Purpose: Precision oncology approach for recurrent and metastatic head and neck squamous cell carcinoma (HNSCC) is necessary due to its dismal prognosis. We performed a genomic profile-based umbrella trial of patients with platinum-refractory HNSCC (KCSG-TRIUMPH). Here, we present an in-depth report of the the nintedanib arm (arm 3) of the current trial. Materials and Methods: The TRIUMPH study was a multicenter, open-label, single-arm phase 2 trial, in which patients were assigned to treatment arms based on next-generation sequencing (NGS)–based, matching genomic profiles. Patients whose tumors harbor fibroblast growth factor receptor (FGFR) alteration were enrolled in the nintedanib arm (arm 3) as part of the TRIUMPH study. The primary endpoint was the overall response rate (ORR), and secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and biomarker analysis. Results: Between October 2017 and August 2020, 207 were enrolled in the TRIUMPH study, and eight were enrolled in the nintedanib arm. ORR and disease control rate were 42.9% and 57.1%, respectively. The median PFS was 5.6 months and the median duration of response was 9.1 months. Median OS was 11.1 months. One patient maintained the partial response for 36 months. Overall, the toxicity profiles were manageable. Conclusion Single-agent nintedanib has demonstrated significant efficacy in FGFR-mutated, recurrent or metastatic HNSCC patients, with tolerable toxicity profiles. The results from the study have provided the basis for routine NGS screening and FGFR-targeted therapy. Because of the small number of patients due to slow accrual in this study, further studies with a larger cohort are warranted for statistical power.

Objectives: The use of menstrual hygiene products and its effect on women’s health remains under studied. Patterns of menstrual hygiene product use and the rationale behind choices among Korean women aged 18-45 years were examined. Methods: This cross-sectional study was a part of the Korea Nurses’ Health Study. A total of 20,613 nurses participated, and 8,658 nurses participated in Module 7 which included a menstrual hygiene productsrelated survey. The data were collected through the mobile survey using a self-reported questionnaire.Participants’ use of menstrual hygiene products and related characteristics were analyzed using frequency (percentage) or mean (SD). Results: The most common types of menstrual hygiene products across all age groups were disposable menstrual pads (89.0%), followed by cloth menstrual pads (4.5%), tampons (4.2%), and only 1.6% used a menstrual cup. Disposable menstrual pads were the most common across all age groups, but in those aged under 30 years this was followed by tampon use (6%). The most important criteria when choosing a menstrual hygiene product was comfort for disposable menstrual pads (31.3%) and tampons (41.5%), natural ingredients or organic products for cloth menstrual pads (51.4%), and custom fit for the menstrual cup (50.7%). However, for all menstrual hygiene products (except cloth menstrual pads), there was a higher proportion of anxiety than perception of safety, and low awareness of toxic shock syndrome. Conclusion It is important for women to use menstrual hygiene products with confidence. More research is needed to better understand potential health effects of menstrual hygiene products.

Korean Society of Thyroid-Head and Neck Surgery appointed a Task Force to provide guidance on the implementation of a surgical treatment of oral cancer. MEDLINE databases were searched for articles on subjects related to “surgical management of oral cancer” published in English. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. The quality of evidence was rated with use RoBANS (Risk of Bias Assessment Tool for Nonrandomized Studies) and AMSTAR (A Measurement Tool to Assess the Methodological Quality of Systematic Reviews). Evidence-based recommendations for practice were ranked according to the American College of Physicians grading system. Additional directives are provided as expert opinions and Delphi questionnaire when insufficient evidence existed. The Committee developed 68 evidence-based recommendations in 34 categories intended to assist clinicians and patients and counselors, and health policy-makers. Proper surgical treatment selection for oral cancer, which is directed by patient- and subsite-specific factors, remains the greatest predictor of successful treatment outcomes. These guidelines are intended for use in conjunction with the individual patient's treatment goals.
Advisory Committees ; Bias (Epidemiology) ; Carcinoma, Squamous Cell ; Counseling ; Expert Testimony ; Humans ; Mouth Neoplasms ; Neck ; Republic of Korea

