Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.

Background/Aims: We examined the efficacy and safety of tegoprazan as a part of first-line triple therapy for Helicobacter pylori eradication. Methods: A randomized, double-blind, controlled, multicenter study was performed to evaluate whether tegoprazan (50 mg)-based triple therapy (TPZ) was noninferior to lansoprazole (30 mg)-based triple therapy (LPZ) (with amoxicillin 1 g and clarithromycin 500 mg; all administered twice daily for 7 days) for treating H. pylori. The primary endpoint was the H. pylori eradication rate. Subgroup analyses were performed according to the cytochrome P450 (CYP) 2C19 genotype, the minimum inhibitory concentration (MIC) of amoxicillin and clarithromycin, and underlying gastric diseases. Results: In total, 350 H. pylori-positive patients were randomly allocated to the TPZ or LPZ group. The H. pylori eradication rates in the TPZ and LPZ groups were 62.86% (110/175) and 60.57% (106/175) in an intention-to-treat analysis and 69.33% (104/150) and 67.33% (101/150) in a per-protocol analysis (non-inferiority test, p=0.009 and p=0.013), respectively. Subgroup analyses according to MICs or CYP2C19 did not show remarkable differences in eradication rate. Both first-line triple therapies were well-tolerated with no notable differences. Conclusions TPZ is as effective as proton pump inhibitor-based triple therapy and is as safe as first-line H. pylori eradication therapy but does not overcome the clarithromycin resistance of H. pylori in Korea

Background: Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi. Methods The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023.

PURPOSE: Head and neck squamous cell carcinoma (HNSCC) is a deadly disease in which precision medicine needs to be incorporated. We aimed to implement next-generation sequencing (NGS) in determining actionable targets to guide appropriate molecular targeted therapy in HNSCC patients. MATERIALS AND METHODS: Ninety-three tumors and matched blood samples underwent targeted sequencing of 244 genes using the Illumina HiSeq 2500 platform with an average depth of coverage of greater than 1,000×. Clinicopathological data from patients were obtained from 17 centers in Korea, and were analyzed in correlation with NGS data. RESULTS: Ninety-two of the 93 tumors were amenable to data analysis. TP53 was the most common mutation, occurring in 47 (51%) patients, followed by CDKN2A (n=23, 25%), CCND1 (n=22, 24%), and PIK3CA (n=19, 21%). The total mutational burden was similar between human papillomavirus (HPV)–negative vs. positive tumors, although TP53, CDKN2A and CCND1 gene alterations occurred more frequently in HPV-negative tumors. HPV-positive tumors were significantly associated with immune signature-related genes compared to HPV-negative tumors. Mutations of NOTCH1 (p=0.027), CDKN2A (p < 0.001), and TP53 (p=0.038) were significantly associated with poorer overall survival. FAT1 mutations were highly enriched in cisplatin responders, and potentially targetable alterations such as PIK3CA E545K and CDKN2A R58X were noted in 14 patients (15%). CONCLUSION: We found several targetable genetic alterations, and our findings suggest that implementation of precision medicine in HNSCC is feasible. The predictive value of each targetable alteration should be assessed in a future umbrella trial using matched molecular targeted agents.
Biomarkers ; Carcinoma, Squamous Cell* ; Cisplatin ; Epithelial Cells* ; Head* ; Humans ; Korea ; Molecular Targeted Therapy ; Neck* ; Precision Medicine ; Statistics as Topic

