1.Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset
Ki Hyeong LEE ; Byoung Chul CHO ; Myung-Ju AHN ; Yun-Gyoo LEE ; Youngjoo LEE ; Jong-Seok LEE ; Joo-Hang KIM ; Young Joo MIN ; Gyeong-Won LEE ; Sung Sook LEE ; Kyung-Hee LEE ; Yoon Ho KO ; Byoung Yong SHIM ; Sang-We KIM ; Sang Won SHIN ; Jin-Hyuk CHOI ; Dong-Wan KIM ; Eun Kyung CHO ; Keon Uk PARK ; Jin-Soo KIM ; Sang Hoon CHUN ; Jangyoung WANG ; SeokYoung CHOI ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(1):48-60
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.
2.The Effect of Tegoprazan on the Treatment of Endoscopic Resection-Induced Artificial Ulcers: A Multicenter, Randomized, Active-Controlled Study
Byung-Wook KIM ; Jong Jae PARK ; Hee Seok MOON ; Wan Sik LEE ; Ki-Nam SHIM ; Gwang Ho BAIK ; Yun Jeong LIM ; Hang Lak LEE ; Young Hoon YOUN ; Jun Chul PARK ; In-Kyung SUNG ; Hyunsoo CHUNG ; Jeong Seop MOON ; Gwang Ha KIM ; Su Jin HONG ; Hyuk Soon CHOI
Gut and Liver 2024;18(2):257-264
Background/Aims:
Tegoprazan is a novel potassium-competitive acid blocker that has beneficial effects on acid-related disorders such as gastroesophageal reflux and peptic ulcer diseases.This study aimed to validate the effect of tegoprazan on endoscopic submucosal dissection (ESD)-induced artificial ulcers.
Methods:
Patients from 16 centers in Korea who underwent ESD for gastric neoplasia were enrolled. After ESD, pantoprazole was administered intravenously for 48 hours. The patients were randomly allocated to either the tegoprazan or esomeprazole group. Tegoprazan 50 mg or esomeprazole 40 mg were administered for 4 weeks, after which gastroscopic evaluation was performed. If the artificial ulcer had not healed, the same dose of tegoprazan or esomeprazole was administered for an additional 4 weeks, and a gastroscopic evaluation was performed.
Results:
One hundred sixty patients were enrolled in this study. The healing rates of artificial ulcers at 4 weeks were 30.3% (23/76) and 22.1% (15/68) in the tegoprazan and esomeprazole groups, respectively (p=0.006). At 8 weeks after ESD, the cumulative ulcer healing rates were 73.7% (56/76) and 77.9% (53/68) in the tegoprazan and esomeprazole groups, respectively (p=0.210). Delayed bleeding occurred in two patients in the tegoprazan group (2.6%) and in one patient in the esomeprazole group (1.5%). Other adverse events were negligible in both groups.
Conclusions
Tegoprazan showed similar effects on post-ESD artificial ulcer healing in comparison with esomeprazole.
3.Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial
Yoon Jin CHOI ; Yong Chan LEE ; Jung Mogg KIM ; Jin Il KIM ; Jeong Seop MOON ; Yun Jeong LIM ; Gwang Ho BAIK ; Byoung Kwan SON ; Hang Lak LEE ; Kyoung Oh KIM ; Nayoung KIM ; Kwang Hyun KO ; Hye-Kyung JUNG ; Ki-Nam SHIM ; Hoon Jai CHUN ; Byung-Wook KIM ; Hyuk LEE ; Jie-Hyun KIM ; Hyunsoo CHUNG ; Sang Gyun KIM ; Jae Young JANG
Gut and Liver 2022;16(4):535-546
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
4.Influences of Workplace Bullying, Social Support and Resilience on Retention Intention among Hospital Nurses: The Mediating Effect of Professional Quality of Life
Journal of Korean Clinical Nursing Research 2021;27(1):23-34
Purpose:
The purpose of this study is to examine the mediating effect of professional quality of life among hospital nurses in the effects of workplace bullying, social support and resilience on retention intention.
