4.Lazertinib versus Gefitinib as First-Line Treatment for EGFR-mutated Locally Advanced or Metastatic NSCLC: LASER301 Korean Subset
Ki Hyeong LEE ; Byoung Chul CHO ; Myung-Ju AHN ; Yun-Gyoo LEE ; Youngjoo LEE ; Jong-Seok LEE ; Joo-Hang KIM ; Young Joo MIN ; Gyeong-Won LEE ; Sung Sook LEE ; Kyung-Hee LEE ; Yoon Ho KO ; Byoung Yong SHIM ; Sang-We KIM ; Sang Won SHIN ; Jin-Hyuk CHOI ; Dong-Wan KIM ; Eun Kyung CHO ; Keon Uk PARK ; Jin-Soo KIM ; Sang Hoon CHUN ; Jangyoung WANG ; SeokYoung CHOI ; Jin Hyoung KANG
Cancer Research and Treatment 2024;56(1):48-60
Purpose:
This subgroup analysis of the Korean subset of patients in the phase 3 LASER301 trial evaluated the efficacy and safety of lazertinib versus gefitinib as first-line therapy for epidermal growth factor receptor mutated (EGFRm) non–small cell lung cancer (NSCLC).
Materials and Methods:
Patients with locally advanced or metastatic EGFRm NSCLC were randomized 1:1 to lazertinib (240 mg/day) or gefitinib (250 mg/day). The primary endpoint was investigator-assessed progression-free survival (PFS).
Results:
In total, 172 Korean patients were enrolled (lazertinib, n=87; gefitinib, n=85). Baseline characteristics were balanced between the treatment groups. One-third of patients had brain metastases (BM) at baseline. Median PFS was 20.8 months (95% confidence interval [CI], 16.7 to 26.1) for lazertinib and 9.6 months (95% CI, 8.2 to 12.3) for gefitinib (hazard ratio [HR], 0.41; 95% CI, 0.28 to 0.60). This was supported by PFS analysis based on blinded independent central review. Significant PFS benefit with lazertinib was consistently observed across predefined subgroups, including patients with BM (HR, 0.28; 95% CI, 0.15 to 0.53) and those with L858R mutations (HR, 0.36; 95% CI, 0.20 to 0.63). Lazertinib safety data were consistent with its previously reported safety profile. Common adverse events (AEs) in both groups included rash, pruritus, and diarrhoea. Numerically fewer severe AEs and severe treatment–related AEs occurred with lazertinib than gefitinib.
Conclusion
Consistent with results for the overall LASER301 population, this analysis showed significant PFS benefit with lazertinib versus gefitinib with comparable safety in Korean patients with untreated EGFRm NSCLC, supporting lazertinib as a new potential treatment option for this patient population.
5.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
6.Intensive Surveillance for Women With Breast Cancer: A Multicenter Retrospective Study in Korea
Sungmin PARK ; Hyeong-Gon MOON ; Jong Won LEE ; Ku Sang KIM ; Zisun KIM ; So-Youn JUNG ; Jihyoun LEE ; Se Kyung LEE ; Byung Joo CHAE ; Sung Ui JUNG ; Jung Whan CHUN ; Jong-Ho CHEUN ; Hyun Jo YOUN
Journal of Breast Cancer 2024;27(4):235-247
Purpose:
This study evaluated the effectiveness of different surveillance intensities on morbidity and mortality in women with breast cancer.
Methods:
This retrospective study included patients who had undergone breast cancer surgery in the Republic of Korea between 2009 and 2011. The patients were divided into two groups based on the intensity of their postsurgical surveillance: intensive surveillance group (ISG) and less-intensive surveillance group. Surveillance intensity was measured based on the frequency and type of follow-up diagnostic tests conducted, including mammography, ultrasonography, computed tomography, magnetic resonance imaging, bone scans, and positron emission tomography scans.
Results:
We included 1,356 patients with a median follow-up period of 121.2 months (range, 12.8–168.0 months). The analysis revealed no significant difference in the overall survival (OS) between the two groups within five years of surgery. However, patients with ISG exhibited significantly better breast cancer-specific survival (BCSS) and distant metastasisfree survival (DMFS) within the same period. Five years after surgery, the differences in survival outcomes between the groups were not statistically significant.
