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.

Purpose: Education on infant safe sleep practices has been known to reduce the risk of sleep-related sudden unexpected infant death. Since sleep environments may vary across sociocultural contexts, infant safe sleep education needs to reflect specific sociocultural settings. This study aimed to develop an educational Protocol for Infant Safe Sleep (PISS) for primary caregivers in Korea that considers parenting behaviors and cultural characteristics. Methods: This study was conducted in three key methodological steps: (1) retrieval, defining, and systematic classification of PISS content; (2) the structural formulation of the content as an educational protocol; and (3) content validation. For the first step, a literature review was conducted, along with an analysis of educational materials from institution websites related to infant safe sleep and online parenting communities. Field observations were also conducted to identify relevant Korean culture characteristics. Based on these findings, the PISS was developed. Content validity index was assessed by six professionals, and the results were reflected into the educational program. Results: The PISS intervention provided an educational video and booklet and enhanced learning via phone counseling and educational kit, which comprised an illustrated safe sleep sticker and a calendar-style activity diary. The educational content consisted of (1) sleep location, (2) sleep position, (3) bedding, (4) clothes and temperature, and (5) other considerations. Conclusion This study developed the PISS, an intangible educational intervention based on Korean sociocultural characteristics and specific guidelines for primary caregivers. Future research should evaluate the effectiveness of this program in promoting safe sleep practices.

Purpose: To develop the 2025 update to the Korean colorectal cancer (CRC) screening guidelines by systematically evaluating recent evidence, integrating domestic data, and addressing changes since the 2015 guideline revision, thereby providing an evidence-based standard for clinicians and policymakers. Methods: A multidisciplinary committee developed the guidelines using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. The process included formulation of three key questions addressing screening efficacy, diagnostic accuracy, and optimal screening age and interval. A systematic review of international guidelines and primary literature was conducted, yielding 327 eligible studies. In addition, a utility-based analysis using a Markov model was performed to determine optimal screening ages and intervals. Results: The evidence synthesis identified high-certainty evidence supporting the use of the fecal immunochemical test (FIT) for reducing CRC mortality and moderate-certainty evidence for colonoscopy. Evidence for computed tomographic colonography (CTC) and stool DNA testing was rated as very low certainty. Based on the evidence review and cost-utility analysis, the committee conditionally recommends CRC screening for asymptomatic, average-risk adults aged 45–74 years using either colonoscopy every 10 years or FIT every 1–2 years. CTC and stool DNA testing were not recommended owing to insufficient evidence. Conclusion The 2025 Korean Guidelines for Colorectal Cancer Screening present updated, evidence-based recommendations tailored to the domestic healthcare context. By conditionally endorsing both colonoscopy and FIT for individuals aged 45–74 years, these guidelines aim to improve population-level screening effectiveness and reduce the burden of CRC in South Korea.

Background/Aims: The International Anorectal Physiology Working Group (IAPWG) has proposed a standardized protocol and the London classification to enhance the consistency and diagnostic accuracy of anorectal manometry (ARM). However, real-world adoption in Asian countries has not been systematically assessed. This study aims to evaluate current ARM practices and adherence to the IAPWG protocol across Asian centers. Methods: A cross-sectional, 50-item web-based survey was distributed to gastroenterologists and motility specialists practicing in Asian countries. Results: Thirty-one centers from 8 countries responded (20 in Korea, 3 in Japan, 2 in Taiwan, 1 in China, and 7 in other countries). High-resolution ARM was used in 80.6% of centers, primarily with solid-state catheters. While all centers performed rest and short squeeze maneuvers, only 58.1% conducted all maneuvers recommended by the IAPWG protocol.Considerable variation was observed in test methodology and interpretation, including definitions of resting pressure, squeeze duration, push maneuver repetition, and rectal balloon volume for rectoanal inhibitory reflex. For balloon expulsion and rectal sensory testing, centers differed in patient positioning, balloon type, inflation methods, and threshold definitions. Only 38.7% of centers reported having institutional normative values for test interpretation, and 64.5% applied the London classification. Conclusions Across Asian centers, ARM practice shows marked regional variation and incomplete implementation of the IAPWG standardized protocol and London classification, highlighting persistent gaps in standardization. Strengthening procedural guidance, regionally appropriate normative data, and interpretation criteria through coordinated education and international collaboration is needed to support more consistent and clinically meaningful use of ARM in routine practice.

