1.Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study
Hyung Seok SON ; Min Kyung SHIN ; Jong Hun LEE ; Moon Bum KIM ; Kwang Ho YOO ; Sun Young CHOI ; Hye Sung HAN ; Joon SEOK ; Beom Joon KIM ; Yang Won LEE
Annals of Dermatology 2026;38(1):33-41
Background:
A novel botulinum toxin type A (Protoxin; Protox Inc.) has been developed.
Objective:
To evaluate the efficacy and safety of the newly developed Protoxin compared to the approved drug onabotulinumtoxinA (OBoNT) in moderate to severe glabellar lines.
Methods:
Adults with a glabellar line Facial Wrinkle Scale (FWS) score of 2 (moderate) or 3 (severe) were enrolled in the study. Subjects were randomized in a 1:1 ratio to receive either Protoxin or OBoNT. A total of 20 units of botulinum toxin was injected at five sites in the glabellar region (4 units at each site). FWS scores were assessed at baseline and at weeks 4, 8, 12, and 16 post-injection. The primary endpoint was the proportion of subjects at week 4 who had a reduction of 2 or more points in FWS and a final score of 0 (none) or 1 (mild).
Results:
A total of 274 subjects were randomized, of whom 78.1% were female. At week 4 post-treatment, the improvement rate of glabellar lines was 62.22% in the Protoxin group and 62.96% in the OBoNT group. The lower limit of the two-sided 95% confidence interval (−12.24%) exceeded the −15% margin, confirming the non-inferiority of the new drug. Safety profiles were comparable between the two groups.
Conclusion
Protoxin demonstrated efficacy and safety profiles comparable to those of OBoNT in the treatment of moderate to severe glabellar lines.
2.Nationwide Survey on Endoscopic Submucosal Dissection for Early Gastric Cancer in Korea: Results From the Korean College of Helicobacter and Upper Gastrointestinal Research (KCHUGR) 2023 Survey
Jae Yong PARK ; Jeong Hoon LEE ; Tae-Se KIM ; Da Hyun JUNG ; Bong Eun LEE ; Yonghoon CHOI ; Wan-Sik LEE ; Young-Il KIM ; Sun Hyung KANG ; Hyunsoo CHUNG ; Su Jin KIM ; Joon Sung KIM ; Donghoon KANG ; Su Youn NAM ; Seung Han KIM ; Hyo-Joon YANG ; Hyun LIM ; Jin LEE ; Seon-Young PARK ; Seung-Woo LEE ; Sun Moon KIM ; Sam Ryong JEE ; Dae Young CHEUNG ; Chung Hyun TAE ; Seokin KANG ; Sung Chul PARK ; Seung In SEO ; Cheol Min SHIN ; Kee Don CHOI ; Jong Yeul LEE ;
Journal of Gastric Cancer 2026;26(2):169-183
Purpose:
Endoscopic submucosal dissection (ESD) has become a standard minimally invasive treatment for selected patients with early gastric cancer (EGC). This study presents the first nationwide survey of patients with EGC treated with ESD in 2023, conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research.
Materials and Methods:
Data were retrospectively collected from participating referral centers across Korea using a standardized case report form covering patient characteristics, tumor features, procedural details, histopathological findings, and clinical outcomes.Descriptive and comparative analyses were conducted to summarize nationwide ESD practice patterns and outcomes.
Results:
Data from 5,460 ESD cases from 5,250 patients across 27 institutions were analyzed. The mean age was 67.4 years, with 74.1% males. Multiple synchronous lesions were identified in 3.7%. Most lesions were located in the lower third of the stomach (64.0%), and differentiated-type adenocarcinomas accounted for 87.8%. The en bloc and complete resection rates were 99.2% and 91.4%, respectively. Curative resection was achieved in 80.5%, whereas local non-curative resection (L-NCR) and surgical non-curative resection (S-NCR) were identified in 2.8% and 16.7%, respectively. Additional surgery was performed more frequently in patients with S-NCR than in those with L-NCR (59.3% vs. 24.7%). The bleeding and perforation rates were 3.6% and 0.9%, respectively, and were mostly managed conservatively or endoscopically. The median length of hospitalization was 4.0 days.
Conclusions
This first nationwide survey provides a comprehensive overview of the current practice of EGC treatment using ESD in Korea, demonstrating high technical success and safety, and establishing a baseline dataset for future longitudinal research.
