1.A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10)
Keun-Wook LEE ; Dae Young ZANG ; Min-Hee RYU ; Hye Sook HAN ; Ki Hyang KIM ; Mi-Jung KIM ; Sung Ae KOH ; Sung Sook LEE ; Dong-Hoe KOO ; Yoon Ho KO ; Byeong Seok SOHN ; Jin Won KIM ; Jin Hyun PARK ; Byung-Ho NAM ; In Sil CHOI
Cancer Research and Treatment 2023;55(4):1250-1260
Purpose:
This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.
Materials and Methods:
Elderly (≥ 70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-fluorouracil [5-FU]/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B: 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs. monotherapy.
Results:
After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population (group A [n=53] and group B [n=51]), median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.56 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy (15.9 vs. 7.2 months, p=0.056). Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥ grade 3), there were no TRAEs with a frequency difference of > 5%.
Conclusion
Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.
2.Efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for hepatitis C in Korea: a Phase 3b study
Jeong HEO ; Yoon Jun KIM ; Sung Wook LEE ; Youn-Jae LEE ; Ki Tae YOON ; Kwan Soo BYUN ; Yong Jin JUNG ; Won Young TAK ; Sook-Hyang JEONG ; Kyung Min KWON ; Vithika SURI ; Peiwen WU ; Byoung Kuk JANG ; Byung Seok LEE ; Ju-Yeon CHO ; Jeong Won JANG ; Soo Hyun YANG ; Seung Woon PAIK ; Hyung Joon KIM ; Jung Hyun KWON ; Neung Hwa PARK ; Ju Hyun KIM ; In Hee KIM ; Sang Hoon AHN ; Young-Suk LIM
The Korean Journal of Internal Medicine 2023;38(4):504-513
Despite the availability of direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection in Korea, need remains for pangenotypic regimens that can be used in the presence of hepatic impairment, comorbidities, or prior treatment failure. We investigated the efficacy and safety of sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir for 12 weeks in HCV-infected Korean adults. Methods: This Phase 3b, multicenter, open-label study included 2 cohorts. In Cohort 1, participants with HCV genotype 1 or 2 and who were treatment-naive or treatment-experienced with interferon-based treatments, received sofosbuvir–velpatasvir 400/100 mg/day. In Cohort 2, HCV genotype 1 infected individuals who previously received an NS5A inhibitor-containing regimen ≥ 4 weeks received sofosbuvir–velpatasvir–voxilaprevir 400/100/100 mg/day. Decompensated cirrhosis was an exclusion criterion. The primary endpoint was SVR12, defined as HCV RNA < 15 IU/mL 12 weeks following treatment. Results: Of 53 participants receiving sofosbuvir–velpatasvir, 52 (98.1%) achieved SVR12. The single participant who did not achieve SVR12 experienced an asymptomatic Grade 3 ASL/ALT elevation on day 15 and discontinued treatment. The event resolved without intervention. All 33 participants (100%) treated with sofosbuvir–velpatasvir–voxilaprevir achieved SVR 12. Overall, sofosbuvir–velpatasvir and sofosbuvir–velpatasvir–voxilaprevir were safe and well tolerated. Three participants (5.6%) in Cohort 1 and 1 participant (3.0%) in Cohort 2 had serious adverse events, but none were considered treatment-related. No deaths or grade 4 laboratory abnormalities were reported. Conclusions: Treatment with sofosbuvir–velpatasvir or sofosbuvir–velpatasvir–voxilaprevir was safe and resulted in high SVR12 rates in Korean HCV patients.
3.Elevated On-Treatment Diastolic Blood Pressure and Cardiovascular Outcomes in the Presence of Achieved Systolic Blood Pressure Targets
Dae-Hee KIM ; In-Jeong CHO ; Woohyeun KIM ; Chan Joo LEE ; Hyeon-Chang KIM ; Jeong-Hun SHIN ; Si-Hyuck KANG ; Mi-Hyang JUNG ; Chang Hee KWON ; Ju-Hee LEE ; Hack Lyoung KIM ; Hyue Mee KIM ; Iksung CHO ; Dae Ryong KANG ; Hae-Young LEE ; Wook-Jin CHUNG ; Kwang Il KIM ; Eun Joo CHO ; Il-Suk SOHN ; Sungha PARK ; Jinho SHIN ; Sung Kee RYU ; Seok-Min KANG ; Wook Bum PYUN ; Myeong-Chan CHO ; Ju Han KIM ; Jun Hyeok LEE ; Sang-Hyun IHM ; Ki-Chul SUNG
Korean Circulation Journal 2022;52(6):460-474
Background and Objectives:
This study aimed to investigate the association between cardiovascular events and 2 different levels of elevated on-treatment diastolic blood pressures (DBP) in the presence of achieved systolic blood pressure targets (SBP).
