1.Biomarker-guided targeted therapy in platinum-resistant ovarian cancer (AMBITION; KGOG 3045): a multicentre, open-label, five-arm, uncontrolled, umbrella trial
Jung-Yun LEE ; Byoung-Gie KIM ; Jae-Weon KIM ; Jung Bok LEE ; Eunhyang PARK ; Je-Gun JOUNG ; Sunghoon KIM ; Chel Hun CHOI ; Hee Seung KIM ;
Journal of Gynecologic Oncology 2022;33(4):e45-
Objective:
Management of heavily pre-treated platinum-resistant ovarian cancer remains a therapeutic challenge. Outcomes are poor with non-platinum, single-agent chemotherapy (CT); however, molecularly targeted anticancer therapies provide new options.
Methods:
This open-label, investigator-initiated, phase 2 umbrella trial (NCT03699449) enrolled patients with platinum-resistant ovarian cancer (at least 2 prior lines of CT and Eastern Cooperative Oncology Group 0/1) to receive combination therapy based on homologous recombination deficiency (HRD) and programmed death ligand 1 (PD-L1) status determined by archival tumour sample assessment. HRD-positive patients were randomised to either olaparib 200mg bid tablet + cediranib 30mg qd (arm 1) or olaparib 300mg bid tablet + durvalumab 1,500mg q4w (arm 2). HRD-negative patients were allocated to either durvalumab 1,500 mg q4w + pegylated liposomal doxorubicin (PLD) or topotecan or weekly paclitaxel (6 cycles; arm 3, those with PD-L1 expression) or durvalumab 1,500 mg q4w + tremelimumab 75mg q4w (4 doses) + PLD or topotecan or weekly paclitaxel (4 cycles; arm 4, those without PD-L1 expression). Arm 5 (durvalumab 1,500 mg q4w + tremelimumab 300mg [1 dose] + weekly paclitaxel [60 mg/m2 D1,8,15 q4w for 4 cycles] was initiated after arm 4 completed. The primary endpoint was objective response rate (ORR; Response Evaluation Criteria in Solid Tumours 1.1).
Results:
Between Dec 2018 and Oct 2020, 70 patients (median 57 years; median 3 prior treatment lines [range 2–10]) were treated (n=16, 14, 5, 18, and 17, respectively). Overall ORR was 37.1% (26/70, 95% confidence interval=25.9, 49.5); 2 achieved complete response. ORR was 50%, 42.9%, 20%, 33.3%, and 29.4%, respectively. Grade 3/4 treatment-related adverse events (TRAEs) were reported in 37.5%, 35.7%, 20%, 66.7%, and 35.3% of patients, respectively. No TRAEs leading to treatment discontinuation and no grade 5 TRAEs were observed.
Conclusion
This study, the first biomarker-driven umbrella trial in platinum-resistant recurrent ovarian cancer, suggests clinical utility with biomarker-driven targeted therapy. All treatment combinations were manageable, and without unexpected toxicities.
2.The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 1. Definition, Methodology and First-line Management
Woo-Jung SONG ; Mira CHOI ; Dong Hun LEE ; Jae-Woo KWON ; Gun-Woo KIM ; Myung Hwa KIM ; Mi-Ae KIM ; Min-Hye KIM ; Byung-Keun KIM ; Sujeong KIM ; Joung Soo KIM ; Jung Eun KIM ; Ju-Young KIM ; Joo-Hee KIM ; Hyun Jung KIM ; Hye One KIM ; Hyo-Bin KIM ; Joo Young ROH ; Kyung Hee PARK ; Kui Young PARK ; Han-Ki PARK ; Hyunsun PARK ; Jung Min BAE ; Ji Yeon BYUN ; Dae Jin SONG ; Young Min AHN ; Seung Eun LEE ; Young Bok LEE ; Joong Sun LEE ; Ji Hyun LEE ; Kyung-Hwan LIM ; Young-Min YE ; Yoon-Seok CHANG ; You Hoon JEON ; Jiehyun JEON ; Mihn-Sook JUE ; Sun Hee CHOI ; Jeong-Hee CHOI ; Gyu-Young HUR ; Young Min PARK ; Dae Hyun LIM ; Sang Woong YOUN
Allergy, Asthma & Immunology Research 2020;12(4):563-578
Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.
