Purpose: Adjuvant pembrolizumab improved disease-free survival (DFS) and overall survival (OS) versus placebo in participants with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy in the global phase 3 KEYNOTE-564 study. This post hoc subgroup analysis evaluated the efficacy and safety of adjuvant pembrolizumab in East Asian (Japan, South Korea, and Taiwan) participants enrolled in KEYNOTE-564. Materials and Methods: Eligible participants were randomly assigned 1:1 to receive adjuvant pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 17 cycles. The primary endpoint was DFS by investigator assessment. OS was a key secondary endpoint. Safety was a secondary endpoint. Results: The East Asian subgroup included 126 participants (pembrolizumab, n=58; placebo, n=68). Median follow-up was 62.1 months (range, 49.6 to 73.0 months). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41 to 1.20). Median DFS was not reached with pembrolizumab versus 58.8 months with placebo; estimated 48-month rate was 61.3% versus 51.2%. Hazard ratio for OS was 0.47 (95% confidence interval, 0.15 to 1.49). Median OS was not reached with pembrolizumab and placebo; estimated 48-month rate was 94.8% versus 91.2%. Treatment-related adverse events occurred in 70.7% of participants (29.3% grade 3 or 4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3 or 4) receiving placebo. No pembrolizumab-related deaths occurred. Conclusion In the KEYNOTE-564 East Asian subgroup, adjuvant pembrolizumab provided DFS and OS benefits versus placebo and had a safety profile consistent with the global results. These results further support pembrolizumab as adjuvant treatment for East Asian patients with RCC at increased risk of recurrence after nephrectomy.

Objective: Since coronavirus disease 2019 (COVID-19) vaccination began, abnormal uterine bleeding (AUB) has occurred at a high rate. This study assessed the association between COVID-19 vaccination and AUB. Methods: In this retrospective cohort study, we analyzed mobile application data on menstrual cycles to investigate differences in the prevalence, duration, and amount of intermenstrual bleeding (IMB) after COVID-19 vaccination. We also analyzed the duration of menstruation, menstrual cycle length, and associated symptoms after the COVID-19 vaccination. Additionally, we investigated the prevalence of IMB according to the vaccine type. Results: After vaccination, IMB prevalence increased to 3.35% (odds ratio [OR], 1.61; 95% confidence interval [CI], 1.46-1.76; p<0.0001) and IMB duration increased by 0.43 days (95% CI, 0.25-0.60; p<0.0001). The proportion of respondents whose amount of IMB was heavier than regular menstruation increased (OR, 2.96; 95% CI, 1.47-5.93; p=0.002). Menstrual duration decreased by -0.01 days (95% CI, -0.023 to 0.003; p=0.114), and menstrual cycle length increased by 1.39 days (95% CI, 1.30-1.48; p<0.0001). The proportion of participants who answered that there was a difference in menstruation amount increased (OR, 1.52; 95% CI, 1.41-1.64; p<0.0001). The prevalence of IMB increased regardless of the vaccine type. Conclusion There were statistically significant differences in the prevalence, duration and amount of IMB, menstrual duration, menstrual cycle length, and menstrual amount after COVID-19 vaccination. However, these values were not clinically meaningful and could be regarded as within the normal menstruation range.

