1.Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies
Yong Wha MOON ; Seung Ki KIM ; Keun Seok LEE ; Moon Hee LEE ; Yeon Hee PARK ; Kyong Hwa PARK ; Gun Min KIM ; Seungtaek LIM ; Seung Ah LEE ; Jae Duk CHOI ; Eunhye BAEK ; Hyesun HAN ; Seungjae BAEK ; Seock-Ah IM
Cancer Research and Treatment 2023;55(3):766-777
Purpose:
We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials.
Materials and Methods:
Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.
Results:
Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.
Conclusion
This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.
2.Determining the etiology of small bowel obstruction in patients without intraabdominal operative history: a retrospective study
Youngjin JANG ; Sung Min JUNG ; Tae Gil HEO ; Pyong Wha CHOI ; Jae Il KIM ; Sung-Won JUNG ; Heungman JUN ; Yong Chan SHIN ; Eunhae UM
Annals of Coloproctology 2022;38(6):423-431
Purpose:
Most of the causes of small bowel obstruction (SBO) in patients without a history of abdominal surgery are unclear at initial assessment. This study was conducted to identify the etiology and clinical characteristics of SBO in virgin abdomens and discuss the proper management.
Methods:
A retrospective review involving operative cases of SBO from a single institute, which had no history of abdominal surgery, was conducted between January 2010 and December 2020. Clinical information, including radiological, operative, and pathologic findings, was investigated to determine the etiology of SBO.
Results:
A total of 55 patients were included in this study, with a median age of 57 years and male sex (63.6%) constituting the majority. The most frequently reported symptoms were abdominal pain and nausea or vomiting. Neoplasm as an underlying cause accounted for 34.5% of the cases, of which 25.5% were malignant cases. In patients aged ≥60 years (n=23), small bowel neoplasms were the underlying cause in 12 (52.2%), of whom 9 (39.1%) were malignant cases. Adhesions and Crohn disease were more frequent in patients aged <60 years. Coherence between preoperative computed tomography scans and intraoperative findings was found in 63.6% of the cases.
Conclusion
There were various causes of surgical cases of SBO in virgin abdomens. In older patients, hidden malignancy should be considered as a possible cause of SBO in a virgin abdomen. Patients with symptoms of recurrent bowel obstruction who have no history of prior abdominal surgery require thorough medical history and close follow-up.
3.Apparent treatment-resistant hypertension among ambulatory hypertensive patients: a cross-sectional study from 13 general hospitals
Sehun KIM ; Jin Joo PARK ; Mi-Seung SHIN ; Choong Hwan KWAK ; Bong-Ryeol LEE ; Sung-Ji PARK ; Hae-Young LEE ; Sang-Hyun KIM ; Seok-Min KANG ; Byung-Su YOO ; Joong-Wha CHUNG ; Si Wan CHOI ; Sang-Ho JO ; Jinho SHIN ; Dong-Ju CHOI
The Korean Journal of Internal Medicine 2021;36(4):888-897
Background/Aims:
To examine the prevalence and clinical characteristics of apparent treatment-resistant hypertension among ambulatory hypertensive patients.
Methods:
We enrolled adult ambulatory hypertensive patients at 13 well-qualified general hospitals in Korea from January to June 2012. Apparent resistant hypertension was defined as an elevated blood pressure > 140/90 mmHg with the use of three antihypertensive agents, including diuretics, or ≥ 4 antihypertensives, regardless of the blood pressure. Controlled hypertension was defined as a blood pressure within the target using three antihypertensives, including diuretics.
Results:
Among 16,915 hypertensive patients, 1,172 (6.9%) had controlled hypertension, and 1,514 (8.9%) had apparent treatment-resistant hypertension. Patients with apparent treatment-resistant hypertension had an earlier onset of hypertension (56.8 years vs. 58.8 years, p = 0.007) and higher body mass index (26.3 kg/m2 vs. 24.9 kg/m2, p < 0.001) than those with controlled hypertension. Drug compliance did not differ between groups. In the multivariable analysis, earlier onset of hypertension (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.97 to 0.99; p < 0.001) and the presence of comorbidities (OR, 2.06; 95% CI, 1.27 to 3.35; p < 0.001), such as diabetes mellitus, ischemic heart disease, heart failure, and chronic kidney disease, were independent predictors. Among the patients with apparent treatment-resistant hypertension, only 5.2% were receiving ≥ 2 antihypertensives at maximally tolerated doses.
Conclusions
Apparent treatment-resistant hypertension prevalence is 8.9% among ambulatory hypertensive patients in Korea. An earlier onset of hypertension and the presence of comorbidities are independent predictors. Optimization of medical treatment may reduce the rate of apparent treatment-resistant hypertension.
