Background: Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea. Methods: An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response. Results: During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients). Conclusion This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.

Background/Aims: Several prediction models for evaluating the prognosis of nonmetastatic resected pancreatic ductal adenocarcinoma (PDAC) have been developed, and their performances were reported to be superior to that of the 8th edition of the American Joint Committee on Cancer (AJCC) staging system. We developed a prediction model to evaluate the prognosis of resected PDAC and externally validated it with data from a nationwide Korean database. Methods: Data from the Surveillance, Epidemiology and End Results (SEER) database were utilized for model development, and data from the Korea Tumor Registry System-Biliary Pancreas (KOTUS-BP) database were used for external validation. Potential candidate variables for model development were age, sex, histologic differentiation, tumor location, adjuvant chemotherapy, and the AJCC 8th staging system T and N stages. For external validation, the concordance index (C-index) and time-dependent area under the receiver operating characteristic curve (AUC) were evaluated. Results: Between 2004 and 2016, data from 9,624 patients were utilized for model development, and data from 3,282 patients were used for external validation. In the multivariate Cox proportional hazard model, age, sex, tumor location, T and N stages, histologic differentiation, and adjuvant chemotherapy were independent prognostic factors for resected PDAC. After an exhaustive search and 10-fold cross validation, the best model was finally developed, which included all prognostic variables. The C-index, 1-year, 2-year, 3-year, and 5-year time-dependent AUCs were 0.628, 0.650, 0.665, 0.675, and 0.686, respectively. Conclusions The survival prediction model for resected PDAC could provide quantitative survival probabilities with reliable performance. External validation studies with other nationwide databases are needed to evaluate the performance of this model.

Purpose: Postoperative delirium (POD) is a common complication in elderly patients after major abdominal surgery for cancer. Although POD is related with a poor outcome, there have not been many reports about POD after abdominal surgery in Korea. The aims of study were to analyze the characteristics and surgical outcomes of elderly patients with POD and to identify the risk factors of POD. Methods: From November 2016 to January 2019, we prospectively enrolled 63 patients who were aged ≥75 years and underwent major abdominal surgery for cancer. POD was daily assessed for up to 10 days postoperatively with the Confusion Assessment Method and a validated chart review. Results: POD occurred in eight patients (12.7%). Univariate analysis showed that the occurrence of POD was related to sodium <135 mEq/L (P=0.037), combined resection (P=0.023), longer surgery/anesthesia time (P=0.023 and P=0.037, respectively), increased blood loss (P=0.004), postoperative admission to intensive care unit (ICU) (P=0.023), and duration of Foley catheter (P=0.011), however, multivariate analysis identified no significant risk factors of POD. There was no difference in postoperative outcomes such as hospital stay, mortality, reoperation, and morbidity between patients with POD and without POD. Conclusion Elderly patients with hyponatremia, combined resection, longer operation/anesthesia time and admission to ICU had tendencies to develop POD after major abdominal surgery. Surgeons should pay more attention to prevent POD, and a large-scale prospective study is needed to identify the risk factors of POD.

Purpose: Postoperative delirium (POD) is a common complication in elderly patients after major abdominal surgery for cancer. Although POD is related with a poor outcome, there have not been many reports about POD after abdominal surgery in Korea. The aims of study were to analyze the characteristics and surgical outcomes of elderly patients with POD and to identify the risk factors of POD. Methods: From November 2016 to January 2019, we prospectively enrolled 63 patients who were aged ≥75 years and underwent major abdominal surgery for cancer. POD was daily assessed for up to 10 days postoperatively with the Confusion Assessment Method and a validated chart review. Results: POD occurred in eight patients (12.7%). Univariate analysis showed that the occurrence of POD was related to sodium <135 mEq/L (P=0.037), combined resection (P=0.023), longer surgery/anesthesia time (P=0.023 and P=0.037, respectively), increased blood loss (P=0.004), postoperative admission to intensive care unit (ICU) (P=0.023), and duration of Foley catheter (P=0.011), however, multivariate analysis identified no significant risk factors of POD. There was no difference in postoperative outcomes such as hospital stay, mortality, reoperation, and morbidity between patients with POD and without POD. Conclusion Elderly patients with hyponatremia, combined resection, longer operation/anesthesia time and admission to ICU had tendencies to develop POD after major abdominal surgery. Surgeons should pay more attention to prevent POD, and a large-scale prospective study is needed to identify the risk factors of POD.

