1.Oncological Outcomes in Men with Metastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide with versus without Confirmatory Bone Scan
Chang Wook JEONG ; Jang Hee HAN ; Dong Deuk KWON ; Jae Young JOUNG ; Choung-Soo KIM ; Hanjong AHN ; Jun Hyuk HONG ; Tae-Hwan KIM ; Byung Ha CHUNG ; Seong Soo JEON ; Minyong KANG ; Sung Kyu HONG ; Tae Young JUNG ; Sung Woo PARK ; Seok Joong YUN ; Ji Yeol LEE ; Seung Hwan LEE ; Seok Ho KANG ; Cheol KWAK
Cancer Research and Treatment 2024;56(2):634-641
Purpose:
In men with metastatic castration-resistant prostate cancer (mCRPC), new bone lesions are sometimes not properly categorized through a confirmatory bone scan, and clinical significance of the test itself remains unclear. This study aimed to demonstrate the performance rate of confirmatory bone scans in a real-world setting and their prognostic impact in enzalutamide-treated mCRPC.
Materials and Methods:
Patients who received oral enzalutamide for mCRPC during 2014-2017 at 14 tertiary centers in Korea were included. Patients lacking imaging assessment data or insufficient drug exposure were excluded. The primary outcome was overall survival (OS). Secondary outcomes included performance rate of confirmatory bone scans in a real-world setting. Kaplan-Meier analysis and multivariate Cox regression analysis were performed.
Results:
Overall, 520 patients with mCRPC were enrolled (240 [26.2%] chemotherapy-naïve and 280 [53.2%] after chemotherapy). Among 352 responders, 92 patients (26.1%) showed new bone lesions in their early bone scan. Confirmatory bone scan was performed in 41 patients (44.6%), and it was associated with prolonged OS in the entire population (median, 30.9 vs. 19.7 months; p < 0.001), as well as in the chemotherapy-naïve (median, 47.2 vs. 20.5 months; p=0.011) and post-chemotherapy sub-groups (median, 25.5 vs. 18.0 months; p=0.006). Multivariate Cox regression showed that confirmatory bone scan performance was an independent prognostic factor for OS (hazard ratio 0.35, 95% confidence interval, 0.18 to 0.69; p=0.002).
Conclusion
Confirmatory bone scan performance was associated with prolonged OS. Thus, the premature discontinuation of enzalutamide without confirmatory bone scans should be discouraged.
2.Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
Nam Hoon KIM ; Juneyoung LEE ; Suk CHON ; Jae Myung YU ; In-Kyung JEONG ; Soo LIM ; Won Jun KIM ; Keeho SONG ; Ho Chan CHO ; Hea Min YU ; Kyoung-Ah KIM ; Sang Soo KIM ; Soon Hee LEE ; Chong Hwa KIM ; Soo Heon KWAK ; Yong‐ho LEE ; Choon Hee CHUNG ; Sihoon LEE ; Heung Yong JIN ; Jae Hyuk LEE ; Gwanpyo KOH ; Sang-Yong KIM ; Jaetaek KIM ; Ju Hee LEE ; Tae Nyun KIM ; Hyun Jeong JEON ; Ji Hyun LEE ; Jae-Han JEON ; Hye Jin YOO ; Hee Kyung KIM ; Hyeong-Kyu PARK ; Il Seong NAM-GOONG ; Seongbin HONG ; Chul Woo AHN ; Ji Hee YU ; Jong Heon PARK ; Keun-Gyu PARK ; Chan Ho PARK ; Kyong Hye JOUNG ; Ohk-Hyun RYU ; Keun Yong PARK ; Eun-Gyoung HONG ; Bong-Soo CHA ; Kyu Chang WON ; Yoon-Sok CHUNG ; Sin Gon KIM
Endocrinology and Metabolism 2024;39(5):722-731
Background:
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods:
This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion
This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
3.Comparison of Short-Term Outcomes and Safety Profiles between Androgen Deprivation Therapy+Abiraterone/Prednisone and Androgen Deprivation Therapy+Docetaxel in Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer
Dong Jin PARK ; Tae Gyun KWON ; Jae Young PARK ; Jae Young JOUNG ; Hong Koo HA ; Seong Soo JEON ; Sung-Hoo HONG ; Sungchan PARK ; Seung Hwan LEE ; Jin Seon CHO ; Sung-Woo PARK ; Se Yun KWON ; Jung Ki JO ; Hong Seok PARK ; Sang-Cheol LEE ; Dong Deuk KWON ; Sun Il KIM ; Sang Hyun PARK ; Soodong KIM ; Chang Wook JEONG ; Cheol KWAK ; Seock Hwan CHOI ;
The World Journal of Men's Health 2024;42(3):620-629
Purpose:
This study aimed to compare the short-term outcomes and safety profiles of androgen-deprivation therapy (ADT)+abiraterone/prednisone with those of ADT+docetaxel in patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Materials and Methods:
A web-based database system was established to collect prospective cohort data for patients with mHSPC in Korea. From May 2019 to November 2022, 928 patients with mHSPC from 15 institutions were enrolled. Among these patients, data from 122 patients who received ADT+abiraterone/prednisone or ADT+docetaxel as the primary systemic treatment for mHSPC were collected. The patients were divided into two groups: ADT+abiraterone/prednisone group (n=102) and ADT+docetaxel group (n=20). We compared the demographic characteristics, medical histories, baseline cancer status, initial laboratory tests, metastatic burden, oncological outcomes for mHSPC, progression after mHSPC treatment, adverse effects, follow-up, and survival data between the two groups.