Purpose: Regenerative medicine is expected to offer an alternative to liver transplantation for treating liver diseases in the future, with one significant challenge being the establishment of an effective stem cell administration route. This study assessed the antifibrogenic effects of adipose-derived stem cells (ASCs) in a liver fibrosis mouse model, focusing on 2 methods of delivery: intravenous injection and scaffold implantation. Methods: An extracellular matrix mimic scaffold was utilized for culturing peroxisome proliferator-activated receptor gamma coactivator 1-alpha–overexpressing ASCs (tASCs). These scaffolds, laden with tASCs, were then implanted subcutaneously in mice exhibiting liver fibrosis. In contrast, the Cell groups received biweekly intravenous injections of tASCs for 4 weeks. After 4 weeks, tissue samples were harvested from the euthanized mice for subsequent analysis. Results: Real-time PCR and Western blot analyses on liver tissues, focusing on markers like alpha-smooth muscle actin (α-SMA), matrix metalloproteinase-2, and transforming growth factor-beta 1 (TGF-β1), showed that both delivery routes substantially lowered fibrotic and inflammatory markers compared to controls (P < 0.05), with no significant differences between the routes. Histological examinations, along with immunohistochemical analysis of α-SMA, collagen type I alpha, and TGF-β1, revealed that the scaffold implantation approach resulted in a greater reduction in fibrosis and lower immunoreactivity for fibrotic markers than intravenous delivery (P < 0.05). Conclusion These findings indicate that delivering tASCs via a scaffold could be more effective, or at least similarly effective, in treating liver fibrosis compared to intravenous delivery. Scaffold implantation could offer a beneficial alternative to frequent intravenous treatments, suggesting its potential utility in clinical applications for liver disease treatment.

Objective: Since coronavirus disease 2019 (COVID-19) vaccination began, abnormal uterine bleeding (AUB) has occurred at a high rate. This study assessed the association between COVID-19 vaccination and AUB. Methods: In this retrospective cohort study, we analyzed mobile application data on menstrual cycles to investigate differences in the prevalence, duration, and amount of intermenstrual bleeding (IMB) after COVID-19 vaccination. We also analyzed the duration of menstruation, menstrual cycle length, and associated symptoms after the COVID-19 vaccination. Additionally, we investigated the prevalence of IMB according to the vaccine type. Results: After vaccination, IMB prevalence increased to 3.35% (odds ratio [OR], 1.61; 95% confidence interval [CI], 1.46-1.76; p<0.0001) and IMB duration increased by 0.43 days (95% CI, 0.25-0.60; p<0.0001). The proportion of respondents whose amount of IMB was heavier than regular menstruation increased (OR, 2.96; 95% CI, 1.47-5.93; p=0.002). Menstrual duration decreased by -0.01 days (95% CI, -0.023 to 0.003; p=0.114), and menstrual cycle length increased by 1.39 days (95% CI, 1.30-1.48; p<0.0001). The proportion of participants who answered that there was a difference in menstruation amount increased (OR, 1.52; 95% CI, 1.41-1.64; p<0.0001). The prevalence of IMB increased regardless of the vaccine type. Conclusion There were statistically significant differences in the prevalence, duration and amount of IMB, menstrual duration, menstrual cycle length, and menstrual amount after COVID-19 vaccination. However, these values were not clinically meaningful and could be regarded as within the normal menstruation range.

Purpose: Regenerative medicine is expected to offer an alternative to liver transplantation for treating liver diseases in the future, with one significant challenge being the establishment of an effective stem cell administration route. This study assessed the antifibrogenic effects of adipose-derived stem cells (ASCs) in a liver fibrosis mouse model, focusing on 2 methods of delivery: intravenous injection and scaffold implantation. Methods: An extracellular matrix mimic scaffold was utilized for culturing peroxisome proliferator-activated receptor gamma coactivator 1-alpha–overexpressing ASCs (tASCs). These scaffolds, laden with tASCs, were then implanted subcutaneously in mice exhibiting liver fibrosis. In contrast, the Cell groups received biweekly intravenous injections of tASCs for 4 weeks. After 4 weeks, tissue samples were harvested from the euthanized mice for subsequent analysis. Results: Real-time PCR and Western blot analyses on liver tissues, focusing on markers like alpha-smooth muscle actin (α-SMA), matrix metalloproteinase-2, and transforming growth factor-beta 1 (TGF-β1), showed that both delivery routes substantially lowered fibrotic and inflammatory markers compared to controls (P < 0.05), with no significant differences between the routes. Histological examinations, along with immunohistochemical analysis of α-SMA, collagen type I alpha, and TGF-β1, revealed that the scaffold implantation approach resulted in a greater reduction in fibrosis and lower immunoreactivity for fibrotic markers than intravenous delivery (P < 0.05). Conclusion These findings indicate that delivering tASCs via a scaffold could be more effective, or at least similarly effective, in treating liver fibrosis compared to intravenous delivery. Scaffold implantation could offer a beneficial alternative to frequent intravenous treatments, suggesting its potential utility in clinical applications for liver disease treatment.

