1.Safety and Effectiveness of Eribulin in Patients with Advanced or Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes in Real-World Clinical Practice: A 6-Year Post-marketing Surveillance Study in South Korea
Yee Soo CHAE ; Kyung A KWON ; Moon Hee LEE ; Mi Sun AHN ; Kyung-Hun LEE ; Su-Jin KOH ; Joohyuk SOHN ; Keon Uk PARK ; Min Young KIM ; Youngji PYO ; Bo Young KIM ; Kyung Hae JUNG
Cancer Research and Treatment 2026;58(2):513-524
Purpose:
This 6-year post-marketing surveillance (PMS) study was conducted in South Korea to evaluate the real-world safety and effectiveness of eribulin in patients with advanced or metastatic breast cancer previously treated with anthracyclines and taxanes.
Materials and Methods:
During the study period (17 August 2012 to 16 August 2018), case-report files (CRFs) of patients receiving eribulin were collected. The main study endpoint was to assess the safety of eribulin. Evaluation of the effectiveness of eribulin was an exploratory endpoint. Patients were followed for 1 year after eribulin initiation.
Results:
CRFs were collected from 64 investigators at 64 sites for 1,079 patients. The safety analysis set (SAS) included 1,001 eribulin recipients; effectiveness was assessed in 244 patients. In the SAS, patients were predominantly female (99.6%), with a median age of 53.0 years, and diagnosed with metastatic breast cancer (92.0%). Eribulin was administered as a median 4th line chemotherapy. A total of 2,124 treatment-emergent adverse events (TEAEs) were reported in 661 patients (66.0%). Neutropenia was the most common TEAE (32.5% of patients), occurring at a median of 9-11 days from initial eribulin administration. Overall response and disease control rates were 31.7% and 95.6%, respectively, and the median duration of eribulin use (time to treatment failure) was 3.0 months.
Conclusion
This large real-world PMS analysis in patients with advanced or metastatic breast cancer demonstrated the effectiveness of eribulin and found no new safety concerns relative to safety information from prior clinical and real-world studies, and approvals in South Korea and other countries.
2.Korean colorectal cancer screening guidelines for asymptomatic, average-risk adults: the 2025 revision
EunKyo KANG ; Jae Myung CHA ; Seo Young KANG ; Kiheon LEE ; Su Young KIM ; Younghoon KIM ; An Na SEO ; Hyo-Jin KANG ; Jong Keon JANG ; Kwang-Pil KO ; Aesun SHIN ; Dae Kyung SOHN ; Youngki HONG ; Eun-Jung CHO ; Minje HAN ; Soo Young KIM ; Hyeon Ji LEE ; Chang Kyun CHOI ; Mina SUH
Journal of the Korean Medical Association 2026;69(3):268-280
Purpose:
To develop the 2025 update to the Korean colorectal cancer (CRC) screening guidelines by systematically evaluating recent evidence, integrating domestic data, and addressing changes since the 2015 guideline revision, thereby providing an evidence-based standard for clinicians and policymakers.
Methods:
A multidisciplinary committee developed the guidelines using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. The process included formulation of three key questions addressing screening efficacy, diagnostic accuracy, and optimal screening age and interval. A systematic review of international guidelines and primary literature was conducted, yielding 327 eligible studies. In addition, a utility-based analysis using a Markov model was performed to determine optimal screening ages and intervals.
Results:
The evidence synthesis identified high-certainty evidence supporting the use of the fecal immunochemical test (FIT) for reducing CRC mortality and moderate-certainty evidence for colonoscopy. Evidence for computed tomographic colonography (CTC) and stool DNA testing was rated as very low certainty. Based on the evidence review and cost-utility analysis, the committee conditionally recommends CRC screening for asymptomatic, average-risk adults aged 45–74 years using either colonoscopy every 10 years or FIT every 1–2 years. CTC and stool DNA testing were not recommended owing to insufficient evidence.
Conclusion
The 2025 Korean Guidelines for Colorectal Cancer Screening present updated, evidence-based recommendations tailored to the domestic healthcare context. By conditionally endorsing both colonoscopy and FIT for individuals aged 45–74 years, these guidelines aim to improve population-level screening effectiveness and reduce the burden of CRC in South Korea.
