1.A Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer
Keun-Wook LEE ; Sae-Won HAN ; Tae Won KIM ; Joong Bae AHN ; Ji Yeon BAEK ; Sang Hee CHO ; Howard LEE ; Jin Won KIM ; Ji-Won KIM ; Tae-You KIM ; Yong Sang HONG ; Seung-Hoon BEOM ; Yongjun CHA ; Yoonjung CHOI ; Seonhui KIM ; Yung-Jue BANG
Cancer Research and Treatment 2024;56(2):590-601
Purpose:
GC1118 is a novel antibody targeting epidermal growth factor receptor (EGFR) with enhanced blocking activity against both low- and high-affinity EGFR ligands. A phase 1b/2a study was conducted to determine a recommended phase 2 dose (RP2D) of GC1118 in combination with 5-fluorouracil, leucovorin, and irinotecan (FOLFIRI) (phase 1b) and to assess the safety and efficacy of GC1118 plus FOLFIRI as a second-line therapy for recurrent/metastatic colorectal cancer (CRC) (phase 2a).
Materials and Methods:
Phase 1b was designed as a standard 3+3 dose-escalation study with a starting dose of GC1118 (3 mg/kg/week) in combination with biweekly FOLFIRI (irinotecan 180 mg/m2; leucovorin 400 mg/m2; 5-fluorouracil 400 mg/m2 bolus and 2,400 mg/m2 infusion over 46 hours) in patients with solid tumors refractory to standard treatments. The subsequent phase 2a part was conducted with objective response rate (ORR) as a primary endpoint. Patients with KRAS/NRAS/BRAF wild-type, EGFR-positive, recurrent/metastatic CRC resistant to the first-line treatment were enrolled in the phase 2a study.
Results:
RP2D of GC1118 was determined to be 3 mg/kg/wk in the phase 1b study (n=7). Common adverse drug reactions (ADRs) observed in the phase 2a study (n=24) were acneiform rash (95.8%), dry skin (66.7%), paronychia (58.3%), and stomatitis (50.0%). The most common ADR of ≥ grade 3 was neutropenia (33.3%). ORR was 42.5% (95% confidence interval [CI], 23.5 to 62.0), and median progression-free survival was 6.7 months (95% CI, 4.0-8.0).
Conclusion
GC1118 administered weekly at 3 mg/kg in combination with FOLFIRI appears as an effective and safe treatment option in recurrent/metastatic CRC.
2.Risk Factors of Postpartum Depression Among Korean Women:An Analysis Based on the Korean Pregnancy Outcome Study (KPOS)
So Hyun SHIM ; Su Young LEE ; Inkyung JUNG ; Seok-Jae HEO ; You Jung HAN ; Dong Wook KWAK ; Min Hyoung KIM ; Hee Jin PARK ; Jin Hoon CHUNG ; Ji Hyae LIM ; Moon Young KIM ; Dong Hyun CHA ; Sung Shin SHIM ; Hee Young CHO ; Hyun Mee RYU
Journal of Korean Medical Science 2024;39(3):e31-
Background:
Postpartum depression (PPD) can negatively affect infant well-being and child development. Although the frequency and risk factors of PPD symptoms might vary depending on the country and culture, there is limited research on these risk factors among Korean women. This study aimed to elucidate the potential risk factors of PPD throughout pregnancy to help improve PPD screening and prevention in Korean women.
Methods:
The pregnant women at 12 gestational weeks (GW) were enrolled from two obstetric specialized hospitals from March 2013 to November 2017. A questionnaire survey was administered at 12 GW, 24 GW, 36 GW, and 4 weeks postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale, and PPD was defined as a score of ≥ 10.
Results:
PPD was prevalent in 16.3% (410/2,512) of the participants. Depressive feeling at 12 GW and postpartum factors of stress, relationship with children, depressive feeling, fear, sadness, and neonatal intensive care unit admission of baby were significantly associated with a higher risk of PPD. Meanwhile, high postpartum quality of life and marital satisfaction at postpartum period were significantly associated with a lower risk of PPD. We developed a model for predicting PPD using factors as mentioned above and it had an area under the curve of 0.871.
Conclusion
Depressive feeling at 12 GW and postpartum stress, fear, sadness, relationship with children, low quality of life, and low marital satisfaction increased the risk of PPD. A risk model that comprises significant factors can effectively predict PPD and can be helpful for its prevention and appropriate treatment.
