Purpose: This 6-year post-marketing surveillance (PMS) study was conducted in South Korea to evaluate the real-world safety and effectiveness of eribulin in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes. Materials and Methods: During the study period (17 August 2012 to 16 August 2018), case-report files (CRFs) of patients receiving eribulin were collected. The main study endpoint was to assess the safety of eribulin. Evaluation of the effectiveness of eribulin was an exploratory endpoint. Patients were followed for 1 year after eribulin initiation. Results: CRFs were collected from 64 investigators at 64 sites for 1,079 patients. The safety analysis set (SAS) included 1,001 eribulin recipients; effectiveness was assessed in 244 patients. In the SAS, patients were predominantly female (99.6%), with a median age of 53.0 years, and diagnosed with metastatic breast cancer (92.0%). Eribulin was administered as a median 4th line chemotherapy. A total of 2,124 treatment-emergent adverse events (TEAEs) were reported in 661 patients (66.0%). Neutropenia was the most common TEAE (32.5% of patients), occurring at a median of 9-11 days from initial eribulin administration. Overall response and disease control rates were 31.7% and 95.6%, respectively, and the median duration of eribulin use (time to treatment failure) was 3.0 months. Conclusion This large real-world PMS analysis in patients with advanced or metastatic breast cancer demonstrated the effectiveness of eribulin and found no new safety concerns relative to safety information from prior clinical and real-world studies, and approvals in South Korea and other countries.

Objective: Extracorporeal cardiopulmonary resuscitation (ECPR) is increasingly used for refractory cardiac arrest, but its prognostic determinants in emergency department (ED) settings remain unclear. This study investigated the predictors of survival and the prognostic value of lactate and bilirubin in ECPR patients treated at a single university hospital. Methods: Adult ECPR patients treated in a single university hospital ED from 2018 to 2023 were reviewed retrospectively. The clinical variables, laboratory markers, and procedural factors were collected from medical records. Univariate and multivariate logistic regression analyses were performed, and lactate/bilirubin were assessed by quartiles to examine the dose-response trends. Results: Fifty-eight patients were included, of whom 25 (43.1%) survived to discharge. Older age, higher lactate, and elevated bilirubin were associated with mortality, and all three remained independent predictors in multivariate analysis (age odds ratio [OR], 0.93; lactate OR, 0.97; bilirubin OR, 0.41). Survival declined markedly across the lactate (68.8%→0%) and bilirubin quartiles (60.0%→13.3%; P for trend <0.01). The cardiopulmonary resuscitation (CPR) to extracorporeal membrane oxygenation (ECMO) time was shorter in the survivors than the non-survivors (39.9±18.9 min vs. 51.8±23.2 min; P=0.069), whereas the door to ECMO time did not differ. Conclusion Higher lactate and bilirubin concentrations, advanced age, and prolonged CPR to ECMO time were independently associated with poor outcomes after ECPR. Early ECMO initiation and prompt metabolic correction may improve survival in cardiac arrest patients receiving ECPR in the ED.

Objective: This study evaluated the clinical outcomes of patients with acute ischemic stroke (AIS) based on different reperfusion strategies-intravenous thrombolysis (IVT) alone, mechanical thrombectomy (MT) alone, combined IVT+MT, or non-reperfusion therapy (non-RT)-managed under a standardized “Brain Salvage through Emergent Stroke Therapy (BEST) Protocol” in a single emergency center. Methods: This study conducted a single-center, retrospective cohort study of 261 AIS patients diagnosed under the BEST Protocol between March 2022 and February 2023. The patients were classified into four groups: IVT alone (n=38), MT alone (n=34), IVT+MT (n=30), and non-RT (n=159). The primary outcome was a favorable functional outcome (modified Rankin Scale≤2) at 90 days. Multivariable logistic regression was performed to determine the independent association of treatment strategies, adjusting for age, initial National Institutes of Health Stroke Scale score, and atrial fibrillation (AF). Results: The baseline characteristics showed significant differences in initial NIHSS, large vessel occlusion (LVO), and AF (P<0.001). After excluding LVO from the final model for parsimony, multivariable analysis revealed that, compared to the non-RT group, the MT alone group (adjusted odds ratio [aOR], 3.58; 95% confidence interval [CI], 1.23-10.42; P=0.019) and the IVT+MT group (aOR, 5.75; 95% CI, 1.75-18.92; P=0.004) were strongly associated with a favorable 90-day outcome after adjusting for covariates. Conclusion In a standardized system like the BEST Protocol, MT-based strategies (MT alone or IVT+MT) were independently associated with a significantly higher likelihood of favorable 90-day functional outcomes compared to non-RT.

