Purpose: While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head. Materials and Methods: We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results: A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy. Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.

Purpose: While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head. Materials and Methods: We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results: A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy. Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.

Purpose: While fluoropyrimidine-based chemotherapy regimens are recommended second-line treatment for patients with advanced biliary tract cancer (BTC), there have been no studies comparing different regimens head-to-head. Materials and Methods: We performed individual patient-level meta-analysis based on data from the intention-to-treat population of the phase 2b NIFTY trial (liposomal irinotecan [nal-IRI] plus fluorouracil and leucovorin [5-FU/LV] vs. 5-FU/LV; NCT03542508) and the phase 2 FIReFOX trial (modified oxaliplatin plus 5-FU/LV [mFOLFOX] vs. modified irinotecan plus 5-FU/LV [mFOLFIRI]; NCT03464968). Pairwise log-rank tests and multivariable analysis using Cox proportional hazards modeling with shared frailty to account for the trial's effect were used to compare overall survival (OS) between regimens. Results: A total of 277 patients were included. The nal-IRI plus 5-FU/LV group (n=88) showed significantly better OS compared to the mFOLFOX group (n=49, pairwise log-rank, p=0.02), and mFOLFIRI group (n=50, p=0.03). Multivariable analysis showed consistent trends in OS with adjusted hazard ratios of 1.39 (mFOLFOX vs. nal-IRI plus 5-FU/LV: 95% confidence interval [CI], 0.93 to 2.07; p=0.11) and 1.36 (mFOLFIRI vs. nal-IRI plus 5-FU/LV: 95% CI, 0.92 to 2.03; p=0.13), respectively. Compared to the 5-FU/LV group, the mFOLFOX group and the mFOLFIRI group did not show differences in terms of OS (pairwise log-rank p=0.83 and p=0.58, respectively). The nal-IRI plus 5-FU/LV group experienced more frequent diarrhea, while the mFOLFOX group experienced peripheral neuropathy. Conclusion Nal-IRI plus 5-FU/LV showed favorable survival outcomes compared to mFOLFOX, mFOLFIRI, or 5-FU/LV. The safety profiles of these regimens should be considered along with efficacy.

Background: Turner syndrome (TS) is a common chromosomal abnormality, which is caused by loss of all or part of one X chromosome. Hormone replacement therapy in TS is important in terms of puberty, growth and prevention of osteoporosis however, such a study has never been conducted in Korea. Therefore, the purpose of our study was to determine relationship between the starting age, duration of estrogen replacement therapy (ERT) in TS and develop a hormone replacement protocol suitable for the situation in Korea. Methods: This is retrospective study analyzed the medical records in TS patients treated at the Severance hospital, Yonsei University College of Medicine, Seoul, Korea from 1997 to 2019. Total of 188 subjects who had received a bone density test at least once were included in the study. Korean National Health and Nutrition Examination Survey (KNHANES) was used for achieving bone mineral density (BMD) of normal control group. Student’s t-test, MannWhitney U test, ANOVA and correlation analysis were performed using SPSS 18.0. Results: Each BMD measurement was significantly lower in women with TS than in healthy Korean women. Early start and longer duration of ERT is associated with higher lumbar spine BMD but not femur neck BMD. Femur neck BMD, but not lumbar spine BMD was significantly higher in women with mosaicism than 45XO group. Conclusion Early onset and appropriate duration of hormone replacement therapy is important for increasing bone mineral density in patients with Turner syndrome. Also, ERT affects differently to TS patients according to mosaicism.