3.The Effect of Vanishing Twin on Firstand Second-Trimester Maternal Serum Markers and Nuchal Translucency: A Multicenter Prospective Cohort Study
Se Jin LEE ; You Jung HAN ; Minhyoung KIM ; Jae-Yoon SHIM ; Mi-Young LEE ; Soo-young OH ; JoonHo LEE ; Soo Hyun KIM ; Dong Hyun CHA ; Geum Joon CHO ; Han-Sung KWON ; Byoung Jae KIM ; Mi Hye PARK ; Hee Young CHO ; Hyun Sun KO ; Ji Hye BAE ; Chan-Wook PARK ; Joong Shin PARK ; Jong Kwan JUN ; Sohee OH ; Da Rae LEE ; Hyun Mee RYU ; Seung Mi LEE
Journal of Korean Medical Science 2023;38(38):e300-
Background:
The purpose of this study was to evaluate the effect of vanishing twin (VT) on maternal serum marker concentrations and nuchal translucency (NT).
Methods:
This is a secondary analysis of a multicenter prospective cohort study in 12 institutions. Serum concentrations of pregnancy-associated plasma protein-A in the first trimester and alpha-fetoprotein (AFP), total human chorionic gonadotrophin, unconjugated estriol, and inhibin A in the second trimester were measured, and NT was measured between 10 and 14 weeks of gestation.
Results:
Among 6,793 pregnant women, 5,381 women were measured for serum markers in the first or second trimester, including 65 cases in the VT group and 5,316 cases in the normal singleton group. The cases in the VT group had a higher median multiple of the median value of AFP and inhibin A than the normal singleton group. The values of other serum markers and NT were not different between the two groups. After the permutation test with adjustment,AFP and inhibin A remained significant differences. The frequency of abnormally increased AFP was also higher in the VT group than in the normal singleton group.
Conclusion
VT can be considered as an adjustment factor for risk assessment in the secondtrimester serum screening test.
4.Successful Simultaneous Treatment of Benign Stricture and Colonic Neoplasm Arising from Colonic Interposition after Esophagectomy: A Case Report
Seung Hee KIM ; Jin Won KIM ; Seon-Young PARK ; Hyun-Soo KIM ; Chae June LIM ; Gang Han LEE ; Jae Woong LIM ; Young Eun SEO ; Shin Young PARK ; Yo Han LEE ; Yong-Wook JUNG ; Woo Rim KANG ; Hye-Su YOU ; Dong Hyun KIM
The Korean Journal of Gastroenterology 2023;82(3):140-144
Colonic interposition is the main procedure used in esophageal reconstruction. We report a rare case of simultaneous treatment of an anastomotic site stricture and a neoplasm in the interpositioned colon. A 69-year-old female visited our outpatient clinic with symptoms of progressive dysphagia for 1 year. At the age of 30 years, the patient underwent esophagectomy with retrosternal colonic interposition because of severe esophageal burns after chemical ingestion. Upper gastrointestinal endoscopy revealed stricture at the anastomosis site and a 10-mm flat elevated high-grade dysplasia in the interpositioned colon. First, through-the-scope balloon dilatation was performed for strictures. However, stenosis was observed during the second upper gastrointestinal endoscopy session.Therefore, a second session of through-the-scope balloon dilatation was performed, and simultaneously, endoscopic submucosal dissection was also successfully performed. After 2 months of follow-up, stenosis persisted; consequently, balloon dilatation was performed. No recurrence of neoplasm was confirmed endoscopically. Through-the-scope balloon dilatation of the stricture site and simultaneous endoscopic submucosal dissection of the neoplasm in the interpositioned colon were successfully performed.
5.Erratum: Assessment of Disease Severity and Quality of Life in Patients with Atopic Dermatitis from South Korea
Sang Wook SON ; Ji Hyun LEE ; Jiyoung AHN ; Sung Eun CHANG ; Eung Ho CHOI ; Tae Young HAN ; Yong Hyun JANG ; Hye One KIM ; Moon-Bum KIM ; You Chan KIM ; Hyun Chang KO ; Joo Yeon KO ; Sang Eun LEE ; Yang Won LEE ; Bark-Lynn LEW ; Chan Ho NA ; Chang Ook PARK ; Chun Wook PARK ; Kui Young PARK ; Kun PARK ; Young Lip PARK ; Joo Young ROH ; Young-Joon SEO ; Min Kyung SHIN ; Sujin LEE ; Sang Hyun CHO
Annals of Dermatology 2023;35(1):86-87
6.Assessment of Disease Severity and Quality of Life in Patients with Atopic Dermatitis from South Korea
Sang Wook SON ; Ji Hyun LEE ; Jiyoung AHN ; Sung Eun CHANG ; Eung Ho CHOI ; Tae Young HAN ; Yong Hyun JANG ; Hye One KIM ; Moon-Bum KIM ; You Chan KIM ; Hyun Chang KO ; Joo Yeon KO ; Sang Eun LEE ; Yang Won LEE ; Bark-Lynn LEW ; Chan Ho NA ; Chang Ook PARK ; Chun Wook PARK ; Kui Young PARK ; Kun PARK ; Young Lip PARK ; Joo Young ROH ; Young-Joon SEO ; Min Kyung SHIN ; Sujin LEE ; Sang Hyun CHO
Annals of Dermatology 2022;34(6):419-430
Background:
Data illustrating the impact of atopic dermatitis (AD) on lives of adults with AD in South Korea are limited.
