1.Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation
Ju Youn KIM ; Juwon KIM ; Seung-Jung PARK ; Kyoung-Min PARK ; June Soo KIM ; Sung-Hwan KIM ; Jaemin SHIM ; Eue Keun CHOI ; Dae-Hyeok KIM ; Il-Young OH ; Young Keun ON ;
Journal of Korean Medical Science 2024;39(8):e72-
Background:
In the Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban 20 mg was the on-label dose, and the dose-reduction criterion for rivaroxaban was a creatinine clearance of < 50 mL/min. Some Asian countries are using reduced doses label according to the J-ROCKET AF trial. The aim of this study was to assess the safety and efficacy of a high-dose rivaroxaban regimen (HDRR, 20/15 mg) and low-dose rivaroxaban regimen (LDRR, 15/10 mg) among elderly East Asian patients with atrial fibrillation (AF) in real-world practice.
Methods:
This study was a multicenter, prospective, non-interventional observational study designed to evaluate the efficacy and safety of rivaroxaban in AF patients > 65 years of age with or without renal impairment.
Results:
A total of 1,093 patients (mean age, 72.8 ± 5.8 years; 686 [62.9%] men) were included in the analysis, with 493 patients allocated to the HDRR group and 598 patients allocated to the LDRR group. A total of 765 patients received 15 mg of rivaroxaban (203 in the HDRR group and 562 in the LDRR group). There were no significant differences in the incidence rates of major bleeding (adjusted hazard ratio [HR], 0.64; 95% confidential interval [CI], 0.21–1.93), stroke (adjusted HR, 3.21; 95% CI, 0.54–19.03), and composite outcomes (adjusted HR, 1.13;95% CI, 0.47–2.69) between the HDRR and LDRR groups.
Conclusion
This study revealed the safety and effectiveness of either dose regimen of rivaroxaban in an Asian population for stroke prevention of AF. Considerable numbers of patients are receiving LDRR therapy in real-world practice in Asia. Both regimens were safe and effective for these patients.
2.Intensified First Cycle of Rituximab Plus Eight Cycles of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone with Rituximab Chemotherapy for Advanced-Stage or Bulky Diffuse Large B-Cell Lymphoma: A Multicenter Phase II Consortium for Improving Survival of Lymphoma (CISL) Study
Yu Ri KIM ; Jin Seok KIM ; Won Seog KIM ; Hyeon Seok EOM ; Deok-Hwan YANG ; Sung Hwa BAE ; Hyo Jung KIM ; Jae Hoon LEE ; Suk-Joong OH ; Sung-Soo YOON ; Jae-Yong KWAK ; Chul Won CHOI ; Min Kyoung KIM ; Sung Young OH ; Hye Jin KANG ; Seung Hyun NAM ; Hyeok SHIM ; Joon Seong PARK ; Yeung-Chul MUN ; Cheolwon SUH ;
Cancer Research and Treatment 2023;55(4):1355-1362
Purpose:
This phase II, open-label, multicenter study aimed to investigate the efficacy and safety of a rituximab intensification for the 1st cycle with every 21-day of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP-21) among patients with previously untreated advanced-stage or bulky diffuse large B-cell lymphoma (DLBCL).
Materials and Methods:
Ninety-two patients with stage III/IV or bulky DLBCL from 21 institutions were administered 8 cycles of R-CHOP-21 with an additional one dose of rituximab intensification on day 0 of the 1st cycle (RR-CHOP). The primary endpoint was a complete response (CR) rate after 3 cycles of chemotherapy.
Results:
Among the 92 DLBCL patients assessed herein, the response rate after 3 cycles of chemotherapy was 88.0% (38.0% CR+50.0% partial response [PR]). After the completion of 8 cycles of chemotherapy, the overall response rate was observed for 68.4% (58.7% CR+9.8% PR). The 3-year progression-free survival rate was 64.0%, and the 3-year overall survival rate was 70.4%. Febrile neutropenia was one of the most frequent grade 3 adverse events (40.0%) and 5 treatment-related deaths occurred. Compared with the clinical outcomes of patients who received R-CHOP chemotherapy as a historical control, the interim CR rate was higher in male patients with RR-CHOP (20.5% vs. 48.8%, p=0.016).
