1.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
2.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
3.Therapeutic effects of surgical debulking of metastatic lymph nodes in cervical cancer IIICr: a trial protocol for a phase III, multicenter, randomized controlled study (KGOG1047/DEBULK trial)
Bo Seong YUN ; Kwang-Beom LEE ; Keun Ho LEE ; Ha Kyun CHANG ; Joo-Young KIM ; Myong Cheol LIM ; Chel Hun CHOI ; Hanbyoul CHO ; Dae-Yeon KIM ; Yun Hwan KIM ; Joong Sub CHOI ; Chae Hyeong LEE ; Jae-Weon KIM ; Sang Wun KIM ; Yong Bae KIM ; Chi-Heum CHO ; Dae Gy HONG ; Yong Jung SONG ; Seob JEON ; Min Kyu KIM ; Dae Hoon JEONG ; Hyun PARK ; Seok Mo KIM ; Sang-Il PARK ; Jae-Yun SONG ; Asima MUKHOPADHYAY ; Dang Huy Quoc THINH ; Nirmala Chandralega KAMPAN ; Grace J. LEE ; Jae-Hoon KIM ; Keun-Yong EOM ; Ju-Won ROH
Journal of Gynecologic Oncology 2024;35(5):e57-
Background:
Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests.
Methods
The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.
4.Effect of fever or respiratory symptoms on leaving without being seen during the COVID-19 pandemic in South Korea
Dohyung KIM ; Weon JUNG ; Jae Yong YU ; Hansol CHANG ; Se Uk LEE ; Taerim KIM ; Sung Yeon HWANG ; Hee YOON ; Tae Gun SHIN ; Min Seob SIM ; Ik Joon JO ; Won Chul CHA
Clinical and Experimental Emergency Medicine 2022;9(1):1-9
Objective:
Coronavirus disease 2019 (COVID-19) has notably altered the emergency department isolation protocol, imposing stricter requirements on probable infectious disease patients that enter the department. This has caused adverse effects, such as an increased rate of leave without being seen (LWBS). This study describes the effect of fever/respiratory symptoms as the main cause of isolation regarding LWBS after the COVID-19 pandemic.
Methods:
We retrospectively analyzed emergency department visits before (March to July 2019) and after (March to July 2020) the COVID-19 pandemic. Patients were grouped based on existing fever or respiratory symptoms, with the LWBS rate as the primary outcome. Logistic regression analysis was used to identify the risk factors of LWBS. Logistic regression was performed using interaction terminology (fever/respiratory symptom patient [FRP] × post–COVID-19) to determine the interaction between patients with FRPs and the COVID-19 pandemic period.
Results:
A total of 60,290 patients were included (34,492 in the pre–COVID-19, and 25,298 in the post–COVID-19 group). The proportion of FRPs decreased significantly after the pandemic (P < 0.001), while the LWBS rate in FRPs significantly increased from 2.8% to 19.2% (P < 0.001). Both FRPs (odds ratio, 1.76; 95% confidence interval, 1.59–1.84 (P < 0.001) and the COVID-19 period (odds ratio, 2.29; 95% confidence interval, 2.15–2.44; P < 0.001) were significantly associated with increased LWBS. Additionally, there was a significant interaction between the incidence of LWBS in FRPs and the COVID-19 pandemic period (P < 0.001).
Conclusion
The LWBS rate has increased in FRPs after the COVID-19 pandemic; additionally, the effect observed was disproportionate compared with that of nonfever/respiratory symptom patients.
5.Consensus Document on Perioperative Antithrombotic Management: Part 2. Case Study
Yongwhi PARK ; Ae-Young HER ; Hyun Kuk KIM ; Jae Youn MOON ; Jae Hyoung PARK ; Keun-Ho PARK ; Kyung Hoon LEE ; Hyung Joon JOO ; Ho Yeon WON ; Sung Gyun AHN ; Hong Jun PARK ; Sung-Jin HONG ; Beom Joon KIM ; Seung Pil BAN ; Jung-Won SUH ; Young Bin SONG ; Jung Rae CHO ; Young-Hoon JEONG ; Weon KIM ; Eun-Seok SHIN ;
Korean Journal of Medicine 2022;97(4):204-228
Given the progressive improvements in antithrombotic strategies, management of cardiovascular disease has become sophisticated/refined. However, the optimal perioperative management of antithrombotic therapy in patients with acute coronary syndrome or who are scheduled for percutaneous coronary intervention remains unclear. Assessments of the thrombotic and hemorrhagic risks are essential to reduce the rates of mortality and major cardiac events. However, the existing guidelines do not mention these topics. This case-based consensus document deals with common clinical scenarios and offers evidence-based guidelines for individualized perioperative management of antithrombotic therapy in the real world.
