1.Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer: A Randomized Phase II Trial
Sung Hee LIM ; Jina YUN ; Min-Young LEE ; Han Jo KIM ; Kyoung Ha KIM ; Se Hyung KIM ; Sang-Chul LEE ; Sang Byung BAE ; Chan Kyu KIM ; Namsu LEE ; Kyu Taek LEE ; Seong Kyu PARK ; Yun Nah LEE ; Jong Ho MOON
Yonsei Medical Journal 2021;62(8):671-678
Purpose:
Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer.
Materials and Methods:
Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m2 and oxaliplatin 50 mg/m2 on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m2 on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR).
Results:
Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82–27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34–12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%).
Conclusion
The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.
2.Outcomes after liver transplantation in Korea: Incidence and risk factors from Korean transplantation registry
Jong Man KIM ; Deok Gie KIM ; Jihyun KIM ; Keunsung LEE ; Kwang-Woong LEE ; Je Ho RYU ; Bong-Wan KIM ; Dong Lak CHOI ; Young Kyoung YOU ; Dong-Sik KIM ; Yang Won NAH ; Koo Jeong KANG ; Jai Young CHO ; Geun HONG ; Hee Chul YU ; Ju Ik MOON ; Dongho CHOI ; Shin HWANG ; Myoung Soo KIM
Clinical and Molecular Hepatology 2021;27(3):451-462
Background/Aims:
To analyze the incidence and risk factors of outcomes after liver transplantation (LT) in the Korean population.
Methods:
This study analyzed data from the liver cohort of Korean Organ Transplantation Registry (KOTRY) who had LT between May 2014 and December 2017. Study measures included the incidence of post-LT outcomes in recipients of living donor LT (LDLT) and deceased donor LT (DDLT). Cox multivariate proportional hazards model was used to determine the potential risk factors predicting the outcomes.
Results:
A total of 2,563 adult recipients with LT (LDLT, n=1,956; DDLT, n=607) were included, with mean±standard deviation age of 53.9±8.9 years, and 72.2% were male. The post-LT outcomes observed in each LDLT and DDLT recipients were death (4.0% and 14.7%), graft loss (5.0% and 16.1%), rejection (7.0% and 12.0%), renal failure (2.7% and 13.8%), new onset of diabetes (12.5% and 15.4%), and hepatocellular carcinoma (HCC) recurrence (both 6.7%). In both LDLT and DDLT recipients, the most common post-LT complications were renal dysfunction (33.6% and 51.4%), infection (26.7% and 48.4%), and surgical complication (22.5% and 23.9%). Incidence of these outcomes were generally higher among recipients of DDLT than LDLT. Multivariate analysis indicated recipient age and DDLT as significant risk factors associated with death and graft loss. DDLT and ABO incompatible transplant were prognostic factors for rejection, and HCC beyond Milan criteria at pre-transplant was a strong predictor of HCC recurrence.
Conclusions
This study is a good indicator of the post-LT prognosis in the Korean population and suggests a significant burden of post-LT complications.
3.Outcomes after liver transplantation in Korea: Incidence and risk factors from Korean transplantation registry
Jong Man KIM ; Deok Gie KIM ; Jihyun KIM ; Keunsung LEE ; Kwang-Woong LEE ; Je Ho RYU ; Bong-Wan KIM ; Dong Lak CHOI ; Young Kyoung YOU ; Dong-Sik KIM ; Yang Won NAH ; Koo Jeong KANG ; Jai Young CHO ; Geun HONG ; Hee Chul YU ; Ju Ik MOON ; Dongho CHOI ; Shin HWANG ; Myoung Soo KIM
Clinical and Molecular Hepatology 2021;27(3):451-462
Background/Aims:
To analyze the incidence and risk factors of outcomes after liver transplantation (LT) in the Korean population.
Methods:
This study analyzed data from the liver cohort of Korean Organ Transplantation Registry (KOTRY) who had LT between May 2014 and December 2017. Study measures included the incidence of post-LT outcomes in recipients of living donor LT (LDLT) and deceased donor LT (DDLT). Cox multivariate proportional hazards model was used to determine the potential risk factors predicting the outcomes.
