1.Varlitinib and Paclitaxel for EGFR/HER2 Co-expressing Advanced Gastric Cancer: A Multicenter Phase Ib/II Study (K-MASTER-13)
Dong-Hoe KOO ; Minkyu JUNG ; Yeul Hong KIM ; Hei-Cheul JEUNG ; Dae Young ZANG ; Woo Kyun BAE ; Hyunki KIM ; Hyo Song KIM ; Choong-kun LEE ; Woo Sun KWON ; Hyun Cheol CHUNG ; Sun Young RHA
Cancer Research and Treatment 2024;56(4):1136-1145
Purpose:
Varlitinib is a pan-human epidermal growth factor receptor (HER) inhibitor targeting epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), and HER4. We present a phase Ib/II study of a combination of varlitinib and weekly paclitaxel as a second-line treatment for patients with EGFR/HER2 co-expressing advanced gastric cancer (AGC).
Materials and Methods:
Patients whose tumors with EGFR and HER2 overexpression by immunohistochemistry (≥ 1+) were enrolled. Varlitinib and paclitaxel were investigated every 4 weeks. After determining the recommended phase II dose (RP2D) in phase Ib, a phase II study was conducted to evaluate the antitumor activity.
Results:
RP2D was treated with a combination of varlitinib (300 mg twice daily) and paclitaxel. Among 27 patients treated with RP2D, the median progression-free survival and overall survival (OS) were 3.3 months (95% confidence interval [CI], 1.7 to 4.9) and 7.9 months (95% CI, 5.0 to 10.8), respectively, with a median follow-up of 15.7 months. Among 16 patients with measurable disease, the objective response rate (ORR) and disease control rate were 31% and 88%, respectively. Patients with strong HER2 expression (n=8) had a higher ORR and longer OS, whereas those with strong EGFR expression (n=3) had poorer outcomes. The most common adverse events (AEs) of any grade were neutropenia (52%), diarrhea (27%), aspartate aminotransferase/alanine transaminase elevation (22%), and nausea (19%). No treatment-related deaths or unexpected AEs resulting from treatment cessation were observed in patients with RP2D.
Conclusion
A combination of varlitinib and paclitaxel displayed manageable toxicity and modest antitumor activity in patients with EGFR/HER2 co-expressing AGC who progressed after first-line chemotherapy.
2.Impaired fasting glucose levels in overweight or obese subjects for screening of type 2 diabetes in Korea
Jin-Hee LEE ; Suk CHON ; Seon-Ah CHA ; Sun-Young LIM ; Kook-Rye KIM ; Jae-Seung YUN ; Sang Youl RHEE ; Kun-Ho YOON ; Yu-Bae AHN ; Jeong-Taek WOO ; Seung-Hyun KO ;
The Korean Journal of Internal Medicine 2021;36(2):382-391
Background/Aims:
We examined the concordance rate among fasting plasma glucose (FPG), 2-hour post-challenge glucose (2hr PG), and hemoglobin A1c (HbA1c) in the diagnosis of diabetes in a population with a high-risk for type 2 diabetes mellitus (T2DM) in Korea.
Methods:
Among the participants from the Korean Diabetes Prevention Study, individuals with FPG ≥ 100 mg/dL, body mass index (BMI) ≥ 23.0 kg/m2, and no previous history of T2DM were consecutively enrolled after a 75 g glucose tolerance test. We analyzed the differences in the clinical characteristics in subjects with stage 1 (FPG, 100 to 109 mg/dL) and stage 2 (FPG, 110 to 125 mg/dL) impaired fasting glucose (IFG).
Results:
Of 1,637 participants, 27.2% had T2DM and 59.3% had IFG and/or impaired glucose tolerance (IGT). The mean age was 55.0 ± 8.1 years and the mean BMI was 26.3 ± 2.7 kg/m2. Based on FPG criteria, 515 (31.4%) and 352 (21.5%) subjects were classified as having stage 1 and stage 2 IFG, respectively. The 19.0% of stage 1 and 43.5% of stage 2 subjects showed 2hr PG levels in the diabetic range. Even for those in the normal FPG range, 63 (9.5%) participants showed a 2hr PG level of ≥ 200 mg/dL. Of 446 subjects with newly-diagnosed diabetes, 340 (76.2%) showed FPG levels < 126 mg/dL.
