1.Efficacy and Safety of Sirolimus-Eluting Stent With Biodegradable Polymer Ultimaster™ in Unselected Korean Population: A Multicenter, Prospective, Observational Study From Korean Multicenter Ultimaster Registry
Soohyung PARK ; Seung-Woon RHA ; Byoung Geol CHOI ; Jae-Bin SEO ; Ik Jun CHOI ; Sung-Il WOO ; Soo-Han KIM ; Tae Hoon AHN ; Jae Sang KIM ; Ae-Young HER ; Ji-Hun AHN ; Han Cheol LEE ; Jaewoong CHOI ; Jin Soo BYON ; Markz RMP SINURAT ; Se Yeon CHOI ; Jinah CHA ; Su Jin HYUN ; Cheol Ung CHOI ; Chang Gyu PARK
Korean Circulation Journal 2024;54(6):339-350
Background and Objectives:
Ultimaster™, a third-generation sirolimus-eluting stent using biodegradable polymer, has been introduced to overcome long term adverse vascular events, such as restenosis or stent thrombosis. In the present study, we aimed to evaluate the 12-month clinical outcomes of Ultimaster™ stents in Korean patients with coronary artery disease.
Methods:
This study is a multicenter, prospective, observational registry across 12 hospitals. To reflect real-world clinical evidence, non-selective subtypes of patients and lesions were included in this study. The study end point was target lesion failure (TLF) (the composite of cardiac death, target vessel myocardial infarction [MI], and target lesion revascularization [TLR]) at 12-month clinical follow up.
Results:
A total of 576 patients were enrolled between November 2016 and May 2021. Most of the patients were male (76.5%), with a mean age of 66.0±11.2 years. Among the included patients, 40.1% had diabetes mellitus (DM) and 67.9% had acute coronary syndrome (ACS).At 12 months, the incidence of TLF was 4.1%. The incidence of cardiac death was 1.5%, MI was 1.0%, TLR was 2.7%, and stent thrombosis was 0.6%. In subgroup analysis based on the presence of ACS, DM, hypertension, dyslipidemia, or bifurcation, there were no major differences in the incidence of the primary endpoint.
Conclusions
The present registry shows that Ultimaster™ stent is safe and effective for routine real-world clinical practice in non-selective Korean patients, having a low rate of adverse events at least up to 12 months.
2.A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial
Junsik PARK ; Myong Cheol LIM ; Jae-Kwan LEE ; Dae Hoon JEONG ; Se Ik KIM ; Min Chul CHOI ; Byoung-Gie KIM ; Jung-Yun LEE
Journal of Gynecologic Oncology 2022;33(2):e12-
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.
3.Optimal Adjuvant Treatment for Curatively Resected Thoracic Esophageal Squamous Cell Carcinoma: A Radiotherapy Perspective.
Kyung Hwan KIM ; Jee Suk CHANG ; Ji Hye CHA ; Ik Jae LEE ; Dae Joon KIM ; Byoung Chul CHO ; Kyung Ran PARK ; Chang Geol LEE
Cancer Research and Treatment 2017;49(1):168-177
PURPOSE: The purpose of this study was to evaluate the benefits of adjuvant treatment for curatively resected thoracic esophageal squamous cell carcinoma (ESCC) and determine the optimal adjuvant treatments. MATERIALS AND METHODS: One hundred ninety-five patients who underwent a curative resection for thoracic ESCC between 1994 and 2014 were reviewed retrospectively. Postoperatively, the patients received no adjuvant treatment (no-adjuvant group, n=68), adjuvant chemotherapy (AC group, n=62), radiotherapy (RT group, n=41), or chemoradiotherapy (CRT group, n=24). Chemotherapy comprised cisplatin and 5-fluorouracil administration every 3 weeks. The median RT dose was 45.0 Gy (range, 34.8 to 59.4 Gy). The overall survival (OS), disease-free survival (DFS), locoregional recurrence (LRR), and distant metastasis (DM) rates were estimated. RESULTS: At a median follow-up duration of 42.2 months (range, 6.3 to 215.2 months), the 5-year OS and DFS were 37.6% and 31.4%, respectively. After adjusting for other clinicopathologic variables, the AC and CRT groups had a significantly better OS and DFS compared to the no-adjuvant group (p < 0.05). The LRR rate was significantly lower in the RT and CRT groups than in the no-adjuvant group (p < 0.05), whereas no significant difference was observed in the AC group. In the no-adjuvant and AC groups, 25% of patients received high-dose salvage RT due to LRR. The DM rates were similar. The anastomotic stenosis and leakage were similar in the treatment groups. CONCLUSION: Adjuvant treatment might prolong survival after an ESCC resection, and RT contributes to a reduction of the LRR. Overall, the risks and benefits should be weighed properly when selecting the optimal adjuvant treatment.
