1.Clinical Practice Recommendations for the Use of Next-Generation Sequencing in Patients with Solid Cancer: A Joint Report from KSMO and KSP
Miso KIM ; Hyo Sup SHIM ; Sheehyun KIM ; In Hee LEE ; Jihun KIM ; Shinkyo YOON ; Hyung-Don KIM ; Inkeun PARK ; Jae Ho JEONG ; Changhoon YOO ; Jaekyung CHEON ; In-Ho KIM ; Jieun LEE ; Sook Hee HONG ; Sehhoon PARK ; Hyun Ae JUNG ; Jin Won KIM ; Han Jo KIM ; Yongjun CHA ; Sun Min LIM ; Han Sang KIM ; Choong-kun LEE ; Jee Hung KIM ; Sang Hoon CHUN ; Jina YUN ; So Yeon PARK ; Hye Seung LEE ; Yong Mee CHO ; Soo Jeong NAM ; Kiyong NA ; Sun Och YOON ; Ahwon LEE ; Kee-Taek JANG ; Hongseok YUN ; Sungyoung LEE ; Jee Hyun KIM ; Wan-Seop KIM
Cancer Research and Treatment 2024;56(3):721-742
In recent years, next-generation sequencing (NGS)–based genetic testing has become crucial in cancer care. While its primary objective is to identify actionable genetic alterations to guide treatment decisions, its scope has broadened to encompass aiding in pathological diagnosis and exploring resistance mechanisms. With the ongoing expansion in NGS application and reliance, a compelling necessity arises for expert consensus on its application in solid cancers. To address this demand, the forthcoming recommendations not only provide pragmatic guidance for the clinical use of NGS but also systematically classify actionable genes based on specific cancer types. Additionally, these recommendations will incorporate expert perspectives on crucial biomarkers, ensuring informed decisions regarding circulating tumor DNA panel testing.
2.Adjuvant Pembrolizumab in Patients with Stage IIIA/N2 Non–Small Cell Lung Cancer Completely Resected after Neoadjuvant Concurrent Chemoradiation: A Prospective, Open-Label, Single-Arm, Phase 2 Trial
Junghoon SHIN ; Sehhoon PARK ; Kyung Hwan KIM ; Eui-Cheol SHIN ; Hyun Ae JUNG ; Jong Ho CHO ; Jong-Mu SUN ; Se-Hoon LEE ; Yong Soo CHOI ; Jin Seok AHN ; Jhingook KIM ; Keunchil PARK ; Young Mog SHIM ; Hong Kwan KIM ; Jae Myoung NOH ; Yong Chan AHN ; Hongryull PYO ; Myung-Ju AHN
Cancer Research and Treatment 2024;56(4):1084-1095
Purpose:
Optimal treatment for stage IIIA/N2 non–small cell lung cancer (NSCLC) is controversial. We aimed to assess the efficacy and safety of adjuvant pembrolizumab for stage IIIA/N2 NSCLC completely resected after neoadjuvant concurrent chemoradiation therapy (CCRT).
Materials and Methods:
In this open-label, single-center, single-arm phase 2 trial, patients with stage IIIA/N2 NSCLC received adjuvant pembrolizumab for up to 2 years after complete resection following neoadjuvant CCRT. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. As an exploratory biomarker analysis, we evaluated the proliferative response of blood CD39+PD-1+CD8+ T cells using fold changes in the percentage of proliferating Ki-67+ cells from days 1 to 7 of cycle 1 (Ki-67D7/D1).
Results:
Between October 2017 and October 2018, 37 patients were enrolled. Twelve (32%) and three (8%) patients harbored EGFR and ALK alterations, respectively. Of 34 patients with programmed cell death ligand 1 assessment, 21 (62%), nine (26%), and four (12%) had a tumor proportion score of < 1%, 1%-50%, and ≥ 50%, respectively. The median follow-up was 71 months. The median DFS was 22.4 months in the overall population, with a 5-year DFS rate of 29%. The OS rate was 86% at 2 years and 76% at 5 years. Patients with tumor recurrence within 6 months had a significantly lower Ki-67D7/D1 among CD39+PD-1+CD8+ T cells than those without (p=0.036). No new safety signals were identified.
