1.Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80)
Jung-Yun LEE ; David TAN ; Isabelle RAY-COQUARD ; Jung Bok LEE ; Byoung Gie KIM ; Els Van NIEUWENHUYSEN ; Ruby Yun-Ju HUANG ; Ka Yu TSE ; Antonio GONZÁLEZ-MARTIN ; Clare SCOTT ; Kosei HASEGAWA ; Katie WILKINSON ; Eun Yeong YANG ; Stephanie LHEUREUX ; Rebecca KRISTELEIT
Journal of Gynecologic Oncology 2025;36(1):e51-
Background:
Recurrent gynecological clear cell carcinoma (rGCCC) has a low objective response rate (ORR) to chemotherapy. Previous preclinical and clinical data suggest a potential synergy between immune checkpoint inhibitors and bevacizumab in rGCCC.Dostarlimab, a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1), combined with the anti-angiogenic bevacizumab, presents a novel therapeutic approach. This study will investigate the efficacy of dostarlimab +/− bevacizumab in rGCCC.
Methods
DOVE is a global, multicenter, international, open-label, randomized phase 2 study of dostarlimab +/− bevacizumab with standard chemotherapy in rGCCC. We will enroll 198 patients with rGCCC and assign them to one of three groups in a 1:1:1 ratio: arm A (dostarlimab monotherapy), B (dostarlimab + bevacizumab), and C (investigator’s choice of chemotherapy [weekly paclitaxel, pegylated liposomal doxorubicin, doxorubicin, or gemcitabine]). Patients with disease progression in arm A or C will be allowed to cross over to arm B. Stratification factors include prior bevacizumab use, prior lines of therapy (1 vs. >1), and primary site (ovarian vs. non-ovarian). Key inclusion criteria are histologically proven recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, or vulva; up to five prior lines of therapy; disease progression within 12 months after platinumbased chemotherapy; and measurable disease. Key exclusion criteria are prior treatment with an anti–PD-1, anti–programmed death-ligand 1, or anti–programmed death-ligand 2 agent.The primary endpoint is progression-free survival determined by investigators. Secondary endpoints are ORR, disease control rate, clinical benefit rate, progression-free survival 2, overall survival, and toxicity. Exploratory objectives include immune biomarkers.
2.Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80)
Jung-Yun LEE ; David TAN ; Isabelle RAY-COQUARD ; Jung Bok LEE ; Byoung Gie KIM ; Els Van NIEUWENHUYSEN ; Ruby Yun-Ju HUANG ; Ka Yu TSE ; Antonio GONZÁLEZ-MARTIN ; Clare SCOTT ; Kosei HASEGAWA ; Katie WILKINSON ; Eun Yeong YANG ; Stephanie LHEUREUX ; Rebecca KRISTELEIT
Journal of Gynecologic Oncology 2025;36(1):e51-
Background:
Recurrent gynecological clear cell carcinoma (rGCCC) has a low objective response rate (ORR) to chemotherapy. Previous preclinical and clinical data suggest a potential synergy between immune checkpoint inhibitors and bevacizumab in rGCCC.Dostarlimab, a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1), combined with the anti-angiogenic bevacizumab, presents a novel therapeutic approach. This study will investigate the efficacy of dostarlimab +/− bevacizumab in rGCCC.
Methods
DOVE is a global, multicenter, international, open-label, randomized phase 2 study of dostarlimab +/− bevacizumab with standard chemotherapy in rGCCC. We will enroll 198 patients with rGCCC and assign them to one of three groups in a 1:1:1 ratio: arm A (dostarlimab monotherapy), B (dostarlimab + bevacizumab), and C (investigator’s choice of chemotherapy [weekly paclitaxel, pegylated liposomal doxorubicin, doxorubicin, or gemcitabine]). Patients with disease progression in arm A or C will be allowed to cross over to arm B. Stratification factors include prior bevacizumab use, prior lines of therapy (1 vs. >1), and primary site (ovarian vs. non-ovarian). Key inclusion criteria are histologically proven recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, or vulva; up to five prior lines of therapy; disease progression within 12 months after platinumbased chemotherapy; and measurable disease. Key exclusion criteria are prior treatment with an anti–PD-1, anti–programmed death-ligand 1, or anti–programmed death-ligand 2 agent.The primary endpoint is progression-free survival determined by investigators. Secondary endpoints are ORR, disease control rate, clinical benefit rate, progression-free survival 2, overall survival, and toxicity. Exploratory objectives include immune biomarkers.