Results:
A total of 2,563 adult recipients with LT (LDLT, n=1,956; DDLT, n=607) were included, with mean±standard deviation age of 53.9±8.9 years, and 72.2% were male. The post-LT outcomes observed in each LDLT and DDLT recipients were death (4.0% and 14.7%), graft loss (5.0% and 16.1%), rejection (7.0% and 12.0%), renal failure (2.7% and 13.8%), new onset of diabetes (12.5% and 15.4%), and hepatocellular carcinoma (HCC) recurrence (both 6.7%). In both LDLT and DDLT recipients, the most common post-LT complications were renal dysfunction (33.6% and 51.4%), infection (26.7% and 48.4%), and surgical complication (22.5% and 23.9%). Incidence of these outcomes were generally higher among recipients of DDLT than LDLT. Multivariate analysis indicated recipient age and DDLT as significant risk factors associated with death and graft loss. DDLT and ABO incompatible transplant were prognostic factors for rejection, and HCC beyond Milan criteria at pre-transplant was a strong predictor of HCC recurrence.
Conclusions
This study is a good indicator of the post-LT prognosis in the Korean population and suggests a significant burden of post-LT complications.
4.Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer: A Randomized Phase II Trial
Sung Hee LIM ; Jina YUN ; Min-Young LEE ; Han Jo KIM ; Kyoung Ha KIM ; Se Hyung KIM ; Sang-Chul LEE ; Sang Byung BAE ; Chan Kyu KIM ; Namsu LEE ; Kyu Taek LEE ; Seong Kyu PARK ; Yun Nah LEE ; Jong Ho MOON
Yonsei Medical Journal 2021;62(8):671-678
Purpose:
Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer.
Materials and Methods:
Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m2 and oxaliplatin 50 mg/m2 on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m2 on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR).
Results:
Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82–27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34–12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%).
Conclusion
The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.
5.Hepatitis B Prophylaxis after Liver Transplantation in Korea: Analysis of the KOTRY Database
Gil Chun PARK ; Shin HWANG ; Myoung Soo KIM ; Dong Hwan JUNG ; Gi Won SONG ; Kwang Woong LEE ; Jong Man KIM ; Jae Geun LEE ; Je Ho RYU ; Dong Lak CHOI ; Hee Jung WANG ; Bong Wan KIM ; Dong Sik KIM ; Yang Won NAH ; Young Kyoung YOU ; Koo Jeong KANG ; Hee Chul YU ; Yo Han PARK ; Kyung Jin LEE ; Yun Kyu KIM
Journal of Korean Medical Science 2020;35(6):36-
BACKGROUND: Prophylaxis for hepatitis B virus (HBV) recurrence is essential after liver transplantation (LT) in HBV-associated recipients. We conducted real-world analysis of HBV prophylaxis after LT in the Korean population.METHODS: Korean Organ Transplantation Registry (KOTRY) database and additionally collected data (n = 326) were analyzed with special reference to types of HBV prophylaxis.RESULTS: The study cohort comprised 267 cases of living-donor LT and 59 cases of deceased-donor LT. Hepatocellular carcinoma (HCC) was diagnosed in 232 (71.2%) of these subjects. Antiviral agents were used in 255 patients (78.2%) prior to LT. HBV DNA was undetectable in 69 cases (21.2%) and detectable over wide concentrations in the other 257 patients (78.8%) prior to LT. Polymerase chain reaction analysis of the store blood samples detected HBV DNA in all patients, with 159 patients (48.9%) showing concentrations > 100 IU/mL. Post-transplant HBV regimens during the first year included combination therapy in 196 (60.1%), hepatitis B immunoglobulin (HBIG) monotherapy in 121 (37.1%), and antiviral monotherapy in 9 (2.8%). In the second post-transplant year, these regimens had changed to combination therapy in 187 (57.4%), HBIG monotherapy in 112 (34.4%), and antiviral monotherapy in 27 (8.3%). Trough antibody to hepatitis B surface antigen titers > 500 IU/mL and >1,000 IU/mL were observed in 61.7% and 25.2%, respectively. The mean simulative half-life of HBIG was 21.6 ± 4.3 days with a median 17.7 days. Up to 2-year follow-up period, HCC recurrence and HBV recurrence developed in 18 (5.5%) and 6 (1.8%), respectively. HCC recurrence developed in 3 of 6 patients with HBV recurrence.CONCLUSION: Combination therapy is the mainstay of HBV prophylaxis protocols in a majority of Korean LT centers, but HBIG was often administered excessively. Individualized optimization of HBIG treatments using SHL is necessary to adjust the HBIG infusion interval.