Carcinoma, Squamous Cell*
;
Chemoradiotherapy
;
Chemotherapy, Adjuvant
;
Cisplatin
;
Constriction, Pathologic
;
Disease-Free Survival
;
Drug Therapy
;
Epithelial Cells*
;
Esophageal Neoplasms
;
Fluorouracil
;
Follow-Up Studies
;
Humans
;
Neoplasm Metastasis
;
Radiotherapy*
;
Recurrence
;
Retrospective Studies
;
Risk Assessment
4.The direction of restructuring of a Korea field epidemiology training program through questionnaire survey among communicable disease response staff in Korea.
Moo Sik LEE ; Kwan LEE ; Ji Hyuk PARK ; Jee Young HONG ; Min Young JANG ; Byoung Hak JEON ; Sang Yun CHO ; Sun Ja CHOI ; Jeong Ik HONG
Epidemiology and Health 2017;39(1):e2017032-
We used a survey about the need for an educational training of infectious disease response staff in Korea Centers for Disease Control and Prevention (KCDC) and officer in metropolitan cities and provincial government to conduct field epidemiological investigation. The survey was conducted from January 25 to March 15, 2016. A total of 173 participants were selected from four different groups as follows: 27 clinical specialists, 22 Epidemic Intelligence Service (EIS) officers, 82 KCDC staff, and 42 local health department officials. Results revealed that 83% of KCDC staff and 95% of local health department officials agreed on the need for educational training to strengthen capability of personnel to conduct epidemic research and investigation. The level of their need for training was relatively high, while self-confidence levels of individuals to conduct epidemic research and investigation was low. It was concluded that there was a need to develop training programs to enhance the ability of public health officials, EIS officers, KCDC staff, and local health department personnel to conduct epidemic research and investigation.
Centers for Disease Control and Prevention (U.S.)
;
Communicable Diseases*
;
Education*
;
Epidemiology*
;
Intelligence
;
Korea*
;
Public Health
;
Specialization
;
State Government
;
Surveys and Questionnaires
5.The direction of restructuring of a Korea field epidemiology training program through questionnaire survey among communicable disease response staff in Korea
Moo Sik LEE ; Kwan LEE ; Ji Hyuk PARK ; Jee Young HONG ; Min Young JANG ; Byoung Hak JEON ; Sang Yun CHO ; Sun Ja CHOI ; Jeong Ik HONG
Epidemiology and Health 2017;39(1):2017032-
We used a survey about the need for an educational training of infectious disease response staff in Korea Centers for Disease Control and Prevention (KCDC) and officer in metropolitan cities and provincial government to conduct field epidemiological investigation. The survey was conducted from January 25 to March 15, 2016. A total of 173 participants were selected from four different groups as follows: 27 clinical specialists, 22 Epidemic Intelligence Service (EIS) officers, 82 KCDC staff, and 42 local health department officials. Results revealed that 83% of KCDC staff and 95% of local health department officials agreed on the need for educational training to strengthen capability of personnel to conduct epidemic research and investigation. The level of their need for training was relatively high, while self-confidence levels of individuals to conduct epidemic research and investigation was low. It was concluded that there was a need to develop training programs to enhance the ability of public health officials, EIS officers, KCDC staff, and local health department personnel to conduct epidemic research and investigation.
