1.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.
2.Medial Arterial Calcification and the Risk of Amputation of Diabetic Foot Ulcer in Patients With Diabetic Kidney Disease
Joon Myeong SO ; Ji Ho PARK ; Jin Gyeong KIM ; Il Rae PARK ; Eun Yeong HA ; Seung Min CHUNG ; Jun Sung MOON ; Chul Hyun PARK ; Woo-Sung YUN ; Tae-Gon KIM ; Woong KIM ; Ji Sung YOON ; Kyu Chang WON ; Hyoung Woo LEE
Journal of Korean Medical Science 2023;38(21):e160-
We assessed the risk factors for major amputation of diabetic foot ulcers (DFUs) in patients with diabetic kidney disease (DKD) stages 3b–5. For DFU assessment, in addition to DFU location and presence of infection, ischemia, and neuropathy, vascular calcification was assessed using the medial arterial calcification (MAC) score. Of 210 patients, 26 (12.4%) underwent major amputations. Only the location and extension of DFU, represented by Texas grade differed between the minor and major amputation groups. However, after adjusting for covariates, ulcer location of mid- or hindfoot (vs. forefoot, odds ratio [OR] = 3.27), Texas grades 2 or 3 (vs. grade 0, OR = 5.78), and severe MAC (vs. no MAC, OR = 4.46) was an independent risk factor for major amputation (all P < 0.05). The current use of antiplatelets was a possible protective factor for major amputations (OR = 0.37, P = 0.055). In conclusion, DFU with severe MAC is associated with major amputation in patients with DKD.
3.Correlation of oocyte number with serum anti-Müllerian hormone levels measured by either Access or Elecsys in fresh in vitro fertilization cycles
Hye Gyeong JEONG ; Seul Ki KIM ; Jung Ryeol LEE ; Byung Chul JEE
Clinical and Experimental Reproductive Medicine 2022;49(3):202-209
Objective:
The aim of this study was to assess the correlation of oocyte number with serum anti-Müllerian hormone (AMH) levels measured by two automated methods (Access or Elecsys) in fresh stimulated in vitro fertilization (IVF) cycles.
Methods:
In this retrospective study at a university hospital, data were collected from 243 fresh stimulated IVF cycles performed from August 2016 to December 2020. The serum AMH level was measured by Access in 120 cycles and by Elecsys in 123 cycles. The cut-off of serum AMH for prediction of poor responders (three or fewer oocytes) or high responders (15 or more oocytes) was calculated by the receiver operating characteristic curve analysis.
Results:
For the two automated methods, the following equations were derived: total oocyte number=2.378+1.418×(Access-AMH) (r=0.645, p<0.001) and total oocyte number=2.417+2.163×(Elecsys-AMH) (r=0.686, p<0.001). The following combined equation could be derived: (Access-AMH)=0.028+1.525×(Elecsys-AMH). To predict poor responders, the cut-off of Access-AMH was 1.215 ng/mL (area under the curve [AUC], 0.807; 95% confidence interval [CI], 0.730–0.884; p<0.001), and the cut-off of Elecsys-AMH was 1.095 ng/mL (AUC, 0.848; 95% CI, 0.773–0.923; p<0.001). To predict high responders, the cut-off of Access-AMH was 3.450 ng/mL (AUC, 0.922; 95% CI, 0.862–0.981; p<0.001), and the cut-off of Elecsys-AMH was 2.500 ng/mL (AUC, 0.884; 95% CI, 0.778–0.991; p<0.001).
Conclusion
Both automated methods for serum AMH measurement showed a good correlation with oocyte number and good performance for predicting poor and high responders in fresh stimulated IVF cycles. The Access method usually yielded higher measured serum AMH levels than the Elecsys method.