Antiviral Agents
;
Carcinoma, Hepatocellular
;
Cohort Studies
;
DNA
;
Follow-Up Studies
;
Half-Life
;
Hepatitis B Surface Antigens
;
Hepatitis B virus
;
Hepatitis B
;
Hepatitis
;
Humans
;
Immunoglobulins
;
Korea
;
Liver Transplantation
;
Liver
;
Organ Transplantation
;
Polymerase Chain Reaction
;
Recurrence
;
Transplants
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.Hepatitis B Prophylaxis after Liver Transplantation in Korea: Analysis of the KOTRY Database
Gil Chun PARK ; Shin HWANG ; Myoung Soo KIM ; Dong Hwan JUNG ; Gi Won SONG ; Kwang Woong LEE ; Jong Man KIM ; Jae Geun LEE ; Je Ho RYU ; Dong Lak CHOI ; Hee Jung WANG ; Bong Wan KIM ; Dong Sik KIM ; Yang Won NAH ; Young Kyoung YOU ; Koo Jeong KANG ; Hee Chul YU ; Yo Han PARK ; Kyung Jin LEE ; Yun Kyu KIM
Journal of Korean Medical Science 2020;35(6):e36-
BACKGROUND:
Prophylaxis for hepatitis B virus (HBV) recurrence is essential after liver transplantation (LT) in HBV-associated recipients. We conducted real-world analysis of HBV prophylaxis after LT in the Korean population.
METHODS:
Korean Organ Transplantation Registry (KOTRY) database and additionally collected data (n = 326) were analyzed with special reference to types of HBV prophylaxis.
RESULTS:
The study cohort comprised 267 cases of living-donor LT and 59 cases of deceased-donor LT. Hepatocellular carcinoma (HCC) was diagnosed in 232 (71.2%) of these subjects. Antiviral agents were used in 255 patients (78.2%) prior to LT. HBV DNA was undetectable in 69 cases (21.2%) and detectable over wide concentrations in the other 257 patients (78.8%) prior to LT. Polymerase chain reaction analysis of the store blood samples detected HBV DNA in all patients, with 159 patients (48.9%) showing concentrations > 100 IU/mL. Post-transplant HBV regimens during the first year included combination therapy in 196 (60.1%), hepatitis B immunoglobulin (HBIG) monotherapy in 121 (37.1%), and antiviral monotherapy in 9 (2.8%). In the second post-transplant year, these regimens had changed to combination therapy in 187 (57.4%), HBIG monotherapy in 112 (34.4%), and antiviral monotherapy in 27 (8.3%). Trough antibody to hepatitis B surface antigen titers > 500 IU/mL and >1,000 IU/mL were observed in 61.7% and 25.2%, respectively. The mean simulative half-life of HBIG was 21.6 ± 4.3 days with a median 17.7 days. Up to 2-year follow-up period, HCC recurrence and HBV recurrence developed in 18 (5.5%) and 6 (1.8%), respectively. HCC recurrence developed in 3 of 6 patients with HBV recurrence.
CONCLUSION
Combination therapy is the mainstay of HBV prophylaxis protocols in a majority of Korean LT centers, but HBIG was often administered excessively. Individualized optimization of HBIG treatments using SHL is necessary to adjust the HBIG infusion interval.
8.The Multi-Institutional Health Screening Records Database of South Korea: Description and Evaluation of Its Characteristics
Yunha NOH ; Han Eol JEONG ; Hye Jun KIM ; Hanju KO ; Eun Hee NAH ; Ju Young SHIN
Yonsei Medical Journal 2019;60(12):1216-1222
This study sought to describe and to evaluate the characteristics of the Health Screening Records Database (HSRD) of the Korea Association of Health Promotion as a data source for epidemiologic studies. The HSRD was compared to a National Health Insurance Service-Health Screening Cohort (NHIS-HEALS) database for 2015. Common variables between the databases were selected, and sex-based analyses were conducted. The HSRD showed statistical concordance when NHIS-HEALS estimates fell within the HSRD estimate's 95% confidence interval. The HSRD and NHIS-HEALS included 946461 and 111690 participants in health screening programs, respectively. Compared to the NHIS-HEALS, the HSRD had more female (55.2% vs. 42.6%) but fewer older adult participants (34.4% vs. 51.2%). Virtually all variables had clinical concordance, with some having statistical concordance as well, among both general and life-transition program participants. The HSRD comprised more clinical information over a wider age range in contrast to the NHIS-HEALS, while showing clinical concordance. Providing more comprehensive clinical data, the HSRD may serve as an alternative resource for epidemiologic studies.
