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.Transradial Versus Transfemoral Access for Bifurcation Percutaneous Coronary Intervention Using SecondGeneration Drug-Eluting Stent
Jung-Hee LEE ; Young Jin YOUN ; Ho Sung JEON ; Jun-Won LEE ; Sung Gyun AHN ; Junghan YOON ; Hyeon-Cheol GWON ; Young Bin SONG ; Ki Hong CHOI ; Hyo-Soo KIM ; Woo Jung CHUN ; Seung-Ho HUR ; Chang-Wook NAM ; Yun-Kyeong CHO ; Seung Hwan HAN ; Seung-Woon RHA ; In-Ho CHAE ; Jin-Ok JEONG ; Jung Ho HEO ; Do-Sun LIM ; Jong-Seon PARK ; Myeong-Ki HONG ; Joon-Hyung DOH ; Kwang Soo CHA ; Doo-Il KIM ; Sang Yeub LEE ; Kiyuk CHANG ; Byung-Hee HWANG ; So-Yeon CHOI ; Myung Ho JEONG ; Hyun-Jong LEE
Journal of Korean Medical Science 2024;39(10):e111-
Background:
The benefits of transradial access (TRA) over transfemoral access (TFA) for bifurcation percutaneous coronary intervention (PCI) are uncertain because of the limited availability of device selection. This study aimed to compare the procedural differences and the in-hospital and long-term outcomes of TRA and TFA for bifurcation PCI using secondgeneration drug-eluting stents (DESs).
Methods:
Based on data from the Coronary Bifurcation Stenting Registry III, a retrospective registry of 2,648 patients undergoing bifurcation PCI with second-generation DES from 21 centers in South Korea, patients were categorized into the TRA group (n = 1,507) or the TFA group (n = 1,141). After propensity score matching (PSM), procedural differences, in-hospital outcomes, and device-oriented composite outcomes (DOCOs; a composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) were compared between the two groups (772 matched patients each group).
Results:
Despite well-balanced baseline clinical and lesion characteristics after PSM, the use of the two-stent strategy (14.2% vs. 23.7%, P = 0.001) and the incidence of in-hospital adverse outcomes, primarily driven by access site complications (2.2% vs. 4.4%, P = 0.015), were significantly lower in the TRA group than in the TFA group. At the 5-year follow-up, the incidence of DOCOs was similar between the groups (6.3% vs. 7.1%, P = 0.639).
Conclusion
The findings suggested that TRA may be safer than TFA for bifurcation PCI using second-generation DESs. Despite differences in treatment strategy, TRA was associated with similar long-term clinical outcomes as those of TFA. Therefore, TRA might be the preferred access for bifurcation PCI using second-generation DES.
3.Korean Guidelines for Postpolypectomy Colonoscopic Surveillance: 2022 revised edition
Su Young KIM ; Min Seob KWAK ; Soon Man YOON ; Yunho JUNG ; Jong Wook KIM ; Sun-Jin BOO ; Eun Hye OH ; Seong Ran JEON ; Seung-Joo NAM ; Seon-Young PARK ; Soo-Kyung PARK ; Jaeyoung CHUN ; Dong Hoon BAEK ; Mi-Young CHOI ; Suyeon PARK ; Jeong-Sik BYEON ; Hyung Kil KIM ; Joo Young CHO ; Moon Sung LEE ; Oh Young LEE ; ; ;
Intestinal Research 2023;21(1):20-42
Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for managing advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of the limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: adenoma ≥10 mm in size; 3 to 5 (or more) adenomas; tubulovillous or villous adenoma; adenoma containing high-grade dysplasia; traditional serrated adenoma; sessile serrated lesion containing any grade of dysplasia; serrated polyp of at least 10 mm in size; and 3 to 5 (or more) sessile serrated lesions. More studies are needed to fully comprehend the patients who are most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.
4.Multidisciplinary treatment with immune checkpoint inhibitors for advanced stage hepatocellular carcinoma
Ahlim LEE ; Jaejun LEE ; Hyun YANG ; Soo-Yoon SUNG ; Chang Ho JEON ; Su Ho KIM ; Moon Hyung CHOI ; Young Joon LEE ; Ho Jong CHUN ; Si Hyun BAE
Journal of Liver Cancer 2022;22(1):75-83
Hepatocellular carcinoma (HCC) is a cytotoxic chemotherapy-resistant tumor and most HCCs arise in a background of liver cirrhosis of various causes. Although the IMBrave150 trial showed remarkable advancements in the treatment of unresectable HCC with atezolizumab plus bevacizumab (AteBeva), therapeutic outcomes were unsatisfactory in more than half of the patients. Accordingly, many ongoing trials combine conventional modalities with new drugs such as immune checkpoint inhibitors for better treatment outcomes, and they are expected to benefit patients with limited responses to conventional treatment. Here, two patients with advanced stage HCC with preserved liver function and good performance status showed partial response after treatment with combination or sequential therapy of AteBeva, hepatic arterial infusion chemotherapy, radiation therapy, and transarterial chemoembolization. These findings indicate the efficacy of multidisciplinary treatment against advanced HCC. Additional studies are required to establish optimal treatment strategies.