4.Comparative survival outcomes of surgical resection versus radiotherapy after FOLFIRINOX in borderline resectable and locally advanced pancreatic cancer
Jiwon YU ; Jeong Ha LEE ; Hyunju SHIN ; Hee Chul PARK ; Joon Oh PARK ; Jung Yong HONG ; Minsuk KWON ; Ji Eun SHIN ; Kyu Taek LEE ; Kwang Hyuck LEE ; Jong Kyun LEE ; Joo Kyung PARK ; Young Hoon CHOI ; Jin Seok HEO ; In Woong HAN ; Sang Hyun SHIN ; Hongbeom KIM ; Ji Hye MIN ; Jeong Il YU
Precision and Future Medicine 2026;10(1):39-50
Purpose:
This study evaluated the clinical outcomes and prognostic factors in patients with borderline resectable pancreatic cancer (BRPC) and locally advanced pancreatic cancer (LAPC) treated with upfront FOLFIRINOX followed by local-regional therapy (LRT), surgical resection (SR), and radiotherapy (RT). We aimed to identify specific patient subgroups for which RT may serve as a reasonable alternative to SR for local tumor control.
Methods:
We retrospectively analyzed 116 patients (SR group, n= 70; RT group, n= 46) at a single center between 2015 and 2020. Survival outcomes were compared based on LRT modalities, focusing on identifying subgroups in which RT provided an efficacy comparable to that of SR.
Results:
Among 116 patients, the SR group achieved a significantly higher 5-year overall survival (OS) than the RT group (27.1% vs. 8.7%, P< 0.0001), despite similar progression-free survival (P= 0.23). Significant prognostic factors for OS included carbohydrate antigen 19-9 (CA19-9) response in BRPC (P= 0.02) and radiologic partial response in LAPC (P= 0.05). Subgroup analysis revealed that, while SR provided a survival advantage in CA19-9 responders, no significant difference in OS was observed between SR and RT in CA19-9 non-responders (P= 0.37).
Conclusion
Although surgery remains the gold standard, RT may be considered a justifiable local alternative for CA19-9 non-responders and surgically ineligible patients with LAPC, yielding comparable outcomes in these specific, biologically unfavorable subgroups.
5.Nationwide Survey on Endoscopic Submucosal Dissection for Early Gastric Cancer in Korea: Results From the Korean College of Helicobacter and Upper Gastrointestinal Research (KCHUGR) 2023 Survey
Jae Yong PARK ; Jeong Hoon LEE ; Tae-Se KIM ; Da Hyun JUNG ; Bong Eun LEE ; Yonghoon CHOI ; Wan-Sik LEE ; Young-Il KIM ; Sun Hyung KANG ; Hyunsoo CHUNG ; Su Jin KIM ; Joon Sung KIM ; Donghoon KANG ; Su Youn NAM ; Seung Han KIM ; Hyo-Joon YANG ; Hyun LIM ; Jin LEE ; Seon-Young PARK ; Seung-Woo LEE ; Sun Moon KIM ; Sam Ryong JEE ; Dae Young CHEUNG ; Chung Hyun TAE ; Seokin KANG ; Sung Chul PARK ; Seung In SEO ; Cheol Min SHIN ; Kee Don CHOI ; Jong Yeul LEE ;
The Korean Journal of Helicobacter and Upper Gastrointestinal Research 2026;26(1):50-59
Objectives:
Endoscopic submucosal dissection (ESD) has become a standard minimally invasive treatment for selected patients with early gastric cancer (EGC). This study presents the first nationwide survey of patients with EGC treated with ESD in 2023, conducted by the Korean College of Helicobacter and Upper Gastrointestinal Research.
Methods:
Data were retrospectively collected from participating referral centers across Korea using a standardized case report form covering patient characteristics, tumor features, procedural details, histopathological findings, and clinical outcomes. Descriptive and comparative analyses were conducted to summarize nationwide ESD practice patterns and outcomes.
Results:
Data from 5460 ESD cases from 5250 patients across 27 institutions were analyzed. The mean age was 67.4 years, with 74.1% males. Multiple synchronous lesions were identified in 3.7%. Most lesions were located in the lower third of the stomach (64.0%), and differentiated-type adenocarcinomas accounted for 87.8%. The en bloc and complete resection rates were 99.2% and 91.4%, respectively. Curative resection was achieved in 80.5%, whereas local non-curative resection (L-NCR) and surgical non-curative resection (S-NCR) were identified in 2.8% and 16.7%, respectively. Additional surgery was performed more frequently in patients with S-NCR than in those with L-NCR (59.3% vs. 24.7%). The bleeding and perforation rates were 3.6% and 0.9%, respectively, and were mostly managed conservatively or endoscopically. The median length of hospitalization was 4.0 days.
