Background: Immune checkpoint inhibitors (ICIs) have transformed the treatment of metastatic solid tumors; however, they induce immune-related adverse events, such as ICI-induced type 1 diabetes mellitus (ICI-T1DM), a rare but serious condition requiring lifelong insulin therapy. We aimed to identify the risk factors and survival outcomes associated with ICI-T1DM to optimize screening and mitigate adverse effects. Methods: This retrospective cohort study analyzed 6,956 patients treated with ICIs at a tertiary care center between January 1, 2017, and February 28, 2023. ICI-T1DM was classified based on the need for persistent insulin therapy post-ICI and a C-peptide level <1.0 ng/mL. Patient demographics, clinical characteristics, treatment details, and survival outcomes were examined. Results: ICI-T1DM was identified in 32 patients (0.46%) with a median onset time of 41 weeks. Significant risk factors included pre-existing diabetes (hazard ratio [HR], 2.352; 95% confidence interval [CI], 1.140 to 4.854), combination therapy with anti-programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors (HR, 3.666; 95% CI, 1.224 to 10.979), prolonged ICI treatment (≥12 weeks; HR, 4.789; 95% CI, 1.806 to 12.701), and thyroid dysfunction (HR, 4.027; 95% CI, 1.847 to 8.779). ICI-T1DM occurrence and thyroid dysfunction were associated with improved survival (HR, 0.224; 95% CI, 0.093 to 0.539; and HR, 0.616; 95% CI, 0.566 to 0.670). Conclusion Patients with pre-existing diabetes, combined anti–PD-1/PD-L1 and anti–CTLA-4 therapy, prolonged ICI treatment (≥12 weeks), and thyroid dysfunction are at high risk of developing ICI-T1DM. The observed survival benefits in patients with ICI-T1DM underscore the importance of aggressive glucose monitoring and patient education for early detection and management.

Purpose: Considering the high disease burden and unique features of Asian patients with breast cancer (BC), it is essential to have a comprehensive view of genetic characteristics in this population. An institutional targeted sequencing platform was developed through the Korea Research-Driven Hospitals project and was incorporated into clinical practice. This study explores the use of targeted next-generation sequencing (NGS) and its outcomes in patients with advanced/metastatic BC in the real world. Materials and Methods: We reviewed the results of NGS tests administered to BC patients using a customized sequencing platform—FiRST Cancer Panel (FCP)—over 7 years. We systematically described clinical translation of FCP for precise diagnostics, personalized therapeutic strategies, and unraveling disease pathogenesis. Results: NGS tests were conducted on 548 samples from 522 patients with BC. Ninety-seven point six percentage of tested samples harbored at least one pathogenic alteration. The common alterations included mutations in TP53 (56.2%), PIK3CA (31.2%), GATA3 (13.8%), BRCA2 (10.2%), and amplifications of CCND1 (10.8%), FGF19 (10.0%), and ERBB2 (9.5%). NGS analysis of ERBB2 amplification correlated well with human epidermal growth factor receptor 2 immunohistochemistry and in situ hybridization. RNA panel analyses found potentially actionable and prognostic fusion genes. FCP effectively screened for potentially germline pathogenic/likely pathogenic mutation. Ten point three percent of BC patients received matched therapy guided by NGS, resulting in a significant overall survival advantage (p=0.022), especially for metastatic BCs. Conclusion Clinical NGS provided multifaceted benefits, deepening our understanding of the disease, improving diagnostic precision, and paving the way for targeted therapies. The concrete advantages of FCP highlight the importance of multi-gene testing for BC, especially for metastatic conditions.

Purpose: Considering the high disease burden and unique features of Asian patients with breast cancer (BC), it is essential to have a comprehensive view of genetic characteristics in this population. An institutional targeted sequencing platform was developed through the Korea Research-Driven Hospitals project and was incorporated into clinical practice. This study explores the use of targeted next-generation sequencing (NGS) and its outcomes in patients with advanced/metastatic BC in the real world. Materials and Methods: We reviewed the results of NGS tests administered to BC patients using a customized sequencing platform—FiRST Cancer Panel (FCP)—over 7 years. We systematically described clinical translation of FCP for precise diagnostics, personalized therapeutic strategies, and unraveling disease pathogenesis. Results: NGS tests were conducted on 548 samples from 522 patients with BC. Ninety-seven point six percentage of tested samples harbored at least one pathogenic alteration. The common alterations included mutations in TP53 (56.2%), PIK3CA (31.2%), GATA3 (13.8%), BRCA2 (10.2%), and amplifications of CCND1 (10.8%), FGF19 (10.0%), and ERBB2 (9.5%). NGS analysis of ERBB2 amplification correlated well with human epidermal growth factor receptor 2 immunohistochemistry and in situ hybridization. RNA panel analyses found potentially actionable and prognostic fusion genes. FCP effectively screened for potentially germline pathogenic/likely pathogenic mutation. Ten point three percent of BC patients received matched therapy guided by NGS, resulting in a significant overall survival advantage (p=0.022), especially for metastatic BCs. Conclusion Clinical NGS provided multifaceted benefits, deepening our understanding of the disease, improving diagnostic precision, and paving the way for targeted therapies. The concrete advantages of FCP highlight the importance of multi-gene testing for BC, especially for metastatic conditions.

