Background: Neoadjuvant endocrine therapy with an aromatase inhibitor has shown efficacy comparable to that of neoadjuvant chemotherapy in patients with postmenopausal breast cancer. Preclinical and clinical studies have shown that the antidiabetic drug metformin has anti-tumor activity. This prospective, multicenter, phase II randomized, placebo controlled trial was designed to evaluate the direct anti-tumor effect of metformin in non-diabetic postmenopausal women with estrogen-receptor (ER) positive breast cancer. Methods/Design: Patients meeting the inclusion criteria and providing written informed consent will be randomized to 24 weeks of neoadjuvant treatment with letrozole (2.5 mg/day) and either metformin (2000 mg/day) or placebo. Target accrual number is 104 patients per arm. The primary endpoint will be clinical response rate, as measured by calipers. Secondary endpoints include pathologic complete response rate, breast conserving rate, change in Ki67 expression, breast density change, and toxicity profile. Molecular assays will be performed using samples obtained before treatment, at week 4, and postoperatively. Discussion: This study will provide direct evidence of the anti-tumor effect of metformin in non-diabetic, postmenopausal patients with ER-positive breast cancer. Trial registration: ClinicalTrials.gov Identifier NCT01589367
Boo-Young Hwang, Eunsoo Kim, Jae-young Kwon, Ji-youn Lee, Dowon Lee, Eun Ji Park, and Taewoo Kang. Korean J Pain 2020;33:378-85. https://doi.org/10.3344/kjp.2020.33.4.378
Objective Various and accurate psychiatric assessments in patients with breast cancer who frequently suffer from psychological problems due to long-term survivors are warranted. This systematic review aimed to investigate the current evidence on psychometric properties of psychiatric assessment for evaluating psychological problems in breast cancer patients.Methods This systematic review progressed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline. Four electronic databases such as Web of Science, PubMed, Embase, and Cumulative Index to Nursing and Allied Health Literature were searched. This study protocol was registered on Open Science Framework.Results Of the 2,040 articles, 21 papers were finally included. Among them, only five studies showed the performance of psychiatric assessment tools. Among 13 assessment tools used in the selected articles, the Hospital Anxiety and Depression Scale (HADS), Distress Thermometer (DT), or Mini-Mental Adjustment to Cancer Scale was frequently used for the evaluation of psychological problems. The DT and Psychosocial Distress Questionnaire-Breast Cancer showed acceptable performances for the prediction of depression and anxiety assessed by the HADS.Conclusion This systematic review found psychiatric assessment tools with acceptable reliability and validity for breast cancer patients. However, comparative studies on reliability and validity of various scales are required to provide useful information for the selection of appropriate assessment tools based on the clinical settings and treatment stages of breast cancer. Joint research among the fields of psychiatry and breast surgery is needed for research to establish the convergent, concurrent, and predictive validity of psychiatric assessment tools in breast cancer patients.
Background The endoscopic transnasal approach is widely used for reconstructing the medial orbital wall by filling it with a silicone sheet or Merocel, but this technique has the disadvantage of retaining the packing for a long time. To overcome this drawback, a method of positioning an absorbable plate in the orbit has been introduced, but there is a risk of defect recurrence after the plate is absorbed. Here, the authors report the results of a novel surgical technique of placing a nonabsorbable titanium mesh with porous polyethylene into the orbit through the endoscopic transnasal approach. Methods Fourteen patients underwent surgery using the endoscopic transnasal approach. Preoperative computed tomography (CT) was used to calculate the size of the bone defect due to the fracture, and the titanium mesh was designed to be shorter than the anteroposterior length of the defect and longer than its height. The titanium mesh was inserted into the orbit under an endoscopic view. The authors then confirmed that the titanium mesh supported the orbital contents by pressing the eyeball and finished the operation. Immediately after surgery, CT results were evaluated. Results Postoperative CT scans confirmed that the titanium mesh was well-inserted and in the correct position. All patients were discharged without any complications. Conclusions We obtained satisfactory results by inserting a titanium mesh with porous polyethylene into the orbit via the transnasal approach endoscopically.
This study investigated the role of BRAF mutation analysis in thyroid fine-needle aspiration (FNA) samples compared to ultrasonographic and cytological diagnoses. A total 316 patients underwent ultrasonography (US)-guided FNA with BRAFV600E mutation analysis to diagnose thyroid nodules. One hundred sixteen patients with insufficient US images (n = 6), follow-up loss (n = 43), or unknown final diagnosis (n = 67) were excluded from the study. Comparisons between US diagnoses, cytological diagnoses, and BRAF mutation analysis were performed. Of 200 thyroid nodules, there was US diagnosis with 1 false negative and 11 false positive cases, cytological diagnosis with 10 false negative and 2 false positive cases, and BRAFV600E mutation analysis with 19 false negative and 2 false positive cases. The sensitivity, specificity, positive and negative predictive values, and accuracy of BRAFV600E mutation analysis were 83.2%, 98.1%, 97.5%, 86.6%, and 91%, respectively. Of the 18 nodules with Bethesda category III, 9 were true positive, 6 were true negative, 3 was a false negative, and none were false positive on BRAF mutation analysis. In conclusion, we recommend that BRAFV600E mutation analysis only be performed for evaluating thyroid nodules with Bethesda category III, regardless of US diagnosis.