as histopathological risk factors for late neck recurrence in clinical N0 early oral tongue carcinoma.

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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.

Background The Oral Care BC-trial reported that professional oral care (POC) reduces the incidence and severity of oral mucositis in patients receiving everolimus (EVE) and exemestane (EXE). However, the effect of POC on clinical response among patients receiving EVE and EXE was not established. We compared outcomes for estrogen receptor-positive metastatic breast cancer patients who received POC to those who had not, and evaluated clinical prognostic factors. All patients simultaneously received EVE and EXE. Methods Between May 2015 and Dec 2017, 174 eligible patients were enrolled in the Oral Care-BC trial. The primary endpoint was the comparative incidence of grade 1 or worse oral mucositis, as evaluated for both the groups over 8 weeks by an oncologist. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Data were collected after a follow-up period of 13.9 months. Results There were no significant differences in PFS between the POC and Control Groups (P = 0.801). A BMI <  25 mg/m2 and non-visceral metastasis were associated with longer PFS (P = 0.018 and P = 0.003, respectively) and the use of bone modifying agents (BMA) was associated with shorter PFS (P = 0.028). The PFS and OS between the POC and control groups were not significantly different in the Oral-Care BC trial. Conclusions POC did not influence the prognosis of estrogen receptor-positive metastatic breast cancer patients. Patients with non-visceral metastasis, a BMI <  25 mg/m2, and who did not receive BMA while receiving EVE and EXE may have better prognoses. Trial registration The study protocol was registered online at the University Hospital Medical Information Network (UMIN), Japan (protocol ID 000016109), on January 5, 2015 and at ClinicalTrials.gov (NCT02376985).

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BackgroundThis randomized, controlled, multicenter, open-label, phase III study was conducted to determine whether professional oral care (POC) reduces oral mucositis in estrogen receptor-positive metastatic breast cancer patients treated with everolimus and exemestane.MethodsOne hundred seventy-four patients were randomized into the POC group (n = 86) or the control group (n = 88). Four patients in the POC group and one patient in the control group were excluded from the study because they did not receive the protocol treatment. Thus, 169 patients (POC group: 82 patients; control group: 87 patients) were evaluated for efficacy and safety. The POC group received oral health instruction (OHI), professional mechanical tooth and tongue cleaning, gargling with a benzethonium chloride mouthwash, and dexamethasone ointment when grade 1 mucositis manifested. The control group received OHI and gargling. Eight weeks after everolimus and exemestane were administered, the patients were evaluated for oral status (based on the Oral Assessment Guide [OAG] criteria) and oral mucositis status (assessed with Common Terminology Criteria for Adverse Events [CTCAE] functional and clinical examinations).ResultsThe incidences of oral mucositis of any grade and severe mucositis of grade 2 were significantly lower in the POC group (p = 0.034 and p = 0.013, respectively), based on the CTCAE functional and CTCAE clinical examinations (p = 0.034 and p < 0.001, respectively). The longitudinal data of the total OAG score (p = 0.012), total OAG grade (p = 0.014), and the longitudinal data of the OAG score of teeth/dentures (p = 0.026) and mucous membranes (p = 0.011) were significantly different between the two groups. The grade of oral mucositis diagnosed with CTCAE functional/clinical examinations was significantly correlated with the OAG grade for swallow (p = 0.04/p < 0.01), lip (p = < 0.01/p < 0.01), teeth/dentures (p = 0.04/p = 0.01), mucous membrane (p < 0.01/p < 0.01), tongue (p < 0.01/p < 0.01), and saliva (p < 0.01/p < 0.01).ConclusionsProfessional oral care may prevent oral mucositis and improve the condition of teeth/dentures in patients receiving everolimus and exemestane treatment.Trial registration:The study protocol was registered on the website of the University Hospital Medical Information Network (Tokyo, Japan; protocol ID 000016109) on January 5, 2015, and was registered on the ClinicalTrials.gov website (ClinicalTrials.gov identifier: NCT02376985) on March 3, 2015.# These authors contributed equally to this work.

The aim of this study was to compare the estimated public medical care cost of measures to address metallic dental restorations (MDRs) for head and neck radiotherapy using high-energy mega-voltage X-rays. This was considered a first step to clarify which MDR measure was more cost-effective. We estimated the medical care cost of radiotherapy for two representative MDR measures: (i) with MDR removal or (ii) without MDR removal (non-MDR removal) using magnetic resonance imaging and a spacer. A total of 5520 patients received head and neck radiation therapy in 2018. The mean number of MDRs per person was 4.1 dental crowns and 1.3 dental bridges. The mean cost per person was estimated to be 121 720 yen for MDR removal and 54 940 yen for non-MDR removal. Therefore, the difference in total public medical care cost between MDR removal and non-MDR removal was estimated to be 303 268 800 yen. Our results suggested that non-MDR removal would be more cost-effective than MDR removal for head and neck radiotherapy. In the future, a national survey and cost-effectiveness analysis via a multicenter study are necessary; these investigations should include various outcomes such as the rate of local control, status of oral mucositis, frequency of hospital visits and efforts of the medical professionals.