Background: This study analyzed occupational diseases compensated through the government system in the Korean electronics industry and observed changes in the rationale for compensation. Methods: Data from the Korea Workers’ Compensation and Welfare Service (KWCWS) from 2012 to 2023 were analyzed to examine occupational disease issues in South Korea's semiconductor and display industries. Results: KWCWS received 174 occupational disease claims between 2012 and 2023, with 88 (50.6%) approved. The case of a 22-year-old semiconductor worker who died from leukemia has raised awareness and appears to be leading to more claims and higher approval rates. Cancer-related claims, particularly for breast and blood cancers, were the most common. Since 2018, the approval rate for occupational diseases has increased to 60%, which may have been influenced by the Supreme Court's Principle of Presumption of Occupational Diseases and the government’s reduction of the burden of proof. However, approval rates remain lower in small- and medium-sized enterprises (38.0%) compared to large corporations (55.6%), likely because of better documentation and unionization in the latter. The semiconductor industry had more claims and approvals than the LCD industry, primarily due to its longer operational history and greater chemical exposure. Conclusions In South Korea, the increasing approval rate of occupational diseases in the electronics industry from 2012 to 2023 appears to reflect changes in how causal relationships and occupational health policies have been implemented and this is likely due to stakeholder involvement and relevant legal decisions.

Purpose: Regenerative medicine is expected to offer an alternative to liver transplantation for treating liver diseases in the future, with one significant challenge being the establishment of an effective stem cell administration route. This study assessed the antifibrogenic effects of adipose-derived stem cells (ASCs) in a liver fibrosis mouse model, focusing on 2 methods of delivery: intravenous injection and scaffold implantation. Methods: An extracellular matrix mimic scaffold was utilized for culturing peroxisome proliferator-activated receptor gamma coactivator 1-alpha–overexpressing ASCs (tASCs). These scaffolds, laden with tASCs, were then implanted subcutaneously in mice exhibiting liver fibrosis. In contrast, the Cell groups received biweekly intravenous injections of tASCs for 4 weeks. After 4 weeks, tissue samples were harvested from the euthanized mice for subsequent analysis. Results: Real-time PCR and Western blot analyses on liver tissues, focusing on markers like alpha-smooth muscle actin (α-SMA), matrix metalloproteinase-2, and transforming growth factor-beta 1 (TGF-β1), showed that both delivery routes substantially lowered fibrotic and inflammatory markers compared to controls (P < 0.05), with no significant differences between the routes. Histological examinations, along with immunohistochemical analysis of α-SMA, collagen type I alpha, and TGF-β1, revealed that the scaffold implantation approach resulted in a greater reduction in fibrosis and lower immunoreactivity for fibrotic markers than intravenous delivery (P < 0.05). Conclusion These findings indicate that delivering tASCs via a scaffold could be more effective, or at least similarly effective, in treating liver fibrosis compared to intravenous delivery. Scaffold implantation could offer a beneficial alternative to frequent intravenous treatments, suggesting its potential utility in clinical applications for liver disease treatment.