4.Diffusion-Weighted Imaging-Alone Endovascular Thrombectomy Triage in Acute Stroke: Simulating Diffusion-Perfusion Mismatch Using Machine Learning
Yoon-Chul KIM ; Woo-Keun SEO ; In-Young BAEK ; Ji-Eun LEE ; Ha-Na SONG ; Jong-Won CHUNG ; Chi Kyung KIM ; Kyungmi OH ; Sang-il SUH ; Oh Young BANG ; Gyeong-Moon KIM ; Jeffrey L. SAVER ; David S. LIEBESKIND
Journal of Stroke 2022;24(1):148-151
5.Multidetector computed tomography-based evaluation of gastric volumes in patients with out-of-hospital cardiac arrest
Jung-Ju LEE ; Hyun-Jeong PARK ; Gyeong-Gyu YU ; Young-Min KIM ; Sang-Chul KIM ; Jee-Han LEE ; Hyun-Seok CHAI ; Gwan-Jin PARK ; Suk-Woo LEE ; Hoon KIM
Journal of the Korean Society of Emergency Medicine 2022;33(6):532-542
Objective:
Resuscitation-related gastric inflation is associated with inadequate ventilation and the risk of gastric regurgitation in out-of-hospital cardiac arrest (OHCA) patients. This study aims to estimate resuscitation-related gastric inflation values by using multi-detector computed tomography (MDCT) scanning.
Methods:
MDCT imaging data were obtained from OHCA patients undergoing resuscitation from January 2014 to December 2020. Thirty age- and sex-matched healthy controls that underwent an MDCT scan were included. Gastric air volume (GAV), total gastric volume (TGV), and GAV/gastric content volume (GCV) ratio values were estimated.
Results:
In healthy controls (n=30), GAV and TGV values were in the range 5.0-35.0 mL, and 202.0-1,002.0 mL, respectively. The mean GAV and TGV values of OHCA patients (n=97) were 251.0 mL (range, 55.5-896.0) and 878.0 mL (range, 430.5-1,696.0), respectively. Significant between-group differences were determined in the mean GCV, GAV, and GAV/GCV ratio values. In OHCA patients, the cut-off value for abnormal GAV was defined as 56.5 mL (mean value plus two times standard deviation). Patients with abnormal GAV findings on MDCT scans had a longer duration from arrest to the return of spontaneous circulation, low body mass index, and increased rates of lactic acidosis.
Conclusion
Our results indicate an association between gastric air accumulation after resuscitation with longer recovery from arrest to return of spontaneous circulation, low body mass index, and increased lactic acidosis.
6.Multicenter retrospective analysis of patients with chronic lymphocytic leukemia in Korea
Jun Ho YI ; Gyeong-Won LEE ; Ji Hyun LEE ; Kwai Han YOO ; Chul Won JUNG ; Dae Sik KIM ; Jeong-Ok LEE ; Hyeon Seok EOM ; Ja Min BYUN ; Youngil KOH ; Sung Soo YOON ; Jin Seok KIM ; Jee Hyun KONG ; Ho-Young YHIM ; Deok-Hwan YANG ; Dok Hyun YOON ; Do Hyoung LIM ; Won-Sik LEE ; Ho-Jin SHIN
Blood Research 2021;56(4):243-251
Background:
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia in Western countries but is rare in the East Asian countries. Due to its rarity and the lack of feasible novel agents and laboratory prognostic tools, there are limited data on the clinical outcomes of this disease in Asia. To clarify the current treatment status, we performed a multicenter retrospective analysis of patients with CLL in Korea.
Methods:
The medical records of 192 eligible patients between 2008 and 2019 were reviewed for clinical characteristics, treatment courses, and outcomes. The first-line treatment regimens of the patients included in this analysis were as follows: fludarabine/cyclophosphamide/rituximab (FCR) (N=117, 52.7%), obinutuzumab plus chlorambucil (GC) (N=30, 13.5%), and chlorambucil monotherapy (N=24, 10.8%).
Results:
The median progression-free survival (PFS) was 55.6 months, and the average 2-year PFS rate was 80.3%. PFS was not significantly different between the patients receiving FCR and those receiving GC; however, chlorambucil treatment was associated with significantly inferior PFS (P <0.001). The median overall survival was 136.3 months, and the average 5- and 10-year OS rates were 82.0% and 57.4%, respectively.