Adult
;
Cohort Studies
;
Epidemiologic Studies
;
Female
;
Health Promotion
;
Humans
;
Information Storage and Retrieval
;
Korea
;
Mass Screening
;
National Health Programs
;
Observational Study
;
Physical Examination
9.Developmental Trajectories of Attention in Normal Korean Population
Han Nah HUH ; Sung Hee KANG ; Soon Young HWANG ; Hanik K YOO
Journal of the Korean Academy of Child and Adolescent Psychiatry 2019;30(2):66-73
OBJECTIVES: This study aimed to investigate the trajectory of change of diverse attention and working memory in Koreans from 4 to 40 years of age. METHODS: The data of 912 subjects from 4 to 15 years of age obtained from a previous standardization study of the computerized comprehensive attention test were merged with the newly obtained data of 150 subjects aged 16 to 40 years from this study. We evaluated the various kinds of attention, in which each subtest had five indicators. Working memory, with parameters such as number of correct responses and span, was also measured. RESULTS: Our findings indicated that attention developed as age increased, and it decreased or was maintained after a certain age. Selective and sustained attention developed rapidly in children and adolescents, until mid-teens or 20 s when it ceased development. Divided attention, however, developed up to approximately age 20. In addition, working memory developed until mid-teens or 20 s. CONCLUSION: We presented the standardized data on diverse kinds of attention and working memory in children, adolescents, and adults in Korea. We could recognize any patterns of change in attention and working memory with increasing age.
Adolescent
;
Adult
;
Child
;
Humans
;
Korea
;
Memory, Short-Term
;
Neuropsychological Tests
10.Suggestion of Learning Objectives in Social Dental Hygiene: Oral Health Administration Area.
Su Kyung PARK ; Ga Yeong LEE ; Young Eun JANG ; Sang Hee YOO ; Yeun Ju KIM ; Sue Hyang LEE ; Han Nah KIM ; Hye Won JO ; Myoung Hee KIM ; Hee Kyoung KIM ; Da Young RYU ; Min Ji KIM ; Sun Jung SHIN ; Nam Hee KIM ; Mi Sook YOON
Journal of Dental Hygiene Science 2018;18(2):85-96
The purpose of this study is to propose learning objectives in social dental hygiene by analyzing and reviewing learning objectives in oral health administration area of the existing public oral health. This study is a cross-sectional study. The subjects of the study selected with convenience extraction were 15 members of the social dental hygiene subcommittee of the Korean Society of Dental Hygiene Science. Data collection was conducted by self-filling questionnaire. The research tool is from 48 items of A division in the book of learning objectives in the dental hygienist national examination, and this study classified each of them into ‘dental hygiene job relevance’, ‘dental hygiene competency relevance’, ‘timeliness’, and ‘value discrimination of educational goal setting’ to comprise 192 items. Also, to collect expert opinions, this study conducted Delphi survey on 7 academic experts. Statistical analysis was performed using the IBM SPSS Statistics ver. 23.0 program (IBM Co., Armonk, NY, USA). Recoding was performed according to the degree of relevance of each learning objective and frequency analysis was performed. This study removed 18 items from the whole learning objectives in the dental hygienist national examination in the oral health administration area of public oral health. Fifteen revisions were made and 15 existing learning objectives were maintained. Forty-five learning objectives were proposed as new social dental hygiene learning objectives. The topics of learning objectives are divided into social security and medical assistance, oral health care system, oral health administration, and oral health policy. As a result of this study, it was necessary to construct the learning objectives of social dental hygiene in response to changing situation at the time. The contents of education should be revised in order of revision of learning objectives, development of competency, development of learning materials, and national examination.
Cross-Sectional Studies
;
Data Collection
;
Dental Hygienists
;
Discrimination (Psychology)
;
Education
;
Expert Testimony
;
Humans
;
Hygiene
;
Learning*
;
Medical Assistance
;
Oral Health*
;
Oral Hygiene*
;
Social Security

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