Results:
No significant differences in the demographic characteristics, medical histories, metastatic burden, and baseline cancer status were observed between the two groups. The ADT+abiraterone/prednisone group had a lower prostate-specific antigen (PSA) progression rate (7.8% vs. 30.0%; p=0.011) and lower systemic treatment discontinuation rate (22.5% vs. 45.0%; p=0.037). No significant differences in adverse effects, oncological outcomes, and total follow-up period were observed between the two groups.
Conclusions
ADT+abiraterone/prednisone had lower PSA progression and systemic treatment discontinuation rates than ADT+docetaxel. In conclusion, further studies involving larger, double-blinded randomized trials with extended follow-up periods are necessary.
4.2022 Update of the Korean Clinical Practice Guidelines for Stroke: Antithrombotic Therapy for Patients with Acute Ischemic Stroke or Transient Ischemic Attack
Hong-Kyun PARK ; Sang-Bae KO ; Keun-Hwa JUNG ; Min Uk JANG ; Dae-Hyun KIM ; Joon-Tae KIM ; Jay Chol CHOI ; Hye Seon JEONG ; Chulho KIM ; Ji Hoe HEO ; Joung-Ho RHA ; Sun U. KWON ; Jong S. KIM ; Byung-Chul LEE ; Hee-Joon BAE ; Byung-Woo YOON ; Keun-Sik HONG
Journal of Stroke 2022;24(1):166-175
Antithrombotic therapy is a cornerstone of acute ischemic stroke (AIS) management and secondary stroke prevention. Since the first version of the Korean Clinical Practice Guideline (CPG) for stroke was issued in 2009, significant progress has been made in antithrombotic therapy for patients with AIS, including dual antiplatelet therapy in acute minor ischemic stroke or high-risk transient ischemic stroke and early oral anticoagulation in AIS with atrial fibrillation. The evidence is widely accepted by stroke experts and has changed clinical practice. Accordingly, the CPG Committee of the Korean Stroke Society (KSS) decided to update the Korean Stroke CPG for antithrombotic therapy for AIS. The writing members of the CPG committee of the KSS reviewed recent evidence, including clinical trials and relevant literature, and revised recommendations. A total of 35 experts were invited from the KSS to reach a consensus on the revised recommendations. The current guideline update aims to assist healthcare providers in making well-informed decisions and improving the quality of acute stroke care. However, the ultimate treatment decision should be made using a holistic approach, considering the specific medical conditions of individual patients.
5.Analysis of the Time Interval between the Physician Order for Life-Sustaining Treatment Completion and Death
Sung Yoon JOUNG ; Chung-woo LEE ; Youn Seon CHOI ; Seon Mee KIM ; Seok Won PARK ; Eun Shik MO ; Jae Hyun PARK ; Jean SHIN ; Hyun Jin LEE ; Hong Seok PARK
Korean Journal of Family Medicine 2020;41(6):392-397
Background:
This study aimed to explore the time interval distribution pattern between the Physicians Order for Life-Sustaining Treatment (POLST) form completion and death at a tertiary hospital in South Korea. It also examined the association between various independent parameters and POLST form completion timing.
Methods:
A total of 150 critically ill patients admitted to Korea University Guro Hospital between June 1, 2018 and December 31, 2018 who completed the POLST form were retrospectively analyzed and included in this study. Data were analyzed with descriptive statistics, and group comparisons were performed using the chi-square test for categorical variables. Fisher’s exact test was also used to compare cancer versus non-cancer groups.
Results:
More than half the decedents (54.7%) completed their POLST within 15 days of death and 73.4% within 30 days. The non-cancer group had the highest percentage of patients (77.8%) who died within 15 days of POLST form completion while the colorectal (39.1%) and other cancer (37.5%) groups had the lowest (P=0.336).
Conclusion
Our findings demonstrated a current need for more explicit guidance to assist physicians with initiating more timely, proactive end-of-life discussions.