Purpose: There are clinical unmet needs in predicting therapeutic response and precise strategy for the patient with advanced biliary tract cancer (BTC). We aimed to identify genomic alterations predicting therapeutic response and resistance to gemcitabine and cisplatin (Gem/Cis)-based chemotherapy in advanced BTC. Materials and Methods: Genomic analysis of advanced BTC multi-institutional cohorts was performed using targeted panel sequencing. Genomic alterations were analyzed integrating patients’ clinicopathologic data, including clinical outcomes of Gem/Cis-based therapy. Significance of genetic alterations was validated using clinical next-generation sequencing (NGS) cohorts from public repositories and drug sensitivity data from cancer cell lines. Results: 193 BTC patients from three cancer centers were analyzed. Most frequent genomic alterations were TP53 (55.5%), KRAS (22.8%), ARID1A (10.4%) alterations, and ERBB2 amplification (9.8%). Among 177 patients with BTC receiving Gem/Cis-based chemotherapy, ARID1A alteration was the only independent predictive molecular marker of primary resistance showing disease progression for 1st-line chemotherapy in the multivariate regression model (odds ratio, 3.12; p=0.046). In addition, ARID1A alteration was significantly correlated with inferior progression-free survival on Gem/Cis-based chemotherapy in the overall patient population (p=0.033) and in patients with extrahepatic cholangiocarcinoma (CCA) (p=0.041). External validation using public repository NGS revealed that ARID1A mutation was a significant predictor for poor survival in BTC patients. Investigation of multi-OMICs drug sensitivity data from cancer cell lines revealed that cisplatin-resistance was exclusively observed in ARID1A mutant bile duct cancer cells. Conclusion Integrative analysis with genomic alterations and clinical outcomes of the first-line Gem/Cis-based chemotherapy in advanced BTC revealed that patients with ARID1Aalterations showed a significant worse clinical outcome, especially in extrahepatic CCA. Well-designed prospective studies are mandatory to validate the predictive role of ARID1Amutation.

BACKGROUND: The 48/6 Model of Care is an integrative care initiative for improving the health outcomes of hospitalized older patients; however, its applicability in community-dwelling older adults as a health screening tool has not been investigated. The present study aimed to examine the applicability of this model, prevalence of dysfunction in 6 care areas, and its relationship with self-reported mobility in community-dwelling older adults.METHODS: This was a cross-sectional survey study of community-dwelling adults aged 65 or older. Participants were screened for problems using 9 items corresponding to the 6 care areas of the 48/6 Model of Care (cognitive functioning, functional mobility, pain management, nutrition and hydration, bladder and bowel management, and medication management). Mobility was assessed via the Life-Space Assessment (LSA). We examined the correlation between each screening item and the LSA.RESULTS: A total of 444 older adults (260 women, 58.6%) participated. The mean number of health problems was 2.3 ± 2.1, with the most common being pain, cognitive impairment, and urinary incontinence. These problems and LSA scores were significantly different by age groups. A multiple regression analysis showed that polypharmacy (β = −10.567, P < 0.001), dysphagia (β = −9.610, P = 0.021), and pain (β = −7.369, P = 0.004) were significantly associated with life-space mobility after controlling for age.CONCLUSION: The 48/6 Model of Care is applicable to community-dwelling older adults, who show high prevalence of dysfunction in the 6 care areas. This study supports the role of the model in screening for the health status of older adults living in the community, and in estimating mobility.
Adult ; Cognition Disorders ; Cross-Sectional Studies ; Deglutition Disorders ; Female ; Humans ; Mass Screening ; Pain Management ; Polypharmacy ; Prevalence ; Urinary Bladder ; Urinary Incontinence

BACKGROUND: The 48/6 Model of Care is an integrative care initiative for improving the health outcomes of hospitalized older patients; however, its applicability in community-dwelling older adults as a health screening tool has not been investigated. The present study aimed to examine the applicability of this model, prevalence of dysfunction in 6 care areas, and its relationship with self-reported mobility in community-dwelling older adults. METHODS: This was a cross-sectional survey study of community-dwelling adults aged 65 or older. Participants were screened for problems using 9 items corresponding to the 6 care areas of the 48/6 Model of Care (cognitive functioning, functional mobility, pain management, nutrition and hydration, bladder and bowel management, and medication management). Mobility was assessed via the Life-Space Assessment (LSA). We examined the correlation between each screening item and the LSA. RESULTS: A total of 444 older adults (260 women, 58.6%) participated. The mean number of health problems was 2.3 ± 2.1, with the most common being pain, cognitive impairment, and urinary incontinence. These problems and LSA scores were significantly different by age groups. A multiple regression analysis showed that polypharmacy (β = −10.567, P < 0.001), dysphagia (β = −9.610, P = 0.021), and pain (β = −7.369, P = 0.004) were significantly associated with life-space mobility after controlling for age. CONCLUSION The 48/6 Model of Care is applicable to community-dwelling older adults, who show high prevalence of dysfunction in the 6 care areas. This study supports the role of the model in screening for the health status of older adults living in the community, and in estimating mobility.