Objective:
To assess the AD disease severity and its impact on quality of life (QoL) in patients with AD from South Korea.
Methods:
Patients with AD utilizing the specialist dermatology services of major hospitals in South Korea were assessed for disease severity using Eczema Area and Severity Index (EASI) score, for QoL using Dermatology Life Quality Index (DLQI) (for QoL), and for comorbidities and treatment experience via retrospective review of 12-month medical records. Clinical and sociodemographic characteristics were also measured.
Results:
Of the 1,163 patients, 695 (59.8%) were men (mean age [years]±standard deviation: 31.6±12.1). Overall, 52.9% (n=615) patients had moderate-to-severe disease (EASI>7).The QoL of 72.3% (n=840) patients was affected moderately-to-severely (DLQI score: 6~30).Systemic immunosuppressants were used ≥1 over past 12 months in 51.9% (n=603) patients, and the most commonly used were cyclosporines (45.7%, n=531) and systemic corticosteroids (40.5%, n=471). Approximately, 10.8% (n=126) patients consulted or received treatment for AD-related eye problem. Of these, 40% (n=50) patients reported poor, very poor, or completely blind status; approximately, 16.7% patients (n=192) reported having depression or anxiety; and 35.5% (n=410) reported suicidal ideation or suicidal attempt.
Conclusion
A large proportion of patients had moderate-to-severe AD, a compromised QoL, and ocular or mental health comorbidities, indicating a high disease burden despite systemic treatment. These findings highlight the importance of a holistic approach for the evaluation and treatment of patients with AD.
7.Clinical Features and Long-term Prognosis of Crohn’s Disease in Korea: Results from the Prospective CONNECT Study
Seung Wook HONG ; Byong Duk YE ; Jae Hee CHEON ; Ji Hyun LEE ; Ja Seol KOO ; Byung Ik JANG ; Kang-Moon LEE ; You Sun KIM ; Tae Oh KIM ; Jong Pil IM ; Geun Am SONG ; Sung-Ae JUNG ; Hyun Soo KIM ; Dong Il PARK ; Hyun-Soo KIM ; Kyu Chan HUH ; Young-Ho KIM ; Jae Myung CHA ; Geom Seog SEO ; Chang Hwan CHOI ; Hyun Joo SONG ; Gwang Ho BAIK ; Ji Won KIM ; Sung Jae SHIN ; Young Sook PARK ; Chang Kyun LEE ; Jun LEE ; Sung Hee JUNG ; Yunho JUNG ; Sung Chul PARK ; Young-Eun JOO ; Yoon Tae JEEN ; Dong Soo HAN ; Suk-Kyun YANG ; Hyo Jong KIM ; Won Ho KIM ; Joo Sung KIM
Gut and Liver 2022;16(6):907-920
Background/Aims:
The prospective Crohn’s Disease Clinical Network and Cohort Study is a nationwide multicenter cohort study of patients with Crohn’s disease (CD) in Korea, aiming to prospectively investigate the clinical features and long-term prognosis associated with CD.
Methods:
Patients diagnosed with CD between January 2009 and September 2019 were prospectively enrolled. They were divided into two cohorts according to the year of diagnosis: cohort 1 (diagnosed between 2009 and 2011) versus cohort 2 (between 2012 and 2019).
Results:
A total of 1,175 patients were included, and the median follow-up duration was 68 months (interquartile range, 39.0 to 91.0 months). The treatment-free durations for thiopurines (p<0.001) and anti-tumor necrosis factor agents (p=0.018) of cohort 2 were shorter than those of cohort 1. Among 887 patients with B1 behavior at diagnosis, 149 patients (16.8%) progressed to either B2 or B3 behavior during follow-up. Early use of thiopurine was associated with a reduced risk of behavioral progression (adjusted hazard ratio [aHR], 0.69; 95% confidence interval [CI], 0.50 to 0.90), and family history of inflammatory bowel disease was associated with an increased risk of behavioral progression (aHR, 2.29; 95% CI, 1.16 to 4.50). One hundred forty-one patients (12.0%) underwent intestinal resection, and the intestinal resection-free survival time was significantly longer in cohort 2 than in cohort 1 (p=0.003). The early use of thiopurines (aHR, 0.35;95% CI, 0.23 to 0.51) was independently associated with a reduced risk of intestinal resection.
Conclusions
The prognosis of CD in Korea appears to have improved over time, as evidenced by the decreasing intestinal resection rate. Early use of thiopurines was associated with an improved prognosis represented by a reduced risk of intestinal resection.
