1.Adjuvant Pembrolizumab in Patients with Stage IIIA/N2 Non–Small Cell Lung Cancer Completely Resected after Neoadjuvant Concurrent Chemoradiation: A Prospective, Open-Label, Single-Arm, Phase 2 Trial
Junghoon SHIN ; Sehhoon PARK ; Kyung Hwan KIM ; Eui-Cheol SHIN ; Hyun Ae JUNG ; Jong Ho CHO ; Jong-Mu SUN ; Se-Hoon LEE ; Yong Soo CHOI ; Jin Seok AHN ; Jhingook KIM ; Keunchil PARK ; Young Mog SHIM ; Hong Kwan KIM ; Jae Myoung NOH ; Yong Chan AHN ; Hongryull PYO ; Myung-Ju AHN
Cancer Research and Treatment 2024;56(4):1084-1095
Purpose:
Optimal treatment for stage IIIA/N2 non–small cell lung cancer (NSCLC) is controversial. We aimed to assess the efficacy and safety of adjuvant pembrolizumab for stage IIIA/N2 NSCLC completely resected after neoadjuvant concurrent chemoradiation therapy (CCRT).
Materials and Methods:
In this open-label, single-center, single-arm phase 2 trial, patients with stage IIIA/N2 NSCLC received adjuvant pembrolizumab for up to 2 years after complete resection following neoadjuvant CCRT. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and safety. As an exploratory biomarker analysis, we evaluated the proliferative response of blood CD39+PD-1+CD8+ T cells using fold changes in the percentage of proliferating Ki-67+ cells from days 1 to 7 of cycle 1 (Ki-67D7/D1).
Results:
Between October 2017 and October 2018, 37 patients were enrolled. Twelve (32%) and three (8%) patients harbored EGFR and ALK alterations, respectively. Of 34 patients with programmed cell death ligand 1 assessment, 21 (62%), nine (26%), and four (12%) had a tumor proportion score of < 1%, 1%-50%, and ≥ 50%, respectively. The median follow-up was 71 months. The median DFS was 22.4 months in the overall population, with a 5-year DFS rate of 29%. The OS rate was 86% at 2 years and 76% at 5 years. Patients with tumor recurrence within 6 months had a significantly lower Ki-67D7/D1 among CD39+PD-1+CD8+ T cells than those without (p=0.036). No new safety signals were identified.
Conclusion
Adjuvant pembrolizumab may offer durable disease control in a subset of stage IIIA/N2 NSCLC patients after neoadjuvant CCRT and surgery.
2.TNM-Based Head-to-Head Comparison of Urachal Carcinoma and Urothelial Bladder Cancer: Stage-Matched Analysis of a Large Multicenter National Cohort
Sang Hun SONG ; Jaewon LEE ; Young Hwii KO ; Jong Wook KIM ; Seung Il JUNG ; Seok Ho KANG ; Jinsung PARK ; Ho Kyung SEO ; Hyung Joon KIM ; Byong Chang JEONG ; Tae-Hwan KIM ; Se Young CHOI ; Jong Kil NAM ; Ja Yoon KU ; Kwan Joong JOO ; Won Sik JANG ; Young Eun YOON ; Seok Joong YUN ; Sung-Hoo HONG ; Jong Jin OH
Cancer Research and Treatment 2023;55(4):1337-1345
Purpose:
Outcome analysis of urachal cancer (UraC) is limited due to the scarcity of cases and different staging methods compared to urothelial bladder cancer (UroBC). We attempted to assess survival outcomes of UraC and compare to UroBC after stage-matched analyses.
Materials and Methods:
Total 203 UraC patients from a multicenter database and 373 UroBC patients in single institution from 2000 to 2018 were enrolled (median follow-up, 32 months). Sheldon stage conversion to corresponding TNM staging for UraC was conducted for head-to-head comparison to UroBC. Perioperative clinical variables and pathological results were recorded. Stage-matched analyses for survival by stage were conducted.
