Texture Analysis of Food Samples Used for the Evaluation of Masticatory Function.

Introduction Food questionnaire surveys are often used to evaluate masticatory function. In daily clinical practice in Japan, a survey is performed using a list of food groups suitable for the Japanese diet. The foods on the list were categorized into five food groups based on their mastication index. The patient's masticatory function is determined by the food groups that can be eaten. The masticatory index, which indicates chewability, was defined based on the percentage of 110 denture wearers who responded that they could eat food normally. A survey with this list is useful because of its simplicity; however, there is a lack of objective data on the physical properties of food samples. Consequently, to make the results of the food questionnaire survey more objective indicators, we performed a texture analysis of the food samples on the list. Methods We performed a texture analysis of 93 samples from 77 food items on the list. Compression tests were performed using a texture analyzer, and hardness, cohesiveness, adhesiveness, viscosity, and gumminess were calculated by a texture profile analysis. Results Even with the same ingredients, the results differed depending on the presence or absence of food skin, the direction of pressing (vertical or horizontal), cooking methods, and temperature differences. However, the masticatory index was negatively correlated with hardness (-0.4157, p<0.001) and gumminess which is determined as the product of hardness×cohesiveness (-0.4980, p<0.001). Conclusion This study suggests that the masticatory index indicating chewability may be related to the hardness and cohesiveness of food samples. Even for foods with the same hardness, the degree of difficulty in forming a food mass is expected to vary depending on differences in cohesiveness. Moreover, the presence or absence of food skin, the direction of food fibers, cooking methods, and temperature differences change the physical properties of the food. Therefore, the composition and structure of the foods or eating habits of patients should be taken into consideration when conducting a food questionnaire survey.

Efficacy of perioperative oral care management in the prevention of surgical complications in 503 patients after pancreaticoduodenectomy for resectable malignant tumor: A multicenter retrospective analysis using propensity score matching.

BACKGROUND: Pancreaticoduodenectomy has been associated with a high mortality rate and significant postoperative morbidity. Recently, perioperative oral care management has been reported to be effective in preventing postoperative pneumonia and surgical site infection. In this study, we examined the effect of perioperative oral care management in reducing complications after pancreaticoduodenectomy, including surgical site infection. METHODS: This retrospective multicenter study included 503 patients who underwent pancreaticoduodenectomy at 8 facilities between January 2014 and December 2016. Among these, 144 received perioperative oral management by dentists and dental hygienists (oral management group), whereas the remaining 359 did not (control group). The oral care management program included oral health instructions, removal of dental calculus, professional mechanical tooth cleaning, removal of tongue coating, denture cleaning, instructions for gargling, and tooth extraction. The participants were matched using propensity scores to reduce background bias. Various factors were examined for correlation with the development of complications. RESULTS: The incidence of organ/space surgical site infection was significantly lower in the oral management group than in the control group (8.0% vs 19.6%, P = .005). Multivariable logistic regression analysis revealed that hypertension and lack of perioperative oral management were independent risk factors for organ/space surgical site infection. Lack of perioperative oral management had an odds ratio of 2.847 (95% confidence interval 1.335-6.071, P = .007). CONCLUSION: Perioperative oral care management reduces the occurrence of surgical site infections after pancreaticoduodenectomy and should be recommended as a strategy to prevent infections in addition to antibiotic use.

Alkali-treated titanium dioxide promotes formation of proteoglycan layer and altered calcification and immunotolerance capacity in bone marrow stem cell.