3.Pain Lateralization in Cluster Headache and Associated Clinical Factors
Soohyun CHO ; Mi Ji LEE ; Min Kyung CHU ; Jeong Wook PARK ; Heui-Soo MOON ; Pil-Wook CHUNG ; Jong-Hee SOHN ; Byung-Su KIM ; Daeyoung KIM ; Kyungmi OH ; Byung-Kun KIM ; Soo-Jin CHO
Journal of Clinical Neurology 2025;21(3):220-229
Background:
and Purpose The pain lateralization in cluster headache (CH) may be related to the asymmetry in the functions of the brain hemispheres. The right-sided dominance of pain in CH has been found inconsistently across studies, and so we aimed to characterize this and identify the factors influencing pain lateralization during current and previous bouts.
Methods:
This study enrolled 227 patients from the Korean Cluster Headache Registry between October 2018 and December 2020. We evaluated the side of pain during current and previous bouts, demographic features, and clinical characteristics, including handedness. Multivariable logistic regression analyses were performed to identify factors associated with the side of pain.
Results:
The 227 patients with CH included 131 (57.7%) with right-sided pain and 86 (37.9%) with left-sided pain during the current bout (p<0.001). The 189 patients with previous bouts of CH included 86.8% who consistently reported the same side of pain throughout multiple bouts (side-locked pain), with a higher prevalence of pain on the right than the left side (55.0% vs. 31.7%, p<0.001). Multivariable analyses revealed that higher age at diagnosis (odds ratio [OR]=1.045, p=0.031) and shorter CH attacks (OR=0.992, p=0.017) were associated with left-side-locked pain. However, handedness was not associated with the lateralization of leftside-locked pain.
Conclusions
This study has confirmed the predominance of right-sided pain throughout multiple CH bouts. We found that higher age at diagnosis and shorter CH attacks were associated with left-side-locked pain, suggesting that certain clinical factors are associated with the pain laterality. However, the underlying mechanisms linking these factors to lateralized pain remain unclear and therefore require further investigation.
4.Stratifying Risk of Lymph Node Metastasis After Non-Curative Endoscopic Submucosal Dissection of Early Gastric Cancer: Comparison of the eCura System and Elderly Criteria
Tae-woo KIM ; Hyo-Joon YANG ; Giho LEE ; Soo-Kyung PARK ; Yoon Suk JUNG ; Jung Ho PARK ; Dong Il PARK ; Chong Il SOHN
Journal of Gastric Cancer 2025;25(2):370-381
Purpose:
The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system.
Materials and Methods:
A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared.
Results:
In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM.
Conclusions
Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.
5.Validation of the Phoenix Criteria for Sepsis and Septic Shock in a Pediatric Intensive Care Unit
Chang Hoon HAN ; Hamin KIM ; Mireu PARK ; Soo Yeon KIM ; Jong Deok KIM ; Myung Hyun SOHN ; Seng Chan YOU ; Kyung Won KIM
Journal of Korean Medical Science 2025;40(10):e106-
The applicability of the Phoenix criteria and Phoenix Sepsis Score in higher-resource pediatric intensive care units (PICUs) outside the United States requires further validation. A retrospective cohort study analyzed electronic health records of 1,304 PICU admissions under 18 years old with suspected infection between February 2017 and December 2023. The score was calculated using two methods: 24-hour assessment, based on worst sub-scores within 24 hours of admission, and prompt assessment, using values closest to admission within 6 hours before or after. Based on the 24-hour assessment, in-hospital mortality was 8.3% for sepsis and 10.3% for septic shock. The score demonstrated an area under the precision-recall curve of 0.42 (95% confidence interval, 0.31–0.55) for in-hospital mortality. Results were consistent across both assessment methods. The Phoenix criteria and the Phoenix Sepsis Score are reliable predictors of mortality outcomes. Further investigation in diverse clinical settings is warranted.