Methods:
A nation-wide population-based cohort study comprised 237,592 patients with hypertension treated. The primary endpoint was a composite of cardiovascular death, myocardial infarction, and stroke. Elevated DBP was defined according to the Seventh Report of Joint National Committee (JNC7; SBP <140 mmHg, DBP ≥90 mmHg) or to the 2017 American College of Cardiology/American Heart Association (ACC/AHA) definitions (SBP <130 mmHg, DBP ≥80 mmHg).
Results:
During a median follow-up of 9 years, elevated on-treatment DBP by the JNC7 definition was associated with an increased risk of the occurrence of primary endpoint compared with achieved both SBP and DBP (adjusted hazard ratio [aHR], 1.14; 95% confidence interval [CI], 1.05–1.24) but not in those by the 2017 ACC/AHA definition. Elevated ontreatment DBP by the JNC7 definition was associated with a higher risk of cardiovascular mortality (aHR, 1.42; 95% CI, 1.18–1.70) and stroke (aHR, 1.19; 95% CI, 1.08–1.30). Elevated on-treatment DBP by the 2017 ACC/AHA definition was only associated with stroke (aHR, 1.10;95% CI, 1.04–1.16). Similar results were seen in the propensity-score-matched cohort.
Conclusion
Elevated on-treatment DBP by the JNC7 definition was associated a high risk of major cardiovascular events, while elevated DBP by the 2017 ACC/AHA definition was only associated with a higher risk of stroke. The result of study can provide evidence of DBP targets in subjects who achieved SBP targets.
4.Effect of Dialysis on Aryl Hydrocarbon Receptor Transactivating Activity in Patients with Chronic Kidney Disease
Jin Taek KIM ; Sang Hyuk KIM ; Hyang Ki MIN ; Sang Jin JEON ; Su Ah SUNG ; Wook Ha PARK ; Hong Kyu LEE ; Hoon Sung CHOI ; Youngmi Kim PAK ; So Young LEE
Yonsei Medical Journal 2020;61(1):56-63
6.Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea
Hee Yeon LEE ; Ji Hyung HONG ; Jae Ho BYUN ; Hee-Jun KIM ; Sun Kyung BAEK ; Jin Young KIM ; Ki Hyang KIM ; Jina YUN ; Jung A KIM ; Kwonoh PARK ; Hyo Jin LEE ; Jung Lim LEE ; Young-Woong WON ; Il Hwan KIM ; Woo Kyun BAE ; Kyong Hwa PARK ; Der-Sheng SUN ; Suee LEE ; Min-Young LEE ; Guk Jin LEE ; Sook Hee HONG ; Yun Hwa JUNG ; Ho Jung AN
Cancer Research and Treatment 2020;52(1):277-283
Purpose:
The purpose of this study was to evaluate clinical characteristics and treatment pattern of ovarian clear cell carcinoma (OCCC) in Korea and the role of adjuvant chemotherapy in earlystage.
Materials and Methods:
Medical records of 308 cases of from 21 institutions were reviewed and data including age, performance status, endometriosis, thromboembolism, stage, cancer antigen 125, treatment, recurrence, and death were collected.
Results:
Regarding stage of OCCC, it was stage I in 194 (63.6%), stage II in 34 (11.1%), stage III in 66 (21.6%), and stage IV in 11 (3.6%) patients. All patients underwent surgery. Optimal surgery (residual disease ≤ 1 cm) was achieved in 89.3%. Majority of patients (80.5%) received postoperative chemotherapy. The most common regimen was taxane-platinum combination (96%). Median relapse-free survival (RFS) was 138.5 months for stage I, 33.4 for stage II, 19.3 for stage III, and 9.7 for stage IV. Median overall survival (OS) were not reached, 112.4, 48.7, and 18.3 months for stage I, II, III, and IV, respectively. Early-stage (stage I), endometriosis, and optimal debulking were identified as favorable prognostic factors for RFS. Early-stage and optimal debulking were also favorable prognostic factors for OS. Majority of patients with early-stage received adjuvant chemotherapy. However, additional survival benefit was not found in terms of recurrence.