Centers for Disease Control and Prevention (U.S.)
;
Communicable Diseases
;
Education
;
Epidemiology
;
Intelligence
;
Korea
;
Public Health
;
Specialization
;
State Government
;
Surveys and Questionnaires
6.A1c Variability Can Predict Coronary Artery Disease in Patients with Type 2 Diabetes with Mean A1c Levels Greater than 7.
Eun Ju LEE ; You Jeong KIM ; Tae Nyun KIM ; Tae Ik KIM ; Won Kee LEE ; Mi Kyung KIM ; Jeong Hyun PARK ; Byoung Doo RHEE
Endocrinology and Metabolism 2013;28(2):125-132
BACKGROUND: Recent studies suggested that the association of acute glucose variability and diabetic complications was not consistent, and that A1c variability representing long term glucose fluctuation may be related to coronary atherosclerosis in patients with type 1 diabetes. In this study, we attempt to determine whether or not A1c variability can predict coronary artery disease (CAD) in patients with type 2 diabetes. METHODS: We reviewed data of patients with type 2 diabetes who had undergone coronary angiography (CAG) and had been followed up with for 5 years. The intrapersonal standard deviation (SD) of serially-measured A1c levels adjusted by the different number of assessments among patients (adj-A1c-SD) was considered to be a measure of the variability of A1c. RESULTS: Among the 269 patients, 121 of them had type 2 diabetes with CAD. In patients with A1c > or =7%, the mean A1c levels and A1c levels at the time of CAG among the three groups were significantly different. The ratio of patients with CAD was the highest in the high adj-A1c-SD group and the lowest in the low adj-A1c-SD group (P=0.017). In multiple regression analysis, adj-A1c-SD was an independent predictor for CAD in subjects with A1c > or =7% (odds ratio, 2.140; P=0.036). CONCLUSION: Patients with higher A1c variability for several years showed higher mean A1c levels. A1c variability can be an independent predictor for CAD as seen in angiographs of patients with type 2 diabetes with mean A1c levels over 7%.
Coronary Angiography
;
Coronary Artery Disease
;
Coronary Vessels
;
Diabetes Complications
;
Diabetes Mellitus, Type 2
;
Glucose
;
Humans
7.Effects of Menopausal Hormone Therapy on Uterine Myoma in Menopausal Women.
Ik Jin CHANG ; Gi Youn HONG ; Young Lim OH ; Byoung Ryun KIM ; Seong Nam PARK ; Hae Hyeog LEE ; Yong Jin NA ; Jeong NAMKUNG
Journal of Menopausal Medicine 2013;19(3):123-129
OBJECTIVES: The aim of the present study is to evaluate the long term effects of estrogen-progestogen therapy (EPT) on uterine myomas volume in postmenopausal women. METHODS: We performed a retrospective analysis on postmenopausal women with asymptomatic uterine myoma during the period between April, 2008 and September, 2012. Postmenopause was defined as amenorrhea for longer than a year or serum follicle stimulating hormone levels higher than 40 IU/L. The volume of the myoma was assessed by transvaginal ultrasonography for every 6 months after administration of EPT. RESULTS: Thirty-eight women were included in the study, with 32 in the EPT group and 6 in the control group. Overall, uterine myoma volume (mean +/- standard deviation, cm3) in the EPT group was 19.5 +/- 24.6 at baseline, and those at 6 and 12 months were 24.7 +/- 35.1 and 28.5 +/- 56.4, respectively. Myoma volume did not change significantly with EPT, and these changes were not significantly different from the control group. Myoma volume changes were not significantly different in the subgroups according to the route of estrogen administrations and the method of progestogen administrations. Clinically significant volume increases during one year of EPT was noted in 28.1% (9/32), however, only one showed transient increases. CONCLUSION: Our results suggest that treating postmenopausal woman with EPT on a long-term basis does not increase the volume of uterine myomas.