Conclusion
This is one of the largest studies involving Korean patients with CLL. Although the patients had been treated with less favored treatment regimens, the outcomes were not different from those reported in Western studies.
7.A multicenter study of interobserver variability in pathologic diagnosis of papillary breast lesions on core needle biopsy with WHO classification
Hye Ju KANG ; Sun Young KWON ; Ahrong KIM ; Woo Gyeong KIM ; Eun Kyung KIM ; Ae Ree KIM ; Chungyeul KIM ; Soo Kee MIN ; So Young PARK ; Sun Hee SUNG ; Hye Kyoung YOON ; Ahwon LEE ; Ji Shin LEE ; Hyang Im LEE ; Ho Chang LEE ; Sung Chul LIM ; Sun Young JUN ; Min Jung JUNG ; Chang Won JUNG ; Soo Youn CHO ; Eun Yoon CHO ; Hye Jeong CHOI ; So Yeon PARK ; Jee Yeon KIM ; In Ae PARK ; Youngmee KWON
Journal of Pathology and Translational Medicine 2021;55(6):380-387
Background:
Papillary breast lesions (PBLs) comprise diverse entities from benign and atypical lesions to malignant tumors. Although PBLs are characterized by a papillary growth pattern, it is challenging to achieve high diagnostic accuracy and reproducibility. Thus, we investigated the diagnostic reproducibility of PBLs in core needle biopsy (CNB) specimens with World Health Organization (WHO) classification.
Methods:
Diagnostic reproducibility was assessed using interobserver variability (kappa value, κ) and agreement rate in the pathologic diagnosis of 60 PBL cases on CNB among 20 breast pathologists affiliated with 20 medical institutions in Korea. This analysis was performed using hematoxylin and eosin (H&E) staining and immunohistochemical (IHC) staining for cytokeratin 5 (CK5) and p63. The pathologic diagnosis of PBLs was based on WHO classification, which was used to establish simple classifications (4-tier, 3-tier, and 2-tier).
Results:
On WHO classification, H&E staining exhibited ‘fair agreement’ (κ = 0.21) with a 47.0% agreement rate. Simple classifications presented improvement in interobserver variability and agreement rate. IHC staining increased the kappa value and agreement rate in all the classifications. Despite IHC staining, the encapsulated/solid papillary carcinoma (EPC/SPC) subgroup (κ = 0.16) exhibited lower agreement compared to the non-EPC/SPC subgroup (κ = 0.35) with WHO classification, which was similar to the results of any other classification systems.
Conclusions
Although the use of IHC staining for CK5 and p63 increased the diagnostic agreement of PBLs in CNB specimens, WHO classification exhibited a higher discordance rate compared to any other classifications. Therefore, this result warrants further intensive consensus studies to improve the diagnostic reproducibility of PBLs with WHO classification.
8.The Largest Uterine Leiomyoma Removed by RoboticAssisted Laparoscopy in the Late Reproductive Age: A Case Report
Hye Gyeong JEONG ; Min Jung LEE ; Jung Ryeol LEE ; Byung Chul JEE ; Seul Ki KIM
Journal of Menopausal Medicine 2021;27(1):37-41
Uterine leiomyoma is a very common gynecological tumor in the reproductive years. Recent studies have shown that surgical treatment of uterine leiomyoma using robotic-assisted laparoscopic myomectomy (RALM) is associated with significantly fewer complications, lower estimated blood loss, fewer conversions, and less bleeding than conventional laparoscopic myomectomy. This study reports the case of a giant uterine leiomyoma treated using RALM. A 50-year-old woman was referred to our outpatient clinic with progressive abdominal distension. Ultrasonography and magnetic resonance imaging were performed and showed a markedly enlarged uterus containing a 28-cm uterine myoma. RALM confirmed the 28-cm subserosal myoma on the posterior wall of the uterus. The myoma was enucleated, and the myometrial and serosal defect was repaired with a continuous suture using barbed suture materials. The entire myoma was removed using an electric morcellator. The operation lasted for 190 minutes. The total weight of the removed myoma was 3,262 g, and uterine leiomyoma was pathologically diagnosed. There were no postoperative complications. Although the treatment of huge myomas using RALM is controversial and technically demanding, we successfully performed RALM in a patient with a large myoma. This case confirms the efficiency, reliability, and safety of a robotic-assisted laparoscopic approach for removing a huge myoma. In a well-selected case, RALM can be performed by experienced surgeons regardless of the size of fibroids.