Conclusions
This first nationwide survey provides a comprehensive overview of the current practice of EGC treatment using ESD in Korea, demonstrating high technical success and safety, and establishing a baseline dataset for future longitudinal research.
6.Efficacy and Safety of Ifosfamide and Mesna in Metastatic Castration-Resistant Prostate Cancer after Taxane-Based Chemotherapy and Novel Hormonal Therapy Failure
Chang Gon KIM ; Yeo Gyeong KO ; Jongjin YOON ; Chung LEE ; Seung Hoon BEOM ; Young-Deuk CHOI ; Woong Kyu HAN ; Won Sik HAM ; Hyunho HAN ; Jongsoo LEE ; Ji Eun HEO ; Daeseong KIM ; Eun Sil BAEK ; Sangwoo KIM ; Minsun JUNG ; Sang Joon SHIN
Cancer Research and Treatment 2026;58(2):603-612
Purpose:
Limited treatment options exist for patients with metastatic castration-resistant prostate cancer (mCRPC) after the failure of taxane-based chemotherapy and novel hormonal therapy. Here, we report the safety and efficacy of ifosfamide and mesna in patients with mCRPC after the failure of taxane-based chemotherapy and novel hormonal therapy (NCT06236789).
Materials and Methods:
Patients with histologically confirmed prostate cancer who had failed taxane-based chemotherapy and novel hormonal therapy received ifosfamide 2,500 mg/m2 and mesna 1,500 mg/m2 on days 1–3, repeated every 21 days. Safety, objective response rate, disease control rate, reduction in serum prostate-specific antigen (PSA) concentration by >50% (PSA50) or >90% (PSA90), radiographic progression-free survival (rPFS), and overall survival (OS) were analyzed.
Results:
A total of 47 patients with mCRPC were included in the study. The median number of lines of treatment was 5 (range, 3 to 7). All patients were previously administered docetaxel and novel hormonal therapies including abiraterone (51.1%) and/or enzalutamide (61.7%). Thirty-eight patients (80.9%) were administered cabazitaxel. The objective response and disease control rates were 21.3% and 80.9%, respectively. PSA50 and PSA90 were achieved in 31.9% and 10.6%, respectively. During a median follow-up duration of 54.3 months, rPFS and OS were 5.0 and 9.0 months, respectively. All the patients experienced treatment-related adverse events of any grades; however, no new safety signs were detected. Genomic biomarker analysis revealed that alterations in the TP53 pathway were associated with inferior rPFS and OS.
Conclusion
Ifosfamide and mesna showed appreciable efficacy and manageable safety profiles in heavily treated patients with mCRPC.
7.Pre-Treatment Perceived Social Support Is Associated With Chemotherapy-Induced Peripheral Neuropathy in Patients With Breast Cancer: A Longitudinal Study
Joon Sung SHIN ; Sanghyup JUNG ; Geun Hui WON ; Sun Hyung LEE ; Jaehyun KIM ; Saim JUNG ; Chan-Woo YEOM ; Kwang-Min LEE ; Kyung-Lak SON ; Jang-il KIM ; Sook Young JEON ; Han-Byoel LEE ; Bong-Jin HAHM
Psychiatry Investigation 2025;22(4):424-434
Objective:
Previous studies have reported an association between cancer-related symptoms and perceived social support (PSS). The objective of this study was to analyze whether Chemotherapy-Induced Peripheral Neuropathy (CIPN), a prevalent side effect of chemotherapy, varies according to PSS level using a validated tool for CIPN at prospective follow-up.
Methods:
A total of 39 breast cancer patients were evaluated for PSS using the Multidimensional Scale of Perceived Social Support (MSPSS) prior to chemotherapy and were subsequently grouped into one of two categories for each subscale: low-to-moderate PSS and high PSS. CIPN was prospectively evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) at five time points. A linear mixed-effects model with square root transformation was employed to investigate whether the CIPN20 scales varied by PSS level and time point.
Results:
Statistical analysis of the MSPSS total scale and subscales revealed a significant effect of the friends subscale group and time point on the CIPN20 sensory scale. The sensory scale score of CIPN20 was found to be lower in participants with high PSS from friends in comparison to those with low-to-moderate PSS at 1 month post-chemotherapy (p=0.010).
Conclusion
This is the first study to prospectively follow the long-term effect of pre-treatment PSS from friends on CIPN. Further studies based on larger samples are required to analyze the effects of PSS on the pathophysiology of CIPN.