3.Phase II randomized study of dostarlimab alone or with bevacizumab versus non-platinum chemotherapy in recurrent gynecological clear cell carcinoma (DOVE/APGOT-OV7/ENGOT-ov80)
Jung-Yun LEE ; David TAN ; Isabelle RAY-COQUARD ; Jung Bok LEE ; Byoung Gie KIM ; Els Van NIEUWENHUYSEN ; Ruby Yun-Ju HUANG ; Ka Yu TSE ; Antonio GONZÁLEZ-MARTIN ; Clare SCOTT ; Kosei HASEGAWA ; Katie WILKINSON ; Eun Yeong YANG ; Stephanie LHEUREUX ; Rebecca KRISTELEIT
Journal of Gynecologic Oncology 2025;36(1):e51-
Background:
Recurrent gynecological clear cell carcinoma (rGCCC) has a low objective response rate (ORR) to chemotherapy. Previous preclinical and clinical data suggest a potential synergy between immune checkpoint inhibitors and bevacizumab in rGCCC.Dostarlimab, a humanized monoclonal antibody targeting programmed cell death protein 1 (PD-1), combined with the anti-angiogenic bevacizumab, presents a novel therapeutic approach. This study will investigate the efficacy of dostarlimab +/− bevacizumab in rGCCC.
Methods
DOVE is a global, multicenter, international, open-label, randomized phase 2 study of dostarlimab +/− bevacizumab with standard chemotherapy in rGCCC. We will enroll 198 patients with rGCCC and assign them to one of three groups in a 1:1:1 ratio: arm A (dostarlimab monotherapy), B (dostarlimab + bevacizumab), and C (investigator’s choice of chemotherapy [weekly paclitaxel, pegylated liposomal doxorubicin, doxorubicin, or gemcitabine]). Patients with disease progression in arm A or C will be allowed to cross over to arm B. Stratification factors include prior bevacizumab use, prior lines of therapy (1 vs. >1), and primary site (ovarian vs. non-ovarian). Key inclusion criteria are histologically proven recurrent or persistent clear cell carcinoma of the ovary, endometrium, cervix, vagina, or vulva; up to five prior lines of therapy; disease progression within 12 months after platinumbased chemotherapy; and measurable disease. Key exclusion criteria are prior treatment with an anti–PD-1, anti–programmed death-ligand 1, or anti–programmed death-ligand 2 agent.The primary endpoint is progression-free survival determined by investigators. Secondary endpoints are ORR, disease control rate, clinical benefit rate, progression-free survival 2, overall survival, and toxicity. Exploratory objectives include immune biomarkers.
4.The Hospital Work Experience of Generation Y Nurses
Eun Ju MUN ; Eun Yeong LEE ; Hye Jin KIM
Journal of Korean Clinical Nursing Research 2024;30(2):65-74
Purpose:
This study aimed to understand and explore the work experiences of Generation Y nurses in hospital organizations.
Methods:
Participants were nine nurses with generation Y working in the hospital. Data were collected through individual interviews from December 2, 2022 to June 30, 2023. The transcripts were coded and analyzed using Colaizzi's phenomenological method.
Results:
A total of 33 formulated meanings were derived from the meaningful 50 statements of nine study participants, and then categorized them into 12 themes with a collection of five theme clusters.