Introduction: In this study, we report that a proteoglycans (PGs)-layer between the bone and titanium dioxide (TiO2) surface after osseointegration improved the calcification capacity and immunotolerance of human bone marrow mesenchymal stem cells (hBMSCs) on TiO2. Alkaline treatment of TiO2 is a method for promoting osteogenesis in hBMSCs. We hypothesized that promotion of osteogenesis due to alkaline treatment was caused by changing PGs-layer on TiO2. Objective: This study aimed to analyze whether alkaline treatment of TiO2 affects PGs-layer formation and immunotolerance in hBMSCs. Methods: The topology and wettability of the alkaline-treated titanium (Ti-Al) and unprocessed titanium (Ti-MS) surfaces were characterized. Initial cell attachment, cell proliferation, calcification capacity, alkaline phosphatase activity, PGs-layer formation, PGs function, and the expression of osteogenic and immunotolerance-related genes were analyzed. The conditioned medium (CM) from hBMSCs grown on Ti-Al and Ti-MS was added to macrophages (hMps) and Jurkat cells, and immunotolerance gene expression in these cells was analyzed. Results: hBMSCs cultured on Ti-Al showed increased initial cell attachment, cell proliferation, PG-layer formation, and osteogenic capacity compared with hBMSCs on Ti-MS. Gene expression of indoleamine 2,3-dioxygenase (IDO) in the hBMSCs cultured on Ti-Al was higher than that in the hBMSCs on Ti-MS. CM from hBMSCs did not affect markers of M1 and M2 macrophages in hMps. CM from hBMSCs cultured on Ti-Al altered the gene expression of Foxp3 in Jurkat cells compared to that of CM from hBMSCs on Ti-MS. Significance: These results suggest that alkaline treatment of TiO2 altered PGs-layer formation, and changed the osteogenesis and immunotolerance of hBMSCs.

Aß42 treatment of the brain side reduced the level of flotillin from endothelial cells on the blood side via FGF-2 signaling in a blood-brain barrier model.

Our previous study showed that the flotillin level is decreased in the blood of patients with Alzheimer's disease (AD) when compared to that of patients with non-AD and vascular dementia; however, the molecular mechanism remains to be determined. In this study, to elucidate whether Aß accumulation in the brain has an effect on the blood flotillin level, we used our previously established blood-brain barrier (BBB) culture model using microvascular endothelial cells obtained from human induced pluripotent stem cells (iBMECs) and astrocytes prepared from rat cortex. In this BBB model with iBMECs plated on the upper compartment (blood side) and astrocytes plated on the lower compartment (brain side), the trans-endothelial electrical resistance values are high (over 1500 Ωm2) and stable during experiments. We found that the addition of Aß42 (0.5 and 2 µM) to the brain side significantly reduced the level of flotillin secreted by iBMECs on the blood side. The level of basic fibroblast growth factor (FGF-2) in the brain side was significantly reduced by Aß42 treatment, and was accompanied by a reduction in the level of phosphorylation of the fibroblast growth factor receptor in iBMECs. The brain-side Aß42 treatment-induced reduction of flotillin secretion into the blood side was restored in a dose-dependent manner by the addition of FGF-2 into the brain side. These results indicated that Aß accumulation in the brain side reduced FGF-2 release from astrocytes, which attenuated FGF-2-mediated iBMECs signaling via the FGF-2 receptor, and thereby reduced flotillin secretion from iBMECs on the blood side. Our findings revealed a novel signaling pathway crossing the BBB from the brain side to the blood side, which is different from the classical intramural periarterial drainage or lymphatic-system-to-blood pathway.

Two cases of parapharyngeal space tumor resected by a double split mandibular osteotomy technique.

Parapharyngeal space tumors have poor subjective symptoms and often grow until diagnosed; therefore, mandibular transection may be needed to obtain a wider field of view during surgery. However, if a median lower lip incision is performed for the mandibular transection, esthetic problems occur after surgery. Here, we report two cases of parapharyngeal space tumors that were removed with a mandibular lateral segment-osteotomy technique without median lower lip incision to avoid esthetic problems. Case 1 was a 49-year-old woman. She was aware of a right tonsillar swelling, and an imaging test revealed a tumor lesion 60 mm in size in the right parapharyngeal space. Case 2 was a 40-year-old woman with an abnormal position of the uvula, and an imaging test showed the left parapharyngeal space tumor lesion 45 mm in size. Both cases were diagnosed as a pleomorphic adenoma, and surgery under general anesthesia was performed jointly with otolaryngology and oral surgery. The incision was performed from the lower part of the right auricle to the anterior part of the submandibular area. After the tumor resection, the mandible was repositioned, fixed by plates, and the intermaxillary fixation was performed with a surgical stent. In both cases, slight paralysis of the mandibular branch of the facial nerve and the mental nerve was observed after the operation, but they were improved immediately. One year after the operation, the plates were removed. There have been no recurrences until now.

Prevalence of and risk factors for postoperative complications after lower third molar extraction: A multicenter prospective observational study in Japan.

