Purpose: We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods: Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. Results: Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.

Purpose: We evaluated the efficacy and safety of pembrolizumab in patients with recurrent gynecologic cancers in real-world practice. Materials and Methods: We conducted a retrospective, single-institution study of patients with recurrent gynecologic malignancies treated with pembrolizumab. The primary endpoints were the objective response rate (ORR) and safety. Results: Thirty-one patients treated with pembrolizumab were included. The primary disease sites were the uterine cervix (n=18), ovaries (n=8), and uterine corpus (n=5). Fifteen of the 31 patients (48%) had an Eastern Cooperative Oncology Group performance status of ≥2. The median number of prior chemotherapy lines was 2 (range, 1–6), and 14 of 31 patients (45%) had received ≥ 3 prior lines of chemotherapy. The overall ORR was 22.6%: specifically, 22.3% (4 of 18 patients), 12.5% (1 of 8 patients), and 40% (2 of 5 patients) for cervical, ovarian, and endometrial cancers, respectively. During a median follow-up of 4.7 months (range, 0.2–35.3), the median time to response was 1.9 months (range, 1.4–5.7). The median duration of response was not reached (range, 8.8-not reached).The median progression-free survival was 2.5 months (95% confidence interval, 1.7-not reached). Adverse events occurred in 20 patients (64.5%), and only 3 (9.7%) were grade ≥3. There was one case of suspicious treatment-related mortality, apart from which most adverse events were manageable. Conclusion In real-world practice, pembrolizumab was feasible and effective in heavily treated recurrent gynecologic cancer patients with poor performance status who may not be eligible for enrollment in clinical trials.

BACKGROUND: 16S rRNA gene-targeted next-generation sequencing (NGS) can detect microorganisms in a comprehensive reference database. To date, NGS has been successfully applied to samples such as urine, blood, and synovial fluid. However, there is no data for continuous ambulatory peritoneal dialysis (CAPD) fluid. The purpose of this study was to evaluate the clinical usefulness of microbiome analysis of CAPD fluids for the diagnosis of CAPD peritonitis. METHODS: We included 21 patients with high suspicion of CAPD peritonitis. Routine CAPD fluid culture was performed using a pellet of 50 mL CAPD fluid onto the chocolate and blood agar for two days, and thioglycollate broth for one week. 16S rRNA gene-targeted NGS of pellets, stored at −70℃ was performed with MiSeq (Illumina, USA). RESULTS: Many colonized or pathogenic bacteria were detected from CAPD fluids using NGS and the microbiomes were composed of 1 to 29 genera with a cut-off 1.0. Compared to the culture results, NGS detected the same pathogens in 6 of 18 valid results (three samples failed with low read count). Additionally, using NGS, anaerobes such as Bacteroides spp. and Prevotella spp. were detected in six patients. In two of five samples in which no bacterial growth was detected, possible pathogens were detected by NGS. CONCLUSION To our knowledge, this is the first report about the application of 16S rRNA gene-targeted NGS for diagnosis of CAPD peritonitis. Etiology of culture-negative CAPD peritonitis can be better defined in NGS. Furthermore, it also helped the detection of anaerobic bacteria.

Angiomyolipoma (AML) is a rare benign mesenchymal tumor in the liver, which is composed of blood vessels, smooth muscle, and adipose cells. The proportion of each component varies, making a diagnosis difficult. This paper reports a case of AML in the liver without adipose tissue, mimicking a hepatocellular carcinoma (HCC), which was diagnosed by a surgical tissue biopsy. A 65-year-old woman was admitted for an evaluation of a hepatic mass that had been detected by ultrasonography. The serologic markers of viral hepatitis B and C were negative. The liver function tests and alpha fetoprotein level were within the normal limits. Magnetic resonance imaging revealed a 1.9 cm sized mass in segment 6 of the liver with early arterial enhancement and washout on the delayed phase accompanied by a rim-like enhancement, which is similar to the imaging findings of HCC. A frozen section examination during surgery indicated a hepatocellular neoplasm and suggested the possibility of HCC. On the other hand, the final pathologic diagnosis was epithelioid myoid type of AML with no adipose tissue component. The tumor cells were positive for human melanocyte B-45 and negative for cytokeratin and hepatocyte paraffin 1. This paper reports a very rare case of AML without adipose tissue in the liver mimicking HCC that was diagnosed by a surgical tissue biopsy.
Adipose Tissue ; Aged ; alpha-Fetoproteins ; Angiomyolipoma ; Biopsy ; Blood Vessels ; Carcinoma, Hepatocellular ; Diagnosis ; Female ; Frozen Sections ; Hand ; Hepatitis B ; Hepatocytes ; Humans ; Keratins ; Liver Function Tests ; Liver ; Magnetic Resonance Imaging ; Melanocytes ; Muscle, Smooth ; Paraffin ; Ultrasonography

