Background The incidence of oral mucositis (any grade) after everolimus treatment is 58% in the general population and 81% in Asian patients. This study hypothesized that professional oral care (POC) before everolimus treatment could reduce the incidence of everolimus‐induced oral mucositis. Materials and Methods This randomized, multicenter, open‐label, phase III study evaluated the efficacy of POC in preventing everolimus‐induced mucositis. Patients were randomized into POC and control groups (1:1 ratio) and received everolimus with exemestane. Patients in the POC group underwent teeth surface cleaning, scaling, and tongue cleaning before everolimus initiation and continued to receive weekly POC throughout the 8‐week treatment period. Patients in the control group brushed their own teeth and gargled with 0.9% sodium chloride solution or water. The primary endpoint was the incidence of all grades of oral mucositis. We targeted acquisition of 200 patients with a 2‐sided type I error rate of 5% and 80% power to detect 25% risk reduction. Results Between March 2015 and December 2017, we enrolled 175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded. Over the 8 weeks, the incidence of grade 1 oral mucositis was significantly different between the POC group (76.5%, 62 of 82 patients) and control group (89.7%, 78 of 87 patients; p = .034). The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015). As a result of oral mucositis, 18 (22.0%) 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 might be considered as a treatment option of oral care for patients undergoing this treatment. Clinical trial identification number: NCT 02069093. Implications for Practice The Oral Care‐BC trial that prophylactically used professional oral care (POC), available worldwide, did not show a greater than 25% difference in mucositis. The 12% difference in grade 1 or higher mucositis and especially the ∼20% difference in grade 2 mucositis are likely clinically meaningful to patients. POC before treatment should be considered as a treatment option of oral care for postmenopausal patients who are receiving everolimus and exemestane for treatment of hormone receptor‐positive, HER2‐negative advanced breast cancer and metastatic breast cancer. However, POC was not adequate for prophylactic oral mucositis in these patients, and dexamethasone mouthwash prophylaxis is standard treatment before everolimus.
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.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.