Lower third molar extraction is the most common surgical treatment among routine dental and oral surgical procedures. while the surgical procedures for lower third molar extraction are well established, the difficulty of tooth extraction and the frequency of postoperative complications differ depending on the patient's background. To establish a management protocol for the lower third molars, the prevalence of and risk factors for postoperative complications after lower third molar extraction were investigated in a large number of Japanese patients in a multicenter prospective study. During 6 consecutive months in 2020, 1826 lower third molar extractions were performed at the 20 participating institutions. The medical records of the patients were reviewed, and relevant data were extracted. The prevalence of and risk factors for postoperative complications were analyzed. The prevalence of postoperative complications after lower third molar extraction was 10.0%. Multivariate analysis indicated that age (≤32 vs >32, odds ratio [OR]: 1.428, 95% confidence interval [95% CI]: 1.040-1.962, P < .05), the radiographic anatomical relationship between the tooth roots and mandibular canal (overlapping of the roots and canal vs no close anatomical relationship between the roots and the superior border of the canal, OR: 2.078, 95% CI: 1.333-3.238, P < .01; overlapping of the roots and canal vs roots impinging on the superior border of the canal, OR: 1.599, 95% CI: 1.050-2.435, P < .05), and impaction depth according to the Pell and Gregory classification (position C vs position A, OR: 3.7622, 95% CI: 2.079-6.310, P < .001; position C vs position B, OR: 2.574, 95% CI: 1.574-4.210, P < .001) are significant independent risk factors for postoperative complications after lower third molar extraction. These results suggested that higher age and a deeply impacted tooth might be significant independent risk factors for postoperative complications after lower third molar extraction.

Three-Dimensional Printing of an Apigenin-Loaded Mucoadhesive Film for Tailored Therapy to Oral Leukoplakia and the Chemopreventive Effect on a Rat Model of Oral Carcinogenesis.

Oral leukoplakia, which presents as white lesions in the oral cavity, including on the tongue, is precancerous in nature. Conservative treatment is preferable, since surgical removal can markedly reduce the patient's quality of life. In the present study, we focused on the flavonoid apigenin as a potential compound for preventing carcinogenesis, and an apigenin-loaded mucoadhesive oral film was prepared using a three-dimensional (3D) bioprinter (semi-solid extrusion-type 3D printer). Apigenin-loaded printer inks are composed of pharmaceutical excipients (HPMC, CARBOPOL, and Poloxamer), water, and ethanol to dissolve apigenin, and the appropriate viscosity of printer ink after adjusting the ratios allowed for the successful 3D printing of the film. After drying the 3D-printed object, the resulting film was characterized. The chemopreventive effect of the apigenin-loaded film was evaluated using an experimental rat model that had been exposed to 4-nitroquinoline 1-oxide (4NQO) to induce oral carcinogenesis. Treatment with the apigenin-loaded film showed a remarkable chemopreventive effect based on an analysis of the specimen by immunohistostaining. These results suggest that the apigenin-loaded mucoadhesive film may help prevent carcinogenesis. This successful preparation of apigenin-loaded films by a 3D printer provides useful information for automatically fabricating other tailored films (with individual doses and shapes) for patients with oral leukoplakia in a future clinical setting.

Risk factors for osteoradionecrosis of the jaw in patients with oral or oropharyngeal cancer: Verification of the effect of tooth extraction before radiotherapy using propensity score matching analysis.

Background/purpose: Osteoradionecrosis of the jaw (ORN) often occurs in patients with head and neck cancer undergoing radiotherapy (RT). It has been recommended to extract the tooth before RT that may become source of infection, but in recent years, some investigators have reported that tooth extraction before RT increase the risk of developing ORN and therefore should be avoided. The purpose of the study is to evaluate the risk factors for ORN including tooth extraction before RT. Materials and methods: This was a retrospective study of 366 patients with oral or oropharyngeal cancer who underwent RT of 50 Gy or more at six university hospitals, with follow-up of at least six months post-RT. The relationship between each factor and ORN incidence was analyzed using the Cox proportional hazard model. Results: Periapical lesions, more than 50% loss of alveolar bone, and tooth extraction after RT significantly correlated with ORN. Intensity-modulated RT showed a lower incidence than three-dimensional conformal RT, although not statistically different. Tooth extraction before RT significantly reduced ORN incidence, after adjusting the background factors using propensity score matching. Conclusion: In patients with oral or oropharyngeal cancer who underwent RT, periapical lesions, more than 50% loss of alveolar bone, and tooth extraction after RT significantly increased the risk for ORN. Infected tooth extraction before RT significantly reduced the risk.