Conclusions
The oral glucose tolerance test should be actively considered for Korean adults who are overweight or obese with the IFG range (FPG, 100 to 125 mg/ dL) to allow for early detection of diabetes and prompt intervention.
3.Study on Current Curriculum Analysis of Clinical Dental Hygiene for Dental Hygiene Students in Korea.
Yong Keum CHOI ; Yang Keum HAN ; Soo Myoung BAE ; Jin KIM ; Hye Jin KIM ; Se Youn AHN ; Kun Ok LIM ; Hee Jung LIM ; Sun Ok JANG ; Yun Jung JANG ; Jin Ah JUNG ; Hyun Sun JEON ; Ji Eun PARK ; Hyo Jin LEE ; Bo Mi SHIN
Journal of Dental Hygiene Science 2017;17(6):523-532
The purpose of this study was to provide basic data to standardize the clinical dental hygiene curriculum, based on analysis of current clinical dental hygiene curricula in Korea. We emailed questionnaires to 12 schools to investigate clinical dental hygiene curricula, from February to March, 2017. We analyzed the clinical dental hygiene curricula in 5 schools with a 3-year program and in 7 schools with a 4-year program. The questionnaire comprised nine items on topics relating to clinical dental hygiene, and four items relating to the dental hygiene process and oral prophylaxis. The questionnaire included details regarding the subject name, the grade/semester/credit system, course content and class hours, the number of senior professors, and the number of patients available for dental hygiene clinical training purposes. In total, there were 96 topics listed in the curricula relating to clinical dental hygiene training, and topics varied between the schools. There was an average of 20.4 topic credits, and more credits and hours were allocated to the 4-year program than to the 3-year program. On average, the ratio of students to professors was 21.4:1. Course content included infection control, concepts for dental hygiene processes, dental hygiene assessment, intervention and evaluation, case studies, and periodontal instrumentation. An average of 2 hours per patient was spent on dental hygiene practice, with an average of 1.9 visits. On average, student clinical training involved 19 patients and 26.6 patients in the 3-year and 4-year programs, respectively. The average participation time per student per topic was 38.0 hours and 53.1 hours, in the 3-year and 4-year programs, respectively. Standardizing the clinical dental hygiene curricula in Korea will require consensus guidelines on topics, the number of classes required to achieve core competencies as a dental hygienist, and theory and practice time.
Consensus
;
Curriculum*
;
Dental Hygienists
;
Electronic Mail
;
Humans
;
Infection Control
;
Korea*
;
Oral Hygiene*
4.Early Changes in the Serotype Distribution of Invasive Pneumococcal Isolates from Children after the Introduction of Extended-valent Pneumococcal Conjugate Vaccines in Korea, 2011-2013.
Eun Young CHO ; Eun Hwa CHOI ; Jin Han KANG ; Kyung Hyo KIM ; Dong Soo KIM ; Yae Jean KIM ; Young Min AHN ; Byung Wook EUN ; Sung Hee OH ; Sung Ho CHA ; Hye Kyung CHO ; Young Jin HONG ; Kwang Nam KIM ; Nam Hee KIM ; Yun Kyung KIM ; Jong Hyun KIM ; Hyunju LEE ; Taekjin LEE ; Hwang Min KIM ; Kun Song LEE ; Chun Soo KIM ; Su Eun PARK ; Young Mi KIM ; Chi Eun OH ; Sang Hyuk MA ; Dae Sun JO ; Young Youn CHOI ; Jina LEE ; Geun Ryang BAE ; Ok PARK ; Young Joon PARK ; Eun Seong KIM ; Hoan Jong LEE
Journal of Korean Medical Science 2016;31(7):1082-1088
This study was performed to measure early changes in the serotype distribution of pneumococci isolated from children with invasive disease during the 3-year period following the introduction of 10- and 13-valent pneumococcal conjugate vaccines (PCVs) in Korea. From January 2011 to December 2013 at 25 hospitals located throughout Korea, pneumococci were isolated among children who had invasive pneumococcal disease (IPD). Serotypes were determined using the Quellung reaction, and the change in serotype distribution was analyzed. Seventy-five cases of IPD were included. Eighty percent of patients were aged 3-59 months, and 32% had a comorbidity that increased the risk of pneumococcal infection. The most common serotypes were 19A (32.0%), 10A (8.0%), and 15C (6.7%). The PCV7 serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, and 6A) accounted for 14.7% of the total isolates and the PCV13 minus PCV7 types (1, 3, 5, 7F and 19A) accounted for 32.0% of the total isolates. Serotype 19A was the only serotype in the PCV13 minus PCV7 group. The proportion of serotype 19A showed decreasing tendency from 37.5% in 2011 to 22.2% in 2013 (P = 0.309), while the proportion of non-PCV13 types showed increasing tendency from 45.8% in 2011 to 72.2% in 2013 (P = 0.108). Shortly after the introduction of extended-valent PCVs in Korea, serotype 19A continued to be the most common serotype causing IPD in children. Subsequently, the proportion of 19A decreased, and non-vaccine serotypes emerged as an important cause of IPD. The impact of extended-valent vaccines must be continuously monitored.