6.Changes in High-Density Lipoprotein Cholesterol and Risks of Cardiovascular Events: A Post Hoc Analysis from the PICASSO Trial
Eun-Jae LEE ; Sun U. KWON ; Jong-Ho PARK ; Yong-Jae KIM ; Keun-Sik HONG ; Sungwook YU ; Yang-Ha HWANG ; Ji Sung LEE ; Juneyoung LEE ; Joung-Ho RHA ; Sung Hyuk HEO ; Sung Hwan AHN ; Woo-Keun SEO ; Jong-Moo PARK ; Ju-Hun LEE ; Jee-Hyun KWON ; Sung-Il SOHN ; Jin-Man JUNG ; Hahn Young KIM ; Eung-Gyu KIM ; Sung Hun KIM ; Jae-Kwan CHA ; Man-Seok PARK ; Hyo Suk NAM ; Dong-Wha KANG ;
Journal of Stroke 2020;22(1):108-118
Background:
and purpose Whether pharmacologically altered high-density lipoprotein cholesterol (HDL-C) affects the risk of cardiovascular events is unknown. Recently, we have reported the Prevention of Cardiovascular Events in Asian Patients with Ischaemic Stroke at High Risk of Cerebral Haemorrhage (PICASSO) trial that demonstrated the non-inferiority of cilostazol to aspirin and superiority of probucol to non-probucol for cardiovascular prevention in ischemic stroke patients (clinicaltrials.gov: NCT01013532). We aimed to determine whether on-treatment HDL-C changes by cilostazol and probucol influence the treatment effect of each study medication during the PICASSO study.
Methods:
Of the 1,534 randomized patients, 1,373 (89.5%) with baseline cholesterol parameters were analyzed. Efficacy endpoint was the composite of stroke, myocardial infarction, and cardiovascular death. Cox proportional hazards regression analysis examined an interaction between the treatment effect and changes in HDL-C levels from randomization to 1 month for each study arm.
Results:
One-month post-randomization mean HDL-C level was significantly higher in the cilostazol group than in the aspirin group (1.08 mmol/L vs. 1.00 mmol/L, P<0.001). The mean HDL-C level was significantly lower in the probucol group than in the non-probucol group (0.86 mmol/L vs. 1.22 mmol/L, P<0.001). These trends persisted throughout the study. In both study arms, no significant interaction was observed between HDL-C changes and the assigned treatment regarding the risk of the efficacy endpoint.
Conclusions
Despite significant HDL-C changes, the effects of cilostazol and probucol treatment on the risk of cardiovascular events were insignificant. Pharmacologically altered HDL-C levels may not be reliable prognostic markers for cardiovascular risk.
7.Management of Acute Stroke Patients Amid the Coronavirus Disease 2019 Pandemic: Scientific Statement of the Korean Stroke Society
Beom Joon KIM ; Eu Suk KIM ; Myoung Jin SHIN ; Hong Bin KIM ; Hee Young LEE ; Keun-Sik HONG ; Hong-Kyun PARK ; Jun LEE ; Sung-Il SOHN ; Yang-Ha HWANG ; Sang-Bae KO ; Jong-Moo PARK ; Joung-Ho RHA ; Sun U. KWON ; Jong S. KIM ; Ji Hoe HEO ; Byung Chul LEE ; Byung-Woo YOON ; Hee-Joon BAE
Journal of Stroke 2020;22(2):203-205
8.2019 Update of the Korean Clinical Practice Guidelines of Stroke for Endovascular Recanalization Therapy in Patients with Acute Ischemic Stroke
Sang-Bae KO ; Hong-Kyun PARK ; Byung Moon KIM ; Ji Hoe HEO ; Joung-Ho RHA ; Sun U. KWON ; Jong S. KIM ; Byung-Chul LEE ; Sang Hyun SUH ; Cheolkyu JUNG ; Hae Woong JEONG ; Dong-Hun KANG ; Hee-Joon BAE ; Byung-Woo YOON ; Keun-Sik HONG
Journal of the Korean Neurological Association 2020;38(2):77-87
Endovascular recanalization therapy (ERT) has been a standard of care for patients with acute ischemic stroke due to large artery occlusion (LAO) within 6 hours after onset since the five landmark ERT trials up to 2015 demonstrated its clinical benefit. Recently, two randomized clinical trials demonstrated that ERT, even in the late time window up to 16 hours or 24 hours after last known normal time, improved the outcome of patients who had a target mismatch defined as either clinical-core mismatch or perfusion-core mismatch, which prompted the update of national guidelines in several countries. Accordingly, to provide evidence-based and up-to-date recommendations for ERT in patients with acute LAO in Korea, the Clinical Practice Guidelines Committee of the Korean Stroke Society decided to revise the previous Korean Clinical Practice Guidelines of Stroke for ERT. For this update, the members of the writing group were appointed by the Korean Stroke Society and the Korean Society of Interventional Neuroradiology. After thorough reviewing the updated evidence from two recent trials and relevant literature, the writing members revised recommendations, for which formal consensus was achieved by convening an expert panel composed of 45 experts from the participating academic societies. The current guidelines are intended to help healthcare providers, patients, and their caregivers make their well-informed decisions and to improve the quality of care regarding ERT. The ultimate decision for ERT in a particular patient must be made in light of circumstances specific to that patient.