Perioperative oral care can prevent surgical site infection after colorectal cancer surgery: A multicenter, retrospective study of 1,926 cases analyzed by propensity score matching.

BACKGROUND: Surgical site infection is a common postoperative complication of colorectal cancer surgery, and surgical site infection increases medical costs, prolongs hospitalization, and worsens long-term prognosis. Perioperative oral care has been reported to be effective in preventing postoperative pneumonia, although there are only a few reports on its effectiveness in preventing surgical site infection. This study aimed to determine the role of perioperative oral care in surgical site infection prevention after colorectal cancer surgery. METHODS: In this study, 1,926 patients with colorectal cancer from 8 institutions were enrolled; 808 patients (oral care group) received perioperative oral care at the hospital's dental clinic, and 1,118 (control group) did not receive perioperative oral care. The data were matched by propensity score to reduce bias. Ultimately, a total of 1,480 patients were included in the analysis. RESULTS: The incidence of surgical site infection was significantly lower in the oral care group than in the control group (8.4% vs 15.7%, P < .001). Multivariate logistic regression analysis revealed 4 independent risk factors for surgical site infection: low albumin level, rectal cancer, blood loss, and lack of perioperative oral care. Lack of perioperative oral care had an odds ratio of 2.100 (95% confidence interval 1.510-2.930, P < .001). CONCLUSION: These results suggest that perioperative oral care can reduce the incidence of surgical site infection after colorectal cancer resection. Perioperative oral care may have an important role in the future perioperative management of colorectal cancer as a safe and effective method of surgical site infection prevention, although further validation in prospective studies is needed.

Preventive effects of betamethasone valerate ointment for radiation-induced severe oral mucositis in patients with oral or oropharyngeal cancer: protocol for a multicentre, phase II, randomised controlled trial (Bet-ROM study).

INTRODUCTION: This is a randomised, multi-centre, open-label, phase II study to evaluate the efficacy of betamethasone valerate ointment on radiation-induced oral mucositis in patients with head and neck cancer undergoing concomitant radiotherapy with cisplatin or cetuximab. METHODS AND ANALYSIS: The trial will take place at seven hospitals in Japan. Patients will be randomised (1:1) into betamethasone and control groups after the occurrence of grade 1 oral mucositis. In the betamethasone group, patients will use betamethasone valerate ointment five times a day, in addition to usual oral hygiene guidance. The primary endpoint is the incidence and onset time of grade 3 oral mucositis. The secondary endpoints are the incidence and onset time of grade 2 oral mucositis, incidence and onset time of oral candidiasis, completion of radiation therapy and adverse events. Target accrual is 102 patients with a two-sided type I error rate of 5% and 80% power to detect an 80% risk reduction in the incidence of grade 3 oral mucositis. ETHICS AND DISSEMINATION: This study was approved by the Clinical Research Review Board of Nagasaki University (No. CRB20-009). All participants will be required to provide written informed consent. Findings will be disseminated through scientific and professional conferences and peer-reviewed journal publication. The datasets generated during the study will be available from the corresponding author on reasonable request. TRIAL REGISTRATION NUMBER: jRCTs071200013.

Association between dental extraction after radiotherapy and osteoradionecrosis: A multi-centre retrospective study.

OBJECTIVE: Radiotherapy (RT) carries a substantial risk for the development of osteoradionecrosis (ORN) of the jaw. This study was performed to investigate the relationship between dental extractions after RT and the development of ORN. MATERIAL AND METHODS: Thirty-two patients with head and neck cancer who underwent tooth extraction after RT were investigated for correlations between the development of ORN and various factors. RESULTS: Postextraction ORN was diagnosed in 12 (12.1%) teeth of 9 patients. The RT dose against the site of tooth extraction was 62.0 and 37.4 Gy in the ORN and Non-ORN groups, respectively (p < .001). The duration from RT to tooth extraction was 41.2 and 28.2 months in the ORN and Non-ORN groups, respectively (p = .025). Tooth extraction was significantly associated with ORN in patients with a high RT dose against the site (odds ratio = 1.231) and a longer duration of time from RT (odds ratio = 1.084). CONCLUSIONS: Extraction of non-restorable teeth and those with a poor prognosis should not necessarily be postponed even when patients are undergoing RT. However, clinicians should pay special attention to postoperative management after tooth extraction in patients with a high RT dose and longer time from RT.

