1.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
2.Insights into hepatocellular adenomas in Asia: molecular subtypes, clinical characteristics, imaging features, and hepatocellular carcinoma risks
Subin HEO ; In Hye SONG ; Edouard REIZINE ; Maxime RONOT ; Jean-Charles NAULT ; Hae Young KIM ; Sang Hyun CHOI ; So Yeon KIM
Journal of Liver Cancer 2025;25(1):67-78
Hepatocellular adenomas (HCAs) are benign monoclonal liver tumors. Advances in molecular studies have led to the identification of distinct subtypes of HCA with unique pathways, clinical characteristics, and complication risks, underscoring the need for precise diagnosis and tailored management. Malignant transformation and bleeding remain significant concerns. Imaging plays a crucial role in the identification of these subtypes, offering a non-invasive method to guide clinical decision-making. Most studies involving patients with HCAs have been conducted in Western populations; however, the number of studies focused on Asian population has increased in recent years. HCAs exhibit distinct features in Asian population, such as a higher prevalence among male patients and specific subtypes (e.g., inflammatory HCAs). Current clinical guidelines are predominantly influenced by Western data, which may not fully capture these regional differences in epidemiology and subtype distribution. Therefore, this review presents the updated molecular classification of HCAs and their epidemiologic differences between Asian and Western populations, and discuss the role of imaging techniques, particularly magnetic resonance imaging using hepatobiliary contrast agents, in classifying the subtypes and predicting the risk of hepatocellular carcinoma.
3.Early Administration of Nelonemdaz May Improve the Stroke Outcomes in Patients With Acute Stroke
Jin Soo LEE ; Ji Sung LEE ; Seong Hwan AHN ; Hyun Goo KANG ; Tae-Jin SONG ; Dong-Ick SHIN ; Hee-Joon BAE ; Chang Hun KIM ; Sung Hyuk HEO ; Jae-Kwan CHA ; Yeong Bae LEE ; Eung Gyu KIM ; Man Seok PARK ; Hee-Kwon PARK ; Jinkwon KIM ; Sungwook YU ; Heejung MO ; Sung Il SOHN ; Jee Hyun KWON ; Jae Guk KIM ; Young Seo KIM ; Jay Chol CHOI ; Yang-Ha HWANG ; Keun Hwa JUNG ; Soo-Kyoung KIM ; Woo Keun SEO ; Jung Hwa SEO ; Joonsang YOO ; Jun Young CHANG ; Mooseok PARK ; Kyu Sun YUM ; Chun San AN ; Byoung Joo GWAG ; Dennis W. CHOI ; Ji Man HONG ; Sun U. KWON ;
Journal of Stroke 2025;27(2):279-283
4.Low-Density Lipoprotein Cholesterol Level, the Lower the Better? Analysis of Korean Patients in the Treat Stroke to Target Trial
Hanim KWON ; Jae-Chan RYU ; Jae-Kwan CHA ; Sang Min SUNG ; Tae-Jin SONG ; Kyung Bok LEE ; Eung-Gyu KIM ; Yong-Won KIM ; Ji Hoe HEO ; Man Seok PARK ; Kyusik KANG ; Byung-Chul LEE ; Keun-Sik HONG ; Oh Young BANG ; Jei KIM ; Jong S. KIM
Journal of Stroke 2025;27(2):228-236
Background:
and Purpose The Treat Stroke to Target (TST) was a randomized clinical trial involving French and Korean patients demonstrating that a lower low-density lipoprotein cholesterol (LDL-C, <70 mg/dL) target group (LT) experienced fewer cerebro-cardiovascular events than a higher target (90–110 mg/dL) group (HT). However, whether these results can be applied to Asian patients with different ischemic stroke subtypes remains unclear.
Methods:
Patients from 14 South Korean centers were analyzed separately. Patients with ischemic stroke or transient ischemic attack with evidence of atherosclerosis were randomized into LT and HT groups. The primary endpoint was a composite of ischemic stroke, myocardial infarction, coronary or cerebral revascularization, and cardiovascular death.
Results:
Among 712 enrolled patients, the mean LDL-C level was 71.0 mg/dL in 357 LT patients and 86.1 mg/dL in 355 HT patients. The primary endpoint occurred in 24 (6.7%) of LT and in 31 (8.7%) of HT group patients (adjusted hazard ratio [HR]=0.78; 95% confidence interval [CI]=0.45–1.33, P=0.353). Cardiovascular events alone occurred significantly less frequently in the LT than in the HT group (HR 0.26, 95% CI 0.09–0.80, P=0.019), whereas there were no significant differences in ischemic stroke events (HR 1.12, 95% CI 0.60–2.10, P=0.712). The benefit of LT was less apparent in patients with small vessel disease and intracranial atherosclerosis than in those with extracranial atherosclerosis.
Conclusion
In contrast to the French TST, the outcomes in Korean patients were neutral. Although LT was more effective in preventing cardiovascular diseases, it was not so in stroke prevention, probably attributed to the differences in stroke subtypes. Further studies are needed to elucidate the efficacy of statins and appropriate LDL-C targets in Asian patients with stroke.
6.Association between Tumor Size at the Time of Disease Progression and Survival Outcomes
Chi Hoon MAENG ; Bum Jun KIM ; Myung-Ju AHN ; In Sil CHOI ; Dae Young ZANG ; Bo-Hyung KIM ; Minji KWON ; Dae Seog HEO ; Bhumsuk KEAM
Cancer Research and Treatment 2025;57(2):362-368
Purpose:
This study evaluates the prognostic significance of tumor size at disease progression (PD) and depth of response (DOR) in cancer patients.