OBJECTIVE: Posttraumatic embitterment disorder (PTED) is characterized by states of “embitterment”, characteristically similar to “Hwa-byung”, which is a Korean culture-bound syndrome. The present study aimed to assess diagnostic relationships between PTED and Hwa-byung. METHODS: A total of 290 participants completed our survey. PTED and Hwa-byung were diagnosed using a diagnostic interview and scale. Scales for depression, suicide ideation, and anger were used for evaluation. Fisher's exact tests and Mann-Whitney U tests were performed to evaluate diagnostic overlap between PTED and Hwa-byung, and associations of scale scores for depression, suicide ideation, and anger between the PTED, Hwa-byung, and non-diagnosed groups. Associations of these scales between the depressive and non-depressive groups, and suicidal and non-suicidal groups were also evaluated. RESULTS: Among the participants, 1.7% of the sample fit the diagnostic criteria for PTED and 2.1% fit the criteria for Hwa-byung. No individual fit the criteria for both. Anger scores were significantly higher in the Hwa-byung group than in the non-diagnostic group. There were not any significant differences in anger scores between the PTED and non-diagnostic groups. Depression scores were significantly higher in the PTED than in the non-diagnostic groups. In contrast, no significant differences were observed between depression scores in the Hwa-byung and non-diagnostic groups. CONCLUSION: These results suggest that PTED may be a disorder category that is distinct from Hwa-byung.
Anger ; Asian Continental Ancestry Group ; Depression ; Ethnopsychology ; Humans ; Suicide ; Weights and Measures

BACKGROUND AND OBJECTIVES: Heart failure (HF) is an important healthcare issue because of its high mortality, morbidity, and healthcare costs. The number of HF patients is increasing worldwide as a consequence of aging of the population. However, there are limited studies on the prevalence of HF in Korea. This study aimed to estimate the prevalence of HF, its comorbidities, and the projected population with HF in the future. MATERIALS AND METHODS: The prevalence and comorbidity estimates of HF were determined using data from the 2002-2013 National Sample Cohort based on the National Health Information Database. We calculated the projected prevalence of HF by multiplying the estimated prevalence in 2013 by the projected population counts for 2015-2040. RESULTS: The prevalence of HF in Korea was estimated to be 1.53% in 2013. The prevalence of HF in Korea is expected to increase by 2-fold, from 1.60% in 2015 to 3.35% in 2040. By 2040, more than 1.7 million Koreans are expected to have HF. In terms of comorbid diseases of HF, ischemic heart disease, hypertension, and diabetes mellitus were common (45.4%, 43.6%, and 49.1% in 2013, respectively). The prevalence rates of arrhythmia, valvular disease, and cardiomyopathy in HF patients were approximately 22.6%, 5.6%, and 3.1% in 2013, respectively. CONCLUSION: This is the first nationwide report in Korea to demonstrate the prevalence and comorbidities of HF. These data may be used for the prevention and management of HF in Korea.
Aging ; Arrhythmias, Cardiac ; Cardiomyopathies ; Cohort Studies ; Comorbidity ; Delivery of Health Care ; Diabetes Mellitus ; Epidemiology* ; Health Care Costs ; Heart Failure* ; Heart* ; Humans ; Hypertension ; Korea* ; Mortality ; Myocardial Ischemia ; Prevalence ; Risk Factors

Clinical research registration is required in many countries to improve transparency of clinical research and to ensure subject safety. Developed in February 2010, the Clinical Research Information Service (CRIS) is an online registration system for clinical studies in Korea and one of the primary registries of the World Health Organization (WHO) International Clinical Trials Registry Platform. The present analysis investigated the characteristics of studies registered in the CRIS between February 2010 and December 2014. Data for the analysis were extracted from the CRIS database. As of December 31, 2014, 1,323 clinical studies were registered. Of these, 938 (70.9%) were interventional studies and 385 (29.1%) were observational studies. A total of 248 (18.7%) studies were funded by government sources, 1,051 (79.4%) by non-government sources, and 24 (1.8%) by both. The most frequently studied disease category based on the ICD-10 classification was the digestive system (13.1%), followed by the nervous system (9.4%) and musculoskeletal system (9.1%). Only 17.8% of the studies were registered prior to enrollment of the first subject. Comparing the number of registered or approved clinical studies between the CRIS, the Ministry of Food and Drug Safety, and ClinicalTrials.gov suggests that a considerable number of clinical studies are not registered with the CRIS; therefore, we would suggest that such registration should be the mandatory legal requirement.
Biomedical Research ; Clinical Trials as Topic ; Databases, Factual ; Humans ; *Information Services ; Internet ; Registries ; Republic of Korea