9.How Cerebral Vessel Tortuosity Affects Development and Recurrence of Aneurysm: Outer Curvature versus Bifurcation Type
Hyung Jun KIM ; Ha-Na SONG ; Ji-Eun LEE ; Yoon-Chul KIM ; In-Young BAEK ; Ye-Sel KIM ; Jong-Won CHUNG ; Tae Keun JEE ; Je Young YEON ; Oh Young BANG ; Gyeong-Moon KIM ; Keon-Ha KIM ; Jong-Soo KIM ; Seung-Chyul HONG ; Woo-Keun SEO ; Pyeong JEON
Journal of Stroke 2021;23(2):213-222
Background:
and Purpose Previous studies have assessed the relationship between cerebral vessel tortuosity and intracranial aneurysm (IA) based on two-dimensional brain image analysis. We evaluated the relationship between cerebral vessel tortuosity and IA according to the hemodynamic location using three-dimensional (3D) analysis and studied the effect of tortuosity on the recurrence of treated IA.
Methods:
We collected clinical and imaging data from patients with IA and disease-free controls. IAs were categorized into outer curvature and bifurcation types. Computerized analysis of the images provided information on the length of the arterial segment and tortuosity of the cerebral arteries in 3D space.
Results:
Data from 95 patients with IA and 95 controls were analyzed. Regarding parent vessel tortuosity index (TI; P<0.01), average TI (P<0.01), basilar artery (BA; P=0.02), left posterior cerebral artery (P=0.03), both vertebral arteries (VAs; P<0.01), and right internal carotid artery (P<0.01), there was a significant difference only in the outer curvature type compared with the control group. The outer curvature type was analyzed, and the occurrence of an IA was associated with increased TI of the parent vessel, average, BA, right middle cerebral artery, and both VAs in the logistic regression analysis. However, in all aneurysm cases, recanalization of the treated aneurysm was inversely associated with increased TI of the parent vessels.
Conclusions
TIs of intracranial arteries are associated with the occurrence of IA, especially in the outer curvature type. IAs with a high TI in the parent vessel showed good outcomes with endovascular treatment.
10.The Largest Uterine Leiomyoma Removed by RoboticAssisted Laparoscopy in the Late Reproductive Age: A Case Report
Hye Gyeong JEONG ; Min Jung LEE ; Jung Ryeol LEE ; Byung Chul JEE ; Seul Ki KIM
Journal of Menopausal Medicine 2021;27(1):37-41
Uterine leiomyoma is a very common gynecological tumor in the reproductive years. Recent studies have shown that surgical treatment of uterine leiomyoma using robotic-assisted laparoscopic myomectomy (RALM) is associated with significantly fewer complications, lower estimated blood loss, fewer conversions, and less bleeding than conventional laparoscopic myomectomy. This study reports the case of a giant uterine leiomyoma treated using RALM. A 50-year-old woman was referred to our outpatient clinic with progressive abdominal distension. Ultrasonography and magnetic resonance imaging were performed and showed a markedly enlarged uterus containing a 28-cm uterine myoma. RALM confirmed the 28-cm subserosal myoma on the posterior wall of the uterus. The myoma was enucleated, and the myometrial and serosal defect was repaired with a continuous suture using barbed suture materials. The entire myoma was removed using an electric morcellator. The operation lasted for 190 minutes. The total weight of the removed myoma was 3,262 g, and uterine leiomyoma was pathologically diagnosed. There were no postoperative complications. Although the treatment of huge myomas using RALM is controversial and technically demanding, we successfully performed RALM in a patient with a large myoma. This case confirms the efficiency, reliability, and safety of a robotic-assisted laparoscopic approach for removing a huge myoma. In a well-selected case, RALM can be performed by experienced surgeons regardless of the size of fibroids.

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