Purpose: Considering the high disease burden and unique features of Asian patients with breast cancer (BC), it is essential to have a comprehensive view of genetic characteristics in this population. An institutional targeted sequencing platform was developed through the Korea Research-Driven Hospitals project and was incorporated into clinical practice. This study explores the use of targeted next-generation sequencing (NGS) and its outcomes in patients with advanced/metastatic BC in the real world. Materials and Methods: We reviewed the results of NGS tests administered to BC patients using a customized sequencing platform—FiRST Cancer Panel (FCP)—over 7 years. We systematically described clinical translation of FCP for precise diagnostics, personalized therapeutic strategies, and unraveling disease pathogenesis. Results: NGS tests were conducted on 548 samples from 522 patients with BC. Ninety-seven point six percentage of tested samples harbored at least one pathogenic alteration. The common alterations included mutations in TP53 (56.2%), PIK3CA (31.2%), GATA3 (13.8%), BRCA2 (10.2%), and amplifications of CCND1 (10.8%), FGF19 (10.0%), and ERBB2 (9.5%). NGS analysis of ERBB2 amplification correlated well with human epidermal growth factor receptor 2 immunohistochemistry and in situ hybridization. RNA panel analyses found potentially actionable and prognostic fusion genes. FCP effectively screened for potentially germline pathogenic/likely pathogenic mutation. Ten point three percent of BC patients received matched therapy guided by NGS, resulting in a significant overall survival advantage (p=0.022), especially for metastatic BCs. Conclusion Clinical NGS provided multifaceted benefits, deepening our understanding of the disease, improving diagnostic precision, and paving the way for targeted therapies. The concrete advantages of FCP highlight the importance of multi-gene testing for BC, especially for metastatic conditions.

Background: Increasing numbers of studies and research about artificial intelligence (AI) and machine learning (ML) have led to their application in clinical trials. The purpose of this study is to analyze computer-based new technologies (AI/ML) applied on clini-cal trials registered on ClinicalTrials.gov to elucidate current usage of these technologies. Methods: As of March 1st, 2023, protocols listed on ClinicalTrials.gov that claimed to use AI/ML and included at least one of the following interventions—Drug, Biological, Dietary Supplement, or Combination Product—were selected. The selected protocols were classified according to their context of use: 1) drug discovery; 2) toxicity prediction; 3) enrichment; 4) risk stratification/management; 5) dose selection/optimization; 6) adherence; 7) synthetic control; 8) endpoint assessment; 9) postmarketing surveillance; and 10) drug selection. Results The applications of AI/ML were explored in 131 clinical trial protocols. The areas where AI/ML was most frequently utilized in clinical trials included endpoint assessment (n=80), followed by dose selection/optimization (n=15), risk stratification/management (n=13), drug discovery (n=4), adherence (n=4), drug selection (n=1) and enrichment (n=1). Conclusion: The most frequent application of AI/ML in clinical trials is in the fields of endpoint assessment, where the utilization is primarily focuses on the diagnosis of disease by imag-ing or video analyses. The number of clinical trials using artificial intelligence will increase as the technology continues to developrapidly, making it necessary for regulatory associates to establish proper regulations for these clinical trials.

Purpose: To estimate the number of practicing nurses required to resolve staffing differences between capital and non-capital regions and analyze the relationship between regional differences in staffing and salary. Methods: Using public data on population, patients, newly licensed nurses, practicing nurses, and annual salaries, regional differences were analyzed in newly licensed nurses per population, practicing nurses per population, practicing nurses per patient (i.e., staffing level), and salary. The number of additionally required practicing nurses was estimated by multiplying staffing differences by the number of patients in the lower-staffed region. Results: During 2002~2022, 71,107 and 243,611 newly licensed nurses were supplied, while the number of practicing nurses increased by 91,886 and 88,070 in the capital and non-capital regions, respectively. The non-capital region had more practicing nurses per population, whereas the capital region had more practicing nurses per patient. In 2020, 31,330 practicing nurses were additionally required in the non-capital region. Salaries were higher in the capital region, and regional salary differences increased during 2011~2020. Regional salary differences were associated with regional staffing differences and the number of additionally required practicing nurses. Conclusion Government and health insurance policies are required to encourage hospitals in the non-capital region to improve staffing and salaries.

