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 ).

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.

Evaluation of Scoring Systems for Airway Management After Oral Cancer Surgery: A Retrospective Study.

OBJECTIVE: Postoperative airway obstruction following oral cancer surgery is difficult to predict. Scoring systems used to assess the need for tracheotomy use risk factors as criteria. We aimed to examine whether these clinical scoring systems can predict airway obstruction following oral cancer surgery. METHODS: We assessed 95 patients who underwent oral cancer surgery without tracheotomy under general anesthesia between January 2007 and April 2019. We reviewed multiple factors from the patients' medical records, including age, sex, tumor site, body mass index, tumor stage, type of surgery, airway management method, Cameron and Gupta scores, and postoperative airway complications. RESULTS: Tumors were located in the maxilla (n = 14), buccal mucosa (n = 13), mandible (n = 14), floor of the mouth (n = 6), and tongue (n = 48). Twenty-seven patients (28.4%) were graded as Stage 1, 37 patients (38.9%) as Stage 2, 9 patients (9.5%) as Stage 3, and 3 (3.2%) patients as Stage 4. Nine patients (9.5%) had local recurrences, and ten patients (10.5%) had neck metastases. Postoperative oxygen administration alone failed to improve dyspnea in 4 patients (4.2%). The median Cameron scores between patients with and without airway trouble were not significantly different (P = 0.226). However, a significant difference was observed in median Gupta scores between patients with and without airway trouble (P = 0.01). We created a receiver operating characteristic curve to predict postoperative airway trouble based on the preoperative Gupta score; the area under the curve was 0.856 (95% confidence interval: 0.61-1). A Gupta score cutoff value of 3.0 had a sensitivity of 92.3% and specificity of 75.0%. CONCLUSIONS: Screening based on the Gupta score appears to be effective in predicting postoperative airway obstruction. We propose that this screening tool can be used to better plan tracheotomy and other airway management strategies during preoperative patient assessment.

The degree of agreement between score-based decision and clinician's discretion regarding the need for tracheotomy in oral cancer surgery: A retrospective analysis.

ABSTRACT: In oral cancer surgery, the decision to perform a tracheotomy is often determined by the surgeon. In this study, we investigated the competency of clinical scoring systems in identifying patients who require tracheotomy and examined the degree of agreement between the surgeon's decision and the indications of various scoring systems. We identified 110 patients who were surgically treated for oral cancer. Of these, 67 patients (44 men and 23 women) who underwent resection and reconstruction were retrospectively analyzed. To derive the score, we evaluated the endpoint of the airway management score using clinical records and images. We divided the patients into two groups based on the Cameron and Gupta scores (tracheotomy and no-tracheotomy groups) and evaluated the degree of agreement with the surgeon's decision by calculating the κ coefficient. The κ coefficients of the Gupta and Cameron scores were 0.61 (95% confidence interval [CI]: 0.40-0.82) and 0.60 (95% CI: 0.38-0.82), respectively. The clinical evaluation of the κ coefficient indicated that the Cameron and Gupta scores agreed fairly with the surgeon's decision. In this study, the Cameron and Gupta scores fairly agreed with the decision of experienced surgeons and were confirmed as acceptable guides for making clinical judgments.

Oxytetracycline-hydrocortisone ointment reduces the occurrence of both dry socket and post-extraction pain after third molar extraction: An observational study.

OBJECTIVES: Dry socket and post-extraction pain are typical discomforts experienced by patients after tooth extraction. In this study, we inserted gauze coated with oxytetracycline-hydrocortisone ointment into the extraction socket immediately after lower third molar extraction and then evaluated the occurrence of dry socket and post-extraction pain compared with gauze non-insertion. METHODS: This retrospective study was carried out on patients undergoing lower third molar extraction in the Department of Oral Surgery at Shizuoka Prefectural General Hospital in Shizuoka, Japan from November 2018 to October 2019. A comparison was carried out between a gauze-insertion group and a non-insertion group. The occurrence versus non-occurrence of dry socket was determined, and degree of pain was assessed based on a visual analogue scale (VAS) and on patients reporting the number of loxoprofen sodium oral analgesic tablets (60mg/tablet) that they had taken. Dry socket was defined as patient-reported spontaneous pain that did not subside 1 to 3 days postoperatively. Spontaneous post-extraction pain was recorded four times: on the operative day, on the first postoperative day (POD1), on POD3, and during suture removal (POD7). RESULTS: The occurrence of dry socket was lower in the gauze-insertion group than in the non-insertion group (0.9%, 2/215 vs. 19.6%, 9/46, p<0.001). The results also showed that both VAS-defined pain level and the number of analgesic tablets taken were lower in the gauze-insertion group than in the non-insertion group on POD3 and POD7. CONCLUSIONS AND CLINICAL RELEVANCE: Inserting gauze coated with oxytetracycline-hydrocortisone ointment into the extraction socket immediately after third molar extraction reduces the occurrence of both dry socket and post-extraction pain.

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.

[A case of huge submandibular malignant tumor treated successfully with UFT chemotherapy].

We report a patient with a huge submandibular malignant tumor showing an excellent response to chemotherapy with UFT. A 76-year-old woman complaining of a submandibular mass was referred to us. The mass had an irregular margin and measured 11 x 7 cm on CT scan. A left submandibular lymph node was enlarged slightly. Fine needle aspiration cytology of the mass indicated undifferentiated malignant tumor. We diagnosed her with unresectable malignant tumor. She was treated with oral UFT (600 mg/day), as she refused chemoradiotherapy. The malignant tumor became dramatically smaller in 4 weeks, and clinically disappeared in 6 weeks. Oral UFT was discontinued due to liver dysfunction. There has been no evidence of recurrence for 5 years after discontinuation of chemotherapy. The patient remains under observation.