Perioperative management of von Willebrand patients at the time of implant placement: Case report.

In the management of patients with type 1 von Willebrand disease, supplementation with Con Facto F® as well as hemodynamic stabilization with appropriate analgesia and sedation may be important to reduce the risk of bleeding.

Oral care and oral assessment guide in breast cancer patients receiving everolimus and exemestane: subanalysis of a randomized controlled trial (Oral Care-BC).

BACKGROUND: Oral mucositis is a clinically significant adverse event linked to cancer therapy; it reduces the quality of life of patients and may result in the discontinuation of treatment and a poorer prognosis. Based on level 3 evidence, the Mucositis Study Group of Multinational Association for Supportive Care in Cancer and the International Society of Oral Oncology recommend oral care for all patients receiving cancer chemotherapy and radiotherapy, although no data from large-scaled randomized controlled trials support the efficacy of oral care in preventing oral mucositis. Therefore, this randomized, controlled, multicenter, open-label, phase III study sought to determine whether professional oral care reduces oral mucositis in everolimus and exemestane-treated estrogen receptor-positive metastatic breast cancer patients. METHODS: Altogether, 169 patients were randomized into the professional oral care (n=82) and control (n=87) groups. The professional oral care group received oral health instruction, professional mechanical tooth and tongue cleaning, gargling with a benzethonium chloride mouthwash, and dexamethasone ointment when grade 1 mucositis manifested. The control group received oral health instruction and gargling. Eight weeks after the everolimus and exemestane administration, the oral status (Oral Assessment Guide criteria) and oral mucositis status (Common Terminology Criteria for Adverse Events functional and clinical examinations) were evaluated. RESULTS: The incidence of oral mucositis of any grade and grade 2 severe mucositis was significantly lower in the professional oral care group, based on the Common Terminology Criteria for Adverse Events functional and clinical examinations. The total Oral Assessment Guide score, total Oral Assessment Guide grade, and Oral Assessment Guide score of teeth/dentures and mucous membranes were significantly different between the two groups. The Oral Assessment Guide grade for swallow, lip, teeth/dentures, mucous membrane, tongue, and saliva significantly correlated to oral mucositis severity. CONCLUSIONS: Professional oral care may prevent oral mucositis and improve teeth/denture conditions in patients receiving everolimus and exemestane.

Perioperative management of thyroglossal duct cystectomy in a pediatric patient: A case report.

Thyroglossal duct on the dorsum of the tongue in the pediatric patient can cause a difficult airway due to the large mass and risk of airway obstruction associated with a swollen tongue after surgery.

Secondary endpoints analysis in patients with estrogen receptor-positive metastatic breast cancer treated with everolimus and exemestane enrolled in Oral Care-BC.

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 ).

Efficacy of antimicrobial photodynamic therapy with Rose Bengal and blue light against cariogenic bacteria.

OBJECTIVE: We evaluated the effect of antimicrobial photodynamic therapy (a-PDT) with Rose Bengal and blue light LED on bacteria that initiate and promote dental caries. DESIGN: Colony forming units of Streptococcus mutans, Streptococcus sobrinus, Streptococcus sanguinis, and Lactobacillus salivarius under planktonic and biofilm conditions were counted after a-PDT treatment using Rose Bengal and blue light LED. In addition, cariogenic bacteria from saliva and dental plaques from ten volunteers were used for evaluation of a-PDT treatment. RESULTS: We found that a-PDT using Rose Bengal at > 10 µg/mL had antimicrobial effects on oral Gram-positive S. mutans, S. sobrinus, S. sanguinis, and L. salivarius under both planktonic and biofilm conditions. The effect was also observed for cariogenic bacteria that formed biofilms containing water-insoluble glucans, through which the bacteria are firmly attached to the tooth surface. Moreover, a-PDT led to a marked reduction in cariogenic bacteria in saliva and dental plaques. CONCLUSION: a-PDT could be a useful approach for controlling dental caries in dental surgery.

Oral dysfunctions and cognitive impairment/dementia.