Conclusion
Intensive surveillance did not demonstrate a significant improvement in OS for patients with breast cancer beyond five years postoperatively. However, within the first five years, intensive surveillance was associated with better BCSS and DMFS. These findings suggest that personalized surveillance strategies may benefit specific patient subsets, particularly in the early years after treatment. Further nationwide randomized studies are warranted to refine surveillance guidelines and optimize outcomes in patients with breast cancer.
7.Omission of Breast Surgery in Predicted Pathologic Complete Response after Neoadjuvant Systemic Therapy: A Multicenter, Single-Arm, Non-inferiority Trial
Ji-Jung JUNG ; Jong-Ho CHEUN ; Soo-Yeon KIM ; Jiwon KOH ; Jai Min RYU ; Tae-Kyung YOO ; Hee-Chul SHIN ; Sung Gwe AHN ; Seho PARK ; Woosung LIM ; Sang-Eun NAM ; Min Ho PARK ; Ku Sang KIM ; Taewoo KANG ; Jeeyeon LEE ; Hyun Jo YOUN ; Yoo Seok KIM ; Chang Ik YOON ; Hong-Kyu KIM ; Hyeong-Gon MOON ; Wonshik HAN ; Nariya CHO ; Min Kyoon KIM ; Han-Byoel LEE
Journal of Breast Cancer 2024;27(1):61-71
Purpose:
Advances in chemotherapeutic and targeted agents have increased pathologic complete response (pCR) rates after neoadjuvant systemic therapy (NST). Vacuum-assisted biopsy (VAB) has been suggested to accurately evaluate pCR. This study aims to confirm the non-inferiority of the 5-year disease-free survival of patients who omitted breast surgery when predicted to have a pCR based on breast magnetic resonance imaging (MRI) and VAB after NST, compared with patients with a pCR who had undergone breast surgery in previous studies.
Methods
The Omission of breast surgery for PredicTed pCR patients wIth MRI and vacuumassisted bIopsy in breaST cancer after neoadjuvant systemic therapy (OPTIMIST) trial is a prospective, multicenter, single-arm, non-inferiority study enrolling in 17 tertiary care hospitals in the Republic of Korea. Eligible patients must have a clip marker placed in the tumor and meet the MRI criteria suggesting complete clinical response (post-NST MRI size ≤ 1 cm and lesion-to-background signal enhancement ratio ≤ 1.6) after NST. Patients will undergo VAB, and breast surgery will be omitted for those with no residual tumor. Axillary surgery can also be omitted if the patient was clinically node-negative before and after NST and met the stringent criteria of MRI size ≤ 0.5 cm. Survival and efficacy outcomes are evaluated over five years.Discussion: This study seeks to establish evidence for the safe omission of breast surgery in exceptional responders to NST while minimizing patient burden. The trial will address concerns about potential undertreatment due to false-negative results and recurrence as well as improved patient-reported quality of life issues from the omission of surgery. Successful completion of this trial may reshape clinical practice for certain breast cancer subtypes and lead to a safe and less invasive approach for selected patients.
8.2023 Korean Society of Echocardiography position paper for diagnosis and management of valvular heart disease, part I: aortic valve disease
Sun Hwa LEE ; Se‑Jung YOON ; Byung Joo SUN ; Hyue Mee KIM ; Hyung Yoon KIM ; Sahmin LEE ; Chi Young SHIM ; Eun Kyoung KIM ; Dong‑Hyuk CHO ; Jun‑Bean PARK ; Jeong‑Sook SEO ; Jung‑Woo SON ; In‑Cheol KIM ; Sang‑Hyun LEE ; Ran HEO ; Hyun‑Jung LEE ; Jae‑Hyeong PARK ; Jong‑Min SONG ; Sang‑Chol LEE ; Hyungseop KIM ; Duk‑Hyun KANG ; Jong‑Won HA ; Kye Hun KIM ;
Journal of Cardiovascular Imaging 2024;32(1):11-
This manuscript represents the official position of the Korean Society of Echocardiography on valvular heart diseases.This position paper focuses on the clinical management of valvular heart diseases with reference to the guidelines recently published by the American College of Cardiology/American Heart Association and the European Society of Cardiology. The committee tried to reflect the recently published results on the topic of valvular heart diseases and Korean data by a systematic literature search based on validity and relevance. In part I of this article, we will review and discuss the current position of aortic valve disease in Korea.