Conclusion
Adjuvant pembrolizumab may offer durable disease control in a subset of stage IIIA/N2 NSCLC patients after neoadjuvant CCRT and surgery.
3.Effect of the human papillomavirus vaccine on the risk of genital warts: a nationwide cohort study of Korean adolescent girls
Jaeyoung CHO ; Eun Mi KIM ; Jihye KIM ; Ju-Young SHIN ; Eui Hyeok KIM ; Jong Heon PARK ; Seunghyun Lewis KWON ; Geun-Yong KWON ; Soon-Ae SHIN ; Jaiyong KIM
Epidemiology and Health 2024;46(1):e2024040-
OBJECTIVES:
The purpose of this study was to assess the effectiveness of human papillomavirus (HPV) vaccination administered to adolescent girls through Korea’s National Immunization Program.
METHODS:
This retrospective cohort study included patients who were 12-13 years old, whether vaccinated or unvaccinated, between July 2016 and December 2017. The incidence of genital warts (GWs) was monitored through 2021. Time-stratified hazard ratios (HRs) were estimated, adjusting for birth year, socioeconomic status, and the level of urbanization of the region, and were presented with 95% confidence intervals (CIs). Data were sourced from the Immunization Registry Integration System, linked with the National Health Information Database.
RESULTS:
The study included 332,062 adolescent girls, with an average follow-up period of approximately 4.6 years. Except for the first year, the HRs for the vaccinated group were lower than those for the unvaccinated group. The HRs for specific cut-off years were as follows: year 2, 0.62 (95% CI, 0.31 to 1.13); year 3, 0.58 (95% CI, 0.35 to 0.96); and year 4 and beyond, 0.39 (95% CI, 0.28 to 0.52).
CONCLUSIONS
Our findings indicate that HPV vaccination was associated with a reduction in the risk of GWs among adolescent girls. Notably, this reduction became significant as the incidence of GWs increased with age.
4.Newly Developed Sex-Specific Z Score Model for Coronary Artery Diameter in a Pediatric Population
Jeong Jin YU ; Hee Joung CHOI ; Hwa Jin CHO ; Sung Hye KIM ; Eun Jung CHEON ; Gi Beom KIM ; Lucy Youngmin EUN ; Se Yong JUNG ; Hyun Ok JUN ; Hyang-Ok WOO ; Sin-Ae PARK ; Soyoung YOON ; Hoon KO ; Ji-Eun BAN ; Jong-Woon CHOI ; Min Seob SONG ; Ji Whan HAN
Journal of Korean Medical Science 2024;39(16):e144-
Background:
This study aimed to generate a Z score calculation model for coronary artery diameter of normal children and adolescents to be adopted as the standard calculation method with consensus in clinical practice.
Methods:
This study was a retrospective, multicenter study that collected data from multiple institutions across South Korea. Data were analyzed to determine the model that best fit the relationship between the diameter of coronary arteries and independent demographic parameters. Linear, power, logarithmic, exponential, and square root polynomial models were tested for best fit.
Results:
Data of 2,030 subjects were collected from 16 institutions. Separate calculation models for each sex were developed because the impact of demographic variables on the diameter of coronary arteries differs according to sex. The final model was the polynomial formula with an exponential relationship between the diameter of coronary arteries and body surface area using the DuBois formula.
Conclusion
A new coronary artery diameter Z score model was developed and is anticipated to be applicable in clinical practice. The new model will help establish a consensus-based Z score model.