Background and Objectives: Graves’ ophthalmopathy (GO) is an autoimmune inflammatory disorder that can adversely affect quality of life in patients with Graves’ disease (GD). The objective of this study was to characterize the clinical features of patients with GO and to identify risk factors associated with its development and the need for anti-inflammatory treatment. Materials and Methods: In this multicenter, retrospective observational study, 818 patients with GD were identified via electronic medical record review. Clinical characteristics were assessed, and logistic regression analyses were performed to identify risk factors for GO development and the need for anti-inflammatory treatment. Results: Among the 818 patients with GD, 135 (16.5%) developed GO, and 60 (7.3%) of these patients received anti-inflammatory treatment. GO was diagnosed at the time of GD diagnosis in 54.8% of cases, and proptosis and eyelid/orbital swelling were the common presenting features. In multivariable analysis, female sex (odds ratio [OR]: 1.75, confidence interval [CI]: 1.02-3.03), goiter (OR: 1.71, CI: 1.08-2.71), and smoking (ex-smokers: OR, 2.18; 95% CI: 1.02-4.65; current smokers: OR, 3.11; CI, 1.78-5.44) were independently associated with GO development, whereas diabetes (OR: 0.35, CI: 0.14-0.89) was inversely associated. Higher total cholesterol (OR: 1.31, CI: 1.01-1.04) and elevated thyrotropin-binding inhibitory immunoglobulin levels (OR: 1.07, CI: 1.02-1.11) were also significantly associated with the need for anti-inflammatory treatment. Conclusion This study delineated the clinical features of GO and identified risk factors for its development and the need for anti-inflammatory treatment in patients with GD, providing valuable information for the management of GO in Korean patients.

Background/Aims: To determine the effectiveness of tyrosine kinase inhibitor (TKI) plus reduced-intensity therapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-positive ALL), this retrospective study compared treatment outcomes and induction mortality according to backbone regimen intensity. Methods: The data of 132 patients diagnosed with Ph-positive ALL were retrospectively collected from five centers. Patients received imatinib plus intensive chemotherapy (modified VPD, KALLA1407, or hyper-CVAD) or reduced-intensity chemotherapy (EWALL) for curative purposes. This study analyzed 117 patients, of which 35,22,46, and 14 received modified VPD, KALLA1407, hyper-CVAD, and EWALL, respectively. All patients used imatinib as a TKI. Results: The median age of the patients who received reduced-intensity chemotherapy was 64.4 years, while that of the patients with intensive regimens was 47.5 years. There was no induction death in the reduced-intensity group, while nine patients died in the intensive therapy group. Major molecular response achievement tended to be higher in the intensive chemotherapy group than in the reduced-intensity group. More patients in the intensive chemotherapy group received allogeneic stem cell transplantation (allo-SCT). There was no statistically significant difference in long-term survival between the two groups in terms of relapse-free survival and overall survival rates. Conclusions When imatinib plus reduced-intensity therapy was used as a frontline treatment, there was no inferiority in obtaining complete remission compared to imatinib plus intensive chemotherapy or significant difference in long-term survival. Since imatinib plus reduced-intensity therapy has limitations in obtaining a deep molecular response, proceeding to allo-SCT should be considered.