BACKGROUND: Administering extracorporeal membrane oxygenation (ECMO) to critically ill patients with acute respiratory distress syndrome has substantially increased over the last decade, however administering ECMO to patients with hematologic malignancies may carry a particularly high risk. Here, we report the clinical outcomes of patients with hematologic malignancies and severe acute respiratory failure who were treated with ECMO. METHODS: We performed a retrospective review of the medical records of patients with hematologic malignancies and severe acute respiratory failure who were treated with ECMO at the medical intensive care unit of a tertiary referral hospital between March 2010 and April 2015. RESULTS: A total of 15 patients (9 men; median age 45 years) with hematologic malignancies and severe acute respiratory failure received ECMO therapy during the study period. The median values of the Acute Physiology and Chronic Health Evaluation II score, Murray Lung Injury Score, and Respiratory Extracorporeal Membrane Oxygenation Survival Prediction Score were 29, 3.3, and -2, respectively. Seven patients received venovenous ECMO, whereas 8 patients received venoarterial ECMO. The median ECMO duration was 2 days. Successful weaning of ECMO was achieved in 3 patients. Hemorrhage complications developed in 4 patients (1 pulmonary hemorrhage, 1 intracranial hemorrhage, and 2 cases of gastrointestinal bleeding). The longest period of patient survival was 59 days after ECMO initiation. No significant differences in survival were noted between venovenous and venoarterial ECMO groups (10.0 vs. 10.5 days; p = 0.56). CONCLUSIONS: Patients with hematologic malignancies and severe acute respiratory failure demonstrate poor outcomes after ECMO treatment. Careful and appropriate selection of candidates for ECMO in these patients is necessary.
Adult* ; APACHE ; Critical Illness ; Extracorporeal Membrane Oxygenation* ; Hematologic Neoplasms* ; Hemorrhage ; Humans ; Intensive Care Units ; Intracranial Hemorrhages ; Lung Injury ; Male ; Medical Records ; Respiratory Distress Syndrome, Adult ; Respiratory Insufficiency* ; Retrospective Studies ; Tertiary Care Centers ; Weaning

The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUC(PRED)). The accuracy and precision of the AUC(PRED) values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and −2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT.
Adult* ; Area Under Curve ; Behavior Therapy ; Body Weight ; Busulfan* ; Drug Dosage Calculations ; Hematopoietic Stem Cell Transplantation* ; Hematopoietic Stem Cells* ; Humans ; Pharmacokinetics ; Prospective Studies*

BACKGROUND: Administering extracorporeal membrane oxygenation (ECMO) to critically ill patients with acute respiratory distress syndrome has substantially increased over the last decade, however administering ECMO to patients with hematologic malignancies may carry a particularly high risk. Here, we report the clinical outcomes of patients with hematologic malignancies and severe acute respiratory failure who were treated with ECMO. METHODS: We performed a retrospective review of the medical records of patients with hematologic malignancies and severe acute respiratory failure who were treated with ECMO at the medical intensive care unit of a tertiary referral hospital between March 2010 and April 2015.
Adult ; APACHE ; Critical Illness ; Extracorporeal Membrane Oxygenation ; Hematologic Neoplasms ; Hemorrhage ; Humans ; Intensive Care Units ; Intracranial Hemorrhages ; Lung Injury ; Male ; Medical Records ; Respiratory Distress Syndrome, Adult ; Respiratory Insufficiency ; Retrospective Studies ; Tertiary Care Centers ; Weaning

PURPOSE: Pediatric-type sarcomas such as rhabdomyosarcoma (RMS), Ewing sarcoma (EWS), primitive neuroectodermal tumor (PNET), and desmoplastic small round-cell tumor (DSRCT) are rare in adults, with limited studies on their prognosis and optimal treatment strategies. We aimed to examine the outcome of children and adult patients with RMS, EWS, PNET, and DSRCT and relevant prognostic factors. MATERIALS AND METHODS: We retrospectively reviewed 220 pediatric-type sarcoma patients at a single institution between 1985 and 2011. Comparisons were made in order to examine differences in demographics, disease characteristics, and survival. Survival analyses were performed using the Kaplan-Meier method with log-rank tests and Cox proportional hazards models. RESULTS: A total of 220 consecutive patients were identified at our institute. Median age was 15.6 years (range, 0 to 81 years) and there were 108 children (49%) and 112 adult patients (51%). According to histological classification, 106 patients (48.2%) had RMS, 60 (27.3%) had EWS, 50 (22.7%) had PNET, and 4 (1.8%) had DSRCT. With a median follow-up period of 6.6 years, the estimated median overall survival (OS) of all patients was 75 months (95% confidence interval [CI], 27.2 to 122.8 months) and median event-free survival (EFS) for all patients was 11 months (95% CI, 8.8 to 13.2 months). No significant difference in OS and EFS was observed between adults and children. In multivariate analysis, distant metastasis (hazard ratio [HR], 1.617; 95% CI, 1.022 to 2.557; p=0.040) and no debulking surgery (HR, 1.443; 95% CI, 1.104 to 1.812; p=0.012) showed independent association with worse OS. CONCLUSION: Metastatic disease and no surgical treatment are poor prognostic factors for OS among pediatric-type sarcomas for both adults and children.
Adult* ; Child* ; Classification ; Demography ; Desmoplastic Small Round Cell Tumor ; Disease-Free Survival ; Follow-Up Studies ; Humans ; Incidence* ; Multivariate Analysis ; Neoplasm Metastasis ; Neuroectodermal Tumors, Primitive ; Prognosis ; Proportional Hazards Models ; Retrospective Studies ; Rhabdomyosarcoma ; Sarcoma* ; Sarcoma, Ewing