OBJECTIVE: Under the overcrowding conditions of large emergency departments, the proportion of elderly patients is increasing in Korea. This paper describes the necessity of the preparedness of Korean emergency departments and society for the rapidly aging population. METHODS: This was a retrospective observational study. Patients who presented to a tertiary hospital emergency department (ED) in one year were included. The use of medical resources between young adult (≥20 and <65 years of age) and elderly patients (≥65 years of age) was compared. RESULTS: This study included 26,712 patients. The young adult group and the elderly group was 15,021 (56.2%) and 11,691 (43.8%), respectively. The ratio of firehouse ambulance visit mode (28.6%) and inter-facility transfer visit mode (18.9%) of the elderly group was higher compared to those of the young adult group (26.4% and 10.6%, P<0.001). The elderly group visited more at daytime (P<0.001). With aging, the admission ratios of the elderly group to the general ward (38.9%) and intensive care unit (13.0%) were higher than the young adult group (9.8% and 4.3%, P<0.001). The mean ED length of stay and mean length of hospitalization of the elderly group was longer than that of the young adult group (P<0.001). The medical cost of the elderly group was approximately three times higher than that of the young adult group. CONCLUSION Elderly patients required more emergency medical resources in both the prehospital and hospital stages. Korean emergency departments and society require efforts for not only expansion but also the appropriate use of medical resources in a rapidly aging population.

PURPOSE: Characteristic signs – the susceptibility vessel sign (SVS) and the prominent hypointense vessel sign (PHVS) – on T2*-based magnetic resonance imaging (T2*MRI) can be seen for acute ischemic stroke with large artery occlusion. In this study, we investigated the evidence to support our hypothesis that these findings may help to predict outcomes after reperfusion therapy. MATERIALS AND METHODS: We searched for papers describing SVS and PHVS in patients treated with reperfusion therapy for acute ischemic stroke, and their functional/radiologic outcomes were systematically reviewed. RESULTS: Nine studies on the SVS and six studies on the PHVS were included. The pooled odds ratio (OR) of recanalization after intravenous thrombolysis or mechanical thrombectomy was not significantly different with the presence of SVS (OR, 0.615; 95% confidence interval [CI], 0.335–1.131 and OR, 0.993; 95% CI, 0.629–1.567). The OR of favorable functional outcome after reperfusion therapy in terms of the presence of PHVS varied (0.083 to 1.831) by study. CONCLUSION: Our meta-analysis of the published data showed that a SVS was not a predictive factor for recanalization after reperfusion therapy for acute ischemic stroke. Currently, the data available on T2*MRI are too limited to warrant reperfusion therapy in routine practice. More data are needed from studies with randomized treatment allocation to determine the role of T2*MRI.
Arteries ; Humans ; Magnetic Resonance Imaging ; Odds Ratio ; Reperfusion* ; Stroke* ; Thrombectomy

Genetic diagnosis of cardiomyopathies is challenging, due to the marked genetic and allelic heterogeneity and the lack of knowledge of the mutations that lead to clinical phenotypes. Here, we present the case of a large family, in which a single TNNI3 mutation caused variable phenotypic expression, ranging from restrictive cardiomyopathy (RCMP) to hypertrophic cardiomyopathy (HCMP) to near-normal phenotype. The proband was a 57-year-old female with HCMP. Examining the family history revealed that her elder sister had expired due to severe RCMP. Using a next-generation sequencing-based gene panel to analyze the proband, we identified a known TNNI3 gene mutation, c.433C>T, which is predicted to cause an amino acid substitution (p.Arg145Trp) in the highly conserved inhibitory region of the cardiac troponin I protein. Sanger sequencing confirmed that six relatives with RCMP or near-normal phenotypes also carried this mutation. To our knowledge, this is the first genetically confirmed family with diverse phenotypic expression of cardiomyopathies in Korea. Our findings demonstrate familial implications, where a single mutation in a sarcomere protein can cause diverse phenotypic expression of cardiomyopathies.
Amino Acid Substitution ; Cardiomyopathies* ; Cardiomyopathy, Hypertrophic ; Cardiomyopathy, Restrictive ; Diagnosis ; Female ; Humans ; Korea ; Middle Aged ; Phenotype ; Population Characteristics ; Sarcomeres ; Siblings ; Troponin I