Conclusion
Rituximab intensification on days 0 to the 1st cycle of the standard 8 cycles R-CHOP-21 for advanced DLBCL yielded favorable response rates after the 3 cycles of chemotherapy and acceptable toxicities, especially for male patients. ClinicalTrials.gov ID: NCT01054781.
3.Modifiable Risk Factors for Cardiovascular Disease in Korea and Japan
Ahmed ARAFA ; Hyeok-Hee LEE ; Ehab S. ESHAK ; Kokoro SHIRAI ; Keyang LIU ; Jiaqi LI ; Naharin Sultana ANNI ; Sun Young SHIM ; Hyeon Chang KIM ; Hiroyasu ISO
Korean Circulation Journal 2021;51(8):643-655
Cardiovascular disease (CVD) is the leading cause of death and a major contributor to disability worldwide. Since the majority of cardiovascular events are preventable, identification of modifiable CVD risk factors and implementation of primordial prevention strategies should be a public health priority. In this aspect, the American Heart Association declared a strategic goal to reduce total CVD mortality in the US by 20% within 10 years via eliminating 7 major CVD risk factors (hypertension, diabetes, dyslipidemia, cigarette smoking, physical inactivity, obesity, and poor-quality diet) in 2010, and their strategy has been achieving. However, the applicability of similar metrics to prevent CVD among East Asians requires an in-depth investigation of the modifiable CVD risk factors based on national and regional evidence-based findings. Herein, this review article aims to discuss several modifiable risk factors for CVDs, using epidemiological evidence from cohort studies and nationally representative data of 2 East Asian countries: Korea and Japan.
4.Modifiable Risk Factors for Cardiovascular Disease in Korea and Japan
Ahmed ARAFA ; Hyeok-Hee LEE ; Ehab S. ESHAK ; Kokoro SHIRAI ; Keyang LIU ; Jiaqi LI ; Naharin Sultana ANNI ; Sun Young SHIM ; Hyeon Chang KIM ; Hiroyasu ISO
Korean Circulation Journal 2021;51(8):643-655
Cardiovascular disease (CVD) is the leading cause of death and a major contributor to disability worldwide. Since the majority of cardiovascular events are preventable, identification of modifiable CVD risk factors and implementation of primordial prevention strategies should be a public health priority. In this aspect, the American Heart Association declared a strategic goal to reduce total CVD mortality in the US by 20% within 10 years via eliminating 7 major CVD risk factors (hypertension, diabetes, dyslipidemia, cigarette smoking, physical inactivity, obesity, and poor-quality diet) in 2010, and their strategy has been achieving. However, the applicability of similar metrics to prevent CVD among East Asians requires an in-depth investigation of the modifiable CVD risk factors based on national and regional evidence-based findings. Herein, this review article aims to discuss several modifiable risk factors for CVDs, using epidemiological evidence from cohort studies and nationally representative data of 2 East Asian countries: Korea and Japan.
5.Prognostic impact of hepatitis B or C on intrahepatic cholangiocarcinoma
Jung Woong SEO ; Byung Soo KWAN ; Young Koog CHEON ; Tae Yoon LEE ; Chan Sup SHIM ; So Young KWON ; Won Hyeok CHOE ; Byung Chul YOO ; Jeong Min YOON ; Jung Hoon LEE
The Korean Journal of Internal Medicine 2020;35(3):566-573
Background/Aims:
Intrahepatic cholangiocarcinoma (ICC) is the second-most common primary liver malignancy, arising from the peripheral intrahepatic bile duct epithelium. Hepatitis B virus (HBV) or hepatitis C virus (HCV) may be involved in the development of ICC. We explored the prognostic value of hepatitis virus infection, as well as other prognostic factors affecting survival in patients with ICC.
Methods:
A retrospective chart review was performed for patients diagnosed with ICC between August 2005 and December 2018 at Konkuk University Medical Center. We identified a total of 131 patients with ICC. Overall survival rates of patients with and without hepatitis were determined. Univariate and multivariate analyses were used to estimate factors influencing survival outcomes.
