Abstract P1-11-01: Oral care evaluation to prevent oral mucositis in estrogen receptor positive metastatic breast cancer patients treated with everolimus (Oral Care-BC): A randomized controlled phase III trial
Authors: N Niikura, K Nakatukasa, T Amamiya, K-i Watanabe, H Hata, Y Kikawa, N Taniike, T Yamanaka, S Mitsunaga, K Nakagami, M Adachi, N Kondo, K Horii, N Hayashi, M Naito, K Kashiwabara, T Yamashita, M Umeda, H Mukai, Y Ota
Journal: Cancer Research (2019)

Abstract Introduction Oral mucositis is a clinically significant complication of mucotoxic cancer therapy. The incidence of oral mucositis (any grade) as an adverse drug reaction of everolimus is 58%, while an analysis of Asian people has reported its occurrence as 81%.This study hypothesizes that the occurrence of oral mucositis will reduce with professional oral care (POC) administered prior to everolimus treatment. Method: This was a randomized, multi-center, open-label, phase III study, to evaluate the efficacy of POC in preventing mucositis induced by everolimus in postmenopausal, estrogen receptor (ER)-positive, metastatic breast cancer patients. Patients were randomized into POC and control groups (1:1 ratio). All patients received everolimus with exemestane and continued the everolimus until disease progression. In the POC group, patients were subjected to teeth surface cleaning, scaling and tongue cleaning, before initiating everolimus, and continued to receive weekly POC from dentist or oral surgeons throughout the 8 weeks of treatment. In the control group, patients brushed their own teeth and gargled with 0.9% sodium chloride solution or water. The primary end-point was to measure the incidence of all grades of oral mucositis. Target accrual was 200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction. This trial has been registered at ClinicalTrials.gov, number NCT 02069093. Result: Between May 26, 2014 and Dec 28, 2017, we enrolled 174 women from 31 institutions; 168 were evaluable for efficacy but 5 were excluded (had not received the protocol treatment [n=4]; no efficacy data [n=1]). In 8 weeks, the incidence of grade 1 oral mucositis was significantly different between the POC group (76.5%, 62 of 81 patients) and control group (89.7%, 78 of 87 patients) (p=0.035). The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 81 patients) and control group (54%, 47 of 87 patients) (p= 0.015). As a result of oral mucositis, 18 (22.2%) patients in the POC group and 28 (32.2%) in the control group had to undergo everolimus dose reduction. Conclusion: POC reduced the incidence and severity of oral mucositis in patients receiving everolimus and exemestane. This could be a new standard in oral care for patients undergoing this treatment. Primary Analysis: Incidence Probability of Oral Mucositis POC Group (n=81) Controll (n=87)P-valuneOral Mucositis over Grade1n% n% Yes6276.5 7889.70.035No1923.5 910.3 Risk Difference, % (95% CI)-11.83 (-22.80, -0.85) POC: Professional oral Care Citation Format: Niikura N, Nakatukasa K, Amamiya T, Watanabe K-i, Hata H, Kikawa Y, Taniike N, Yamanaka T, Mitsunaga S, Nakagami K, Adachi M, Kondo N, Horii K, Hayashi N, Naito M, Kashiwabara K, Yamashita T, Umeda M, Mukai H, Ota Y. Oral care evaluation to prevent oral mucositis in estrogen receptor positive metastatic breast cancer patients treated with everolimus (Oral Care-BC): A randomized controlled phase III trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-01.