8.Intraperitoneal Paclitaxel Combined with S-1 Plus Oxaliplatin for Advanced Gastric Cancer with Peritoneal Metastasis: a Phase I Study
Dong-Wook KIM ; Won Jun SEO ; Sang Il YOUN ; Ye Seob JEE ; You-Jin JANG ; Jong-Han KIM ; Perioperative Intra-Peritoneal & Systemic Chemotherapy for Gastric Cancer (PIPS-GC) study group
Journal of Gastric Cancer 2021;21(4):418-425
Purpose:
We designed a new regimen by combining intraperitoneal (IP) paclitaxel (PTX) with systemic S-1 plus oxaliplatin (SOX) for the treatment of advanced gastric cancer with peritoneal metastasis. This dose-escalation study aimed to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IP PTX administered weekly to patients.
Materials and Methods:
Eight cycles of IP PTX plus SOX regimen were administered to the patients. S-1 was administered orally twice daily at a dose of 80 mg/m2 /day for 14 consecutive days, followed by 7 days of rest. Intravenous oxaliplatin was administered at a fixed dose of 100 mg/m2 on day 1, while IP PTX was administered on days 1 and 8. The initial dose of IP PTX was 40 mg/m2 , and the dose escalation was set in units of 20 mg/m2 up to 80 mg/m2 . Dose-limiting toxicities (DLTs) were defined as grade 3 non-hematologic toxicities, grade 4 leukopenia, grade 3 febrile neutropenia, and grade 3 thrombocytopenia.
Results:
Nine patients were included in the study. No DLTs were observed in any of the enrolled patients. Therefore, the MTD was not reached, and the RD of IP PTX was determined to be 80 mg/m2 . Four patients (44%) showed a decreased peritoneal cancer index score on second-look laparoscopic examination.
Conclusions
The present study determined the dose for further clinical trials of IP PTX to be 80 mg/m2 , when combined with a systemic SOX regimen.
9.Clinical Guidance for Point-of-Care Ultrasound in the Emergency and Critical Care Areas after Implementing Insurance Coverage in Korea
Wook Jin CHOI ; Young Rock HA ; Je Hyeok OH ; Young Soon CHO ; Won Woong LEE ; You Dong SOHN ; Gyu Chong CHO ; Chan Young KOH ; Han Ho DO ; Won Joon JEONG ; Seung Mok RYOO ; Jae Hyun KWON ; Hyung Min KIM ; Su Jin KIM ; Chan Yong PARK ; Jin Hee LEE ; Jae Hoon LEE ; Dong Hyun LEE ; Sin Youl PARK ; Bo Seung KANG
Journal of Korean Medical Science 2020;35(7):54-
Point-of-care ultrasound (POCUS) is a useful tool that is widely used in the emergency and intensive care areas. In Korea, insurance coverage of ultrasound examination has been gradually expanding in accordance with measures to enhance Korean National Insurance Coverage since 2017 to 2021, and which will continue until 2021. Full coverage of health insurance for POCUS in the emergency and critical care areas was implemented in July 2019. The National Health Insurance Act classified POCUS as a single or multiple-targeted ultrasound examination (STU vs. MTU). STU scans are conducted of one organ at a time, while MTU includes scanning of multiple organs simultaneously to determine each clinical situation. POCUS can be performed even if a diagnostic ultrasound examination is conducted, based on the physician's decision. However, the Health Insurance Review and Assessment Service plans to monitor the prescription status of whether the POCUS and diagnostic ultrasound examinations are prescribed simultaneously and repeatedly. Additionally, MTU is allowed only in cases of trauma, cardiac arrest, shock, chest pain, and dyspnea and should be performed by a qualified physician. Although physicians should scan all parts of the chest, heart, and abdomen when they prescribe MTU, they are not required to record all findings in the medical record. Therefore, appropriate prescription, application, and recording of POCUS are needed to enhance the quality of patient care and avoid unnecessary cut of medical budget spending. The present article provides background and clinical guidance for POCUS based on the implementation of full health insurance coverage for POCUS that began in July 2019 in Korea.
Abdomen
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Budgets
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Chest Pain
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Critical Care
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Dyspnea
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Emergencies
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Heart
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Heart Arrest
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Insurance Coverage
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Insurance
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Insurance, Health
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Korea
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Medical Records
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National Health Programs
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Patient Care
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Point-of-Care Systems
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Prescriptions
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Shock
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Thorax
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Ultrasonography
10.Treatment of gestational diabetes diagnosed by the IADPSG criteria decreases excessive fetal growth
Kyoung Hee LEE ; You Jung HAN ; Jin Hoon CHUNG ; Moon Young KIM ; Hyun Mee RYU ; Jin Ha KIM ; Dong Wook KWAK ; Sung Hoon KIM ; Seongwoo YANG ; Minhyoung KIM
Obstetrics & Gynecology Science 2020;63(1):19-26

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