Results:
A total of 17.6% (23/131) of patients were positive for HBV or HCV. Hepatitis B positive ICC patients were significantly younger with higher albumin and higher α-fetoprotein than those without hepatitis viral infections. The median survival of hepatitis-positive and hepatitis-negative groups was 280 and 213 days, respectively. Survival rates were not significantly different between the two groups (p = 0.279). Multivariate analyses indicated that lower serum carbohydrate antigen 19-9 (CA 19-9) (p < 0.001), lower T stage (p = 0.042), the absence of lymph-node metastasis (p = 0.043), and receiving curative surgery (p = 0.033) were independent predictors of better outcomes.
Conclusions
While hepatitis influenced a number of clinical features in ICC patients, it did not affect survival rate. Prognostic factors influencing survival outcomes with ICC were CA 19-9 level, T stage, the presence of lymph node metastasis, and curative surgery.
6.Synchronous Primary Leiomyosarcoma in the Thoracic Vertebra and the Liver
Young Kwan KIM ; Jung A KIM ; Soo Hyung RYU ; Jong Hyun CHOI ; Pei Chuan TSUNG ; Jong Hyeok PARK ; Jeong Seop MOON ; Jae Chan SHIM ; Hye Kyung LEE ; James Matthew LOUTZENHISER
The Korean Journal of Gastroenterology 2019;74(1):57-62
This is a case report of simultaneous primary leiomyosarcomas in the spine and liver. A 64-year-old woman presented to the Seoul Paik Hospital with epigastric discomfort and constipation that she had experienced for two months. A physical examination revealed severe tenderness around the thoraco-lumbar junction. Esophagogastroduodenoscopy showed an ulceroinfiltrative lesion on the gastric angle. An abdominopelvic CT scan revealed two low attenuated lesions in the S4 and S8 regions of the liver, as well as a soft tissue mass at the T10 vertebra. Percutaneous ultrasonography-guided needle biopsy of the hepatic nodules revealed a leiomyosarcoma. The tumor at the T10 vertebra was removed to avoid spinal cord compression. The histology of this tumor was compatible with that of leiomyosarcoma. The potential primary sites for leiomyosarcoma, including the lung, thyroid, breast, kidney, genitourinary organs, and gastrointestinal tract, were subsequently investigated. No detectable abnormal findings that would suggest the origin of the tumor were found. Synchronous primary leiomyosarcomas in the spine and liver are quite rare and have a poor prognosis.
Biopsy, Needle
;
Bone and Bones
;
Breast
;
Constipation
;
Endoscopy, Digestive System
;
Female
;
Gastrointestinal Tract
;
Humans
;
Kidney
;
Leiomyosarcoma
;
Liver
;
Lung
;
Middle Aged
;
Neoplasms, Multiple Primary
;
Physical Examination
;
Prognosis
;
Seoul
;
Spinal Cord Compression
;
Spine
;
Thyroid Gland
;
Tomography, X-Ray Computed
7.A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy: Results of the Korean South West Oncolog.
So Yeon JEON ; Hye Sook HAN ; Woo Kyun BAE ; Moo Rim PARK ; Hyeok SHIM ; Sang Cheol LEE ; Se Il GO ; Hwan Jung YUN ; Yong Jin IM ; Eun Kee SONG
Cancer Research and Treatment 2019;51(1):90-97
PURPOSE: Data on the efficacy of olanzapine in patients receiving moderately emetogenic chemotherapy (MEC) are limited. This study aimed to evaluate and compare the efficacy of olanzapine versus placebo in controlling nausea and vomiting in patients receiving MEC. MATERIALS AND METHODS: We conducted a randomized, double-blind, placebo-controlled study to determine whether olanzapine can reduce the frequency of chemotherapy-induced nausea and vomiting (CINV) and improve the quality of life (QOL) in patients receiving palonosetron and dexamethasone as prophylaxis for MEC-induced nausea and vomiting. The primary end point was complete response for the acute phase (0-24 hours after chemotherapy). The secondary end points were complete response for the delayed (24-120 hours) and overall phase (0-120 hours), proportion of significant nausea (visual analogue scale ≥ 25 mm), use ofrescue medications, and effect on QOL. RESULTS: Fifty-six patients were randomized to the olanzapine (n=29) and placebo (n=27) groups. Complete response rates were not significantly different between the olanzapine and placebo groups in the acute (96.5% vs. 88.0%, p=0.326), delayed (69.0% vs. 48.0%, p=0.118), and overall phases (69.0% vs. 48.0%, p=0.118). However, the percentage of patients with significant nausea (17.2% vs. 44.0%, p=0.032) and the use of rescue medications (0.03±0.19 vs. 1.88±2.88, p=0.002) were lower in the olanzapine group than in the placebo. Furthermore, the olanzapine group demonstrated better QOL (p=0.015). CONCLUSION: Olanzapine combined with palonosetron and dexamethasone significantly improved QOL and vomiting control among previously untreated patients receiving MEC, although the efficacy was limited to the reduction of the frequency of CINV.