Amenorrhea
;
Estrogens
;
Female
;
Follicle Stimulating Hormone
;
Humans
;
Leiomyoma*
;
Methods
;
Myoma
;
Postmenopause
;
Progesterone
;
Retrospective Studies
;
Ultrasonography
;
Uterus
8.In vitro induction of anterior gradient-2-specific cytotoxic T lymphocytes by dendritic cells transduced with recombinant adenoviruses as a potential therapy for colorectal cancer.
Hyun Ju LEE ; Cheol Yi HONG ; Mi Hyun KIM ; Youn Kyung LEE ; Thanh Nhan NGUYEN-PHAM ; Byoung Chul PARK ; Deok Hwan YANG ; Ik Joo CHUNG ; Hyeoung Joon KIM ; Je Jung LEE
Experimental & Molecular Medicine 2012;44(1):60-67
Anterior gradient-2 (AGR2) promotes tumor growth, cell migration, and cellular transformation, and is one of the specific mRNA markers for circulating tumor cells in patients with gastrointestinal cancer. We investigated the feasibility of AGR2 as a potent antigen for tumor immunotherapy against colorectal cancer (CRC) cells using dendritic cells (DCs) transduced with a recombinant adenovirus harboring the AGR2 gene (AdAGR2). DCs transduced with a recombinant adenovirus encoding the AGR2 gene (AdAGR2/DCs) were characterized. These genetically-modified DCs expressed AGR2 mRNA as well as AGR2 protein at a multiplicity of infection of 1,000 without any significant alterations in DC viability and cytokine secretion (IL-10 and IL-12p70) compared with unmodified DCs as a control. In addition, AdAGR2 transduction did not impair DC maturation, but enhanced expression of HLA-DR, CD80, and CD86. AdAGR2/DCs augmented the number of IFN-gamma-secreting T-cells and elicited potent AGR2-specific cytotoxic T lymphocytes capable of lysing AGR2-expressing CRC cell lines. These results suggest that AGR2 act as a potentially important antigen for immunotherapy against CRC in clinical applications.
Adenoviridae
;
Antigen Presentation/genetics
;
Antigens, Neoplasm/immunology
;
Carcinoma/*therapy
;
Cell Line, Tumor
;
Colorectal Neoplasms/*therapy
;
Cytotoxicity, Immunologic/genetics
;
Dendritic Cells/immunology
;
Humans
;
*Immunotherapy, Adoptive
;
Interferon-gamma/secretion
;
Lymphocyte Activation/genetics
;
Proteins/genetics/*metabolism
;
T-Lymphocytes, Cytotoxic/*immunology
;
Transduction, Genetic
;
Transgenes/genetics
;
Tumor Markers, Biological/immunology
9.Durability of a sustained virological response in chronic hepatitis C patients treated with pegylated interferon alfa and ribavirin.
Sang Bun CHOI ; Youn Jae LEE ; Jae Ik LEE ; Young Jin SONG ; Byoung Jin CHOI ; Jong Han KIM ; Eun Uk JUNG ; Sung Jae PARK ; Sang Heon LEE ; Ji Hyun KIM ; Jung Sik CHOI ; Sam Ryong JEE ; Sang Yong SEOL
The Korean Journal of Hepatology 2011;17(3):183-188
BACKGROUND/AIMS: The reappearance rates of hepatitis C virus (HCV) RNA after a sustained virological response (SVR) have been reported to be 1-2%. We investigated the reappearance rate of HCV RNA after SVR in chronic hepatitis C (CHC) patients treated with pegylated interferon (PEG-IFN) and ribavirin. METHODS: In total, 292 CHC patients who achieved an SVR after PEG-IFN and ribavirin treatment were included. They were treated with subcutaneous injections of either PEG-IFN-alpha 2a or 2b plus ribavirin orally. Liver function tests and qualitative HCV RNA assays were performed every 6 months during the follow-up period after an SVR. RESULTS: Among the 292 patients, 224 (genotype 1, 92; genotype non-1, 132) were followed up for more than 6 months after SVR. These 224 patients were aged 48.1+/-11.5 years (mean+/-SD), and 129 of them were male. The median follow-up duration was 18 months (range 6-60 months). The reappearance rate of HCV RNA during follow-up was 0%. Two patients who achieved an SVR developed hepatocellular carcinoma during the follow-up period. CONCLUSIONS: An SVR was maintained in all CHC patients treated with PEG-IFN plus ribavirin during a median follow-up of 18 months. However, a screening test for hepatocellular carcinoma is needed for patients with an SVR.