The Korean Society of Gynecologic Oncology has updated its clinical practice guidelines for endometrial cancer to incorporate advancements in recent high-quality randomized controlled trials. These guidelines address evolving treatment paradigms, and are tailored to the Korean medical context. Key updates include a strong recommendation for doxorubicin/trabectedin combination therapy in metastatic or recurrent unresectable leiomyosarcoma based on the significant survival benefits demonstrated in a randomized controlled trial. For advanced or recurrent endometrial cancer, immune checkpoint inhibitors combined with chemotherapy have received strong recommendations, owing to their proven efficacy and increased accessibility in Korea. Conditional recommendations were made for combination therapies involving durvalumab and olaparib, reflecting their potential benefits, but acknowledging regulatory and accessibility constraints. These guidelines aim to provide evidence-based, practical strategies to optimize care for patients with endometrial cancer while addressing unmet clinical needs and adapting global advancements to Korea’s healthcare environment.

Objective: Since coronavirus disease 2019 (COVID-19) vaccination began, abnormal uterine bleeding (AUB) has occurred at a high rate. This study assessed the association between COVID-19 vaccination and AUB. Methods: In this retrospective cohort study, we analyzed mobile application data on menstrual cycles to investigate differences in the prevalence, duration, and amount of intermenstrual bleeding (IMB) after COVID-19 vaccination. We also analyzed the duration of menstruation, menstrual cycle length, and associated symptoms after the COVID-19 vaccination. Additionally, we investigated the prevalence of IMB according to the vaccine type. Results: After vaccination, IMB prevalence increased to 3.35% (odds ratio [OR], 1.61; 95% confidence interval [CI], 1.46-1.76; p<0.0001) and IMB duration increased by 0.43 days (95% CI, 0.25-0.60; p<0.0001). The proportion of respondents whose amount of IMB was heavier than regular menstruation increased (OR, 2.96; 95% CI, 1.47-5.93; p=0.002). Menstrual duration decreased by -0.01 days (95% CI, -0.023 to 0.003; p=0.114), and menstrual cycle length increased by 1.39 days (95% CI, 1.30-1.48; p<0.0001). The proportion of participants who answered that there was a difference in menstruation amount increased (OR, 1.52; 95% CI, 1.41-1.64; p<0.0001). The prevalence of IMB increased regardless of the vaccine type. Conclusion There were statistically significant differences in the prevalence, duration and amount of IMB, menstrual duration, menstrual cycle length, and menstrual amount after COVID-19 vaccination. However, these values were not clinically meaningful and could be regarded as within the normal menstruation range.

INTRODUCTION: An interdisciplinary panel, comprising professionals from medicine, AI and data science, law and ethics, and patient advocacy, convened to discuss key principles on regulation, implementation and evaluation of AI models in healthcare for Singapore. METHOD: The panel considered 14 statements split across 4 themes: "The Role and Scope of Regulatory Entities," "Regulatory Processes," "Pre-Approval Evaluation of AI Models" and "Medical AI in Practice". Moderated by a thematic representative, the panel deliberated on each statement and modified it until a majority agreement threshold is met. The roundtable meeting was convened in Singapore on 1 July 2024. While the statements reflect local perspectives, they may serve as a reference for other countries navigating similar challenges in AI governance in healthcare. RESULTS: Balanced testing approaches, differentiated regulatory standards for autonomous and assistive AI, and context-sensitive requirements are essential in regulating AI models in healthcare. A hybrid approach-integrating global standards with local needs to ensure AI comple-ments human decision-making and enhances clinical expertise-was recommended. Additionally, the need for patient involvement at multiple levels was underscored. There are active ongoing efforts towards development and refinement of AI governance guidelines and frameworks balancing between regulation and freedom. The statements defined therein provide guidance on how prevailing values and viewpoints can streamline AI implementation into healthcare. CONCLUSION This roundtable discussion is among the first in Singapore to develop a structured set of state-ments tailored for the regulation, implementation and evaluation of AI models in healthcare, drawing on interdisciplinary expertise from medicine, AI, data science, law, ethics and patient advocacy.
Singapore ; Humans ; Artificial Intelligence/standards* ; Delivery of Health Care/organization & administration*