Antiemetics
;
Dexamethasone
;
Drug Therapy*
;
Humans
;
Nausea*
;
Quality of Life
;
Vomiting*
8.Synchronous Primary Leiomyosarcoma in the Thoracic Vertebra and the Liver
Young Kwan KIM ; Jung A KIM ; Soo Hyung RYU ; Jong Hyun CHOI ; Pei Chuan TSUNG ; Jong Hyeok PARK ; Jeong Seop MOON ; Jae Chan SHIM ; Hye Kyung LEE ; James Matthew LOUTZENHISER
The Korean Journal of Gastroenterology 2019;74(1):57-62
This is a case report of simultaneous primary leiomyosarcomas in the spine and liver. A 64-year-old woman presented to the Seoul Paik Hospital with epigastric discomfort and constipation that she had experienced for two months. A physical examination revealed severe tenderness around the thoraco-lumbar junction. Esophagogastroduodenoscopy showed an ulceroinfiltrative lesion on the gastric angle. An abdominopelvic CT scan revealed two low attenuated lesions in the S4 and S8 regions of the liver, as well as a soft tissue mass at the T10 vertebra. Percutaneous ultrasonography-guided needle biopsy of the hepatic nodules revealed a leiomyosarcoma. The tumor at the T10 vertebra was removed to avoid spinal cord compression. The histology of this tumor was compatible with that of leiomyosarcoma. The potential primary sites for leiomyosarcoma, including the lung, thyroid, breast, kidney, genitourinary organs, and gastrointestinal tract, were subsequently investigated. No detectable abnormal findings that would suggest the origin of the tumor were found. Synchronous primary leiomyosarcomas in the spine and liver are quite rare and have a poor prognosis.
Biopsy, Needle
;
Bone and Bones
;
Breast
;
Constipation
;
Endoscopy, Digestive System
;
Female
;
Gastrointestinal Tract
;
Humans
;
Kidney
;
Leiomyosarcoma
;
Liver
;
Lung
;
Middle Aged
;
Neoplasms, Multiple Primary
;
Physical Examination
;
Prognosis
;
Seoul
;
Spinal Cord Compression
;
Spine
;
Thyroid Gland
;
Tomography, X-Ray Computed
9.Multicenter Retrospective Analysis of Clinical Characteristics, Treatment Patterns, and Outcomes in Very Elderly Patients with Diffuse Large B-Cell Lymphoma: The Korean Cancer Study Group LY16-01.