3.The KAAACI/KDA Evidence-Based Practice Guidelines for Chronic Spontaneous Urticaria in Korean Adults and Children: Part 1. Definition, Methodology and First-line Management
Woo-Jung SONG ; Mira CHOI ; Dong Hun LEE ; Jae-Woo KWON ; Gun-Woo KIM ; Myung Hwa KIM ; Mi-Ae KIM ; Min-Hye KIM ; Byung-Keun KIM ; Sujeong KIM ; Joung Soo KIM ; Jung Eun KIM ; Ju-Young KIM ; Joo-Hee KIM ; Hyun Jung KIM ; Hye One KIM ; Hyo-Bin KIM ; Joo Young ROH ; Kyung Hee PARK ; Kui Young PARK ; Han-Ki PARK ; Hyunsun PARK ; Jung Min BAE ; Ji Yeon BYUN ; Dae Jin SONG ; Young Min AHN ; Seung Eun LEE ; Young Bok LEE ; Joong Sun LEE ; Ji Hyun LEE ; Kyung-Hwan LIM ; Young-Min YE ; Yoon-Seok CHANG ; You Hoon JEON ; Jiehyun JEON ; Mihn-Sook JUE ; Sun Hee CHOI ; Jeong-Hee CHOI ; Gyu-Young HUR ; Young Min PARK ; Dae Hyun LIM ; Sang Woong YOUN
Allergy, Asthma & Immunology Research 2020;12(4):563-578
Chronic spontaneous urticaria (CSU) is defined as the occurrence of spontaneous wheals, angioedema, or both for >6 weeks in the absence of specific causes. It is a common condition associated with substantial disease burden both for affected individuals and societies in many countries, including Korea. CSU frequently persists for several years and requires high-intensity treatment; therefore, patients experience deteriorations in quality of life and medication-associated complications. During the last decade, there have been major advances in the pharmacological treatment of CSU and there is an outstanding need for evidence-based guidelines that reflect clinical practice in Korea. The guidelines reported here represent a joint initiative of the Korean Academy of Asthma, Allergy and Clinical Immunology and the Korean Dermatological Association, and aim to provide evidence-based guidance for the management of CSU in Korean adults and children. In Part 1, disease definition, guideline scope and development methodology as well as evidence-based recommendations on the use of antihistamines and corticosteroids are summarized.
4.Evaluation of the stability of sandblasted, large-grit, acid-etched implants with tapered straight body design
Journal of Dental Rehabilitation and Applied Science 2018;34(2):80-88
PURPOSE: Implant surface modification and implant design are the principle targets for achieving successful primary stability. The aim of this study was to measure implant stability quotient (ISQ) values of sandblasted, large-grit, acid-etched (SLA) implants with tapered straight body design during the healing period, and to determine the various factors affecting implant stability. MATERIALS AND METHODS: To measure implant stability, resonance frequency analysis (RFA) was performed in 26 patients (13 women and 13 men) with 44 SLA implants with tapered straight body design. Implant stability (ISQ values) was evaluated at baseline and healing abutment connection (12 weeks), and the correlations between RFA and insertion torque (IT), bone quality, and jawbone were determined. RESULTS: The mean ISQ value of the implants was 69.4 ± 10.2 at the time of implant placement (baseline) and 81.4 ± 6.9 at the time of healing abutment connection (P < 0.05). Significant differences were found between RFA and bone quality and between RFA and jawbone (P < 0.05). No significant differences were found between RFA and IT, insertion area, fixture diameter, and implant length (P > 0.05). CONCLUSION: ISQ values of SLA implants with tapered straight body design were high at baseline and healing abutment connection. It was concluded that SLA implants with tapered straight body design show improved primary and secondary stability, and that immediate or early loading may be applicable.
Female
;
Humans
;
Torque
5.Dual effects of a mixture of grape pomace (Campbell Early) and Omija fruit ethanol extracts on lipid metabolism and the antioxidant defense system in diet-induced obese mice.
Hye Jin HAN ; Un Ju JUNG ; Hye Jin KIM ; Byoung Seok MOON ; Su Jung CHO ; Yong Bok PARK ; Dong Gun LEE ; Myung Sook CHOI
Nutrition Research and Practice 2015;9(3):227-234
BACKGROUND/OBJECTIVES: We investigated the effects of a combination of grape pomace (Vitis labrusca, Campbell Early) and Omija fruit (Schizandra chinensis, Baillon) ethanol extracts on lipid metabolism and antioxidant defense system in diet-induced obese mice. MATERIALS/METHODS: Forty male C57BL/6J mice were divided into four groups and fed high-fat diet (control group, CON) or high-fat diet added 0.5% grape pomace extract (GPE), 0.05% Omija fruit extract (OFE) or 0.5% GPE plus 0.05% OFE (GPE+OFE) for 12 weeks. RESULTS: In contrast to the GPE- or OFE-supplemented groups, the GPE+OFE group showed significantly lower body weight and white adipose tissue weights than the CON group. Moreover, GPE+OFE supplementation significantly decreased plasma total cholesterol and increased the plasma HDL-cholesterol/total-cholesterol ratio (HTR) compared to the control diet. The hepatic triglyceride level was significantly lower in the GPE+OFE and GPE groups by increasing beta-oxidation and decreasing lipogenic enzyme compared to the CON group. Furthermore, GPE+OFE supplementation significantly increased antioxidant enzyme activities with a simultaneous decrease in liver H2O2 content compared to the control diet. CONCLUSIONS: Together our results suggest that supplementation with the GPE+OFE mixture may be more effective in improving adiposity, lipid metabolism and oxidative stress in high-fat diet-fed mice than those with GPE and OFE alone.
