Purpose: This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC). Materials and Methods: Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS). Results: In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib. Conclusion Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.

Purpose: Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system (CNS) metastases. We present results of a subgroup analysis of Korean patients from the pooled data of two global phase II trials: AURA extension (NCT01802632) and AURA2 (NCT02094261). Materials and Methods: Enrolled patients had EGFR T790M-positive NSCLC and disease progression during or after EGFR-TKI therapy. Patients received osimertinib 80 mg orally once daily until disease progression. The primary endpoint was objective response rate (ORR). Results: In total, 66 Korean patients received osimertinib treatment with a median treatment duration of 19 months. In the evaluable-for-response population (n=62), ORR was 74% (95% confidence interval [CI], 61.5 to 84.5) and median duration of response was 9.8 months (95% CI, 7.1 to 16.8). In the full analysis set (n=66), median progression-free survival was 10.9 months (95% CI, 8.3 to 15.0; data cutoff November 1, 2016), and median overall survival was 29.2 months (95% CI, 24.8 to 35.7; data cutoff May 1, 2018). Eight patients with CNS metastases were evaluable for response, none of whom showed CNS progression. The most common adverse events were rash (53%), cough (33%), paronychia, diarrhea, and decreased appetite (each 32%). Conclusion Efficacy and safety profiles of osimertinib in this subgroup are consistent with the global phase II pooled population, which supports osimertinib as a recommended treatment for Korean patients with T790M positive NSCLC.

Purpose: The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program. Materials and Methods: Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected. Results: Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data. Conclusion This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.

BACKGROUND: This study investigated the overall status of diabetes control and screening for diabetic microvascular complications in patients with type 2 diabetes mellitus attending primary care clinics in Korea. METHODS: In this cross-sectional observational study, 191 primary care clinics were randomly selected across Korea from 2015 to 2016. In total, 3,227 subjects were enrolled in the study. RESULTS: The patients followed at the primary care clinics were relatively young, with a mean age of 61.4±11.7 years, and had a relatively short duration of diabetes (mean duration, 7.6±6.5 years). Approximately 14% of subjects had diabetic microvascular complications. However, the patients treated at the primary care clinics had suboptimal control of hemoglobin A1c levels, blood pressure, and serum lipid levels, along with a metabolic target achievement rate of 5.9% according to the Korean Diabetes Association guidelines. The screening rates for diabetic nephropathy, retinopathy, and neuropathy within the past 12 months were 28.4%, 23.3%, and 13.3%, respectively. CONCLUSION: The overall status of diabetes management, including the frequency of screening for microvascular complications, was suboptimal in the primary care clinics. More efforts should be made and more resources need to be allocated for primary care physicians to promote adequate healthcare delivery, which would result in stricter diabetes control and improved management of diabetic complications.
Blood Pressure ; Delivery of Health Care ; Diabetes Complications ; Diabetes Mellitus, Type 2 ; Diabetic Nephropathies ; Humans ; Korea ; Mass Screening ; Observational Study ; Physicians, Primary Care ; Primary Health Care ; Tertiary Care Centers

PURPOSE: The information committee of the Korean Society for Metabolic and Bariatric Surgery (KSMBS) performed the nationwide survey of bariatric and metabolic operations to report IFSO (International Federation for the Surgery of Obesity and Metabolic Disorders) worldwide survey annually. This study aimed to report the trends of bariatric and metabolic surgery in Korea in 2014–2017. MATERIALS AND METHODS: We analyzed the accumulated nationwide survey data conducted for annual ISFO survey from 2014 to 2017. Trends such as the number of operations by hospital type and the number of operations by surgical method were analyzed. RESULTS: The number of operations has decreased sharply in 2015 comparing to 2014 (913⇒550). The number of operations performed in private hospitals dropped sharply from 529 to 250, 198, and 103 cases. The number of revisional surgeries increased to 223 in 2015. The primary surgery number fell from 757 in 2014 to 327 in 2015. In primary surgery, sleeve gastrectomy was gradually increased from 2014 to 143 (18.9%), 105 (32.1%), 167 (47.2%) and 200 (56.3%) and became the most frequently performed surgery. On the other hand, the incidence of adjustable gastric band decreased gradually from 439 (58.0%) to 117 (35.8%), 112 (31.6%) and 59 (16.6%). CONCLUSION: The overall number of obesity metabolic operations has decreased since 2014, especially the number of adjustable gastric band, and the number of operations in private hospitals declined sharply. On the other hand, the number of operations in university hospitals did not change much, and the number of sleeve gastrectomy increased.
Bariatric Surgery ; Gastrectomy ; Hand ; Hospitals, Private ; Hospitals, University ; Incidence ; Korea ; Methods ; Obesity