Adult
;
Antiviral Agents/*therapeutic use
;
Drug Therapy, Combination
;
Female
;
Follow-Up Studies
;
Genotype
;
Hepatitis C, Chronic/*drug therapy
;
Humans
;
Interferon-alpha/*therapeutic use
;
Liver Function Tests
;
Male
;
Middle Aged
;
Polyethylene Glycols/*therapeutic use
;
RNA, Viral/analysis
;
Recombinant Proteins/therapeutic use
;
Ribavirin/*therapeutic use
10.Enhancement of antitumor effect using dendritic cells activated with natural killer cells in the presence of Toll-like receptor agonist.
Thanh Nhan Nguyen PHAM ; Cheol Yi HONG ; Jung Joon MIN ; Joon Haeng RHEE ; Truc Anh Thi NGUYEN ; Byoung Chul PARK ; Deok Hwan YANG ; Young Kyu PARK ; Hyeong Rok KIM ; Ik Joo CHUNG ; Hyeoung Joon KIM ; Je Jung LEE
Experimental & Molecular Medicine 2010;42(6):407-419
Dendritic cells (DCs) play a role in natural killer (NK) cell activation, while NK cells are also able to activate and mature DCs. Toll-like receptors (TLRs) on the surface of DCs and NK cells induce the maturation and activation of these cells when engaged with their cognate ligand. We investigated to generate potent DCs by maturation with NK cells in the presence of TLR agonist in vitro and tested the efficacy of these DC vaccinations in mouse colon cancer model. The optimal ratios of DCs versus NK cells were 1:1 to 1:2. Immature DCs were mature with NK cells in the presence of lipopolysaccharide, which is TLR4 agonist, and further addition of IL-2 induced phenotypically and functionally mature bone marrow-derived DCs. These potent DCs exhibited not only high expression of several costimulatory molecules and high production of IL-12p40 and IL-12p70, but also high allogeneic T cells stimulatory capacity, and the induction of the high activities to generate tumor-specific CTLs. Consistently, vaccination with these DCs efficiently inhibited CT-26 tumor growth in mouse colon cancer model when compared to other vaccination strategies. Interestingly, combination therapy of these DC-based vaccines and with low-dose cyclophosphamide showed dramatic inhibition effects of tumor growth. These results suggest that the DCs maturated with NK cells in the presence of TLR agonist are potent inducer of antitumor immune responses in mouse model and may provide a new source of DC-based vaccines for the development of immunotherapy against colon cancer.
Animals
;
Cancer Vaccines/immunology/metabolism
;
Carcinoma/immunology/pathology/*therapy
;
Cell Line, Tumor
;
Cells, Cultured
;
Colonic Neoplasms/immunology/pathology/*therapy
;
Dendritic Cells/*drug effects/*immunology/transplantation
;
Female
;
Immunotherapy, Adoptive/*methods
;
Killer Cells, Natural/*immunology/physiology
;
Lipopolysaccharides/pharmacology
;
Mice
;
Mice, Inbred BALB C
;
Toll-Like Receptor 4/agonists
;
Toll-Like Receptors/*agonists

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