Adolescent
;
Bacteremia/complications/diagnosis
;
Child
;
Child, Preschool
;
Female
;
Hospitals
;
Humans
;
Infant
;
Male
;
Pneumococcal Infections/microbiology/*prevention & control
;
Pneumococcal Vaccines/*immunology
;
Republic of Korea
;
Serotyping
;
Streptococcus pneumoniae/*classification/isolation & purification
;
Vaccines, Conjugate/*immunology
5.Results of a Phase II Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Patients Who Failed First-Line Therapy Containing Dacarbazine.
Choong Kun LEE ; Minkyu JUNG ; Hye Jin CHOI ; Hye Ryun KIM ; Hyo Song KIM ; Mi Ryung ROH ; Joong Bae AHN ; Hyun Cheol CHUNG ; Su Jin HEO ; Sun Young RHA ; Sang Joon SHIN
Cancer Research and Treatment 2015;47(4):781-789
PURPOSE: There is no standard second-line regimen for malignant melanoma patients with disease progression after first-line chemotherapy, and platinum-alkylating agents combined with paclitaxel have shown modest efficacy. MATERIALS AND METHODS: We conducted a phase II, open-label, single-arm study to test the efficacy of docetaxel combined with carboplatin for malignant melanoma patients who failed previous treatment with dacarbazine. Intravenous docetaxel (35 mg/m2 on days 1 and 8 of each cycle) and carboplatin (area under the curve 3 on days 1 and 8 of each cycle) was administered every 21 days. Primary end point was objective response rate (ORR). RESULTS: Thirty patients were enrolled in the study, and the median follow-up duration was 19.8 months. Among 25 per-protocol patients, there were three responders (1 with complete response and 2 with partial response) and 17 stable disease patients (ORR, 12.0%). Among the per-protocol population, the median progression-free survival (PFS) was 4.3 months and the median overall survival (OS) was 9.6 months. Uveal melanoma patients (n=9) showed the best prognosis compared to other subtypes (median PFS, 7.6 months; OS, 9.9 months). The most common grade 3 or 4 adverse event was neutropenia (n=15, 50.0%). CONCLUSION: Docetaxel combined with carboplatin showed association with an acceptable safety profile and overall efficacy for patients with malignant melanoma who had progressed on chemotherapy containing dacarbazine.
Carboplatin*
;
Dacarbazine*
;
Disease Progression
;
Disease-Free Survival
;
Drug Therapy
;
Follow-Up Studies
;
Humans
;
Melanoma*
;
Neutropenia
;
Paclitaxel
;
Prognosis
6.Cardiovascular Disease Predicts Severe Hypoglycemia in Patients with Type 2 Diabetes.