Adipose Tissue, White
;
Adiposity
;
Animals
;
Body Weight
;
Cholesterol
;
Diet
;
Diet, High-Fat
;
Ethanol*
;
Fruit*
;
Humans
;
Lipid Metabolism*
;
Liver
;
Male
;
Mice
;
Mice, Obese*
;
Oxidative Stress
;
Plasma
;
Triglycerides
;
Vitis*
;
Weights and Measures
6.Obstructive Jaundice Due to Compression of the Common Bile Duct by Variant Right Hepatic Artery.
Min Jae KIM ; Young CHOI ; Gun Jung YOUN ; Rae Seok LEE ; Jong Ho PARK ; Jue Young LEE ; Yeon Ho JOO ; Yun Bok LEE
Korean Journal of Pancreas and Biliary Tract 2014;19(2):79-83
Extrahepatic bile duct can be compressed by right hepatic artery (RHA) and cause a variety of hepatobiliary symptoms. This condition is referred to as RHA syndrome. A 20-year-old man was admitted because of jaundice. No stones or tumor were visible on CT scan and endoscopic retrograde cholangiopancreatography. However, RHA was seen traversing and compressing the mid common bile duct (CBD) with resultant upstream dilatation. The patient was diagnosed with obstructive jaundice due to compression of the CBD by variant RHA originating from gastroduodenal artery. After separation and mobilization of the variant RHA, obstructive jaundice was resolved. Herein, we report a case of a variant form of RHA syndrome that was successfully managed by surgery.
Arteries
;
Bile Ducts, Extrahepatic
;
Cholangiopancreatography, Endoscopic Retrograde
;
Common Bile Duct*
;
Dilatation
;
Hepatic Artery*
;
Humans
;
Jaundice
;
Jaundice, Obstructive*
;
Tomography, X-Ray Computed
;
Young Adult
7.High-resolution Impedance Manometry Criteria in the Sitting Position Indicative of Incomplete Bolus Clearance.
Eui Ju PARK ; Joon Seong LEE ; Tae Hee LEE ; Gene Hyun BOK ; Su Jin HONG ; Hyun Gun KIM ; Seong Ran JEON ; Jin Oh KIM
Journal of Neurogastroenterology and Motility 2014;20(4):491-496
BACKGROUND/AIMS: We used high-resolution impedance manometry (HRIM) to determine the length of breaks on the isobaric contour which would predict incomplete bolus clearance in patients in the sitting position. METHODS: In total, 651 swallows in 71 patients with esophageal symptoms were studied using a solid-state HRIM system in the sitting position. Each swallow was classified as complete or incomplete bolus clearance by impedance criteria and peristaltic integrity was evaluated using 20- and 30-mmHg pressure topography isobaric contours. Correlations between the lengths of the breaks for 20- and 30-mmHg were analyzed. RESULTS: Complete bolus clearance was observed in 83.3% (542/651) of swallows. Breaks of 3 and 7 cm or less were associated with a bolus clearance of 96.8% on the 20-mmHg and 94.7% on the 30-mmHg isobaric contour, respectively (P < 0.001). The areas under the ROC curves for the 20 and 30 mmHg isobaric contours were 0.900 and 0.950, respectively. The sensitivity and specificity for complete bolus clearance were 75.6% and 89.3% for breaks 3 cm or less on the 20-mmHg isobaric contour and 87.9% and 78.7% for breaks 7 cm or less on the 30-mmHg contour (P < 0.001). CONCLUSIONS: Breaks of < 3 cm in the 20-mmHg isobaric contour or < 7 cm in the 30-mmHg isobaric contour were associated with com -plete bolus clearance. The threshold for breaks in the sitting position was greater than previous reports using the supine position and longer breaks predicted incomplete bolus clearance.