4.Apparent treatment-resistant hypertension among ambulatory hypertensive patients: a cross-sectional study from 13 general hospitals
Sehun KIM ; Jin Joo PARK ; Mi-Seung SHIN ; Choong Hwan KWAK ; Bong-Ryeol LEE ; Sung-Ji PARK ; Hae-Young LEE ; Sang-Hyun KIM ; Seok-Min KANG ; Byung-Su YOO ; Joong-Wha CHUNG ; Si Wan CHOI ; Sang-Ho JO ; Jinho SHIN ; Dong-Ju CHOI
The Korean Journal of Internal Medicine 2021;36(4):888-897
Background/Aims:
To examine the prevalence and clinical characteristics of apparent treatment-resistant hypertension among ambulatory hypertensive patients.
Methods:
We enrolled adult ambulatory hypertensive patients at 13 well-qualified general hospitals in Korea from January to June 2012. Apparent resistant hypertension was defined as an elevated blood pressure > 140/90 mmHg with the use of three antihypertensive agents, including diuretics, or ≥ 4 antihypertensives, regardless of the blood pressure. Controlled hypertension was defined as a blood pressure within the target using three antihypertensives, including diuretics.
Results:
Among 16,915 hypertensive patients, 1,172 (6.9%) had controlled hypertension, and 1,514 (8.9%) had apparent treatment-resistant hypertension. Patients with apparent treatment-resistant hypertension had an earlier onset of hypertension (56.8 years vs. 58.8 years, p = 0.007) and higher body mass index (26.3 kg/m2 vs. 24.9 kg/m2, p < 0.001) than those with controlled hypertension. Drug compliance did not differ between groups. In the multivariable analysis, earlier onset of hypertension (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.97 to 0.99; p < 0.001) and the presence of comorbidities (OR, 2.06; 95% CI, 1.27 to 3.35; p < 0.001), such as diabetes mellitus, ischemic heart disease, heart failure, and chronic kidney disease, were independent predictors. Among the patients with apparent treatment-resistant hypertension, only 5.2% were receiving ≥ 2 antihypertensives at maximally tolerated doses.
Conclusions
Apparent treatment-resistant hypertension prevalence is 8.9% among ambulatory hypertensive patients in Korea. An earlier onset of hypertension and the presence of comorbidities are independent predictors. Optimization of medical treatment may reduce the rate of apparent treatment-resistant hypertension.
5.2021 Clinical Practice Guidelines for Diabetes Mellitus in Korea
Kyu Yeon HUR ; Min Kyong MOON ; Jong Suk PARK ; Soo-Kyung KIM ; Seung-Hwan LEE ; Jae-Seung YUN ; Jong Ha BAEK ; Junghyun NOH ; Byung-Wan LEE ; Tae Jung OH ; Suk CHON ; Ye Seul YANG ; Jang Won SON ; Jong Han CHOI ; Kee Ho SONG ; Nam Hoon KIM ; Sang Yong KIM ; Jin Wha KIM ; Sang Youl RHEE ; You-Bin LEE ; Sang-Man JIN ; Jae Hyeon KIM ; Chong Hwa KIM ; Dae Jung KIM ; SungWan CHUN ; Eun-Jung RHEE ; Hyun Min KIM ; Hyun Jung KIM ; Donghyun JEE ; Jae Hyun KIM ; Won Seok CHOI ; Eun-Young LEE ; Kun-Ho YOON ; Seung-Hyun KO ;
Diabetes & Metabolism Journal 2021;45(4):461-481
The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.
6.2021 Clinical Practice Guidelines for Diabetes Mellitus in Korea
Kyu Yeon HUR ; Min Kyong MOON ; Jong Suk PARK ; Soo-Kyung KIM ; Seung-Hwan LEE ; Jae-Seung YUN ; Jong Ha BAEK ; Junghyun NOH ; Byung-Wan LEE ; Tae Jung OH ; Suk CHON ; Ye Seul YANG ; Jang Won SON ; Jong Han CHOI ; Kee Ho SONG ; Nam Hoon KIM ; Sang Yong KIM ; Jin Wha KIM ; Sang Youl RHEE ; You-Bin LEE ; Sang-Man JIN ; Jae Hyeon KIM ; Chong Hwa KIM ; Dae Jung KIM ; SungWan CHUN ; Eun-Jung RHEE ; Hyun Min KIM ; Hyun Jung KIM ; Donghyun JEE ; Jae Hyun KIM ; Won Seok CHOI ; Eun-Young LEE ; Kun-Ho YOON ; Seung-Hyun KO ;
Diabetes & Metabolism Journal 2021;45(4):461-481
The Committee of Clinical Practice Guidelines of the Korean Diabetes Association (KDA) updated the previous clinical practice guidelines for Korean adults with diabetes and prediabetes and published the seventh edition in May 2021. We performed a comprehensive systematic review of recent clinical trials and evidence that could be applicable in real-world practice and suitable for the Korean population. The guideline is provided for all healthcare providers including physicians, diabetes experts, and certified diabetes educators across the country who manage patients with diabetes or the individuals at the risk of developing diabetes mellitus. The recommendations for screening diabetes and glucose-lowering agents have been revised and updated. New sections for continuous glucose monitoring, insulin pump use, and non-alcoholic fatty liver disease in patients with diabetes mellitus have been added. The KDA recommends active vaccination for coronavirus disease 2019 in patients with diabetes during the pandemic. An abridgement that contains practical information for patient education and systematic management in the clinic was published separately.