5.Clinical practice recommendations for the use of next-generation sequencing in patients with solid cancer: a joint report from KSMO and KSP
Miso KIM ; Hyo Sup SHIM ; Sheehyun KIM ; In Hee LEE ; Jihun KIM ; Shinkyo YOON ; Hyung-Don KIM ; Inkeun PARK ; Jae Ho JEONG ; Changhoon YOO ; Jaekyung CHEON ; In-Ho KIM ; Jieun LEE ; Sook Hee HONG ; Sehhoon PARK ; Hyun Ae JUNG ; Jin Won KIM ; Han Jo KIM ; Yongjun CHA ; Sun Min LIM ; Han Sang KIM ; Choong-Kun LEE ; Jee Hung KIM ; Sang Hoon CHUN ; Jina YUN ; So Yeon PARK ; Hye Seung LEE ; Yong Mee CHO ; Soo Jeong NAM ; Kiyong NA ; Sun Och YOON ; Ahwon LEE ; Kee-Taek JANG ; Hongseok YUN ; Sungyoung LEE ; Jee Hyun KIM ; Wan-Seop KIM
Journal of Pathology and Translational Medicine 2024;58(4):147-164
In recent years, next-generation sequencing (NGS)–based genetic testing has become crucial in cancer care. While its primary objective is to identify actionable genetic alterations to guide treatment decisions, its scope has broadened to encompass aiding in pathological diagnosis and exploring resistance mechanisms. With the ongoing expansion in NGS application and reliance, a compelling necessity arises for expert consensus on its application in solid cancers. To address this demand, the forthcoming recommendations not only provide pragmatic guidance for the clinical use of NGS but also systematically classify actionable genes based on specific cancer types. Additionally, these recommendations will incorporate expert perspectives on crucial biomarkers, ensuring informed decisions regarding circulating tumor DNA panel testing.
6.Efficacy and Safety of Nasolabial Fold Correction Using Collagen-Stimulating Filler:A Systematic Review and Meta-Analysis
Chang Yong KIM ; Ji Won LIM ; Jae Young SUNG ; Young Ah CHO ; Yang Won LEE ; Yong Beom CHOE ; Da-Ae YU
Korean Journal of Dermatology 2024;62(5):269-278
Background:
Nasolabial folds (NLFs) constitute a pivotal aspect of facial aesthetics and are the primary focal points in facial rejuvenation procedures. Collagen-stimulating fillers have gained popularity due to their long-lasting effects and biocompatibility.
Objective:
This study aimed to comprehensively evaluate the therapeutic efficacy and safety profiles of collagenstimulating fillers for NLF correction.
Methods:
A thorough search of the databases including PubMed, Embase, and Cochrane was performed. Randomized controlled trials published between 2000 and 2023 on the treatment outcomes of collagen-stimulating fillers for NLFs were included. A systematic review and meta-analysis were conducted using the Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS), and adverse events.
Results:
Among the 144 pertinent studies, nine met the inclusion criteria, including 299 participants for polycaprolactone (PCL), 291 for poly L-lactic acid (PLLA), and 382 for calcium hydroxylapatite (CaHA). PCL showed significantly higher improvement in GAIS (risk ratio [RR], 3.14; 95% confidence interval [CI], 2.29∼4.30; p<0.001) and WSRS (mean difference, 0.71; 95% CI, 0.36∼1.06; p<0.001) at a 12-month interval compared with hyaluronic acid (HA). CaHA showed marked 12-month GAIS improvement versus HA (RR, 1.51; 95% CI, 1.21∼1.88; p<0.001). PLLA exhibited superior wrinkle improvement compared with HA at week 24, especially in individuals under 52 years of age. No severe complications occurred.
Conclusion
Collagen-stimulating fillers have the potential to be safe, effective, and long-lasting options for NLF correction. Nevertheless, due to the limited data and heterogeneity among the included studies, cautious interpretation is required. Further high-quality clinical trials are required to validate these findings.