PURPOSE: Differences in the utility of routine angiographic follow-up (RAF) and clinical follow-up (CF) after percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI) are not well understood. The present study aimed to compare the 3-year clinical outcomes of RAF and CF in AMI patients who underwent PCI with drug-eluting stents (DES). MATERIALS AND METHODS: A total of 774 consecutive AMI patients who underwent PCI with DES were enrolled. RAF was performed at 6 to 9 months after index PCI (n=425). The remaining patients were medically managed and clinically followed (n=349); symptom-driven events were captured. To adjust for any potential confounders, a propensity score matched analysis was performed using a logistic regression model, and two propensity-matched groups (248 pairs, n=496, C-statistic=0.739) were generated. Cumulative clinical outcomes up to 3 years were compared between RAF and CF groups. RESULTS: During the 3-year follow-up period, the cumulative incidences of revascularization [target lesion revascularization: hazard ratio (HR), 2.40; 95% confidence interval (CI), 1.18–4.85; p=0.015, target vessel revascularization (TVR): HR, 3.33; 95% CI, 1.69–6.58; p=0.001, non-TVR: HR, 5.64; 95% CI, 1.90–16.6; p=0.002] and major adverse cardiac events (MACE; HR, 3.32; 95% CI, 1.92–5.73; p<0.001) were significantly higher in the RAF group than the CF group. However, the 3-year incidences of death and myocardial infarction were not different between the two groups. CONCLUSION: RAF following index PCI with DES in AMI patients was associated with increased incidences of revascularization and MACE. Therefore, CF seems warranted for asymptomatic patients after PCI for AMI.
Coronary Angiography ; Drug-Eluting Stents ; Follow-Up Studies* ; Humans ; Incidence ; Logistic Models ; Myocardial Infarction* ; Percutaneous Coronary Intervention* ; Propensity Score

PURPOSE: We compared oncologic outcomes between surgery and radiofrequency ablation (RFA) in patients with metachronous isolated hepatic metastases from colorectal cancer.METHODS: We retrospectively analyzed 123 patients treated with hepatic resection and 82 patients treated with RFA for metachronous hepatic metastases between April 2000 and October 2011. Re-recurrence pattern and 3-year re-recurrence free survival (RFS) rate compared between groups. Factors associated with RFS were evaluated.RESULTS: The patients in the two groups were similar in age, gender, location of primary tumor, disease-free interval to hepatic metastasis, pathological stage of primary disease, number of metastatic lesions. The mean diameter of the biggest hepatic metastatic lesion was significantly larger in the resection group than in the RFA group. The RFS rate after hepatic metastasis treatment was significantly higher in the resection group than in the RFA group (48.6% vs. 33.7%, respectively; P=0.015). Marginal recurrence at the RFA site was observed in 14 of the 82 patients (17.1%). The size and number of metastatic lesions, stage of primary disease, disease-free interval to hepatic metastasis, and modality of treatment were confirmed as re-recurrence-associated factors after hepatic metastasis treatment. Among patients with solitary metastases of ≤3 cm, the RFS rate was not different between the resection and RFA groups (52.4% vs. 53.4%, respectively; P=0.491).CONCLUSION: Surgical resection for metachronous hepatic metastases achieved higher RFS and lower local recurrence rates. However, the RFS rate in patients with a solitary hepatic metastasis of ≤3 cm was similar between the resection and RFA groups.
Catheter Ablation ; Colorectal Neoplasms ; Hepatectomy ; Humans ; Liver ; Neoplasm Metastasis ; Recurrence ; Retrospective Studies

Conventional coronary angiography (CAG) has limitations in evaluating lesions producing ischemia. Three dimensional quantitative coronary angiography (3D-QCA) shows reconstructed images of CAG using computer based algorithm, the Cardio-op B system (Paieon Medical, Rosh Ha'ayin, Israel). The aim of this study was to evaluate whether 3D-QCA can reliably predict ischemia assessed by myocardial fractional flow reserve (FFR) < 0.80. 3D-QCA images were reconstructed from CAG which also were evaluated with FFR to assess ischemia. Minimal luminal diameter (MLD), percent diameter stenosis (%DS), minimal luminal area (MLA), and percent area stenosis (%AS) were obtained. The results of 3D-QCA and FFR were compared. A total of 266 patients was enrolled for the present study. FFR for all lesions ranged from 0.57 to 1.00 (0.85 +/- 0.09). Measurement of MLD, %DS, MLA, and %AS all were significantly correlated with FFR (r = 0.569, 0609, 0.569, 0.670, respectively, all P < 0.001). In lesions with MLA < 4.0 mm2, %AS of more than 65.5% had a 80% sensitivity and a 83% specificity to predict FFR < 0.80 (area under curve, AUC was 0.878). 3D-QCA can reliably predict coronary lesions producing ischemia and may be used to guide therapeutic approach for coronary artery disease.
Aged ; Coronary Angiography/*methods ; Coronary Circulation ; Coronary Stenosis/etiology/*physiopathology/*radiography ; Female ; *Fractional Flow Reserve, Myocardial ; Humans ; Imaging, Three-Dimensional/*methods ; Male ; Myocardial Ischemia/complications/physiopathology/*radiography ; Radiographic Image Enhancement/methods ; Radiographic Image Interpretation, Computer-Assisted/methods ; Reproducibility of Results ; Sensitivity and Specificity