7.Real-World Experience with Pembrolizumab Treatment in Patients with Heavily Treated Recurrent Gynecologic Malignancies
Min Chul CHOI ; Yong Wha MOON ; Sang Geun JUNG ; Hyun PARK ; Won Duk JOO ; Seung Hun SONG ; Chan LEE ; Gwangil KIM ; Kyoung Ah KIM
Yonsei Medical Journal 2020;61(10):844-850
Purpose:
We evaluated the efficacy and safety of pembrolizumab in patients with recurrent gynecologic cancers in real-world practice.
Materials and Methods:
We conducted a retrospective, single-institution study of patients with recurrent gynecologic malignancies treated with pembrolizumab. The primary endpoints were the objective response rate (ORR) and safety.
Results:
Thirty-one patients treated with pembrolizumab were included. The primary disease sites were the uterine cervix (n=18), ovaries (n=8), and uterine corpus (n=5). Fifteen of the 31 patients (48%) had an Eastern Cooperative Oncology Group performance status of ≥2. The median number of prior chemotherapy lines was 2 (range, 1–6), and 14 of 31 patients (45%) had received ≥ 3 prior lines of chemotherapy. The overall ORR was 22.6%: specifically, 22.3% (4 of 18 patients), 12.5% (1 of 8 patients), and 40% (2 of 5 patients) for cervical, ovarian, and endometrial cancers, respectively. During a median follow-up of 4.7 months (range, 0.2–35.3), the median time to response was 1.9 months (range, 1.4–5.7). The median duration of response was not reached (range, 8.8-not reached).The median progression-free survival was 2.5 months (95% confidence interval, 1.7-not reached). Adverse events occurred in 20 patients (64.5%), and only 3 (9.7%) were grade ≥3. There was one case of suspicious treatment-related mortality, apart from which most adverse events were manageable.
Conclusion
In real-world practice, pembrolizumab was feasible and effective in heavily treated recurrent gynecologic cancer patients with poor performance status who may not be eligible for enrollment in clinical trials.
8.The Management of Retained Rectal Foreign Body
Ju Hun KIM ; Eunhae UM ; Sung Min JUNG ; Yong Chan SHIN ; Sung-Won JUNG ; Jae Il KIM ; Tae Gil HEO ; Myung Soo LEE ; Heungman JUN ; Pyong Wha CHOI
Annals of Coloproctology 2020;36(5):335-343
Purpose:
Because insertion of a foreign body (FB) into the anus is considered a taboo practice, patients with a retained rectal FB may hesitate to obtain medical care, and attending surgeons may lack experience with removing these FBs. We performed this study to evaluate the clinical characteristics of Korean patients with a retained rectal FB and propose management guideline for such cases based on our experience.
Methods:
We retrospectively investigated 14 patients between January 2006 and December 2018. We assessed demographic features, mechanism of FB insertion, clinical course between diagnosis and management, and outcomes.
Results:
All patients were male (mean age, 43 years) and presented with low abdominal pain (n = 2), anal bleeding (n = 2), or concern about a retained rectal FB without symptoms (n = 10). FB insertion was most commonly associated with sexual gratification or anal eroticism (n = 11, 78.6%). All patients underwent general anesthesia for anal sphincter relaxation with the exception of 2 who underwent FB removal in the emergency department. FBs were retrieved transanally using a clamp (n = 2), myoma screw (n = 1), clamp application following abdominal wall compression (n = 2), or laparotomy followed by rectosigmoid colon milking (n = 2). Colotomy and primary repair were performed in four patients, and Hartmann operation was performed in one patient with fecal peritonitis. No morbidity or mortality was reported. All patients refused postextraction anorectal functional and anatomical evaluation and psychological counseling.