6.Consensus Document on Perioperative Antithrombotic Management: Part 1. A Review
Yongwhi PARK ; Ae-Young HER ; Hyun Kuk KIM ; Jae Youn MOON ; Jae Hyoung PARK ; Keun-Ho PARK ; Kyung Hoon LEE ; Hyung Joon JOO ; Ho Yeon WON ; Sung Gyun AHN ; Hong Jun PARK ; Sung-Jin HONG ; Beom Joon KIM ; Seung Pil BAN ; Jung-Won SUH ; Young Bin SONG ; Jung Rae CHO ; Young-Hoon JEONG ; Weon KIM ; Eun-Seok SHIN ;
Korean Journal of Medicine 2022;97(3):150-163
The prevalence of ischemic heart disease is steadily growing as populations age. Antithrombotic treatment is a key therapeutic modality for the prevention of secondary cerebro-cardiovascular disease. Patients with acute coronary syndrome or who are undergoing percutaneous coronary intervention must be treated with dual antiplatelet therapy for a mandatory period. The optimal perioperative antithrombotic regimen remains debatable; antithrombotics can cause bleeding. Inadequate antithrombotic regimens are associated with perioperative ischemic events, but continuation of therapy may increase the risks of perioperative hemorrhagic complications (including mortality). Many guidelines on the perioperative management of antithrombotic agents have been established by academic societies. However, the existing guidelines do not cover all specialties, nor do they describe the thrombotic and hemorrhagic risks associated with various surgical interventions. Moreover, few practical recommendations on the modification of antithrombotic regimens in patients who require non-deferrable interventions/surgeries or procedures associated with a high risk of hemorrhage have appeared. Therefore, cardiologists, specialists performing invasive procedures, surgeons, dentists, and anesthesiologists have not come to a consensus on optimal perioperative antithrombotic regimens. The Korean Platelet-Thrombosis Research Group presented a positioning paper on perioperative antithrombotic management. We here discuss commonly encountered clinical scenarios and engage in evidence-based discussion to assist individualized, perioperative antithrombotic management in clinical practice.
7.Identification of Patients with Recurrent Epithelial Ovarian Cancer Who Will Benefit from More Than Three Lines of Chemotherapy
Aeran SEOL ; Ga Won YIM ; Joo Yeon CHUNG ; Se Ik KIM ; Maria LEE ; Hee Seung KIM ; Hyun Hoon CHUNG ; Jae-Weon KIM ; Noh Hyun PARK ; Yong Sang SONG
Cancer Research and Treatment 2022;54(4):1219-1229
Purpose:
This study aimed to identify patients who would benefit from third and subsequent lines of chemotherapy in recurrent epithelial ovarian cancer (EOC).
Materials and Methods:
Recurrent EOC patients who received third, fourth, or fifth-line palliative chemotherapy were retrospectively analyzed. Patients’ survival outcomes were assessed according to chemotherapy lines. Based on the best objective response, patients were divided into good-response (stable disease or better) and poor response (progressive disease or those who died before response assessment) groups. Survival outcomes were compared between the two groups, and factors associated with chemotherapy responses were investigated.
Results:
A total of 189 patients were evaluated. Ninety-four and 95 patients were identified as good and poor response group respectively, during the study period of 2008 to 2021. The poor response group showed significantly worse progression-free survival (median, 2.1 months vs. 9.7 months; p < 0.001) and overall survival (median, 5.0 months vs. 22.9 months; p < 0.001) compared with the good response group. In multivariate analysis adjusting for clinicopathologic factors, short treatment-free interval (TFI) (hazard ratio [HR], 5.557; 95% confidence interval [CI], 2.403 to 12.850), platinum-resistant EOC (HR, 2.367; 95% CI, 1.017 to 5.510), and non-serous/endometrioid histologic type (HR, 5.045; 95% CI, 1.152 to 22.088) were identified as independent risk factors for poor response. There was no difference in serious adverse events between good and poor response groups (p=0.167).
Conclusion
Third and subsequent lines of chemotherapy could be carefully considered for palliative purposes in recurrent EOC patients with serous or endometrioid histology, initial platinum sensitivity, and long TFIs from the previous chemotherapy regimen.