Purpose: Claudin 18.2 (CLDN18.2) has emerged as a promising therapeutic target for CLDN18.2-expressing gastric cancer (GC). We sought to examine the heterogeneity of CLDN18.2 expression between primary GC (PGC) and metastatic GC (MGC) using various scoring methods. Materials and Methods: We retrospectively analyzed data from 102 patients with pathologically confirmed paired primary and metastatic gastric or gastroesophageal junction adenocarcinomas. CLDN18.2 expression was evaluated through immunohistochemistry on formalin-fixed paraffin-embedded tissue samples. We assessed CLDN18.2 positivity using multiple scoring approaches, including the immunoreactivity score, H-score, and the percentage of tumor cells showing moderate-to-strong staining intensity. We analyzed the concordance rates between PGC and MGC and the association of CLDN18.2 positivity with clinicopathological features. Results: CLDN18.2 positivity varied from 25% to 65% depending on the scoring method, with PGC consistently showing higher expression levels than MGC. Intratumoral heterogeneity was noted in 25.5% of PGCs and 19.6% of MGCs. Intertumoral heterogeneity, manifesting as discordance in CLDN18.2 positivity between PGC and MGC, was observed in about 20% of cases, with moderate agreement across scoring methods (κ=0.47 to 0.60).In PGC, higher CLDN18.2 positivity correlated with synchronous metastasis, presence of peritoneal metastasis, poorly differentiated grade, and biopsy specimens. In MGC, positivity was associated with synchronous metastasis, presence of peritoneal metastasis, and metastatic peritoneal tissues. Conclusions CLDN18.2 expression demonstrates significant heterogeneity between PGC and MGC, with a 20% discordance rate. Comprehensive tissue sampling and reassessment of CLDN18.2 status are crucial, especially before initiating CLDN18.2-targeted therapies.

Purpose: Claudin 18.2 (CLDN18.2) has emerged as a promising therapeutic target for CLDN18.2-expressing gastric cancer (GC). We sought to examine the heterogeneity of CLDN18.2 expression between primary GC (PGC) and metastatic GC (MGC) using various scoring methods. Materials and Methods: We retrospectively analyzed data from 102 patients with pathologically confirmed paired primary and metastatic gastric or gastroesophageal junction adenocarcinomas. CLDN18.2 expression was evaluated through immunohistochemistry on formalin-fixed paraffin-embedded tissue samples. We assessed CLDN18.2 positivity using multiple scoring approaches, including the immunoreactivity score, H-score, and the percentage of tumor cells showing moderate-to-strong staining intensity. We analyzed the concordance rates between PGC and MGC and the association of CLDN18.2 positivity with clinicopathological features. Results: CLDN18.2 positivity varied from 25% to 65% depending on the scoring method, with PGC consistently showing higher expression levels than MGC. Intratumoral heterogeneity was noted in 25.5% of PGCs and 19.6% of MGCs. Intertumoral heterogeneity, manifesting as discordance in CLDN18.2 positivity between PGC and MGC, was observed in about 20% of cases, with moderate agreement across scoring methods (κ=0.47 to 0.60).In PGC, higher CLDN18.2 positivity correlated with synchronous metastasis, presence of peritoneal metastasis, poorly differentiated grade, and biopsy specimens. In MGC, positivity was associated with synchronous metastasis, presence of peritoneal metastasis, and metastatic peritoneal tissues. Conclusions CLDN18.2 expression demonstrates significant heterogeneity between PGC and MGC, with a 20% discordance rate. Comprehensive tissue sampling and reassessment of CLDN18.2 status are crucial, especially before initiating CLDN18.2-targeted therapies.

Purpose: Claudin 18.2 (CLDN18.2) has emerged as a promising therapeutic target for CLDN18.2-expressing gastric cancer (GC). We sought to examine the heterogeneity of CLDN18.2 expression between primary GC (PGC) and metastatic GC (MGC) using various scoring methods. Materials and Methods: We retrospectively analyzed data from 102 patients with pathologically confirmed paired primary and metastatic gastric or gastroesophageal junction adenocarcinomas. CLDN18.2 expression was evaluated through immunohistochemistry on formalin-fixed paraffin-embedded tissue samples. We assessed CLDN18.2 positivity using multiple scoring approaches, including the immunoreactivity score, H-score, and the percentage of tumor cells showing moderate-to-strong staining intensity. We analyzed the concordance rates between PGC and MGC and the association of CLDN18.2 positivity with clinicopathological features. Results: CLDN18.2 positivity varied from 25% to 65% depending on the scoring method, with PGC consistently showing higher expression levels than MGC. Intratumoral heterogeneity was noted in 25.5% of PGCs and 19.6% of MGCs. Intertumoral heterogeneity, manifesting as discordance in CLDN18.2 positivity between PGC and MGC, was observed in about 20% of cases, with moderate agreement across scoring methods (κ=0.47 to 0.60).In PGC, higher CLDN18.2 positivity correlated with synchronous metastasis, presence of peritoneal metastasis, poorly differentiated grade, and biopsy specimens. In MGC, positivity was associated with synchronous metastasis, presence of peritoneal metastasis, and metastatic peritoneal tissues. Conclusions CLDN18.2 expression demonstrates significant heterogeneity between PGC and MGC, with a 20% discordance rate. Comprehensive tissue sampling and reassessment of CLDN18.2 status are crucial, especially before initiating CLDN18.2-targeted therapies.