6.Development of a house dust mite-induced mouse model for allergen-specific immunotherapy in allergic rhinitis
Seok Min KIM ; Ji An KIM ; Hwan Soo KIM ; Jong-Seo YOON ; Hyun Hee KIM ; Yoon Hong CHUN
Allergy, Asthma & Respiratory Disease 2022;10(4):195-201
Purpose:
Allergen-specific immunotherapy (AIT) is the only known curative treatment for allergic diseases. Recently, novel immunotherapies have been developed to overcome the inconvenience and adverse reactions associated with conventional AIT. Validated animal models are essential for screening novel immunotherapies; however, effective models for AIT in allergic rhinitis (AR) are lacking. Herein, we aimed to develop an optimal protocol for AIT using a house dust mite (HDM)-induced AR mouse model.
Methods:
BALB/c mice were intraperitoneally injected with the alum-absorbed HDM extract (5 µg) on days 0, 7, and 14. Sensitized mice were administered three subcutaneous injections of HDM extract (250 µg/100 µL; SCIT group) and phosphate-buffered saline (100 µL; negative and positive control groups) at 2-day intervals. Next, HDM extract (25 µg) was intranasally administered to SCIT and positive control groups for five consecutive days. Nasal symptoms, ear swelling, eosinophil count, antibody levels, and nasal mucosa histopathology were assessed in all groups. Cytokine production was analyzed in the splenocyte culture supernatant.
Results:
Compared with the positive control group, the SCIT group exhibited reduced nasal symptoms, ear swelling, and eosinophil count in nasopharyngeal lavage. Compared with the positive control group, the SCIT group had reduced eosinophil, mast cell, and goblet cell counts in the nasal mucosa. Serum levels of HDM-specific IgG1 were higher in the SCIT group than in the positive control group. The stimulation index of splenocytes was reduced in the SCIT group when compared with that in the positive control group.Compared with the positive control group, the SCIT group exhibited decreased levels of interleukin (IL)-4 and IL-17, whereas those of IL-10 and interferon-gamma levels were increased.
Conclusion
AR mice treated with the AIT-HDM protocol showed attenuated nasal symptoms and improved histopathological findings and cytokine profiles compared with the untreated AR mice. Our findings suggest that the examined model may be useful for screening new AITs.
7.Korean guidelines for postpolypectomy colonoscopic surveillance: 2022 revised edition
Su Young KIM ; Min Seob KWAK ; Soon Man YOON ; Yunho JUNG ; Jong Wook KIM ; Sun-Jin BOO ; Eun Hye OH ; Seong Ran JEON ; Seung-Joo NAM ; Seon-Young PARK ; Soo-Kyung PARK ; Jaeyoung CHUN ; Dong Hoon BAEK ; Mi-Young CHOI ; Suyeon PARK ; Jeong-Sik BYEON ; Hyung Kil KIM ; Joo Young CHO ; Moon Sung LEE ; Oh Young LEE ; ; ;
Clinical Endoscopy 2022;55(6):703-725
Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for the management of advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: (1) adenoma ≥10 mm in size; (2) 3 to 5 (or more) adenomas; (3) tubulovillous or villous adenoma; (4) adenoma containing high-grade dysplasia; (5) traditional serrated adenoma; (6) sessile serrated lesion (SSL) containing any grade of dysplasia; (7) serrated polyp of at least 10 mm in size; and (8) 3 to 5 (or more) SSLs. More studies are needed to fully comprehend the patients most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.
8.Korean Guidelines for Postpolypectomy Colonoscopic Surveillance: 2022 Revised Edition
Su Young KIM ; Min Seob KWAK ; Soon Man YOON ; Yunho JUNG ; Jong Wook KIM ; Sun-Jin BOO ; Eun Hye OH ; Seong Ran JEON ; Seung-Joo NAM ; Seon-Young PARK ; Soo-Kyung PARK ; Jaeyoung CHUN ; Dong Hoon BAEK ; Mi-Young CHOI ; Suyeon PARK ; Jeong-Sik BYEON ; Hyung Kil KIM ; Joo Young CHO ; Moon Sung LEE ; Oh Young LEE ; The Korean Society of Gastrointestinal Endoscopy, The Korean Society of Gastroenterology, Korean Ass
The Korean Journal of Gastroenterology 2022;80(3):115-134
Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for managing advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of the limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: 1) adenoma ≥10 mm in size; 2) 3-5 (or more) adenomas; 3) tubulovillous or villous adenoma; 4) adenoma containing high-grade dysplasia; 5) traditional serrated adenoma; 6) sessile serrated lesion (SSL) containing any grade of dysplasia; 7) serrated polyp of at least 10 mm in size; and 8) 3-5 (or more) SSLs. More studies are needed to fully comprehend the patients who are most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.
