4.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.
5.Comparative Study on the Immunogenicity of COVID-19 mRNA Vaccines in Patients Receiving Adjuvant and Palliative Chemotherapy
Hyun-Woo CHOI ; Younggon JUNG ; Uh Jin KIM ; Sang-Cheol LEE ; Jung Hye KWON ; Hyeonjong KIM ; Sarah KIM ; Yoonjung LEE ; Hyun-Jung SHIM ; Sang-Hee CHO ; Ik-Joo CHUNG ; Eu Chang HWANG ; Seung Ji KANG ; Woo Kyun BAE ; Seung-Jung KEE
Chonnam Medical Journal 2024;60(1):69-77
This study was conducted to investigate potential differences in vaccine efficacy between patients undergoing palliative chemotherapy and receiving adjuvant chemotherapy. Additionally, the study proved the influence of vaccination timing on vaccine efficacy during active chemotherapy. Anti-receptor-binding domain (RBD) IgG binding antibody assays and surrogate neutralizing antibody assays were performed after BNT162b2 or mRNA-1273 vaccination in 45 solid cancer patients (23 adjuvant and 22 palliative chemotherapy) and in 24 healthy controls before vaccination (baseline), at every two to four weeks after the first (post-dose 1) and the second vaccination (post-dose 2). The levels of anti-RBD IgG and neutralizing antibodies increased significantly from baseline through post-dose 1 to post-dose 2 in all three groups. At the post-dose 1, the anti-RBD IgG and neutralizing antibody levels were significantly lower in cancer patients than in healthy controls. However, by post-dose 2, the seropositivity of anti-RBD IgG and neutralizing antibodies uniformly reached 100% across all groups, with no significant disparity in antibody levels among the three groups. Moreover, the antibody titers were not significantly different between patients with a vaccine and chemotherapy interval of more than 14 days or those with less than 14 days. This study demonstrated that after second doses of mRNA COVID-19 vaccines, humoral immune responses in patients receiving chemotherapy were comparable to those of healthy controls, regardless of whether the purpose of the anti-cancer treatment was palliative or adjuvant. Furthermore, the timing of vaccination did not affect the level of humoral immunity after the second vaccination.
6.Clinical effects of non-pharmaceutical interventions for COVID-19 on other nationally notifiable infectious diseases in South Korea
Hyun-Jin LEE ; Beom Seuk HWANG ; Seong Ho IM ; Seog-Kyun MUN ; Munyoung CHANG
The Korean Journal of Internal Medicine 2024;39(5):823-832
Background/Aims:
This study aimed to assess the impact of non-pharmaceutical interventions (NPIs) implemented during the COVID-19 pandemic on nationally notifiable infectious diseases (NNIDs) in South Korea.
Methods:
Long-term data on seven NNIDs from 2018 to 2021 were analyzed to identify trends and change points using a change point detection technique. The timings of the NPI implementations were compared to the identified change points to determine their association.
Results:
Varicella, mumps, and scarlet fever showed a significant decrease in incidence following the implementation of NPIs during the COVID-19 pandemic. These diseases, which are primarily transmitted through respiratory droplets, demonstrated a clear response to NPIs. However, carbapenem-resistant Enterobacterales (CRE) showed an increasing trend unrelated to the timing of NPI implementation, suggesting the complex nature of controlling healthcare-associated infections. Hepatitis A, hepatitis C, and scrub typhus did not show significant changes associated with NPIs, likely due to their non-respiratory route of transmission.
Conclusions
NPIs effectively controlled NNIDs, particularly those transmitted through respiratory infections. However, the impact varied depending on the disease. Understanding the effectiveness and limitations of NPIs is crucial for developing comprehensive public health strategies during infectious disease outbreaks.
7.Treatment Efficacy of Various Maneuvers for Lateral Canal Benign Paroxysmal Positional Vertigo With Apogeotropic Nystagmus: A Randomized Controlled Trial
Hyun Jin LEE ; Eun-Ju JEON ; Sungil NAM ; Seog-Kyun MUN ; Shin-Young YOO ; Seong Hyun BU ; Jin Woong CHOI ; Jae Ho CHUNG ; Seok Min HONG ; Seung-Hwan LEE ; Min-Beom KIM ; Ja-Won KOO ; Hyun Ji KIM ; Jae-Hyun SEO ; Seong-Ki AHN ; Shi Nae PARK ; Minbum KIM ; Won-Ho CHUNG
Clinical and Experimental Otorhinolaryngology 2023;16(3):251-258
Objectives:
The aim of this study was to determine the most effective treatment approach by comparing the impacts of various otolith reduction techniques in patients with apogeotropic lateral semicircular canal benign paroxysmal positional vertigo (LC-BPPV).
Methods:
We performed a multicenter randomized prospective study from January to December 2015, involving 72 consecutive patients with apogeotropic LC-BPPV. The patients were divided into three treatment groups: therapeutic head-shaking (group A), the Gufoni-Appiani maneuver (group B), and the cupulolith repositioning maneuver (CuRM; group C). Each group underwent evaluation and treatment up to the fourth week. Treatment success was defined as the disappearance of positional vertigo and nystagmus.