9.2019 Update of the Korean Clinical Practice Guidelines of Stroke for Endovascular Recanalization Therapy in Patients with Acute Ischemic Stroke
Sang Bae KO ; Hong Kyun PARK ; Byung Moon KIM ; Ji Hoe HEO ; Joung Ho RHA ; Sun U KWON ; Jong S KIM ; Byung Chul LEE ; Sang Hyun SUH ; Cheolkyu JUNG ; Hae Woong JEONG ; Dong Hun KANG ; Hee Joon BAE ; Byung Woo YOON ; Keun Sik HONG
Neurointervention 2019;14(2):71-81
Endovascular recanalization therapy (ERT) has been a standard of care for patients with acute ischemic stroke due to large artery occlusion (LAO) within 6 hours after onset, since five landmark ERT trials conducted by 2015 demonstrated its clinical benefit. Recently, two randomized clinical trials demonstrated that ERT, even in the late time window of up to 16 hours or 24 hours after last known normal time, improved the outcome of patients who had a target mismatch, defined as either clinical-core mismatch or perfusion-core mismatch, which prompted the update of national guidelines in several countries. Accordingly, to provide evidence-based and up-to-date recommendations for ERT in patients with acute LAO in Korea, the Clinical Practice Guidelines Committee of the Korean Stroke Society decided to revise the previous Korean Clinical Practice Guidelines of Stroke for ERT. For this update, the members of the writing group were appointed by the Korean Stroke Society and the Korean Society of Interventional Neuroradiology. After thoroughly reviewing the updated evidence from two recent trials and relevant literature, the writing members revised recommendations, for which formal consensus was achieved by convening an expert panel composed of 45 experts from the participating academic societies. The current guidelines are intended to help healthcare providers, patients, and their caregivers make well-informed decisions and to improve the quality of care regarding ERT. The ultimate decision for ERT in a particular patient must be made in light of circumstances specific to that patient.
Arteries
;
Caregivers
;
Cerebral Infarction
;
Consensus
;
Health Personnel
;
Humans
;
Korea
;
Mechanical Thrombolysis
;
Reperfusion
;
Standard of Care
;
Stroke
;
Writing
10.2019 Update of the Korean Clinical Practice Guidelines of Stroke for Endovascular Recanalization Therapy in Patients with Acute Ischemic Stroke
Sang Bae KO ; Hong Kyun PARK ; Byung Moon KIM ; Ji Hoe HEO ; Joung Ho RHA ; Sun U KWON ; Jong S KIM ; Byung Chul LEE ; Sang Hyun SUH ; Cheolkyu JUNG ; Hae Woong JEONG ; Dong Hun KANG ; Hee Joon BAE ; Byung Woo YOON ; Keun Sik HONG
Journal of Stroke 2019;21(2):231-240
Endovascular recanalization therapy (ERT) has been a standard of care for patients with acute ischemic stroke due to large artery occlusion (LAO) within 6 hours after onset, since five landmark ERT trials conducted by 2015 demonstrated its clinical benefit. Recently, two randomized clinical trials demonstrated that ERT, even in the late time window of up to 16 hours or 24 hours after last known normal time, improved the outcome of patients who had a target mismatch, defined as either clinical-core mismatch or perfusion-core mismatch, which prompted the update of national guidelines in several countries. Accordingly, to provide evidence-based and up-to-date recommendations for ERT in patients with acute LAO in Korea, the Clinical Practice Guidelines Committee of the Korean Stroke Society decided to revise the previous Korean Clinical Practice Guidelines of Stroke for ERT. For this update, the members of the writing group were appointed by the Korean Stroke Society and the Korean Society of Interventional Neuroradiology. After thoroughly reviewing the updated evidence from two recent trials and relevant literature, the writing members revised recommendations, for which formal consensus was achieved by convening an expert panel composed of 45 experts from the participating academic societies. The current guidelines are intended to help healthcare providers, patients, and their caregivers make well-informed decisions and to improve the quality of care regarding ERT. The ultimate decision for ERT in a particular patient must be made in light of circumstances specific to that patient.
Arteries
;
Caregivers
;
Cerebral Infarction
;
Consensus
;
Health Personnel
;
Humans
;
Korea
;
Mechanical Thrombolysis
;
Reperfusion
;
Standard of Care
;
Stroke
;
Writing

Result Analysis
Print
Save
E-mail