Conclusion
Majority of patients had early-stage and received postoperative chemotherapy regardless of stage. Early-stage and optimal debulking were identified as favorable prognostic factors. In stage IA or IB, adding adjuvant chemotherapy did not show difference in survival. Further study focusing on OCCC is required.
7.Relationship between Cardiac Geometry and Serum Hepcidin in Chronic Kidney Disease: Analysis from the KNOW-CKD Study
Hyang Ki MIN ; Yun Kyu OH ; Kyu Hun CHOI ; Kyu Beck LEE ; Sue K PARK ; Curie AHN ; Sung Woo LEE
Journal of Korean Medical Science 2020;35(1):e2-
BACKGROUND:
Few studies have examined the relationship between cardiac function and geometry and serum hepcidin levels in patients with chronic kidney disease (CKD). We aimed to identify the relationship between cardiac function and geometry and serum hepcidin levels.
METHODS:
We reviewed data of 1,897 patients in a large-scale multicenter prospective Korean study. Logistic regression analysis was used to identify the relationship between cardiac function and geometry and serum hepcidin levels.
RESULTS:
The mean relative wall thickness (RWT) and left ventricular mass index (LVMI) were 0.38 and 42.0 g/m2.7, respectively. The mean ejection fraction (EF) and early diastolic mitral inflow to annulus velocity ratio (E/e′) were 64.1% and 9.9, respectively. Although EF and E/e′ were not associated with high serum hepcidin, RWT and LVMI were significantly associated with high serum hepcidin levels in univariate logistic regression analysis. In multivariate logistic regression analysis after adjusting for variables related to anemia, bone mineral metabolism, comorbidities, and inflammation, however, only each 0.1-unit increase in RWT was associated with increased odds of high serum hepcidin (odds ratio, 1.989; 95% confidence interval, 1.358–2.916; P < 0.001). In the subgroup analysis, the independent relationship between RWT and high serum hepcidin level was valid only in women and patients with low transferrin saturation (TSAT).
CONCLUSION
Although the relationship was not cause-and-effect, increased RWT was independently associated with high serum hepcidin, particularly in women and patients with low TSAT. The relationship between cardiac geometry and serum hepcidin in CKD patients needs to be confirmed in future studies.
8.Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy in management of peritoneal carcinomatosis: Single center experience in Korea
Hee Ju LEE ; HyungJoo BAIK ; Yo Han PARK ; Sang Hyuk SEO ; Kwang Hee KIM ; Ki Beom BAE ; Kwan Hee HONG ; Ki Hyang KIM ; Jung Mi BYUN ; Dae Hoon JEONG ; Kyung Bok LEE ; Min Kyung OH ; Kwang Rae CHO ; Min Sung AN
Korean Journal of Clinical Oncology 2019;15(2):61-67
PURPOSE: Peritoneal carcinomatosis (PC) has been considered a terminal condition and cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIEPC) is regarded as an alternative therapeutic option. This study aimed to evaluate the 30-day clinical outcomes of CRS/HIPEC and the feasibility of the surgery by investigating the morbidity and mortality in Inje University Hospital.METHODS: Data were retrospectively collected from 19 patients with PC who underwent CRS/HIPEC at Inje University Hospital in 2018. We evaluated pre-, intra-operative parameters and postoperative clinical outcomes and early complications.RESULTS: The mean operating time was 506.95 minutes and the mean blood loss was 837.11 mL. Six cases (31.58%) had morbidity of grade III or above. A longer operating time (≥560 minutes, P=0.038) and large blood loss (≥700 mL, P=0.060) were positively correlated with grade III or worse postoperative complications.CONCLUSION: Our early experience with CRS/HIPEC resulted in a 31.58% morbidity rate of grade III and above, with risk factors being longer operating time and greater intraoperative blood loss. As the surgical team's skills improve, a shorter operating time with less intraoperative blood loss could result in better short-term outcomes of CRS/HIPEC.
