratio). All patients will receive everolimus (10 mg daily) with exemestane (25 mg daily) and will continue everolimus until disease progression. Before the initiation of everolimus, instruction on a professional brushing method will be provided to both groups by specialists. In the professional oral care group, patients will receive teeth surface cleaning, scaling, and tongue cleaning before starting everolimus, and will continue to receive professional oral care weekly from oral surgeons throughout the 8 week treatment. In the control group, patients will brush their own teeth and gargle with 0.9% sodium chloride solution or water. The primary endpoint is the incidence of all grades of oral mucositis. The secondary endpoints are the incidence of over grade 2 and over 3 oral mucositis as determined by an oncologist and oral surgeons. The endpoints include onset and duration of oral mucositis. Major eligibility criteria include: 1) Postmenopausal women with ER positive MBC, and 2) No more than one prior chemotherapy treatment for MBC. Target accrual is 200 patients with a two-sided type I error rate of 5% and 80% power to detect 25% risk reduction. This study has just begun, and 5 of a planned 200 patients have been enrolled. (This study was registered with the UMIN 000016109). Citation Format: Niikura N, Ohta Y, Hayashi N, Naito M, Kashiwabara K, Watanabe K, Yamashita T, Mukai H, Umeda M. Evaluation of the use of oral care to prevent oral mucositis in estrogen receptor positive metastatic breast cancer patients treated with everolimus: Phase III randomized control trial. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT1-03-02.