Methods:
A descriptive and cross-sectional study was conducted on 414 hospital nurses who worked for at least two months at a general hospital in the Seoul metropolitan area. The data were analyzed using IBM SPSS 23.0/AMOS 22.0 programs and employed reliability verification, descriptive statistics include frequency analysis, confirmatory factor analysis, structural equation modeling, and bootstrapping.
Results:
As a result of the study's structural modeling verification, workplace bullying had a negative effect, social support had a positive effect, resilience had a positive effect on professional quality of life, and professional quality of life had a positive effect on retention intention. Also, workplace bullying, social support, and resilience did not directly impact on retention intention. However, the professional quality of life had a complete mediating effect in the relationships between workplace bullying, social support, resilience and retention intention. The study results verified the mediating effect of professional quality of life affecting the retention intention.
Conclusion
In order to improve professional quality of life and retention intention, strategies to prevent workplace bullying and promote social support and resilience are needed.
5.Influences of Workplace Bullying, Social Support and Resilience on Retention Intention among Hospital Nurses: The Mediating Effect of Professional Quality of Life
Journal of Korean Clinical Nursing Research 2021;27(1):23-34
Purpose:
The purpose of this study is to examine the mediating effect of professional quality of life among hospital nurses in the effects of workplace bullying, social support and resilience on retention intention.
Methods:
A descriptive and cross-sectional study was conducted on 414 hospital nurses who worked for at least two months at a general hospital in the Seoul metropolitan area. The data were analyzed using IBM SPSS 23.0/AMOS 22.0 programs and employed reliability verification, descriptive statistics include frequency analysis, confirmatory factor analysis, structural equation modeling, and bootstrapping.
Results:
As a result of the study's structural modeling verification, workplace bullying had a negative effect, social support had a positive effect, resilience had a positive effect on professional quality of life, and professional quality of life had a positive effect on retention intention. Also, workplace bullying, social support, and resilience did not directly impact on retention intention. However, the professional quality of life had a complete mediating effect in the relationships between workplace bullying, social support, resilience and retention intention. The study results verified the mediating effect of professional quality of life affecting the retention intention.
Conclusion
In order to improve professional quality of life and retention intention, strategies to prevent workplace bullying and promote social support and resilience are needed.
6.Impact of Hospital Volume of Percutaneous Coronary Intervention (PCI) on In-Hospital Outcomes in Patients with Acute Myocardial Infarction: Based on the 2014 Cohort of the Korean Percutaneous Coronary Intervention (K-PCI) Registry
Byong-Kyu KIM ; Deuk-Young NAH ; Kang Un CHOI ; Jun-Ho BAE ; Moo-Yong RHEE ; Jae-Sik JANG ; Keon-Woong MOON ; Jun-Hee LEE ; Hee-Yeol KIM ; Seung-Ho KANG ; Woo hyuk SONG ; Seung Uk LEE ; Byung-Ju SHIM ; Hang jae CHUNG ; Min Su HYON
Korean Circulation Journal 2020;50(11):1026-1036
Background and Objectives:
The relationship between the hospital percutaneous coronary intervention (PCI) volumes and the in-hospital clinical outcomes of patients with acute myocardial infarction (AMI) remains the subject of debate. This study aimed to determine whether the in-hospital clinical outcomes of patients with AMI in Korea are significantly associated with hospital PCI volumes.
Methods:
We selected and analyzed 17,121 cases of AMI, that is, 8,839 cases of non-ST-segment elevation myocardial infarction and 8,282 cases of ST-segment elevation myocardial infarction, enrolled in the 2014 Korean percutaneous coronary intervention (K-PCI) registry. Patients were divided into 2 groups according to hospital annual PCI volume, that is, to a high-volume group (≥400/year) or a low-volume group (<400/year). Major adverse cardiovascular and cerebrovascular events (MACCEs) were defined as composites of death, cardiac death, non-fatal myocardial infarction (MI), stent thrombosis, stroke, and need for urgent PCI during index admission after PCI.