9.2023 Korean Society of Echocardiography position paper for the diagnosis and management of valvular heart disease, part II: mitral and tricuspid valve disease
Chi Young SHIM ; Eun Kyoung KIM ; Dong‑Hyuk CHO ; Jun‑Bean PARK ; Jeong‑Sook SEO ; Jung‑Woo SON ; In‑Cheol KIM ; Sang‑Hyun LEE ; Ran HEO ; Hyun‑Jung LEE ; Sahmin LEE ; Byung Joo SUN ; Se‑Jung YOON ; Sun Hwa LEE ; Hyung Yoon KIM ; Hyue Mee KIM ; Jae‑Hyeong PARK ; Geu‑Ru HONG ; Hae Ok JUNG ; Yong‑Jin KIM ; Kye Hun KIM ; Duk‑Hyun KANG ; Jong‑Won HA ; Hyungseop KIM ;
Journal of Cardiovascular Imaging 2024;32(1):10-
This manuscript represents the official position of the Korean Society of Echocardiography on valvular heart diseases.This position paper focuses on the diagnosis and management of valvular heart diseases with referring to the guide‑ lines recently published by the American College of Cardiology/American Heart Association and the European Society of Cardiology. The committee sought to reflect national data on the topic of valvular heart diseases published to date through a systematic literature search based on validity and relevance. In the part II of this article, we intend to pre‑ sent recommendations for diagnosis and treatment of mitral valve disease and tricuspid valve disease.
10.Masticatory Function, Sex, and Risk of Dementia Among Older Adults:A Population-Based Cohort Study
Dae Jong OH ; Ji Won HAN ; Jun Sung KIM ; Tae Hui KIM ; Kyung Phil KWAK ; Bong Jo KIM ; Shin Gyeom KIM ; Jeong Lan KIM ; Seok Woo MOON ; Joon Hyuk PARK ; Seung-Ho RYU ; Jong Chul YOUN ; Dong Young LEE ; Dong Woo LEE ; Seok Bum LEE ; Jung Jae LEE ; Jin Hyeong JHOO ; Ki Woong KIM
Journal of Korean Medical Science 2024;39(36):e246-
Background:
A decline in masticatory function may indicate brain dysfunction related to dementia, but the relationship between masticatory function and dementia risk remains unclear. This study aimed to investigate whether masticatory function is associated with the risk of cognitive decline and dementia.
Methods:
Data were obtained from the nationwide prospective cohort study of randomly sampled community-dwelling Koreans aged ≥ 60 years. The 5,064 non-demented participants, whose number of chewing cycles per bite was assessed by clinical interview, were followed for 8 years with biennial assessments of cognitive performance and clinical diagnoses of all-cause dementia and Alzheimer’s disease (AD). Structural brain magnetic resonance imaging was collected from a subset of cohort participants and their spouses for imaging analyses.
Results:
Males who chewed ≥ 30 cycles/bite had faster decline in global cognition and memory function and were at higher risk for incident all-cause dementia (hazard ratio [HR], 2.91; 95% confidence interval [CI], 1.18–7.18) and AD (HR, 3.22; 95% CI, 1.14–9.11) compared to males with less than 10 cycles/bite. Additionally, increased chewing cycles in males were associated with reduced brain volume, particularly in regions involved in compensatory cognitive control of mastication. There was no significant association between chewing cycles and the risk of dementia or brain volume in females.
Conclusion
Older men who frequently chew their meals could be considered a notable population at risk for dementia who should be carefully assessed for their cognitive trajectories.

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