Results:
This study included 72 patients (49 male and 23 female), with a mean (±standard deviation) age of 55.4±13.5 years. The mean duration of vertigo experienced prior to treatment was 3.9±4.4 days. The mean latency and duration of nystagmus were 2.7±3.0 seconds and 47.9±15.8 seconds, respectively. The overall treatment frequency was 2.0±0.9. The number of treatments differed significantly among the three groups (P<0.05). After 4 weeks, the success rates for groups A, B, and C were 90.5%, 92.3%, and 100%, respectively. No significant difference was observed in the success rate across treatment methods and periods (P>0.05). However, CuRM was the only method with a 100% treatment success rate.
Conclusion
While no clear difference was observed among the three treatments for LC-BPPV, CuRM was found to be superior to the other approaches in the long term.
8.In Vivo Stem Cell Imaging Principles and Applications
Seongje HONG ; Dong-Sung LEE ; Geun-Woo BAE ; Juhyeong JEON ; Hak Kyun KIM ; Siyeon RHEE ; Kyung Oh JUNG
International Journal of Stem Cells 2023;16(4):363-375
Stem cells are the foundational cells for every organ and tissue in our body. Cell-based therapeutics using stem cells in regenerative medicine have received attracting attention as a possible treatment for various diseases caused by congenital defects. Stem cells such as induced pluripotent stem cells (iPSCs) as well as embryonic stem cells (ESCs), mesenchymal stem cells (MSCs), and neuroprogenitors stem cells (NSCs) have recently been studied in various ways as a cell-based therapeutic agent. When various stem cells are transplanted into a living body, they can differentiate and perform complex functions. For stem cell transplantation, it is essential to determine the suitability of the stem cell-based treatment by evaluating the origin of stem, the route of administration, In vivo bio-distribution, transplanted cell survival, function, and mobility. Currently, these various stem cells are being imaged In vivo through various molecular imaging methods. Various imaging modalities such as optical imaging, magnetic resonance imaging (MRI), ultrasound (US), positron emission tomography (PET), and single-photon emission computed tomography (SPECT) have been introduced for the application of various stem cell imaging. In this review, we discuss the principles and recent advances of In vivo molecular imaging for application of stem cell research.
9.Effects of Bazedoxifene/Vitamin D Combination Therapy on Serum Vitamin D Levels and Bone Turnover Markers in Postmenopausal Women with Osteopenia: A Randomized Controlled Trial
Chaiho JEONG ; Jeonghoon HA ; Jun-Il YOO ; Young-Kyun LEE ; Jung Hee KIM ; Yong-Chan HA ; Yong-Ki MIN ; Dong-Won BYUN ; Ki-Hyun BAEK ; Ho Yeon CHUNG
Journal of Bone Metabolism 2023;30(2):189-199
Background:
This study aimed to evaluate the effectiveness of bazedoxifene/vitamin D combination therapy in preventing osteoporosis in postmenopausal women with osteopenia.
Methods:
This was an open-label, multicenter randomized-controlled, phase 4 clinical trial. Women between ages of 55 and 70 years in 9 medical tertiary centers in Korea were enrolled and assigned into 2 groups: an experiment group and a control group. The experimental group received bazedoxifene 20 mg/vitamin D 800 IU tablets for 6 months, and the control group received calcium 100 mg/vitamin D 1,000 IU tablets for 6 months.
Results:
A total of 142 patients (70 in the experimental group and 72 in the control group) were included. The least-square mean±standard error of change in propeptide of type I collagen after 3 months was -6.87±2.56% in the experimental group and 1.22±2.54% in the control group. After 6 months, it was -21.07±2.75% in the experimental group and 1.26±2.71% in the control group. The difference between the 2 groups was -22.33% (p<0.01). The change of C-terminal telopeptide was -12.55±4.05% in the experimental group and 11.02±4.03% in the control group after 3 months. It was -22.0±3.95% and 10.20±3.89, respectively, after 6 months. The difference between the 2 groups was -32.21% (p<0.01) after 6 months. There was no significant difference in adverse events between the 2 groups.
Conclusions
The osteoporosis preventive effect and safety of administering bazedoxifene/vitamin D combination pill were confirmed in postmenopausal women who needed osteoporosis prevention.
10.Position Statement: Postmenopausal Osteoporosis Treatment Strategies in Korea
So Young PARK ; Se Hwa KIM ; Young-Kyun LEE ; Jung-Ho SHIN ; Yong-Chan HA ; Ho Yeon CHUNG
Journal of Bone Metabolism 2023;30(4):289-295
Classifying patients with osteoporosis according to fracture risk and establishing adequate treatment strategies is crucial to effectively treat osteoporosis. The Korean Society for Bone and Mineral Research has issued a position statement regarding appropriate treatment strategies for postmenopausal osteoporosis. According to previous fragility fracture history, bone mineral density (BMD) test results, fracture risk assessment tool, and several clinical risk factors, fracture risk groups are classified into low, moderate, high, and very-high-risk groups. In high-risk groups, bisphosphonates (BPs) and denosumab are recommended as first-line therapies. Sequential BP treatment after denosumab discontinuation is required to prevent the rebound phenomenon. In the very high-risk group, anabolic drugs (teriparatide or romosozumab) are recommended as a first-line therapy; sequential therapy with antiresorptive agents is required to maintain BMD gain and reduce fracture risk. Fracture risk was reassessed annually, and the treatment plan was determined based on the results, according to the osteoporosis treatment algorithm for fracture risk.

Result Analysis
Print
Save
E-mail