Carcinoma
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Drug Therapy
;
Humans
;
Korea
;
Mortality
;
Postoperative Complications
;
Retrospective Studies
;
Risk Factors
9.Sub-morbid dehydration-associated glomerular hyperfiltration: An emerging reality?
Hyang Ki MIN ; Su Ah SUNG ; So Young LEE ; Sung Woo LEE
Kidney Research and Clinical Practice 2019;38(2):196-204
BACKGROUND: Severe dehydration decreases renal perfusion. However, it is unclear whether sub-morbid dehydration affects kidney function similarly. Although there have been numerous animal and human studies that have suggested mild dehydration is associated with glomerular hyperfiltration, it has not been confirmed on a large-scale in the general population. Therefore, we aimed to identify the relationship between hydration status and kidney function. METHODS: We reviewed the data of 28,342 adults who participated in the Korea National Health and Nutrition Examination Surveys. Urine specific gravity unit (SGU) was the primary variable that indicated hydration status, and the estimated glomerular filtration rate (eGFR) was used as the primary outcome. RESULTS: Multivariate linear regression analysis showed urine SGU was positively associated with eGFR, which was J-shaped in the multivariate generalized additive model plot. In the penalized spline curve analysis, the odds ratio for high eGFR was steadily increased. Although increased urine SGU was associated with decreased blood pressure and pulse rate, it had no effect on increased fasting glucose and total cholesterol, suggesting conflicting cardio-metabolic dehydration effects. CONCLUSION: Dehydration, presumably sub-morbid in an ambulatory community-dwelling general population, is associated with higher kidney function. The clinical significance of sub-morbid dehydration-associated glomerular hyperfiltration needs further investigation.
Adult
;
Animals
;
Blood Pressure
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Cholesterol
;
Dehydration
;
Fasting
;
Glomerular Filtration Rate
;
Glucose
;
Heart Rate
;
Humans
;
Kidney
;
Korea
;
Linear Models
;
Odds Ratio
;
Perfusion
;
Renal Insufficiency, Chronic
;
Specific Gravity
10.The Reappraisal of the Slide-Swing Skin Flap: A Versatile Technique for Surgical Defects
Min Soo KIM ; Seul Ki LEE ; Mihn Sook JUE ; Hyang Joon PARK
Annals of Dermatology 2019;31(5):525-529
BACKGROUND: The slide-swing skin flap is a combination of transposition and adjacent skin sliding and can be used to close large, round defects with a flap that is smaller than the primary defect to produce aesthetically good results. OBJECTIVE: To evaluate the efficacy and safety of the slide-swing skin flap for various surgical defects caused by skin tumor excisions. METHODS: This retrospective case series, which includes 33 Asian patients between the ages of 25 and 86 years, describes the slide-swing skin flap after primary excision for malignant or premalignant skin conditions. The outcomes were assessed 12 weeks after surgery using the patient and observer scar assessment scale (POSAS). RESULTS: Patients were 25 male and 8 female, and the causes of surgery were various malignant skin tumors including malignant melanoma, dermatofibrosarcoma protuberans, and malignant nodular hidradenoma. Tumors were on the lower limb in eleven patients, back in nine patients, chest in five patients, face in three patients, buttock in three patients and two patients had tumors in other locations. The mean defect size was 3.5×3.1±1.9×2.2 cm (range, 1.4×0.9~9.0×12.0 cm). The mean patient POSAS total score was 9.7±3.0 and mean patient overall opinion score was 1.8±0.7. The mean observer POSAS total score was 11.0±2.7 and mean observer overall opinion score was 1.9±0.5. All flaps survived and postoperative recoveries were uneventful. CONCLUSION: The slide-swing skin flap is highly versatile and can be used to cover various surgical defects, irrespective of size and location, with excellent functional and cosmetic results.
Acrospiroma
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Asian Continental Ancestry Group
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Buttocks
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Cicatrix
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Dermatofibrosarcoma
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Female
;
Humans
;
Lower Extremity
;
Male
;
Melanoma
;
Retrospective Studies
;
Skin Neoplasms
;
Skin
;
Surgical Flaps
;
Thorax

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