7.Injectable Poloxamer Hydrogel Formulations for Intratympanic Delivery of Dexamethasone
Thi Phuc LE ; Yang YU ; Ik Sung CHO ; Eun Yeong SUH ; Hyuk Chan KWON ; Sun-Ae SHIN ; Yong-Ho PARK ; Kang Moo HUH
Journal of Korean Medical Science 2023;38(17):e135-
Background:
In this study, we prepared and evaluated an injectable poloxamer (P407) hydrogel formulation for intratympanic (IT) delivery of dexamethasone (DEX).
Methods:
DEX-loaded P407 hydrogels were characterized in terms of thermogelation, drug loading capacities, particle size, and drug release. The in vivo toxicity and drug absorption of the DEX-loaded P407 formulation after IT injection were evaluated using an animal model by performing histopathological analysis and drug concentration measurements.
Results:
The P407 hydrogel effectively solubilized hydrophobic DEX and demonstrated a sustained release compared to the hydrophilic DEX formulation. The in vivo study showed that the hydrogel formulation delivered considerable drug concentrations to the inner ear and displayed a favorable safety profile without apparent cytotoxicity or inflammation.
Conclusion
P407 hydrogel can be useful as an injectable inner ear delivery formulation for hydrophobic drugs due to their biocompatibility, drug-solubilizing capacity, thermogelation, and controlled release.
8.Reducing Microbial Contamination in Hematopoietic Stem Cell Products and Quality Improvement Strategy: Retrospective Analysis of 1996-2021 Data
You Keun KO ; Jong Kwon LEE ; Hye Kyung PARK ; Ae Kyung HAN ; Sun Kyoung MUN ; Hye Jeong PARK ; Hae Kyoung CHOUNG ; Se Mi KIM ; Kwang Mo CHOI ; Nam Yong LEE ; Duck CHO ; Dae Won KIM ; Eun-Suk KANG
Annals of Laboratory Medicine 2023;43(5):477-484
Background:
Sterility and safety assurance of hematopoietic stem cell (HSC) products is critical in transplantation. Microbial contamination can lead to product disposal and increases the risk of unsuccessful clinical outcomes. Therefore, it is important to implement and maintain good practice guidelines and regulations for the HSC collection and processing unit in each hospital. We aimed to share our experiences and suggest strategies to improve the quality assurance of HSC processing.
Methods:
We retrospectively analyzed microbial culture results of 11,743 HSC products processed over a 25-year period (January 1996 to May 2021). Because of reorganization of the HSC management system in 2008, the 25-year period was divided into periods 1 (January 1996 to December 2007) and 2 (January 2008 to May 2021). We reviewed all culture results of the HSC products and stored aliquot samples and collected culture results for peripheral blood and catheter samples.
Results:
Of the 11,743 products in total, 35 (0.3%) were contaminated by microorganisms, including 19 (0.5%) of 3,861 products during period 1 and 16 (0.2%) of 7,882 products during period 2. Penicillium was the most commonly identified microorganism (15.8%) during period 1 and coagulase-negative Staphylococcus was the most commonly identified (31.3%) during period 2. HSC product contamination occurred most often during HSC collection and processing.
Conclusions
The contamination rate decreased significantly during period 2, when the HSC management system was reorganized. Our results imply that handling HSC products by trained personnel and adopting established protocols, including quality assurance programs, aid in decreasing the contamination risk.
9.Updates of Evidence-Based Nursing Practice Guideline for Prevention of Venous Thromboembolism
Yong Ae CHO ; Young EUN ; Seon Heui LEE ; Mi Yang JEON ; Jin Hee JUNG ; Min Young HAN ; Nari KIM ; Jin Hyung HUH
Journal of Korean Clinical Nursing Research 2023;29(1):24-41
Purpose:
This study aimed to update the previously published nursing practice guideline for prevention of venous thromboembolism (VTE).
Methods:
The guideline was updated according to the manuals developed by National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN), and a Handbook for Clinical Practice Guideline Developer Version 10.