Data on the frequency of nosocomial infections during extracorporeal membrane oxygenation (ECMO) in adult populations remain scarce. We investigated the risk factors for nosocomial infections in adult patients undergoing venoarterial ECMO (VA-ECMO) support. From January 2011 to December 2015, a total of 259 patients underwent ECMO. Of these, patients aged 17 years or less and patients undergoing ECMO for less than 48 hours were excluded. Of these, 61 patients diagnosed with cardiogenic shock were evaluated. Mean patient age was 60.6 ± 14.3 years and 21 (34.4%) patients were female. The mean preoperative Sequential Organ Failure Assessment (SOFA) score was 8.6 ± 2.2. The mean duration of ECMO support was 6.8 ± 7.4 days. The rates of successful ECMO weaning and survival to discharge were 44.3% and 31.1%, respectively. There were 18 nosocomial infections in 14 (23.0%) patients. These included respiratory tract infections in 9 cases and bloodstream infections in a further 9. In multivariate analysis, independent predictors of infection during ECMO were the preoperative creatinine level (hazard ratio [HR], 2.176; 95% confidence interval [CI], 1.065–4.447; P = 0.033) and the duration of ECMO support (HR, 1.400; 95% CI, 1.081–1.815; P = 0.011). A higher preoperative creatinine level and an extended duration of ECMO support are risk factors for infection. Therefore, to avoid the development of nosocomial infections, strategies to shorten the length of ECMO support should be applied whenever possible.

Epidermoid cysts are benign developmental anomalies that are rarely observed in the oral cavity of neonate. If large in size, especially in the developing fetus or newborn infant, they can cause swallowing difficulty and occasionally respiratory difficulty. We report a case of epidermoid cyst in the oral cavity detected prenatal sonography. The sonographic finding was large cystic mass, measuring 30x25 mm. In this case, supplies and equipment for an emergency tracheostomy were made available prior to the delivery. However, the infant did not require intervention to secure the airway. The lesion was surgically excised, and histologic diagnosis was epidermoid cyst. After 6 months of follow up, the cyst had not recurred. This case illustrates the value of accurate prenatal diagnosis and planned perinatal management using a team approach.
Deglutition ; Emergencies ; Epidermal Cyst ; Equipment and Supplies ; Fetus ; Follow-Up Studies ; Humans ; Infant ; Infant, Newborn ; Mouth ; Prenatal Diagnosis ; Tracheostomy

The supraclavicular lymph node (SCN) is frequently involved in lymphoma and metastatic malignancies of the breast and lung, but is extremely rarely involved in pancreatic cancer. Only 10 such cases have been reported in the medical literature worldwide. We herein report an additional two cases. An 83-year-old male patient had a 7.6 x 5 cm pancreatic tumor from the pancreatic head to tail, and a 71-year-old male patient had a 2.8 x 1.9 cm pancreatic body tumor. PET-CT revealed SCN metastasis, and subsequent excisional biopsy confirmed metastatic adenocarcinoma. With the more popular use of PET-CT in patients with pancreatic cancer, the number of cases of metastasis to the SCN is expected to increase. This suggests that lymphatic spread is the main metastatic route in pancreatic cancer. Further large-scale studies along with increased numbers of case reports are needed to determine whether lymphatic spread is the main metastatic route in pancreatic cancer.
Adenocarcinoma ; Biopsy ; Breast ; Head ; Humans ; Lung ; Lymph Nodes ; Lymphoma ; Male ; Neoplasm Metastasis ; Pancreatic Neoplasms