OBJECTIVE: Syncope is mostly benign, but it can also be caused by a life-threatening situation. In Korea, no studies have investigated application of the Canadian Syncope Risk Score (CSRS) to patients with syncope; therefore, this study was started to evaluate the usefulness of CSRS. METHODS: A total of 222 patients who visited the emergency room with syncope for one year from January 2016 to December 2016 were enrolled in this study. Patients were divided into two groups, a serious adverse events (SAE) group and a non-serious adverse events group. The scores of the nine CSRS variables were added and the CSRS was then calculated after the addition. RESULTS: The CSRS score for patients with SAE ranged from 0 to 8. The CSRS score was 18.6%, 31.7%, 55.6%, and 58.8% for 0, 1, 2, and 3, respectively. In the case of CSRS 0 and 1, 17 patients (81.0%) and 11 patients (84.6%) were non-cardiac. In the case of CSRS 2, 7 were non-cardiac (70.0%). In the case of CSRS 3, 6 cases (60.0%) were cardiogenic and 4 cases (40.0%) were non-cardiogenic. The area under the receiver operating characteristic curve of CSRS to predict SAE was 0.71. Setting the CSRS cutoff value to 0, we found that sensitivity and specificity of predicting SAE was 67.19% and 67.09%, respectively. CONCLUSION: CSRS may be difficult to predict for acute intracranial disease or acute hemorrhagic disease requiring transfusion; therefore, it is necessary to supplement it further.
Emergencies* ; Emergency Service, Hospital ; Humans ; Korea* ; Risk Factors ; ROC Curve ; Sensitivity and Specificity ; Syncope*

BACKGROUND: Critical care physician staffing is a crucial element of the intensive care unit (ICU) organization, and is associated with better outcomes in ICUs. Adult ICUs in Korea have been suffering from inadequate full-time intensivists and nurses because of insufficient reimbursement rates (<50% of the original critical care cost) from the National Health Insurance System. Recently, full-time intensivists have been introduced as a prerequisite for adult ICUs of tertiary hospitals in Korea. The purpose of this study was to examine the perception of intensivist staffing among critical care program directors regarding the barriers and solutions when implementing an intensivist model of critical care in Korea. METHODS: An email survey of critical care program directors in designated teaching hospitals for critical care subspecialty training by the Korean Society of Critical Care Medicine was performed. The survey domains included vision, culture, resources, barriers, and potential solutions to implementing intensivist physician staffing (IPS). RESULTS: Forty-two critical care program directors were surveyed. A total of 28 directors (66.7%) responded to email queries. Of these, 27 directors (96.4%) agreed that IPS would improve the quality of care in the ICU, although half of them reported a negative perception of relevant clinical colleagues for the role of full-time intensivists and poor resources for IPS in their hospitals. Increased financial burden due to hiring full-time intensivists and concerns regarding exclusion from the management of their critically ill patients in the ICU, together with loss of income for primary attending physicians were stated by the respondents to be major barriers to implementing IPS. Financial incentives for the required cost from the health insurance system and enhancement of medical law relevant to critical care were regarded as solutions to these issues. CONCLUSIONS: Critical care program directors believe that intensivist-led critical care can improve the outcome of ICUs. They indicated the financial burden due to IPS and underestimation of a full-time intensivist's role to be major barriers. The program directors agreed that a partnership between hospital leaders and the Ministry of Health and Welfare was needed to overcome these barriers.
Adult* ; Critical Care ; Critical Illness ; Electronic Mail ; Hospitals, Teaching ; Humans ; Insurance, Health ; Intensive Care Units ; Jurisprudence ; Korea ; Motivation ; National Health Programs ; Personnel Staffing and Scheduling ; Surveys and Questionnaires ; Tertiary Care Centers

We found an error in this article. The author's name should be corrected as following: from "Younsuk Koh" to "Younsuck Koh".

BACKGROUND: Critical care physician staffing is a crucial element of the intensive care unit (ICU) organization, and is associated with better outcomes in ICUs. Adult ICUs in Korea have been suffering from inadequate full-time intensivists and nurses because of insufficient reimbursement rates (<50% of the original critical care cost) from the National Health Insurance System. Recently, full-time intensivists have been introduced as a prerequisite for adult ICUs of tertiary hospitals in Korea. The purpose of this study was to examine the perception of intensivist staffing among critical care program directors regarding the barriers and solutions when implementing an intensivist model of critical care in Korea. METHODS: An email survey of critical care program directors in designated teaching hospitals for critical care subspecialty training by the Korean Society of Critical Care Medicine was performed. The survey domains included vision, culture, resources, barriers, and potential solutions to implementing intensivist physician staffing (IPS). RESULTS: Forty-two critical care program directors were surveyed. A total of 28 directors (66.7%) responded to email queries. Of these, 27 directors (96.4%) agreed that IPS would improve the quality of care in the ICU, although half of them reported a negative perception of relevant clinical colleagues for the role of full-time intensivists and poor resources for IPS in their hospitals. Increased financial burden due to hiring full-time intensivists and concerns regarding exclusion from the management of their critically ill patients in the ICU, together with loss of income for primary attending physicians were stated by the respondents to be major barriers to implementing IPS. Financial incentives for the required cost from the health insurance system and enhancement of medical law relevant to critical care were regarded as solutions to these issues. CONCLUSIONS: Critical care program directors believe that intensivist-led critical care can improve the outcome of ICUs. They indicated the financial burden due to IPS and underestimation of a full-time intensivist's role to be major barriers. The program directors agreed that a partnership between hospital leaders and the Ministry of Health and Welfare was needed to overcome these barriers.
Adult ; Critical Care ; Critical Illness ; Electronic Mail ; Hospitals, Teaching ; Humans ; Insurance, Health ; Intensive Care Units ; Jurisprudence ; Korea ; Motivation ; National Health Programs ; Personnel Staffing and Scheduling ; Surveys and Questionnaires ; Tertiary Care Centers