Conclusion
This study found that Generation Y nurses experienced role confusion and physical and mental burden as they caught in the middle in other generations. Even they were wondering whether to continue working as a nurse, which seems that it is crucial to establish a recognition and compensation system to maintain Generation Y nurses in the field. In addition, Generation Y nurses have been found to endure difficult hospital work and demonstrate patience even when working alone, while also deriving strength from their colleagues. Therefore, it is necessary to establish a program for intergenerational harmony among nurses.
5.Real-World Eligibility and Cost-Effectiveness Analysis of Empagliflozin for Heart Failure in Korea
Eui-Soon KIM ; Sun-Kyeong PARK ; Jong-Chan YOUN ; Hye Sun LEE ; Hae-Young LEE ; Hyun-Jai CHO ; Jin-Oh CHOI ; Eun-Seok JEON ; Sang Eun LEE ; Min-Seok KIM ; Jae-Joong KIM ; Kyung-Kuk HWANG ; Myeong-Chan CHO ; Shung Chull CHAE ; Seok-Min KANG ; Jin Joo PARK ; Dong-Ju CHOI ; Byung-Su YOO ; Jae Yeong CHO ; Kye Hun KIM ; Byung-Hee OH ; Barry GREENBERG ; Sang Hong BAEK
Journal of Korean Medical Science 2024;39(1):e8-
Background:
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry.
Methods:
A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY).
Results:
Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY).
Conclusion
There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications.
6.Trends in Incidence and Drug Prescriptions for Croup in Children Under 5 Years of Age: A 2002–2019 Population-Based Study
Bo Hee KIM ; Eun Kyo HA ; Hana YOO ; Soonchul LEE ; Yeong Ho RHA ; Man Yong HAN ; Ju Hee KIM
Journal of Korean Medical Science 2024;39(9):e95-
Background:
Tracking national croup trends can provide important insights for childhood health management. This study aimed to analyze the incidence and drug prescription trends in Korean children over a two-decade period.
Methods:
This population-based study encompassed 479,783 children aged < 5 years from 2002–2019, utilizing the National Health Insurance Service-National Sample Cohort. We identified participants with a primary croup diagnosis who were admitted to or visited the emergency room. Age-specific and age-adjusted incidence rates/10,000 person-years were calculated. We assessed using orthogonal polynomial contrasts and stratified by various factors (sex, age, residential area, economic status, comorbidities, and healthcare facility types). We observed changes in the use of five medications: inhaled steroids, systemic steroids, inhaled epinephrine, antibiotics, and short-acting bronchodilators. Generalized binomial logistic regression was used to analyze factors influencing prescription strategies.
Results:
In 2002, the croup-related visits were 16.1/10,000 person-years, increasing to 98.3 in 2019 (Pfor trend < 0.001). This trend persisted, regardless of age, sex, region, and economic status. Children with comorbid atopic dermatitis or asthma maintained consistent croup rates, while those without comorbidities increased. Treatment trends showed decreasing antibiotic (73–47%) and oxygen use (21.3–3.4%), with increasing nebulized epinephrine (9.3–41.5%) and multiple drug prescriptions (67.8–80.3%). Primary care centers exhibited a greater increase in prescription usage and hospitalization duration than did tertiary healthcare institutions.
Conclusion
Over the past two decades, croup incidence has risen, accompanied by increased epinephrine use and decreased antibiotic prescriptions. Longer hospitalization and higher medication use were mainly observed in primary care facilities.