6.Pain Lateralization in Cluster Headache and Associated Clinical Factors
Soohyun CHO ; Mi Ji LEE ; Min Kyung CHU ; Jeong Wook PARK ; Heui-Soo MOON ; Pil-Wook CHUNG ; Jong-Hee SOHN ; Byung-Su KIM ; Daeyoung KIM ; Kyungmi OH ; Byung-Kun KIM ; Soo-Jin CHO
Journal of Clinical Neurology 2025;21(3):220-229
Background:
and Purpose The pain lateralization in cluster headache (CH) may be related to the asymmetry in the functions of the brain hemispheres. The right-sided dominance of pain in CH has been found inconsistently across studies, and so we aimed to characterize this and identify the factors influencing pain lateralization during current and previous bouts.
Methods:
This study enrolled 227 patients from the Korean Cluster Headache Registry between October 2018 and December 2020. We evaluated the side of pain during current and previous bouts, demographic features, and clinical characteristics, including handedness. Multivariable logistic regression analyses were performed to identify factors associated with the side of pain.
Results:
The 227 patients with CH included 131 (57.7%) with right-sided pain and 86 (37.9%) with left-sided pain during the current bout (p<0.001). The 189 patients with previous bouts of CH included 86.8% who consistently reported the same side of pain throughout multiple bouts (side-locked pain), with a higher prevalence of pain on the right than the left side (55.0% vs. 31.7%, p<0.001). Multivariable analyses revealed that higher age at diagnosis (odds ratio [OR]=1.045, p=0.031) and shorter CH attacks (OR=0.992, p=0.017) were associated with left-side-locked pain. However, handedness was not associated with the lateralization of leftside-locked pain.
Conclusions
This study has confirmed the predominance of right-sided pain throughout multiple CH bouts. We found that higher age at diagnosis and shorter CH attacks were associated with left-side-locked pain, suggesting that certain clinical factors are associated with the pain laterality. However, the underlying mechanisms linking these factors to lateralized pain remain unclear and therefore require further investigation.
7.Stratifying Risk of Lymph Node Metastasis After Non-Curative Endoscopic Submucosal Dissection of Early Gastric Cancer: Comparison of the eCura System and Elderly Criteria
Tae-woo KIM ; Hyo-Joon YANG ; Giho LEE ; Soo-Kyung PARK ; Yoon Suk JUNG ; Jung Ho PARK ; Dong Il PARK ; Chong Il SOHN
Journal of Gastric Cancer 2025;25(2):370-381
Purpose:
The novel curability criteria for elderly (EL) patients have been proposed to stratify their risk of lymph node metastasis (LNM), following non-curative endoscopic submucosal dissection (ESD) for early gastric cancer (EGC). Hence, this study aimed to evaluate the effectiveness of the EL criteria and compare them with those of the well-known eCura system.
Materials and Methods:
A retrospective analysis was performed on 143 patients who did not meet the curative ESD criteria at a tertiary hospital in Korea between 2011 and 2022. Of these, 102 underwent additional surgery, while 41 were followed up without further treatment. The LNM rates based on the EL and eCura systems were stratified and compared.
Results:
In the surgery group, 29.4% (30/102) patients were classified as EL-low (EL-L) and 70.2% (72/102) as EL-high (EL-H). The LNM rates (95% confidence interval) were 0.0% (0.0–11.6) and 9.7% (4.0–19.0) for EL-L and EL-H, respectively (P=0.102). EL-L was closely aligned with the eCura low-risk category, with a similar patient proportion (32.4%) and an LNM rate of 0.0% (0.0–10.6). The eCura system classified 94.1% (48/51) of the EL-L patients as lowrisk, with an 86% concordance rate (123/143). Discordant cases included patients with positive vertical margins, but without other risk factors, who were classified as EL-H without LNM.
Conclusions
Patients with EL-L showed no LNM, and the EL criteria demonstrated high concordance with the eCura system. The EL criteria may be as effective as the eCura system in identifying low-risk patients after non-curative ESD for EGC.