9.Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis
Myungsu LEE ; Jin Wook CHUNG ; Kwang-Hun LEE ; Jong Yun WON ; Ho Jong CHUN ; Han Chu LEE ; Jin Hyoung KIM ; In Joon LEE ; Saebeom HUR ; Hyo-Cheol KIM ; Yoon Jun KIM ; Gyoung Min KIM ; Seung-Moon JOO ; Jung Suk OH
Korean Journal of Radiology 2021;22(10):1658-1670
Objective:
To assess the two-year treatment outcomes of chemoembolization with drug-eluting embolics (DEE) for nodular hepatocellular carcinoma (HCC).
Materials and Methods:
This study was a prospective, multicenter, registry-based, single-arm trial conducted at five university hospitals in Korea. Patients were recruited between May 2011 and April 2013, with a target population of 200. A DC Bead loaded with doxorubicin was used as the DEE agent. Patients were followed up for two years. Per-patient and perlesion tumor response analysis, per-patient overall survival (OS) and progression-free survival (PFS) analysis, and per-lesion tumor control analysis were performed.
Results:
The final study population included 152 patients, with 207 target lesions for the per-lesion analysis. At one-month, six-month, one-year, and two-year per-patient assessments, complete response (CR) rates were 40.1%, 43.0%, 33.3%, and 19.6%, respectively. The objective response (OR) rates were 91.4%, 55.4%, 35.1%, and 19.6%, respectively. The cumulative two-year OS rate was 79.7%. The cumulative two-year PFS rate was 22.4% and the median survival was 9.3 months. In multivariable analysis, the Child-Pugh score (p = 0.019) was an independent predictor of OS, and tumor multiplicity (p < 0.001), tumor size (p = 0.020), and Child-Pugh score (p = 0.006) were independent predictors of PFS. In per-lesion analysis, one-month, six-month, one-year and two-year CR rates were 57.5%, 58.5%, 45.2%, and 33.3%, respectively, and the OR rates were 84.1%, 65.2%, 46.6%, and 33.3%, respectively. The cumulative two-year per-lesion tumor control rate was 36.2%, and the median time was 14.1 months. The Child-Pugh score (p < 0.001) was the only independent predictor of tumor control. Serious adverse events were reported in 11 patients (7.2%).
Conclusion
DEE chemoembolization for nodular HCCs in the Korean population showed acceptable survival, tumor response, and safety profiles after a two-year follow-up. Good liver function (Child-Pugh score A5) was a key predictor of per-patient OS, PFS, and per-lesion tumor control.
10.A Comparative Study on Aqueous Chitosan Solution and Various Submucosal Injection Fluids Using a Three-Dimensional Sensor
Han Jo JEON ; Seung JEONG ; Hyuk Soon CHOI ; Se Hyun JANG ; Sang Hoon KIM ; Seung Han KIM ; Jae Min LEE ; Eun Sun KIM ; Bora KEUM ; Yoon Tae JEEN ; Hong Sik LEE ; Hoon Jai CHUN ; Jong Hoon CHUNG ; Seong Nam KIM
Gut and Liver 2021;15(2):217-224
Background/Aims:
Chitosan, a natural polymer widely used in the biomaterials field, has been proposed as a potential submucosal injection solution. The purpose of this study was to compare the performance and efficacy of aqueous chitosan solution and commercialized submucosal injection fluids using a three-dimensional sensor and to evaluate the efficacy of the measured parameters.
Methods:
Normal saline (0.9% NaCl), as a control, Eleview ® (Poloxamer 188), Blue Eye TM (0.4% hyaluronic acid), and aqueous chitosan solution (2.0%) were injected into the submucosa of porcine stomachs ex vivo. The mucosal elevation height, elevated surface area, and angle of the tangent of the submucosal fluid cushion were measured using a three-dimensional sensor. The rates of change for each variable were calculated, and the correlation between parameters was analyzed. Tissue specimens were stained with hematoxylin and eosin.
Results:
All variables exhibited the highest values under chitosan injection. The mucosal elevation height rate of change differed significantly between normal saline and chitosan solution (p=0.024). The elevated surface area rates of change for normal saline and Eleview® were significantly different from those for TS-905 and chitosan solution (p=0.006 and p=0.009, respectively). Further, height, area, and angle showed a positive correlation (p<0.001). A histological examination revealed an even distribution of aqueous chitosan within the submucosa without tissue damage.
Conclusions
Aqueous chitosan was superior to normal saline and Eleview® and was noninferior to TS-905. A three-dimensional sensor and the measured parameters were effective and useful for evaluating the performance of submucosal fluids.

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