Conclusion
Retained rectal FB is rare; however, colorectal surgeons should be aware of the various methods that can be used for FB retrieval and the therapeutic algorithm applicable in such cases.
9.Pancreatic High-Grade Neuroendocrine Neoplasms in the Korean Population: A Multicenter Study
Haeryoung KIM ; Soyeon AN ; Kyoungbun LEE ; Sangjeong AHN ; Do Youn PARK ; Jo-Heon KIM ; Dong-Wook KANG ; Min-Ju KIM ; Mee Soo CHANG ; Eun Sun JUNG ; Joon Mee KIM ; Yoon Jung CHOI ; So-Young JIN ; Hee Kyung CHANG ; Mee-Yon CHO ; Yun Kyung KANG ; Myunghee KANG ; Soomin AHN ; Youn Wha KIM ; Seung-Mo HONG ;
Cancer Research and Treatment 2020;52(1):263-276
Purpose:
The most recent 2017 World Health Organization (WHO) classification of pancreatic neuroendocrine neoplasms (PanNENs) has refined the three-tiered 2010 scheme by separating grade 3 pancreatic neuroendocrine tumors (G3 PanNETs) from poorly differentiated pancreatic neuroendocrine carcinomas (PanNECs). However, differentiating between G3 Pan- NETs and PanNECs is difficult in clinical practice.
Materials and Methods:
Eighty-two surgically resected PanNENs were collected from 16 institutions and reclassified according to the 2017 WHO classification based on the histological features and proliferation index (mitosis and Ki-67). Immunohistochemical stains for ATRX, DAXX, retinoblastoma, p53, Smad4, p16, and MUC1 were performed for 15 high-grade PanNENs.
Results:
Re-classification resulted in 20 G1 PanNETs (24%), 47 G2 PanNETs (57%), eight G3 well-differentiated PanNETs (10%), and seven poorly differentiated PanNECs (9%). PanNECs showed more frequent diffuse nuclear atypia, solid growth patterns and apoptosis, less frequent organoid growth and regular vascular patterns, and absence of low-grade PanNET components than PanNETs. The Ki-67 index was significantly higher in PanNEC (58.2%± 15.1%) compared to G3 PanNET (22.6%±6.1%, p < 0.001). Abnormal expression of any two of p53, p16, MUC1, and Smad4 could discriminate PanNECs from G3 PanNETs with 100% specificity and 87.5% sensitivity.
Conclusion
Histological features supporting the diagnosis of PanNECs over G3 PanNETs were the absence of a low-grade PanNET component in the tumor, the presence of diffuse marked nuclear atypia, solid growth pattern, frequent apoptosis and markedly increased proliferative activity with homogeneous Ki-67 labeling. Immunohistochemical stains for p53, p16, MUC1, and Smad4 may be helpful in distinguishing PanNECs from G3 PanNETs in histologically ambiguous cases, especially in diagnostic practice when only small biopsied tissues are available.
10.The Effects of Orofacial Myofunctional Training on the Changes of Lip and Tongue Strength in Elderly People
Seol Hee KIM ; Min Ju KIM ; Seung Hyun LEE ; Bo Wha CHOI ; Yae Jee HEO
Journal of Dental Hygiene Science 2019;19(4):279-287
BACKGROUND: Increasing age and loss of teeth weaken oral muscle strength. This study aimed to investigate the positive effects of orofacial myofunctional training on elderly people.METHODS: Thirty six elderly individuals in a welfare center and a senior citizen center were included in this study. A survey regarding lip and tongue strength suvsequent to orofacial myofunctional training and oral health-related quality of life was conducted from April to June, 2019. Data were analyzed using PASW statistics ver. 18.0.RESULTS: The experimental group, showed an increase in lip strength (from 9.79 to 10.31) and tongue strength (from 41.26 to 43.97) after orofacial myofunctional training. The perception of oral health-relatedquality of life was enhanced (from 2.26 to 2.07). In particular, the frequency of dry cough for food removal while swallowing decresed due to an incresed in the secretion of saliva (p<0.05). Correlation analysis showed that the number of functional teeth was positively related to oral health-related quality of life.CONCLUSION: Orofacial myofunctional training for improving lip and tongue strength is effective in the elderly. In older societies, oral strength should be maintained to improve oral health-related quality of life. It also suggests the interest of oral health workers and applying orofacial myofunctional training programs.
Aged
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Cough
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Deglutition
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Education
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Humans
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Lip
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Muscle Strength
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Myofunctional Therapy
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Oral Health
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Quality of Life
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Saliva
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Tongue
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Tooth

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