With global increases in the aging population, the number of patients with dementia is greatly increasing, which has become a big social problem. Many studies have shown strong associations between oral disorders and systemic disorders, such as diabetes, arthritis, sepsis, aspiration pneumonia, arteriosclerosis, bacterial endocarditis, and other cardiovascular diseases. Similarly, numerous cross-sectional studies showed that patients with dementia usually have poor oral conditions and tooth loss. These have long been considered as a result of difficulty with oral care due to impaired cognitive function, memory, and physical ability in patients with dementia. Indeed, even in patients with mild cognitive impairment, oral care becomes insufficient owing to decreases in spontaneity of grooming and finger dexterity. However, recent studies have shown that tooth loss and occlusal dysfunction may affect brain function and trigger the onset of dementia found in neurodegenerative diseases including Alzheimer's disease. In this review, we highlight the relationships among aging, oral dysfunction, and the development of dementia. Increasing evidence suggests that oral dysfunction is not only a result of dementia in the elderly people, but could also be a causative factor for the onset of dementia.

A multicenter retrospective investigation on the efficacy of perioperative oral management in cancer patients.

Patients develop a number of oral complications during cancer treatments. Oral bacteria are associated with the onset of dental focal infections and the progression of oral mucositis. Dental focal infections are frequently associated with the systemic onset of bacteremia, sepsis, and pneumonia. The degeneration of oral function with these complications may become an obstacle to cancer treatments. Although comprehensive oral management, including oral care, the removal of dental focal infections, and improvements in oral function with dentures, is conducted for cancer patients in Japan, few studies have assessed its efficacy.The aim of the present study was to investigate the incidence of dental/oral complications in cancer patients with perioperative oral managements (POMs) based on a large number of case series with a multicenter retrospective analysis.The medical records of cancer patients with POMs were retrospectively reviewed and the incidence of oral complications and efficacy of oral management were investigated.A total of 2744 cancer patients with POMs (1684 males and 1080 females, mean age 65.9 ±â€Š13.0 years) were included and investigated in the present study. Among these patients, 2097 (76.4%) started POM before the initiation of cancer treatments, with 2130 (77.6%) receiving oral care only and 391 (14.2%) being subjected to invasive treatments, such as tooth extraction. The incidence of dental focal infections during the period of cancer treatments was 8.2%. The most frequent infection was acute periodontitis, including alveolar abscesses (112 patients, 4.1%). The incidence of grade 2 and 3 oral mucositis was 2.8%. Prolonged fever was observed in 113 patients (4.1%), with 7 having dental focal infections (6.2%). These incidence rates were lower than those reported previously.Based on analyses of a large number of patients, the present results support the efficacy of oral management in cancer patients. However, further studies are needed to establish adequate oral management guidelines for cancer patients.

Clinicopathological significance of EGFR pathway gene mutations and CRTC1/3-MAML2 fusions in salivary gland mucoepidermoid carcinoma.

AIMS: Mucoepidermoid carcinoma (MEC) is one of the most common salivary gland carcinomas. Epidermal growth factor receptor (EGFR) signalling pathway gene mutations are important in predicting a patient's prognosis, selecting molecularly targeted drugs and estimating the efficacy of a molecular therapy. However, their significance in MEC have been poorly clarified. CRTC1/3-MAML2 fusions are specific to MEC and may be associated with favourable characteristics in these patients. METHODS AND RESULTS: We looked for CRTC1/3-MAML2 fusions and gene alterations in the EGFR, RAS family (KRAS, HRAS and NRAS), PIK3CA, BRAF and AKT1 in 101 MEC cases. We also examined mutations in TP53. CRTC1/3-MAML2 fusions were found in 62.4% of the cases. KRAS, HRAS and PIK3CA mutations were detected in 6.9%, 2.0% and 6.9%, respectively, but other EGFR pathway genes were not mutated. In total, gene mutations (RAS/PIK3CA) in the EGFR pathway were detected in 14.9% of the cases. TP53 mutations were found in 20.8%. CRTC1/3-MAML2 fusions were associated with a better prognosis and RAS/PIK3CA mutations a worse prognosis of the patients, respectively, and both were selected as independent prognostic factors for the overall survival of the patients. TP53 mutations had no prognostic impact. CRTC1/3-MAML2 fusion-positive rates were inversely associated with the patients' age and the fusions were found in 82% of patients aged < 30 years. CONCLUSIONS: RAS/PIK3CA mutations were frequently detected, and may be a biomarker for a poorer prognosis in MEC patients. CTRC1/3-MAML2 fusions were positive in most of the young MEC patients.

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.

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: NCT02069093. 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.