OBJECTIVES: The purpose of this study was to determine a separation method for each arsenic metabolite in urine by using a high performance liquid chromatography (HPLC)- inductively coupled plasma-mass spectrometer (ICP-MS). METHODS: Separation of the arsenic metabolites was conducted in urine by using a polymeric anion-exchange (Hamilton PRP X-100, 4.6 mm x 150 mm, 5 mum) column on Agilent Technologies 1260 Infinity LC system coupled to Agilent Technologies 7700 series ICP/MS equipment using argon as the plasma gas. RESULTS: All five important arsenic metabolites in urine were separated within 16 minutes in the order of arsenobetaine, arsenite, dimethylarsinate, monomethylarsonate and arsenate with detection limits ranging from 0.15 to 0.27 mug/L (40 muL injection). We used GEQUAS No. 52, the German external quality assessment scheme and standard reference material 2669, National Institute of Standard and Technology, to validate our analyses. CONCLUSIONS: The method for separation of arsenic metabolites in urine was established by using HPLC-ICP-MS. This method contributes to the evaluation of arsenic exposure, health effect assessment and other bio-monitoring studies for arsenic exposure in South Korea.
Argon ; Arsenic* ; Cacodylic Acid ; Chromatography, Liquid ; Environmental Monitoring ; Korea ; Limit of Detection ; Plasma ; Polymers ; Spectrum Analysis*

This study attempted to calculate and investigate the incidence of hospitalized acute myocardial infarction (AMI) and stroke in Korea. Using the National Health Insurance claim data, we investigated patients whose main diagnostic codes included AMI or stroke during 2006 to 2010. As a result, we found out that the number of AMI hospitalized patients had decreased since 2006 and amounted to 15,893 in 2010; and that the number of those with stroke had decreased since 2006 and amounted to 73,501 in 2010. The age-standardized incidence rate of hospitalized AMI, after adjustment for readmission, was 41.6 cases per 100,000-population in 2006, and had decreased to 29.4 cases in 2010 (for trend P < 0.001). In the case of stroke was estimated at 172.8 cases per 100,000-population in 2006, and had decreased to 135.1 cases in 2010 (for trend P < 0.001). In conclusion, the age-standardized incidence rates of both hospitalized AMI and stroke in Korea had decreased continuously during 2006 to 2010. We consider this decreasing trend due to the active use of pharmaceuticals, early vascular intervention, and the national cardio-cerebrovascular disease care project as the primary and secondary prevention efforts.
Acute Disease ; Adolescent ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Child ; Child, Preschool ; Female ; Hospitalization/*trends ; Humans ; Incidence ; Infant ; Infant, Newborn ; Male ; Middle Aged ; Myocardial Infarction/*epidemiology ; Patient Readmission ; Republic of Korea/epidemiology ; Sex Factors ; Stroke/*epidemiology ; Young Adult

The consensus guideline development committee of Korean Society of Gynecologic Oncology was reconvened in March 2012. The committee consisted of 36 experts representing 12 university hospitals and professional organizations. The objective of this committee was to develop standardized guidelines for cervical cancer screening tests for Korean women and to distribute these guidelines to every clinician, eventually improving the quality of medical care. Since the establishment of the consensus guideline development committee, evidence-based guidelines have either been developed de novo considering specific Korean situations or by adaptation of preexisting consensus guidelines from other countries. Recommendations for cervical cancer screening tests, management of atypical squamous and glandular cells, and management of low-grade and high-grade squamous intraepithelial lesions were developed. Additionally, recommendations for human papillomavirus DNA testing and recommendations for adolescent and pregnant women with abnormal cervical screening test results were also included.
Adolescent ; Consensus ; DNA ; Female ; Hospitals, University ; Humans ; Mass Screening ; Pregnant Women ; Societies ; Uterine Cervical Neoplasms