Results:
Rates of MACCE and non-fatal MI were higher in the low-volume group than in the high-volume group (MACCE: 10.9% vs. 8.6%, p=0.001; non-fatal MI: 4.8% vs. 2.6%, p=0.001, respectively). Multivariate regression analysis showed PCI volume did not independently predict MACCE.
Conclusions
Hospital PCI volume was not found to be an independent predictor of in-hospital clinical outcomes in patients with AMI included in the 2014 K-PCI registry.
7.Anesthesia-Related Neurally Mediated Syncope in the Perioperative Period: Two Case Reports
Jae Hang SHIM ; Hyung Joon PARK ; Chang Wook LEE ; Seong Ho PARK ; Yoon Hyuk HWANG ; Woo Jong SHIN ; Woo Jae JEON
Soonchunhyang Medical Science 2020;26(1):7-10
The following report describes the occurrence of severe hypotension and bradycardia in a healthy 50-year-old man following placement from supine to the beach chair position during general anesthesia for injured rotator cuff tendon repair, as well as the occurrence of micturition syncope in a 71-year-old man following postobstructive diuresis after combined spinal–epidural anesthesia for total knee replacement. Rapid decompression of the urinary bladder is associated with severe hypotension, bradycardia, and syncope. Neurally mediated syncope includes true vasovagal and situational syncope that can occur in association with various situations such as cough, micturition, postprandial state, and interscalene block. We report two cases of neurally mediated syncope (true vasovagal and situational) that occurred in different conditions and were controlled well with prompt and proper management without serious complications.
8.Sufficient explanation of management affects patient satisfaction and the practice of post-treatment management in spinal pain, a multicenter study of 1007 patients.
Jae Yun KIM ; Jae Hang SHIM ; Sung Jun HONG ; Jong Yeun YANG ; Hey Ran CHOI ; Yun Hee LIM ; Ho Sik MOON ; Jaemoon LEE ; Jae Hun KIM
The Korean Journal of Pain 2017;30(2):116-125
BACKGROUND: Spinal pain is most common symptom in pain clinic. In most cases, before the treatment of spinal pain, physician explains the patient's disease and treatment. We investigated patient's satisfaction and physician's explanation related to treatments in spinal pain patients by questionnaires. METHODS: Anonymous questionnaires about physician's explanation and patient's satisfaction in each treatment and post-treatment management were asked to individuals suffering from spinal pain. Patients who have spinal pain were participated in our survey of nationwide university hospitals in Korea. The relationships between patient's satisfaction and other factors were analyzed. RESULTS: Between June 2016 and August 2016, 1007 patients in 37 university hospitals completed the questionnaire. In the statistical analysis, patient's satisfaction of treatment increased when pain severity was low or received sufficient preceding explanation about nerve block and medication (P < 0.01). Sufficient explanation increased patient's necessity of a post-treatment management and patients' performance rate of post-treatment management (P < 0.01). CONCLUSIONS: These results show that sufficient explanation increased patients' satisfaction after nerve block and medication. Sufficient explanation also increased the practice of patients' post-treatment management.
Anonyms and Pseudonyms
;
Hospitals, University
;
Humans
;
Korea
;
Nerve Block
;
Pain Clinics
;
Patient Satisfaction*
9.A Nationwide Retrospective Study of Opioid Management Patterns in 2,468 Patients with Spinal Pain in Korea.