PURPOSE: A secondary triage tool for pediatric trauma patients, “modified pediatric trauma score (mPTS)” was introduced to predict high risk trauma. METHODS: Pediatric trauma patients (≤15 years) presenting to the Pusan National University Hospital trauma center emergency department were analyzed retrospectively. The patients were classified into high risk and low risk groups. The high risk group was assigned an Injury Severity Score ≥12, death, intensive care unit admission, or urgent intervention (intubation, closed thoracostomy, emergency angiography and embolization, emergency surgery). The airway, blood pressure, fractures, level of consciousness, and external wounds were evaluated and the mPTS was calculated. RESULTS: One hundred seventy-seven patients were enrolled in this study. The mPTS had a sensitivity, specificity, positive predictive value, and negative predictive value of 88%, 54%, 60%, and 85%, respectively. Overtriage and undertriage was 39% and 14%, respectively. The mPTS missed 6 high risk patients and all 6 patients were abdominal injury patients. The mPTS was modified to include an abdominal physical examination and/or focused assessment with sonography for trauma. The newly developed scoring system was called the extended mPTS (E-mPTS). The E-mPTS had a sensitivity of 98% and negative predictive value of 98%. The safe level of overtriage (38%) was maintained. CONCLUSION: mPTS was applied to the patients and the undertriage rate was too high. The extended mPTS improved undertriage to 2% while maintaining the overtriage rate at a safe level. The E-mPTS is expected to have a resource saving effect when used as a pediatric trauma team activation standard.
Abdominal Injuries ; Angiography ; Blood Pressure ; Busan ; Consciousness ; Emergencies ; Emergency Medicine ; Emergency Service, Hospital ; Humans ; Injury Severity Score ; Intensive Care Units ; Mass Screening* ; Pediatrics ; Physical Examination ; Retrospective Studies ; Sensitivity and Specificity ; Thoracostomy ; Trauma Centers ; Triage ; Wounds and Injuries

PURPOSE: The aim of this study was to verify that laparoscopic resection for treating retroperitoneal benign neurilemmoma (NL) is expected to be favorable for complete resection of tumor with technical feasibility and safety. METHODS: We retrospectively analyzed 47 operations for retroperitoneal neurogenic tumor at Yonsei University College of Medicine, Severance Hospital and Gangnam Severance Hospital between January 2005 and September 2015. After excluding 21 patients, the remaining 26 were divided into 2 groups: those who underwent open surgery (OS) and those who underwent laparoscopic surgery (LS). We compared clinicopathological features between the 2 groups. RESULTS: There was no significant difference in operation time, estimated blood loss, transfusion, complication, recurrence, or follow-up period between 2 groups. Postoperative hospital stay was significantly shorter in the LS group versus the OS group (OS vs. LS, 7.00 ± 3.43 days vs. 4.50 ± 2.16 days; P = 0.031). CONCLUSION: We suggest that laparoscopic resection of retroperitoneal benign NL is feasible and safe by obtaining complete resection of the tumor. LS for treating retroperitoneal benign NL could be useful with appropriate laparoscopic technique and proper patient selection.
Follow-Up Studies ; Humans ; Laparoscopy ; Length of Stay ; Neurilemmoma* ; Patient Selection ; Recurrence ; Retroperitoneal Neoplasms ; Retrospective Studies

PURPOSE: This study evaluated the benefits of adjuvant chemotherapy on elderly patients with advanced gastric cancer (AGC) using meta-analysis of well-designed randomized controlled clinical studies. MATERIALS AND METHODS: PubMed, Embase, and Cochrane were searched to retrieve clinical studies evaluating the benefits of adjuvant chemotherapy in the elderly with AGC. Hazards ratios (HRs) with 95% confidence intervals (CIs) were pooled across studies using a fixed-effects model. RESULTS: Two studies were included in this meta-analysis to estimate HR for the overall survival (OS), and relapse-free survival (RFS) between adjuvant chemotherapy and surgery in elderly and non-elderly patients. HR for OS in the elderly and non-elderly was 0.745 (95% CI, 0.552 to 1.006, p=0.055) and 0.636 (95% CI, 0.522 to 0.776; p < 0.001), respectively, which showed no heterogeneity regarding HR between the two groups (p(interaction)=0.389). HR for RFS in the elderly and non-elderly was 0.613 (95% CI, 0.466 to 0.806; p < 0.001) and 0.633 (95% CI, 0.533 to 0.753; p < 0.001), respectively (p(interaction)=0.846). CONCLUSION: Meta-analysis suggests that the benefit of adjuvant chemotherapy to the elderly is not big enough to reach statistical significance while the HR for OS is less than 1 (0.745) and no heterogeneity are observed regarding the HR between the elderly and non-elderly patients.
Aged* ; Chemotherapy, Adjuvant* ; Humans ; Population Characteristics ; Stomach Neoplasms*