8.Validation of the Phoenix Criteria for Sepsis and Septic Shock in a Pediatric Intensive Care Unit
Chang Hoon HAN ; Hamin KIM ; Mireu PARK ; Soo Yeon KIM ; Jong Deok KIM ; Myung Hyun SOHN ; Seng Chan YOU ; Kyung Won KIM
Journal of Korean Medical Science 2025;40(10):e106-
The applicability of the Phoenix criteria and Phoenix Sepsis Score in higher-resource pediatric intensive care units (PICUs) outside the United States requires further validation. A retrospective cohort study analyzed electronic health records of 1,304 PICU admissions under 18 years old with suspected infection between February 2017 and December 2023. The score was calculated using two methods: 24-hour assessment, based on worst sub-scores within 24 hours of admission, and prompt assessment, using values closest to admission within 6 hours before or after. Based on the 24-hour assessment, in-hospital mortality was 8.3% for sepsis and 10.3% for septic shock. The score demonstrated an area under the precision-recall curve of 0.42 (95% confidence interval, 0.31–0.55) for in-hospital mortality. Results were consistent across both assessment methods. The Phoenix criteria and the Phoenix Sepsis Score are reliable predictors of mortality outcomes. Further investigation in diverse clinical settings is warranted.
9.Low vitamin C concentrations and prognosis in critically ill children
Min Jung KIM ; Yoon Hee KIM ; Soo Yeon KIM ; Jong Deok KIM ; Mireu PARK ; Hamin KIM ; Myung Hyun SOHN ; Kyung Won KIM
Acute and Critical Care 2025;40(3):482-490
The administration of high-dose vitamins has been focused on in critically ill patients as adjunctive therapy for life-threatening conditions. We evaluated the association between serum vitamin C concentrations and patient prognosis. Methods: We retrospectively reviewed and collected clinical and biochemical data, including thiamine and vitamin C levels, of patients admitted to the pediatric intensive care unit (PICU). Results: In total, 177 patients were admitted to the PICU during the study period, and 63 children were enrolled in this study. The most common reason for PICU admission was sepsis (33.3%). The median thiamine and vitamin C levels were 3.6 µg/dl (interquartile range [IQR], 2.9–4.5 µg/dl) and 2.84 µg/ml (IQR, 1.61–4.55 µg/ml), respectively. Thiamine deficiency was observed in 10 patients (15.9%), and 17 (27.0%) had vitamin C deficiency. There were no differences in the vitamin levels according to the reason for PICU admission. Vitamin C levels were affected by nutritional status. The length of stay in the PICU and duration of mechanical ventilation were longer in patients with vitamin C deficiency than in those without (P=0.035 and P=0.010, respectively). The serum delta neutrophil index and C-reactive protein and lactate levels increased in the vitamin C-deficient group (P=0.028 and P=0.039, respectively). There was a significant difference in Pediatric Index of Mortality 3 scores according to vitamin C levels but not in mortality directly. Conclusions: Vitamin C deficiency was associated with elevated inflammatory marker levels, increased mechanical ventilation durations, and PICU admission. Our results support the potential benefits of vitamin C administration in critically ill children.
10.Validation of the Phoenix Criteria for Sepsis and Septic Shock in a Pediatric Intensive Care Unit
Chang Hoon HAN ; Hamin KIM ; Mireu PARK ; Soo Yeon KIM ; Jong Deok KIM ; Myung Hyun SOHN ; Seng Chan YOU ; Kyung Won KIM
Journal of Korean Medical Science 2025;40(10):e106-
The applicability of the Phoenix criteria and Phoenix Sepsis Score in higher-resource pediatric intensive care units (PICUs) outside the United States requires further validation. A retrospective cohort study analyzed electronic health records of 1,304 PICU admissions under 18 years old with suspected infection between February 2017 and December 2023. The score was calculated using two methods: 24-hour assessment, based on worst sub-scores within 24 hours of admission, and prompt assessment, using values closest to admission within 6 hours before or after. Based on the 24-hour assessment, in-hospital mortality was 8.3% for sepsis and 10.3% for septic shock. The score demonstrated an area under the precision-recall curve of 0.42 (95% confidence interval, 0.31–0.55) for in-hospital mortality. Results were consistent across both assessment methods. The Phoenix criteria and the Phoenix Sepsis Score are reliable predictors of mortality outcomes. Further investigation in diverse clinical settings is warranted.

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