Purpose: This study aimed to examine changes in nurse staffing grades and nursing fee revenues following the third amendment of the resource-based relative value scale, implemented in January 2024. Methods: Revised nurse staffing grades were determined based on the number of patients per nurse (PpN), calculated by dividing the daily patient census by the number of registered nurses working in general wards. Changes in staffing grades were analyzed from the fourth quarter of 2023 to the first quarter of 2024 among 44 tertiary hospitals, 328 general hospitals, and 1,378 non-general hospitals. Results: In 2024, the previous "best grade" (grade 1) was subdivided into two or three grades. The best grade was redefined as grade S (PpN<1.5) in tertiary and general hospitals and grade A (PpN<2.0) in non-general hospitals. By 2024, 72.4%, 11.8%, and 22.5% of tertiary, general, and non-general hospitals, respectively, achieved the best grade. The estimated additional annual nursing fee revenues per nurse in 2024 (compared to 2023) for hospitals advancing from grade 1 to grade S ranged from 1,088,455 to 11,412,655 KRW in tertiary hospitals and 11,483,834 KRW in general hospitals. Conclusion To ensure appropriate nurse staffing levels, nursing fees should be proportionally differentiated based on staffing requirements. Additional revenues should be strategically allocated to enhance nurse compensation, thereby improving workforce sustainability and care quality.

Purpose: To estimate the number of practicing nurses required to resolve staffing differences between capital and non-capital regions and analyze the relationship between regional differences in staffing and salary. Methods: Using public data on population, patients, newly licensed nurses, practicing nurses, and annual salaries, regional differences were analyzed in newly licensed nurses per population, practicing nurses per population, practicing nurses per patient (i.e., staffing level), and salary. The number of additionally required practicing nurses was estimated by multiplying staffing differences by the number of patients in the lower-staffed region. Results: During 2002~2022, 71,107 and 243,611 newly licensed nurses were supplied, while the number of practicing nurses increased by 91,886 and 88,070 in the capital and non-capital regions, respectively. The non-capital region had more practicing nurses per population, whereas the capital region had more practicing nurses per patient. In 2020, 31,330 practicing nurses were additionally required in the non-capital region. Salaries were higher in the capital region, and regional salary differences increased during 2011~2020. Regional salary differences were associated with regional staffing differences and the number of additionally required practicing nurses. Conclusion Government and health insurance policies are required to encourage hospitals in the non-capital region to improve staffing and salaries.

Purpose: This study aimed to examine changes in nurse staffing grades and nursing fee revenues following the third amendment of the resource-based relative value scale, implemented in January 2024. Methods: Revised nurse staffing grades were determined based on the number of patients per nurse (PpN), calculated by dividing the daily patient census by the number of registered nurses working in general wards. Changes in staffing grades were analyzed from the fourth quarter of 2023 to the first quarter of 2024 among 44 tertiary hospitals, 328 general hospitals, and 1,378 non-general hospitals. Results: In 2024, the previous "best grade" (grade 1) was subdivided into two or three grades. The best grade was redefined as grade S (PpN<1.5) in tertiary and general hospitals and grade A (PpN<2.0) in non-general hospitals. By 2024, 72.4%, 11.8%, and 22.5% of tertiary, general, and non-general hospitals, respectively, achieved the best grade. The estimated additional annual nursing fee revenues per nurse in 2024 (compared to 2023) for hospitals advancing from grade 1 to grade S ranged from 1,088,455 to 11,412,655 KRW in tertiary hospitals and 11,483,834 KRW in general hospitals. Conclusion To ensure appropriate nurse staffing levels, nursing fees should be proportionally differentiated based on staffing requirements. Additional revenues should be strategically allocated to enhance nurse compensation, thereby improving workforce sustainability and care quality.

Background/Aims: Immune checkpoint inhibitors (ICIs) can induce immune-related adverse events, including endocrine dysfunctions, which can have serious consequences on patient health and quality of life. The clinical course and characteristics of immune-related hypophysitis (irH) are not well established. This study aimed to analyze the clinical course and characteristics of irH. Methods: This single-center, retrospective study analyzed data from electronic medical records of Asan Medical Center, spanning January 2017 through June 2021. It included adult patients with solid tumors who underwent thyroid and adrenal function tests, along with gonadotropin and/or growth hormone evaluations, following the initiation of ICI treatment within the same period. The study explored the clinical characteristics of ICI-treated patients with and without irH, the incidence of irH, the time to irH onset, and the associated hormonal changes. Results: Twenty-one patients were included in this analysis. Clinical characteristics did not differ significantly between the irH (n = 13) and non-irH (n = 8) groups. Deficiency rates in the irH group were 23.1% for thyroid-stimulating hormone (n = 3), 76.9% for adrenocorticotropic hormone (n = 10), 61.5% for gonadotropin (n = 8), and 15.4% for growth hormone (n = 2). The overall incidence was 0.9 per person-year, with 6-month and 1-year cumulative incidences of 38.8% and 57.1%, respectively. The median time from ICI initiation to irH diagnosis was 7.7 months. Time to levothyroxine replacement was shorter in the irH group. Conclusions The findings provide evidence that could facilitate the prediction of ICI-induced irH based on clinical course and characteristics.