Jae Seung YUN ; Seung Hyun KO ; Sun Hye KO ; Ki Ho SONG ; Ki Dong YOO ; Kun Ho YOON ; Yong Moon PARK ; Yu Bae AHN
Diabetes & Metabolism Journal 2015;39(6):498-506
BACKGROUND: To investigate whether a history of prior cardiovascular disease (CVD) is associated with severe hypoglycemia (SH) in patients with type 2 diabetes. METHODS: We conducted a prospective cohort study from January 2001 to December 2012 with a median follow-up time of 9.5 years (5,814 person-years). Patients aged 25 to 75 years with type 2 diabetes and without chronic kidney disease were enrolled (n=894), and 624 patients completed follow-up. SH was defined as hypoglycemic episodes requiring hospitalization or medical care in an emergency department. We used the Cox proportional hazards regression analysis to test associations between SH episodes and potential explanatory variables. RESULTS: Among the 624 participants who completed follow-up, 60 patients (9.6%) had previous CVD. Compared to patients without CVD, patients with previous CVD were older, had a longer duration of diabetes and hypertension, received more insulin, and had more diabetic microvascular complications at baseline. During follow-up, 62 patients (9.9%) experienced at least one SH episode (incidence of 1.33 per 100 patient-years). The development of SH was associated with a history of CVD (hazard ratio, 1.99; 95% confidence interval, 1.07 to 3.72; P=0.031) after adjusting for sex, age, diabetic duration, hypertension, hemoglobin A1c levels, diabetic complications, cardiovascular autonomic neuropathy, and insulin use. CONCLUSION: A history of CVD was an independent risk factor for the development of SH in patients with type 2 diabetes mellitus. For patients with CVD, modulation of glycemic targets and diabetic education for the prevention of hypoglycemia should be implemented.
Cardiovascular Diseases*
;
Cohort Studies
;
Diabetes Complications
;
Diabetes Mellitus, Type 2
;
Education
;
Emergency Service, Hospital
;
Follow-Up Studies
;
Hospitalization
;
Humans
;
Hypertension
;
Hypoglycemia*
;
Insulin
;
Prospective Studies
;
Renal Insufficiency, Chronic
;
Risk Factors
7.Comparison of Biometric Measurements and Refractive Results between Applanation Ultrasonography and Three Different Interferometries.
Ji Sun MOON ; Jeong Ah SHIN ; Gi Hyun BAE ; Sung Kun CHUNG
Journal of the Korean Ophthalmological Society 2015;56(11):1720-1727
PURPOSE: To compare ocular biometry and refractive results measured using conventional applanation ultrasonography and 3 different optical interferometries, Lenstar LS900(R), AL-Scan(R) and OA-2000(R). METHODS: The biometries of 31 cataractous eyes were measured using ultrasonography, Lenstar LS900(R), AL-Scan(R) or OA-2000(R). The axial length, anterior chamber depth and keratometry were measured. The SRK/T formula was used to calculate intraocular lens power. Two months after cataract surgery, the refractive outcome was determined and results from the 4 different biometry methods were compared. RESULTS: Axial lengths were 23.39 +/- 0.95 mm, 23.42 +/- 0.98 mm, 23.43 +/- 0.98 mm and 23.44 +/- 0.98 mm measured using ultrasonography, Lenstar LS900(R), AL-Scan(R) and OA-2000(R), respectively with no statistically significant differences observed (p = 0.996). The anterior chamber depth and keratometry were 3.14 +/- 0.41 mm, 3.10 +/- 0.38 mm and 3.13 +/- 0.39 mm (p = 0.936) and 44.41 +/- 1.52 D, 44.54 +/- 1.57 D and 44.44 +/- 1.52 D (p = 0.937) for Lenstar LS900(R), AL-Scan(R) and OA-2000(R) respectively. There were no statistically significant differences between the 3 optical devices. The mean absolute error of the 4 different devices were not statistically significant (p = 0.722). CONCLUSIONS: The ocular biometric measurements and prediction of postoperative refraction using ultrasonography, Lenstar LS900(R), AL-Scan(R) or OA-2000(R) showed no significant differences.
Anterior Chamber
;
Biometry
;
Cataract
;
Interferometry*
;
Lenses, Intraocular
;
Optical Devices
;
Refractive Errors
;
Ultrasonography*
8.A Case of Pseudohyperphosphatemia in a Patient with Multiple Myeloma.
Sun Ah LEE ; Jung Lim LEE ; Kun Woo PARK ; Hyeong Seok KIM ; Soo Hyun BAE ; Soon Hee CHANG
Korean Journal of Medicine 2013;84(1):130-134
Hyperphosphatemia develops when there is impaired renal phosphate excretion or massive extracellular fluid phosphate load. For example, renal insufficiency, hypoparathyroidism, exogenous phosphate administration, and extensive cellular injury induce a hyperphosphatemic state. In patients with multiple myeloma, renal insufficiency occurs as a result of hypercalcemia, light chain tubulopathy, urate nephropathy or infection, and hyperphosphatemia usually results from renal failure. We report here a case of a patient with multiple myeloma who had an elevated serum phosphate level measured by the phosphomolybdate UV method without significant renal insufficiency and was finally diagnosed with pseudohyperphosphatemia.