Background: s/Aims: Hepatocellular carcinoma (HCC) is the sixth most common cancer and second leading cause of cancer-related deaths in South Korea. This study evaluated the characteristics of Korean patients newly diagnosed with HCC in 2016-2018. Methods: Data from the Korean Primary Liver Cancer Registry (KPLCR), a representative database of patients newly diagnosed with HCC in South Korea, were analyzed. This study investigated 4,462 patients with HCC registered in the KPLCR in 2016-2018. Results: The median patient age was 63 years (interquartile range, 55-72). 79.7% of patients were male. Hepatitis B infection was the most common underlying liver disease (54.5%). The Barcelona Clinic Liver Cancer (BCLC) staging system classified patients as follows: stage 0 (14.9%), A (28.8%), B (7.5%), C (39.0%), and D (9.8%). The median overall survival was 3.72 years (95% confidence interval, 3.47-4.14), with 1-, 3-, and 5-year overall survival rates of 71.3%, 54.1%, and 44.3%, respectively. In 2016-2018, there was a significant shift toward BCLC stage 0-A and Child-Turcotte-Pugh liver function class A (P<0.05), although survival rates did not differ by diagnosis year. In the treatment group (n=4,389), the most common initial treatments were transarterial therapy (31.7%), surgical resection (24.9%), best supportive care (18.9%), and local ablation therapy (10.5%). Conclusions Between 2016 and 2018, HCC tended to be diagnosed at earlier stages, with better liver function in later years. However, since approximately half of the patients remained diagnosed at an advanced stage, more rigorous and optimized HCC screening strategies should be implemented.

Background/Aims: Fexuprazan, a novel potassium-competitive acid blocker, was developed for treating acid-related disorders. Pharmacokinetic and pharmacodynamic properties of fexuprazan, unlike those of proton pump inhibitors, are independent of food effect. This study aims to evaluate differences in efficacy and safety of fexuprazan in patients with erosive esophagitis (EE) according to the timing of dosing. Methods: In this multicenter, open-label noninferiority study, patients who had typical reflux symptoms with endoscopically confirmed EE were randomized 1:1 to receive fexuprazan 40 mg daily 30 minutes before or after meal. Treatment was completed after 2 weeks or 4 weeks when healing was endoscopically confirmed. The primary endpoint was the proportion of patients with healed EE confirmed by endoscopy up to week 4. Safety endpoints included treatment-emergent adverse events (TEAEs). Results: In the prior-to-meal group (n = 89) and after-meal group (n = 86), 4-week EE healing rates were 98.77% and 100.00% (difference, 0.01%; 95% CI, –0.01% to 0.04%) and 2-week EE healing rates were 95.77% and 97.14% (difference, 0.01%; 95% CI, –0.05% to 0.07%), respectively. TEAEs were 9.78% and 8.70% in the prior-to-meal group and the after-meal group, respectively. Conclusions Non-inferiority analysis revealed that taking fexuprazan after meal was non-inferior to taking fexuprazan before meals in patients with EE. The frequency of adverse events was similar between the 2 study groups. The drug is safe and effective for healing EE regardless of the timing of dosing.

Objectives: Lonely death is defined as “a person living in a state of social isolation, disconnected from family, relatives, and others, who dies from suicide, illness, or other causes”. This study investigated the characteristics of individuals who die alone in Korea. Methods: We constructed a database of lonely death cases by linking data from the Korea Crime Scene Investigation Unit of the Korea National Police Agency with National Health Insurance Service (NHIS) records. A descriptive analysis was performed to evaluate the demographics, underlying diseases, and healthcare utilization patterns among lonely death cases. Results: Among the 3122 individuals identified as lonely death cases, 2621 (84.0%) were male and 501 (16.0%) were female. The most common age group was 50-59 years (n=930, 29.8%). The NHIS covered 2161 individuals (69.2%), whereas 961 individuals (30.8%) were enrolled in Medical Aid (MA). The highest number of lonely deaths occurred in Seoul areas, with 1468 cases (47.0%). Mood disorders were diagnosed in 1020 individuals (32.7%), and various alcohol-related diseases, including alcoholic liver disease, were also observed. Outpatient visits increased leading up to death but declined in the final 3 months, while hospitalizations decreased and emergency room visits slightly increased. Conclusions Most lonely death cases involved male in their 50s, with a disproportionately high number of MA beneficiaries compared to the general population. Many of these individuals also experienced mental health issues or alcohol-related disorders. Preventing social isolation and strengthening social safety nets are critical to reducing the occurrence of lonely deaths.