Jung Hye CHOI ; Tae Min KIM ; Hyo Jung KIM ; Sung Ae KOH ; Yeung Chul MUN ; Hye Jin KANG ; Yun Hwa JUNG ; Hyeok SHIM ; So Young CHONG ; Der Sheng SUN ; Soonil LEE ; Byeong Bae PARK ; Jung Hye KWON ; Seung Hyun NAM ; Jun Ho YI ; Young Jin YUH ; Jong Youl JIN ; Jae Joon HAN ; Seok Hyun KIM
Cancer Research and Treatment 2018;50(2):590-598
PURPOSE: The treatment strategy for elderly patients older than 80 years with diffuse large B-cell lymphoma (DLBCL) has not been established because of poor treatment tolerability and lack of data. MATERIALS AND METHODS: This multicenter retrospective study was conducted to investigate clinical characteristics, treatment patterns and outcomes of patients older than 80 years who were diagnosed with DLBCL at 19 institutions in Korea between 2005 and 2016. RESULTS: A total of 194 patients were identified (median age, 83.3 years). Of these, 114 patients had an age-adjusted International Prognostic Index (aaIPI) score of 2-3 and 48 had a Charlson index score of 4 or more. R-CHOP was given in 124 cases, R-CVP in 13 cases, other chemotherapy in 17 cases, radiation alone in nine cases, and surgery alone in two cases. Twenty-nine patients did not undergo any treatment. The median number of chemotherapy cycles was three. Only 37 patients completed the planned treatment cycles. The overall response rate from 105 evaluable patients was 90.5% (complete response, 41.9%). Twentynine patients died due to treatment-related toxicities (TRT). Thirteen patients died due to TRT after the first cycle. Median overall survival was 14.0 months. The main causes of death were disease progression (30.8%) and TRT (27.1%). In multivariate analysis, overall survival was affected by aaIPI, hypoalbuminemia, elevated creatinine, and treatment. CONCLUSION: Age itself should not be a contraindication to treatment. However, since elderly patients show higher rates of TRT due to infection, careful monitoring and dose modification of chemotherapeutic agents is needed.
Aged*
;
B-Lymphocytes*
;
Cause of Death
;
Creatinine
;
Disease Progression
;
Drug Therapy
;
Humans
;
Hypoalbuminemia
;
Korea
;
Lymphoma, B-Cell*
;
Multivariate Analysis
;
Retrospective Studies*
10.Gender-related Difference in Clinical Outcome of the Patient with Atrial Fibrillation after Radiofrequency Catheter Ablation
Seung Young ROH ; Jaemin SHIM ; Kwang No LEE ; Jinhee AHN ; Dong Hyeok KIM ; Dae In LEE ; Jong Il CHOI ; Young Hoon KIM
Korean Circulation Journal 2018;48(7):605-618
BACKGROUND AND OBJECTIVES: Previous studies provided controversial result about gender differences in the clinical outcome after radiofrequency catheter ablation (RFCA) for atrial fibrillation (AF). We assessed pure difference after adjustment of referral bias. METHODS: The clinical outcomes including freedom from AF/atrial tachycardia (AT) recurrence after RFCA were compared between women and men in 1:1 confounding factor matching with age, AF type, periods since diagnosis (±12 months), and procedure era (±12 months). Subgroup analysis was performed in categories defined by AF type and age of 55 (mean menopausal age of Asian women). RESULTS: Total 1,875 patients with AF underwent 2,307 RFCA between January 1998 and May 2014 in a single center. Total 367 women (19.6%, 59±10 years) who had undergone first ablation were included. Women had larger left atrial diameter index (26±4 vs. 23±4 mm/m2; p < 0.001) and higher peri-procedural complications (9.2% vs. 4.9%; p=0.030) compared to men. The freedom from AF/AT recurrence after RFCA was not different between both groups (71% vs. 76%; log-rank p=0.131, mean follow-up of 55 months). Women with non-paroxysmal AF (PAF) had significantly worse outcome (54% vs. 69%; p=0.014), especially in subgroup with age ≤55 (48% vs. 71%; p=0.010). In multivariate analysis, female gender was an independent predictor of recurrence in subgroup with non-PAF and age ≤55 (hazard ratio [HR], 2.539; 95% confidence interval [CI], 1.112–5.801; p=0.027). CONCLUSIONS: The clinical outcome after RFCA was not different between both genders regardless of referral bias. However, the gender difference became evident in patients under 55 years with non-PAF.
Asian Continental Ancestry Group
;
Atrial Fibrillation
;
Bias (Epidemiology)
;
Catheter Ablation
;
Diagnosis
;
Female
;
Follow-Up Studies
;
Freedom
;
Humans
;
Male
;
Multivariate Analysis
;
Recurrence
;
Referral and Consultation
;
Tachycardia

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