Extracellular Fluid
;
Humans
;
Hypercalcemia
;
Hyperphosphatemia
;
Hypoparathyroidism
;
Light
;
Molybdenum
;
Multiple Myeloma
;
Phosphoric Acids
;
Renal Insufficiency
;
Uric Acid
9.A Case of Anaplastic Lymphoma Kinase-Negative Primary Gastric Anaplastic Large Cell Lymphoma.
Hyeong Seok KIM ; Kun Woo PARK ; Jung Lim LEE ; Soo Hyun BAE ; Won Seok DO ; Mi Young KIM ; Sun Ah LEE
Korean Journal of Medicine 2012;83(5):674-678
Primary malignant lymphoma of the stomach comprises 1 to 7% of all gastric malignancies and is mostly B-cell type. Anaplastic large cell lymphoma (ALCL) of the stomach is very rare and regarded to have a poor prognosis. A 66-year-old man complained of dyspepsia for 3 days. A esophagogastroduodenoscopic examination revealed a flat, depressed ulcer at the distal antrum. Biopsy of the lesion showed diffuse infiltration of large pleomorphic lymphoid cells that were positive for CD3 and CD30 and negative for cytokeratin and anaplastic lymphoma kinase (ALK). We diagnosed the patient with ALK-negative primary gastric ALCL with multiple lymphadenopathies, and he received systemic chemotherapy. CHOP-like regimens followed by consolidation therapy have been widely used for ALK-negative ALCL. However, the patient maintained complete remission for 36 months with only induction chemotherapy. This case suggests that heavy treatment for ALK-negative ALCL is not required for all patients.
Aged
;
B-Lymphocytes
;
Biopsy
;
Dyspepsia
;
Humans
;
Induction Chemotherapy
;
Keratins
;
Lymphocytes
;
Lymphoma
;
Lymphoma, Large-Cell, Anaplastic
;
Phosphotransferases
;
Prognosis
;
Receptor Protein-Tyrosine Kinases
;
Stomach
;
Ulcer
10.The Seroprevalence Rate, Vaccination Rate and Seroconversion Rate of Hepatitis A in Central Region of Korea.
Seung Wook YUN ; Won Kyung LEE ; Sun Young CHO ; Sung Hoon MOON ; Hyun Deok SHIN ; Se Young YUN ; Suk Bae KIM ; Jeong Eun SHIN ; Hong Ja KIM ; Il Han SONG ; Kun Song LEE ; Jae Hyun LEE
The Korean Journal of Gastroenterology 2011;57(3):166-172
BACKGROUND/AIMS: Acute hepatitis A (HAV) is markedly increasing recently on. Some patients with acute hepatitis A show severe clinical course. The seroprevalence rate of IgG anti-HAV has been changing with the regions and the times. Vaccination and seroconversion rate of HAV are not well known. In this study, we aimed to study the difference of seroprevalence rate of IgG anti-HAV according to various clinical factors and to know the vaccination rate and seroconversion rate below 10 years old in the central region of South Korea including Cheonan city. METHODS: Seven hundred seventy two subjects were included in the study from January to September 2009. We analyzed seroprevalence rate of IgG anti-HAV according to sex, age, region, and other viral markers. We interviewed the history of vaccination(1st, 2nd) and analyzed seroconversion rate according to vaccination time below 10 years old. RESULTS: The total seroprevalence rate of IgG anti-HAV was 65.3%. The seroprevalence rate of IgG anti-HAV rate in 2nd, 3rd, and 4th decade was very low (1.9%, 18.8%, 44.8%). The vaccination rate of children was about 50%. The seroconversion rate after 1st, and 2nd vaccination were 85%, 96%. CONCLUSIONS: Catch-up vaccination for teenagers and young adults is needed. Immunizing children with HAV vaccine as a routine schedule should be considered.
Adolescent
;
Adult
;
Aged
;
Aged, 80 and over
;
Child
;
Child, Preschool
;
Female
;
Hepatitis A/*epidemiology/prevention & control
;
Hepatitis A Antibodies/*blood
;
*Hepatitis A Vaccines
;
Hepatitis A Virus, Human/immunology
;
Humans
;
Immunoglobulin G/blood
;
Male
;
Middle Aged
;
Republic of Korea
;
Seroepidemiologic Studies

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