Electric Impedance*
;
Humans
;
Manometry*
;
ROC Curve
;
Sensitivity and Specificity
;
Supine Position
;
Swallows
8.Endoscopic Resection of Hypopharyngeal Squamous Cell Carcinoma.
Gene Hyun BOK ; Won Young CHO ; Joo Young CHO ; So Young JIN ; Ji Ho AHN ; Chang Gyun CHUN ; Tae Hee LEE ; Hyun Gun KIM
Clinical Endoscopy 2013;46(2):189-192
Hypopharyngeal cancers are often diagnosed at an advanced stage and have a poor prognosis. Even when they are diagnosed at an operable stage, surgery often results in substantial morbidity and decreased patients' quality of life. Although the endoscopic diagnosis of early hypopharyngeal cancer is difficult, recent developments in advanced imaging endoscopy have enabled easier diagnosis of these lesions. Endoscopic resection of early hypopharyngeal cancer is a potential minimally invasive treatment that can preserve the function and quality of life of patients. Reports of this procedure are limited, however. We report a case of hypopharygeal cancer treated with endoscopic resection.
Carcinoma, Squamous Cell
;
Endoscopy
;
Humans
;
Hypopharyngeal Neoplasms
;
Prognosis
;
Quality of Life
9.Evaluation of the Efficiency of a Computerized Physician Order Entry System Serving Pediatric Patients who Visit the Emergency Ddepartment.
Seong Ju LEE ; Won Bin PARK ; Jin Seong CHO ; Sung Youl HYUN ; Yong Su LIM ; Jin Joo KIM ; Su Bok LEE ; Hyuk Jun YANG ; Gun LEE
Journal of the Korean Society of Emergency Medicine 2012;23(1):132-140
PURPOSE: The purpose of this article was to evaluate the efficiency of an automated prescription program serving pediatric patients who visited our emergency department. We expected that the program would reduce pediatric patient prescription errors and shorten the length of stay in the emergency department. METHODS: We developed the computerized physician order entry system to serve the pediatric patients visiting the emergency department and recommended that the emergency medicine residents use this program. We compared the rate of error as it affected prescription dosage and length of stay in the emergency department, before and after the program was deployed. We also performed a survey with 20 emergency medicine residents that have used the program. RESULTS: Of the total number of prescriptions filled, the number of prescription dosing errors observed was 40(4.5%) before and 22(2.8%) after the program was deployed. The results of the survey revealed high system usability and satisfaction. However, the length of stay in the emergency department was not affected. CONCLUSION: The computerized physician order entry system for pediatric patients visiting the emergency department was effective in reducing prescription related medical errors.
Emergencies
;
Emergency Medicine
;
Humans
;
Length of Stay
;
Medical Errors
;
Medical Order Entry Systems
;
Prescriptions
10.Frozen Section Biopsy to Evaluation of Obscure Lateral Resection Margins during Gastric Endoscopic Submucosal Dissection for Early Gastric Cancer.
Eun Jung KANG ; Joo Young CHO ; Tae Hee LEE ; So Young JIN ; Won Young CHO ; Jin Hyun BOK ; Hyun Gun KIM ; Jin Oh KIM ; Joon Seong LEE ; Il Hyun LEE
Journal of Gastric Cancer 2011;11(3):155-161
PURPOSE: To determine the diagnostic utility of a frozen section biopsy in patients undergoing endoscopic submucosal dissection (ESD) for early gastric neoplasms with obscure margins even with chromoendoscopy using acetic acid and indigo carmine (AI chromoendoscopy). MATERIALS AND METHODS: The lateral spread of early gastric neoplasms was unclear even following AI chromoendoscopy in 38 patients who underwent ESD between June 2007 and May 2011. Frozen section biopsies were obtained by agreement of the degree of lateral spread between two endoscopists. Thus, frozen section biopsies were obtained from 23 patients (FBx group) and not in the other 15 patients (AI group). RESULTS: No significant differences were observed for size, histology, invasive depth, and location of lesions between the AI and FBx groups. No false positive or false negative results were observed in the frozen section diagnoses. Adenocarcinoma was revealed in three patients and tubular adenoma in one, thereby changing the delineation of lesion extent and achieving free lateral margins. The rates of free lateral resection margins and curative resection were significantly higher in the FBx group than those in the AI group. CONCLUSIONS: Frozen section biopsy can help endoscopists perform more safe and accurate ESD in patients with early gastric neoplasm.
Acetic Acid
;
Adenocarcinoma
;
Adenoma
;
Biopsy
;
Frozen Sections
;
Humans
;
Indigo Carmine
;
Indoles
;
Stomach Neoplasms

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