7.The storage mite Tyrophagus putrescentiae induces greater lung inflammation than house dust mites in mice
Eun-Min KIM ; Ju Yeong KIM ; You Shine KWAK ; Myung-Hee YI ; Tai-Soon YONG
Parasites, Hosts and Diseases 2024;62(3):365-377
Exposure to storage mite (SM) and house dust mite (HDM) allergens is a risk factor for sensitization and asthma development; however, the related immune responses and their pathology have not been fully investigated. The HDMs Dermatophagoides farinae and Dermatophagoides pteronyssinus and SM Tyrophagus putrescentiae are potent allergens that induce asthma. Most SM-related studies have focused on the allergic reactions of individuals by measuring their immunoglobulin (Ig)E expression. Considering the limited research on this topic, the present study aims to investigate the differences in the immune responses induced by HDMs and SMs and histologically analyze lung tissues in a mouse asthma model to understand the differential effects of HDM and SM. The results revealed that all mite species induced airway inflammation. Mice challenged with T. putrescentiae had the highest airway resistance and total cell, eosinophil, and neutrophil counts in the bronchoalveolar lavage fluid (BALF). The SM-sensitized groups showed more severe lesions and mucus hypersecretions than the HDM-sensitized groups. Although the degree of HDM and SM exposure was the same, the damage to the respiratory lung tissue was more severe in SM-exposed mice, which resulted in excessive mucin secretion and increased fibrosis. Furthermore, these findings suggest that SM sensitization induces a more significant hypersensitivity response in mucosal immunity than HDM sensitization in asthma models.
8.Resection Via Transpalatal Approach of Huge Solitary Fibrous Tumor Involving Pterygopalatine Fossa
Jang Wook GWAK ; Sea Eun YI ; Yeong Ju LEE ; Myeong Sang YU
Korean Journal of Otolaryngology - Head and Neck Surgery 2023;66(1):44-49
Solitary fibrous tumors (SFTs) are spindle-cell tumors that rarely arise within extrathoracic area. Massive SFTs involving the pterygopalatine fossa are extremely rare and surgical excision represents a multidisciplinary surgical challenge. We present a case of 64-year-old female with a huge mass originating from the pterygopalatine fossa invading the skull base. Distinct microscopic findings and a positive nuclear staining of signal transducer and activator of transcription 6 (STAT-6) pathologically confirmed SFT. The right internal maxillary artery branch was embolized preoperatively and a surgical excision was performed through a combined technique of transpalatal, mid-facial degloving and endoscopic approach. Postoperative radiotherapy successfully removed the remnant tumor adjacent to the carvenous sinus. Follow- up MR images showed no evidence of recurrence for two years. To our knowledge, there has been no previous report of the successful treatment of this vast extent of SFT in the pterygopalatine region via endoscopic-external-combined approach and radiotherapy.
9.Improving order-to-antibiotic time by operating an automated dispensing cabinet system in the emergency medical center
Dong Geun SON ; Wook Jin CHOI ; Hyun Kyung YOON ; Hyun Ju HWANG ; Eun Ji PARK ; Soo Yeon LEE ; Seo Yeong SON ; Chang Geun OH
Journal of the Korean Society of Emergency Medicine 2022;33(4):421-421
10.Two Case Reports of Leukocytoclastic Vasculitis after ChAdOx1 nCoV-19 Vaccine
Hae Eun PARK ; Ju Hee HAN ; Yeong Ho KIM ; Ji Hyun LEE ; Young Min PARK ; Hwa Young LEE ; Chul Hwan BANG
Korean Journal of Dermatology 2022;60(7):444-448
Leukocytoclastic vasculitis after the BNT162b2 vaccine and ChAdOx1 nCoV-19 Corona Virus vaccine [recombinant] has been observed. Herein, we report two cases of leukocytoclastic vasculitis that developed after the ChAdOx1-S [recombinant] vaccination. A 61-year-old and a 52-year-old woman presented with pruritic purpuric macules and papules on both lower legs. The patients had been vaccinated with the ChAdOx1-S [recombinant] vaccine. The histopathological analyses were consistent with a diagnosis of leukocytoclastic vasculitis. They were treated with oral prednisolone and improved within 1 month of treatment. We assume that the rash had arisen from the deposition of spike protein at the skin tissue induced by the viral vector of the COVID-19 vaccine or hyperimmune responses by excipients present in vaccine preparations. To our knowledge, our cases would be the first Korean cases of leukocytoclastic vasculitis after the ChAdOx1-S [recombinant] vaccination.

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