Results:
The updated nursing practice guideline for prevention of VTE was consisted of 16 domains, 46 subdomains, and 216 recommendations. The recommendations in each domain were: 4 general issues, 8 assessment of risk and bleeding factors, 5 interventions for prevention of VTE, 18 mechanical interventions, 36 pharmacological interventions, 36 VTE prevention starategies for medical patients, 25 for cancer patients, 13 for pregnancy, 8 for surgical patients, 7 for thoractic and cardiac surgery, 16 for orthopedic surgery, 10 for cranial and spinal surgery, 5 for vascular surgery, 13 for other surgery, 3 educations and information, and 2 documentation and report. For these recommendations, the level of evidence was 32.1% for level I, 51.8% for level II, and 16.1% for level III according to the infectious diseases society of America (IDSA) rating system. A total of 112 new recommendations were developed and 49 previous recommendations were deleted.
Conclusion
The updated nursing practice guideline for prevention of VTE is expected to serve as an evidence-based practice guideline for prevention of VTE in South Korea. It is recommended that this guideline will disseminate to clinical nursing settings nationwide to improve the effectiveness of prevention of VTE practice.
10.Ticagrelor Monotherapy After 3-Month Dual Antiplatelet Therapy in Acute Coronary Syndrome by High Bleeding Risk: The Subanalysis From the TICO Trial
Yong-Joon LEE ; Yongsung SUH ; Jung-Sun KIM ; Yun-Hyeong CHO ; Kyeong Ho YUN ; Yong Hoon KIM ; Jae Young CHO ; Ae-Young HER ; Sungsoo CHO ; Dong Woon JEON ; Sang-Yong YOO ; Deok-Kyu CHO ; Bum-Kee HONG ; Hyuckmoon KWON ; Sung-Jin HONG ; Chul-Min AHN ; Dong-Ho SHIN ; Chung-Mo NAM ; Byeong-Keuk KIM ; Young-Guk KO ; Donghoon CHOI ; Myeong-Ki HONG ; Yangsoo JANG ; For the TICO investigators
Korean Circulation Journal 2022;52(4):324-337
Background and Objectives:
Identifying patients with high bleeding risk (HBR) is important when making decisions for antiplatelet therapy strategy. This study evaluated the impact of ticagrelor monotherapy after 3-month dual antiplatelet therapy (DAPT) according to HBR in acute coronary syndrome (ACS) patients treated with drug eluting stents (DESs).
Methods:
In this post-hoc analysis of the TICO trial, HBR was defined by 2 approaches: meeting Academic Research Consortium for HBR (ARC-HBR) criteria or Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent DAPT (PRECISEDAPT) score ≥25. The primary outcome was a 3–12 months net adverse clinical event (composite of major bleeding and adverse cardiac and cerebrovascular events).
Results:
Of the 2,980 patients without adverse events during the first 3 months after DES implantation, 453 (15.2%) were HBR by ARC-HBR criteria and 504 (16.9%) were HBR by PRECISE-DAPT score. The primary outcome rate was higher in HBR versus non-HBR patients (by ARC-HBR criteria: hazard ratio [HR], 2.87; 95% confidence interval [CI], 1.76– 4.69; p<0.001; by PRECISE-DAPT score: HR, 3.09; 95% CI, 1.92–4.98; p<0.001). Ticagrelor monotherapy after 3-month DAPT was associated with lower primary outcome rate than ticagrelor-based 12-month DAPT regardless of HBR by ARC-HBR criteria, with similar magnitudes of therapy effect for HBR and non-HBR patients (p-interaction=0.400). Results were consistent by PRECISE-DAPT score (p-interaction=0.178).
Conclusions
In ACS patients treated with DESs, ticagrelor monotherapy after 3-month DAPT was associated with lower rate of adverse clinical outcomes regardless of HBR, with similar magnitudes of therapy effect between HBR and non-HBR.Trial Registration: ClinicalTrials.gov Identifier: NCT02494895

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