Objective: As the coronavirus disease 2019 (COVID-19) pandemic has been prolonged, the pre-hospital screening test performed in hospitals has changed from polymerase chain reaction (PCR) to rapid antigen test (RAT). RAT has lower sensitivity than PCR, but a lower cost and shorter test time. In the hospital where this study was conducted, the preadmission COVID-19 test was changed from PCR to RAT on February 24, 2023. This study compared the efficacy of PCR and RAT as the pre-admission COVID-19 test. Methods: This was a retrospective observational study comparing two periods, 90 days from November 25, 2022 to February 23, 2023, and 90 days from February 28, 2023 to May 29, 2023. Patients hospitalized from the emergency medical center during these two periods were included. Binomial logistic regression was used to compare the emergency department length of stay (ED LOS) between the two groups (PCR vs. RAT). Logistic regression was used to compare the mortality. Results: Four thousand seven hundred and thirty-eight patients were admitted through the emergency room: 2,202 patients in the PCR group and 2,443 patients in the RAT group. No statistically significant differences in the characteristics and severity were observed between the two groups. The mean ED LOS of PCR 5.07 hours (interquartile range, 3.80-6.75) was longer than RAT 3.65 hours (interquartile range, 2.83-4.68) (P<0.001). Mortality was higher in PCR 8.9% than RAT 6.6% (P=0.005). Conclusion The study showed that ED LOS and mortality were reduced when using RAT rather than PCR as a preadmission COVID-19 test.

Immunoglobulin A nephropathy (IgAN) is a major cause of end-stage kidney disease (ESKD). The International IgA Nephropathy Prediction Tool (IIgAN-PT) predicts IgAN prognosis, but improvement in the prediction performance using machine learning (ML)-based methods is needed. Methods: We analyzed 4,425 biopsy-confirmed patients with IgAN and ≥6 months of follow-up from nine tertiary university hospitals in Korea. The study population was divided into development and validation cohorts. Using the collected 87 clinicodemographic and pathological variables, ML-based prediction models for ESKD or estimated glomerular filtration rate decline (50% reduction or <15 mL/min/1.73 m2 ) were constructed: 1) the conventional CatBoost model, 2) the optimized CatBoost model with Cox proportional hazards, 3) the deep Cox proportional hazards model, and 4) the deep Cox mixture model. The area under the curve (AUC) and calibration plots were used to investigate the discriminative and calibration performance of the models, which were then compared with those of the IIgAN-PT full model. Results: The full model showed excellent performance (AUC [95% confidence interval] for 5-year outcome, 0.896 [0.853–0.940]), with acceptable calibration results. The ML-based models showed good performance in predicting adverse kidney outcomes and revealed acceptable discrimination performance in the external validation (AUC [95% confidence interval] for the 5-year outcome: 1) 0.829 [0.791–0.866]; 2) 0.847 [0.804–0.890]; 3) 0.823 [0.784–0.862]; and 4) 0.832 [0.794–0.870]), although the models showed underestimation in calibration analysis of the external validation cohort. With the validation data, the overall performance of the IIgAN-PT was non-inferior to that of the ML-based model. Conclusions: Our ML-based models showed good performance in predicting adverse kidney outcomes in patients with IgAN but they did not outperform the IIgAN-PT.

Background: The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database. Methods: This study was conducted using AEs reported from January 2009to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPPIV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected. Results: Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of re-ported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, phar-yngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15). Conclusions Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.

Background: and Purpose We delineated the association between otolithic dysfunction and blood pressure (BP) variability. Methods: We prospectively recruited 145 consecutive patients (age=71 [59–79] years, median [interquartile range]; 76 females) with orthostatic intolerance between December 2021 and December 2023 at a tertiary hospital in South Korea. Each patient underwent evaluations of cervical and ocular vestibular-evoked myogenic potentials (oVEMPs), 24-h noninvasive ambulatory BP monitoring (ABPM), and a head-up tilt-table test using the Finometer device. As measures of BP variability, the standard deviations (SDs) of the systolic BP (SBP SD) and the diastolic BP were calculated based on serial ABPM recordings. Patients were divided into those with orthostatic hypotension (OH, n=68) and those with a normal head-up tilt-table test despite orthostatic intolerance (NOI, n=77) groups. Results: A multivariable logistic regression analysis showed that OH was associated with bilateral oVEMP abnormalities (p=0.021), SBP SD (p=0.012), and female sex (p=0.004). SBP SD was higher in patients with OH than in those with NOI (p<0.001), and was not correlated with n1–p1 amplitude (p=0.491) or normalized p13–n23 amplitude (p=0.193) in patients with OH.The sensitivity and specificity for differentiating OH from NOI were 72.1% and 67.5%, respectively, at a cutoff value of 12.7 mm Hg for SBP SD, with an area under the receiver operating characteristic curve of 0.73. Conclusions Bilaterally deficient oVEMP responses may be associated with OH regardless of 24-h BP variability, reflecting the integrity of the otolith-autonomic reflex during orthostasis. Alternatively, 24-h BP variability is predominantly regulated by the baroreflex, which also participates in securing orthostatic tolerance complementary to the vestibulo-autonomic reflex.