8.Identification of rare coding variants associated with Kawasaki disease by whole exome sequencing
Jae-Jung KIM ; Young Mi HONG ; Sin Weon YUN ; Kyung-Yil LEE ; Kyung Lim YOON ; Myung-Ki HAN ; Gi Beom KIM ; Hong-Ryang KIL ; Min Seob SONG ; Hyoung Doo LEE ; Kee Soo HA ; Hyun Ok JUN ; Byung-Ok CHOI ; Yeon-Mok OH ; Jeong Jin YU ; Gi Young JANG ; Jong-Keuk LEE ;
Genomics & Informatics 2021;19(4):e38-
Kawasaki disease (KD) is an acute pediatric vasculitis that affects genetically susceptible infants and children. To identify coding variants that influence susceptibility to KD, we conducted whole exome sequencing of 159 patients with KD and 902 controls, and performed a replication study in an independent 586 cases and 732 controls. We identified five rare coding variants in five genes (FCRLA, PTGER4, IL17F, CARD11, and SIGLEC10) associated with KD (odds ratio [OR], 1.18–4.41; p = 0.0027–0.031). We also performed association analysis in 26 KD patients with coronary artery aneurysms (CAAs; diameter > 5 mm) and 124 patients without CAAs (diameter < 3 mm), and identified another five rare coding variants in five genes (FGFR4, IL31RA, FNDC1, MMP8, and FOXN1), which may be associated with CAA (OR, 3.89–37.3; p = 0.0058–0.0261). These results provide insights into new candidate genes and genetic variants potentially involved in the development of KD and CAA.
9.Associations between Physical Activity Level and Metabolic Risk Factors in Gynecological Cancer Survivors
Sang-Hwa LEE ; Jae-Weon KIM ; Seok-Ju SEONG ; Yeon-Soo KIM
The Korean Journal of Sports Medicine 2020;38(2):101-109
Purpose:
This study aimed to investigate the associations between physical activity (PA), health-related fitness, and metabolic risk factors in Korean gynecological cancer survivors using propensity score matching.
Methods:
A cross-sectional analysis was performed using national representative data between 2015 and 2018 from the Korea National Health and Nutrition Examination Survey (KNHANES VI3 and VI1–3). PA was self-reported through the global PA questionnaire, and health-related fitness was measured using handgrip strength and resting heart rate. Metabolic risk factors were measured by performing blood analyses, including fasting glucose, total cholesterol, and triglyceride levels, and blood pressure.
Results:
The total number of subjects was 268 (gynecological cancer, n=134; non-cancer, n=134). The results showed that the gynecological cancer survivors (time since diagnosis, <5 years and ≥5 years) participated in less amounts of weekly total moderate-to-vigorous intensity PA (160.0±170.1 vs. 144.6±177.3 vs. 334.1±191.3 min/wk; p<0.001), travel PA (94.5±119.3 vs. 109.4±143.9 vs. 215.7±170.7 min/wk; p<0.001), and walking (190.7±174.5 vs. 258.8±280.8 vs. 444.5±434.7 min/wk; p<0.001) than did the non-cancer population. Moreover, the gynecological cancer survivors who met the aerobic PA guidelines had significantly lower fasting glucose (p=0.035) and triacylglyceride levels (p=0.013), and systolic blood pressure (p=0.035) than the non-active participants.
Conclusion
The PA of the gynecological cancer survivors was lower than that of the general population. Aerobic PA was significantly associated with lower levels of metabolic disturbances in Korean gynecological cancer survivors.
10.lity and Acceptability of Prehabilitation before Surgery for Endometrial Cancer
Sang-Hwa LEE ; Na-Ra LEE ; Jae-Weon KIM ; Maria LEE ; Seok-Ju SEONG ; Jae-Yun SONG ; Yeon-Soo KIM
The Korean Journal of Sports Medicine 2020;38(2):85-94
Purpose:
To investigate the safety of and adherence to a prehabilitation program among patients with endometrial cancer and to provide preliminary evidence of the program’s efficacy in terms of health-related fitness (HRF) and patient-reported outcomes.
Methods:
Nineteen patients with endometrial cancer were recruited in a 2-week trial for a one-on-one supervised exercise program. All patients participated in an individual exercise program—the Challenge, Overcome, Resolve, and Enhance (CORE) program—which consisted of 60 minutes of moderate-to-vigorous intensity resistance, core stability, and aerobic exercise, supervised five times within 2 weeks before surgery.
Results:
Seventeen (89.5%) of the 19 participants completed the CORE program, and no adverse events occurred. All participants accomplished the daily mean step counts and sustained the prescribed target heart rate (reserve 50%–60%) during the CORE program sessions. Participants who completed the exercise program exhibited significantly improved HRF (cardiorespiratory fitness, 30-second chair stand, hand grip strength, curl-ups, sit and reach, single-leg standing with closed eyes; p<0.001 for all) without changes in the body mass index (p=0.113). Their quality of life (general, p=0.001; function, p=0.001; symptom, p=0.003), symptom clusters (p=0.006), anxiety (p<0.001), and depression (p<0.001) were significantly improved.
Conclusion
The 2-week prehabilitation CORE program is safe and feasible for patients scheduled to undergo surgery for early-stage endometrial cancer and may improve their physical and psychological health status.

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