PURPOSE: Pediatric emergencies with seizure and decreased mental status or loss of consciouseness may cause severe complications without early proper management. Distribution of neurological disorders may differ according to various demographics, it would be valuable to evaluate recent data in Korea. METHODS: Patients who had neurological problems and below 18 years old were defined as case. 1,058(5.6%) cases who visited the emergency department of Chung-Ang University Hospital from January 2005 to December 2008 were analyzed. The patients were also divided into four age groups: age 1 year or younger, preschool children(2-5 years), middle childhood group(6-10 years), and adolescent group(11-18 years). RESULTS: The male to female ratio was 1.5:1. Most children were between 2 to 5 years old(mean age=3 years). Febrile convulsion is the most common neurological disorders among infant and preschooler, meningitis is the most common among middle childhood, epilepsy and headache is the most common among adolescent. Main initial presentations were seizure followed by fever, headache and vomiting. Febrile convulsion was the most common neurological disorders followed by epilepsy and meningitis. Final dispositions of patients were admission, discharge, against medical device, and transfer to other hospital. Admission rate of patients with neurological disorders was higher than those of total patients. CONCLUSION: Neurological disorders are increasing in pediatric emergencies and have highest admission rate, mostly because of the parent's anxiety and severity of disease itself. Therefore, not only detect and treat neurological disorder in early stage, but also reassuring parent is important.
Adolescent ; Anxiety ; Child ; Demography ; Emergencies ; Epilepsy ; Female ; Fever ; Headache ; Humans ; Infant ; Korea ; Male ; Meningitis ; Nervous System Diseases ; Parents ; Seizures ; Seizures, Febrile ; Vomiting

PURPOSE: Screening in cervical cancer is now progressing to discover candidate genes and proteins that may serve as biological markers and that play a role in tumor progression. We examined the protein expression patterns of the squamous cell carcinoma (SCC) tissues from Korean women with using two-dimensional polyacrylamide gel electrophoresis (2-DE) and matrix assisted laser desorption/ionization-time of flight (MALDI-TOF) mass spectrometer. MATERIALS AND METHODS: Normal cervix and SCC tissues were solubilized and 2-DE was performed using pH 3~10 linear IPG strips of 17 cm length. The protein expression was evaluated using PDQuest 2-D software(TM). The differentially expressed protein spots were identified with a MALDI-TOF mass spectrometer, and the peptide mass spectra identifications were performed using the Mascot program and by searching the Swiss-prot or NCBInr databases. RESULTS: A total of 35 proteins were detected in SCC. 17 proteins were up-regulated and 18 proteins weredown-regulated. Among the proteins that were identified, 12 proteins (pigment epithelium derived factor, annexin A2 and A5, keratin 19 and 20, heat shock protein 27, smooth muscle protein 22 alpha, alpha-enolase, squamous cell carcinoma antigen 1 and 2, glutathione S-transferase and apolipoprotein a1) were protein previously known to be involved in tumor, and 21 proteins were newly identified in this study. CONCLUSION: 2-DE offers the total protein expression profiles of SCC tissues; further characterization of these differentially expressed proteins will give a chance to identify the badly needed tumor-specific diagnostic markers for SCC.
Annexin A2 ; Apolipoproteins ; Biomarkers ; Carcinoma, Squamous Cell ; Cervix Uteri ; Databases, Protein ; Electrophoresis, Polyacrylamide Gel ; Epithelium ; Female ; Glutathione Transferase ; HSP27 Heat-Shock Proteins ; Humans ; Hydrogen-Ion Concentration ; Keratin-19 ; Mass Screening ; Muscle, Smooth ; Phosphopyruvate Hydratase ; Uterine Cervical Neoplasms*