Materials and Methods:
We performed post hoc analysis using data from six prospective clinical trials conducted by the Korean Cancer Study Group. Patients with tumor size at PD was categorized into ‘Mild PD’ and ‘Significant PD’ based on the cutoff values of relative change from baseline using maximally selected rank statistics. The overall survival (OS) and progression-free survival (PFS) were compared between PD and DOR categories.
Results:
Among the 194 evaluable patients, 130 experienced PD. A 35.48% decrease from baseline in tumor size at PD was chosen for the cutoff between mild and significant PD for OS (mild PD: tumor size from the baseline ≤ −35.48%; significant PD > −35.48%). The mild PD had superior OS compared to the significant PD (25.8 vs. 12.8 months; Hazard ratio [HR] 0.47, 95% CI 0.266-0.843, p=0.009). When using an exploratory cutoff based on whether the tumor size was below vs. exceeded from the baseline (mild PD: tumor size from the baseline ≤ 0%; significant PD > 0%), OS remained significantly longer in the mild PD (17.1 vs. 11.8 months; HR 0.60, 95% CI 0.392-0.932, p=0.021). The greatest DOR was associated with the longest OS and PFS (p<0.001 for both).
Conclusion
Tumor size at PD and DOR were significant prognostic factors for progressive disease. Maintaining a sufficiently reduced tumor size even during PD was associated with better survival outcomes.
7.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
8.Sentinel Safety Monitoring System for Adverse Events of Special Interest Associated With Non-NIP Vaccines in Korea
Hakjun HYUN ; Jung Yeon HEO ; Yu Jung CHOI ; Eliel NHAM ; Jin Gu YOON ; Ji Yun NOH ; Joon Young SONG ; Woo Joo KIM ; Won Suk CHOI ; Min Joo CHOI ; Yu Bin SEO ; Jacob LEE ; Hee Jin CHEONG
Journal of Korean Medical Science 2025;40(16):e152-
South Korea’s current vaccination policies leave a surveillance gap for non-National Immunization Program (NIP) vaccines. In this study, we proposed a sentinel surveillance approach for monitoring the safety of non-NIP vaccines. Vaccination data were collected retrospectively among patients hospitalized with pre-defined adverse events of special interest (AESI) by reviewing electronic medical records in five university hospitals. This approach incorporates expert assessment to determine the causal relationship. We confirmed that 16 patients had received non-NIP vaccines among 860 patients diagnosed with AESI.We concluded one case of preeclampsia was possibly related to tetanus-diphtheria-pertussis vaccination. We propose a multi-hospital-based, retrospective assessment system for predefined AESIs as an alternative to active vaccine safety monitoring method. These efforts are expected to enhance both the accuracy and timeliness of safety monitoring in South Korea.
9.Insights into hepatocellular adenomas in Asia: molecular subtypes, clinical characteristics, imaging features, and hepatocellular carcinoma risks
Subin HEO ; In Hye SONG ; Edouard REIZINE ; Maxime RONOT ; Jean-Charles NAULT ; Hae Young KIM ; Sang Hyun CHOI ; So Yeon KIM
Journal of Liver Cancer 2025;25(1):67-78
Hepatocellular adenomas (HCAs) are benign monoclonal liver tumors. Advances in molecular studies have led to the identification of distinct subtypes of HCA with unique pathways, clinical characteristics, and complication risks, underscoring the need for precise diagnosis and tailored management. Malignant transformation and bleeding remain significant concerns. Imaging plays a crucial role in the identification of these subtypes, offering a non-invasive method to guide clinical decision-making. Most studies involving patients with HCAs have been conducted in Western populations; however, the number of studies focused on Asian population has increased in recent years. HCAs exhibit distinct features in Asian population, such as a higher prevalence among male patients and specific subtypes (e.g., inflammatory HCAs). Current clinical guidelines are predominantly influenced by Western data, which may not fully capture these regional differences in epidemiology and subtype distribution. Therefore, this review presents the updated molecular classification of HCAs and their epidemiologic differences between Asian and Western populations, and discuss the role of imaging techniques, particularly magnetic resonance imaging using hepatobiliary contrast agents, in classifying the subtypes and predicting the risk of hepatocellular carcinoma.
10.Early Administration of Nelonemdaz May Improve the Stroke Outcomes in Patients With Acute Stroke
Jin Soo LEE ; Ji Sung LEE ; Seong Hwan AHN ; Hyun Goo KANG ; Tae-Jin SONG ; Dong-Ick SHIN ; Hee-Joon BAE ; Chang Hun KIM ; Sung Hyuk HEO ; Jae-Kwan CHA ; Yeong Bae LEE ; Eung Gyu KIM ; Man Seok PARK ; Hee-Kwon PARK ; Jinkwon KIM ; Sungwook YU ; Heejung MO ; Sung Il SOHN ; Jee Hyun KWON ; Jae Guk KIM ; Young Seo KIM ; Jay Chol CHOI ; Yang-Ha HWANG ; Keun Hwa JUNG ; Soo-Kyoung KIM ; Woo Keun SEO ; Jung Hwa SEO ; Joonsang YOO ; Jun Young CHANG ; Mooseok PARK ; Kyu Sun YUM ; Chun San AN ; Byoung Joo GWAG ; Dennis W. CHOI ; Ji Man HONG ; Sun U. KWON ;
Journal of Stroke 2025;27(2):279-283

Result Analysis
Print
Save
E-mail