Background: This study aimed to describe the experience of providing older adult patients with transitional care from an acute care hospital to home in cooperation with a public health center, in order to present the barriers to that care and suggest better organizational methods. Methods: This was a cross-sectional study to show the results of the Geriatric Screening for Care-10 (GSC-10) and outcomes of transitional care. Among 659 hospitalized patients aged 65 years or above who lived in an administrative district, forty-five subjects were enrolled between June 24, 2019 and January 23, 2020. Within 48 hours of admission, using the 10 areas of GSC-10, they were assessed for cognitive impairment, depression, polypharmacy (5 or more medications), functional mobility, dysphagia, malnutrition, pain, and incontinence, and were reassessed before discharge. The transitional care plan (containing the treatment summary, the results of the GSC-10 assessment, and the post-discharge plan) was forwarded to a representative of the public health center, who provided continued disease management and various health care services, such as chronic disease and frailty care, and physical rehabilitation. Results: Of all the participants, 64.4% had more than 1 GSC-10 concern. The most prevalent concerns were functional immobility (35.6%) and polypharmacy (22.2%). About 15.6% of the participants were readmitted to a nursing home or hospital. A total of 38 participants received the transitional care intervention. They received an average of 2.7 administered interventions. However, the rate of rejection was high (30.1%) and patients were visited an average of 16.5 days after discharge. Conclusion Through our experience of providing transitional care from an acute care hospital to home in cooperation with a public health center, we expect that the transitional care suitable for the Korean medical situation could be established and successful.

BACKGROUND: Geriatric syndromes are associated with morbidity and poor quality of life (QOL). Urinary incontinence (UI) is one of the most prevalent geriatric syndromes. However, there is little research on the association of UI and UI-related QOL with other geriatric syndromes. We investigated the relationship between geriatric syndromes and UI according to gender and UI-related QOL among older inpatients. METHODS: This study was conducted among 444 older inpatients (aged 65 years and older) between October 2016 and July 2017. We examined geriatric syndromes and related factors involving cognitive impairment, delirium, depression, mobility decline, polypharmacy, undernutrition, pain, and fecal incontinence. UI-related QOL was assessed using the International Consultation on Incontinence Questionnaire-Short Form. Multiple logistic regression analysis was used to evaluate these associations. RESULTS: Geriatric syndromes and related factors were associated with UI. Mobility decline (odds ratio [OR], 4.16; 95% confidence interval [CI], 2.29–7.56), polypharmacy (OR, 3.35; 95% CI, 1.89–5.92), and pain (OR, 6.80; 95% CI, 3.53–13.09) were related to UI in both genders. Especially, delirium (OR, 7.55; 95% CI, 1.61–35.44) and fecal incontinence (OR, 10.15; 95% CI, 2.50–41.17) were associated with UI in men, while cognitive impairment (OR, 4.19; 95% CI, 1.14–15.44) was significantly associated with UI in women. Patients with depression were more likely to have poor UI-related QOL (OR, 8.54; 95% CI, 1.43–51.15). CONCLUSION: UI was associated with different geriatric syndromes and related factors according to gender. Care for patients with depression, related to poor UI-related QOL, should be considered in primary care to improve the UIrelated QOL of these individuals.
Cognition Disorders ; Cross-Sectional Studies ; Delirium ; Depression ; Fecal Incontinence ; Female ; Humans ; Inpatients ; Logistic Models ; Male ; Malnutrition ; Polypharmacy ; Primary Health Care ; Quality of Life ; Urinary Incontinence