Sung Soo CHUNG ; Chun Kun PARK ; Kyu Jung CHO ; Kyoung Hyo CHOI ; Jin Hyok KIM ; Sung Bum KIM ; Sung Uk KUH ; Jae Chul LEE ; Jae Hyup LEE ; Kyu Yeol LEE ; Sun Ho LEE ; Seong Hwan MOON ; Si Young PARK ; Jae Hang SHIM ; Byung Chul SON ; Myung Ha YOON ; Hye Jeong PARK
Asian Spine Journal 2016;10(6):1122-1131
STUDY DESIGN: Retrospective patient data collection and investigator survey. PURPOSE: To investigate patterns of opioid treatment for pain caused by spinal disorders in Korea. OVERVIEW OF LITERATURE: Opioid analgesic prescription and adequacy of consumption measures in Korea have markedly increased in the past decade, suggesting changing patterns in pain management practice; however, there is lack of integrated data specific to Korean population. METHODS: Patient data were collected from medical records at 34 university hospitals in Korea. Outpatients receiving opioids for pain caused by spinal disorders were included in the study. Treatment patterns, including opioid types, doses, treatment duration, outcomes, and adverse drug reactions (ADRs), were evaluated. Investigators were interviewed on their perceptions of opioid use for spinal disorders. RESULTS: Among 2,468 analyzed cases, spinal stenosis (42.8%) was the most common presentation, followed by disc herniation (24.2%) and vertebral fracture (17.5%). In addition, a greater proportion of patients experienced severe pain (73.9%) rather than moderate (19.9%) or mild (0.7%) pain. Oxycodone (51.9%) and fentanyl (50.8%) were the most frequently prescribed opioids; most patients were prescribed relatively low doses. The median duration of opioid treatment was 84 days. Pain relief was superior in patients with longer treatment duration (≥2 months) or with nociceptive pain than in those with shorter treatment duration or with neuropathic or mixed-type pain. ADRs were observed in 8.6% of cases. According to the investigators' survey, "excellent analgesic effect" was a perceived advantage of opioids, while safety concerns were a disadvantage. CONCLUSIONS: Opioid usage patterns in patients with spinal disorders are in alignment with international guidelines for spinal pain management. Future prospective studies may address the suitability of opioids for spinal pain treatment by using appropriate objective measurement tools.
Analgesics, Opioid
;
Chronic Pain
;
Data Collection
;
Drug-Related Side Effects and Adverse Reactions
;
Fentanyl
;
Hospitals, University
;
Humans
;
Korea*
;
Medical Records
;
Nociceptive Pain
;
Outpatients
;
Oxycodone
;
Pain Management
;
Prescriptions
;
Prospective Studies
;
Research Personnel
;
Retrospective Studies*
;
Spinal Diseases
;
Spinal Stenosis
;
Spine
10.The Differences in Prevalence and Sociodemographic Characteristics of Irritable Bowel Syndrome According to Rome II and Rome III.
Dong Won PARK ; Oh Young LEE ; Sung Gon SHIM ; Dae Won JUN ; Kang Nyeong LEE ; Hye Young KIM ; Hang Lak LEE ; Byung Chul YOON ; Ho Soon CHOI
Journal of Neurogastroenterology and Motility 2010;16(2):186-193
BACKGROUND/AIMS: Irritable bowel syndrome (IBS) is one of the most frequently observed disorders by primary care and practitioners. The aim of this study was to estimate the prevalence of IBS using the Rome II and III criteria in the general Korean population and also to compare sociodemographic differences between subjects diagnosed by these criteria. METHODS: Telephone interview surveys were performed with a total of 1,009 individuals in Korea, 15 years of age or older. The questionnaire, based on the Rome II and III criteria, was validated. RESULTS: Among the 1,009 subjects, the prevalence of IBS was 8.0% under the Rome II criteria (81 subjects; 6.4%, male; 9.6%, female), and 9.0% (91 subjects; 7.0%, male; 11.0%, female) under the Rome III criteria. The accordance rate of Rome II and III was 73.5%. Both groups showed highest frequency in the age of 30s (13.9% vs. 15.3% respectively). Female subjects showed a higher prevalence than male subjects under Rome III (91 subjects; 11.0% in female, 7.0% in male; p < 0.05), but not under Rome II criteria. Many patients older than 50 years were added when analyzed under the Rome III criteria, but not under the Rome II criteria (p = 0.017). CONCLUSIONS: The Rome III criteria were less restrictive and showed good agreement with the Rome II criteria. The prevalence of IBS was increased in young women.
Female
;
Humans
;
Interviews as Topic
;
Irritable Bowel Syndrome
;
Korea
;
Male
;
Prevalence
;
Primary Health Care
;
Surveys and Questionnaires
;
Rome

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