8.Primary Cholangiocarcinoma of the Liver Presenting as a Complicated Hepatic Cyst: A Diagnostic Challenge
Chang Won HA ; Sang Deok SHIN ; Myung Ji GOH ; Byeong Geun SONG ; Wonseok KANG ; Dong Hyun SINN ; Geum-Youn GWAK ; Yong-Han PAIK ; Moon Seok CHOI ; Joon Hyeok LEE
The Korean Journal of Gastroenterology 2025;85(1):83-88
Primary cholangiocarcinoma is a rare bile duct epithelial neoplasm that can present with atypical clinical manifestations, complicating its diagnosis. A 62-year-old male showed symptoms suggestive of a complicated hepatic cyst that was later identified as intrahepatic cholangiocarcinoma. The patient presented with abdominal discomfort without fever. Imaging revealed a large cystic lesion in the liver. Despite the initial treatment for a presumed abscess, a biopsy confirmed cholangiocarcinoma. This case highlights the diagnostic challenge of distinguishing between benign complicated hepatic cysts and malignancies, particularly when typical markers of infection are absent. Early biopsy and vigilant assessments are crucial in such presentations to avoid a delayed diagnosis and initiate appropriate treatment.
9.Miliary Tuberculosis Initially Presenting as an Isolated Hepatic Abscess
Chang Won HA ; Sang Deok SHIN ; Myung Ji GOH ; Byeong Geun SONG ; Wonseok KANG ; Dong Hyun SINN ; Geum-Youn GWAK ; Yong-Han PAIK ; Moon Seok CHOI ; Joon Hyeok LEE
The Korean Journal of Gastroenterology 2025;85(1):78-82
Hepatic tuberculosis, typically associated with miliary tuberculosis, can occasionally present as localized liver lesions. This case report describes a 77-year-old male presenting with persistent abdominal pain and fever, following an endoscopic retrograde cholangiopancreatography for bile duct sludge removal. Subsequent computed tomography revealed focal liver lesions. Despite initial treatment with antibiotics for a suspected inflammatory liver abscess, his condition did not improve. A liver biopsy was performed, revealing caseous granulomas, and the tuberculosis polymerase chain reaction result was positive. The patient was diagnosed with primary hepatic tuberculosis, which later disseminated. Oral anti-tuberculosis therapy was initiated and is currently being closely monitored. This case emphasizes the importance of considering hepatic tuberculosis in the differential diagnosis of liver lesions, particularly in cases involving cholestatic liver function tests, and persistent symptoms unresponsive to conventional antibiotics.
10.Using machine learning techniques for early prediction of tracheal intubation in patients with septic shock: a multi-center study in South Korea
Ji Han HEO ; Taegyun KIM ; Tae Gun SHIN ; Gil Joon SUH ; Woon Yong KWON ; Hayoung KIM ; Heesu PARK ; Heejun KIM ; Sol HAN ;
Acute and Critical Care 2025;40(2):221-234
Background:
Patients with septic shock frequently require tracheal intubation in the emergency department (ED). However, the criteria for tracheal intubation are subjective, based on physician experience, or require serial evaluations over relatively long intervals to make accurate predictions, which might not be feasible in the ED. We used supervised learning approaches and features routinely available during the initial stages of evaluation and resuscitation to stratify the risks of tracheal intubation within a 24-hour time window.
Methods:
We retrospectively analyzed the data of patients diagnosed with septic shock based on the SEPSIS-3 criteria across 21 university hospital EDs in the Republic of Korea. A principal component analysis revealed a complex, non-linear decision boundary with respect to the application of tracheal intubation within a 24-hour time window. Stratified five-fold cross validation and a grid search were used with extreme gradient boost. Shapley values were calculated to explain feature importance and preferences.
Results:
In total, data for 4,762 patients were analyzed; within that population, 1,486 (31%) were intubated within a 24-hour window, and 3,276 (69%) were not. The area under the receiver operating characteristic curve and F1 scores for intubation within a 24-hour window were 0.829 (95% CI, 0.801–0.878) and 0.654 (95% CI, 0.627–0.681), respectively. The Shapley values identified lactate level after initial fluids, suspected lung infection, initial pH, Sequential Organ Failure Assessment score at enrollment, and respiratory rate at enrollment as important features for prediction.
Conclusions
An extreme gradient boosting machine can moderately discriminate whether intubation is warranted within 24 hours of the recognition of septic shock in the ED.

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