Results:
UraC patients were younger (mean age, 54 vs. 67 years; p < 0.001), with 163 patients (80.3%) receiving partial cystectomy and 23 patients (11.3%) radical cystectomy. UraC was more likely to harbor ≥ pT3a tumors (78.8% vs. 41.8%). While 5-year recurrence-free survival, cancer-specific survival (CSS) and overall survival were comparable between two groups (63.4%, 67%, and 62.1% in UraC and 61.5%, 75.9%, and 67.8% in UroBC, respectively), generally favorable prognosis for UraC in lower stages (pT1-2) but unfavorable outcomes in higher stages (pT4) compared to UroBC was observed, although only 5-year CSS in ≥ pT4 showed statistical significance (p=0.028). Body mass index (hazard ratio [HR], 0.929), diabetes mellitus (HR, 1.921), pathologic T category (HR, 3.846), and lymphovascular invasion (HR, 1.993) were predictors of CSS for all patients.
Conclusion
Despite differing histology, UraC has comparable prognosis to UroBC with relatively favorable outcome in low stages but worse prognosis in higher stages. The presented system may be useful for future grading and risk stratification of UraC.
3.The Effect of Vanishing Twin on Firstand Second-Trimester Maternal Serum Markers and Nuchal Translucency: A Multicenter Prospective Cohort Study
Se Jin LEE ; You Jung HAN ; Minhyoung KIM ; Jae-Yoon SHIM ; Mi-Young LEE ; Soo-young OH ; JoonHo LEE ; Soo Hyun KIM ; Dong Hyun CHA ; Geum Joon CHO ; Han-Sung KWON ; Byoung Jae KIM ; Mi Hye PARK ; Hee Young CHO ; Hyun Sun KO ; Ji Hye BAE ; Chan-Wook PARK ; Joong Shin PARK ; Jong Kwan JUN ; Sohee OH ; Da Rae LEE ; Hyun Mee RYU ; Seung Mi LEE
Journal of Korean Medical Science 2023;38(38):e300-
Background:
The purpose of this study was to evaluate the effect of vanishing twin (VT) on maternal serum marker concentrations and nuchal translucency (NT).
Methods:
This is a secondary analysis of a multicenter prospective cohort study in 12 institutions. Serum concentrations of pregnancy-associated plasma protein-A in the first trimester and alpha-fetoprotein (AFP), total human chorionic gonadotrophin, unconjugated estriol, and inhibin A in the second trimester were measured, and NT was measured between 10 and 14 weeks of gestation.
Results:
Among 6,793 pregnant women, 5,381 women were measured for serum markers in the first or second trimester, including 65 cases in the VT group and 5,316 cases in the normal singleton group. The cases in the VT group had a higher median multiple of the median value of AFP and inhibin A than the normal singleton group. The values of other serum markers and NT were not different between the two groups. After the permutation test with adjustment,AFP and inhibin A remained significant differences. The frequency of abnormally increased AFP was also higher in the VT group than in the normal singleton group.
Conclusion
VT can be considered as an adjustment factor for risk assessment in the secondtrimester serum screening test.
5.A single-arm, phase II study of niraparib and bevacizumab maintenance therapy in platinum-sensitive, recurrent ovarian cancer patients previously treated with a PARP inhibitor: Korean Gynecologic Oncology Group (KGOG 3056)/NIRVANA-R trial
Junsik PARK ; Myong Cheol LIM ; Jae-Kwan LEE ; Dae Hoon JEONG ; Se Ik KIM ; Min Chul CHOI ; Byoung-Gie KIM ; Jung-Yun LEE
Journal of Gynecologic Oncology 2022;33(2):e12-
Background:
Given the expanding clinical use of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPis), there is a significant need for optimal strategies with which to treat patients whose cancer progresses while using a PARPi. However, the treatment consensus after PARPi has not been established. The aim of the Korean Gynecologic Oncology Group (KGOG) 3056/NIRVANA-R trial is to investigate the efficacy of niraparib in combination with bevacizumab as a maintenance therapy in platinum-sensitive ovarian cancer patients who were previously treated with a PARPi.
Methods
The KGOG 3056/NIRVANA-R is a multi-centre, investigator-initiated, single-arm, phase II trial of patients with platinum-sensitive recurrent ovarian cancer recruited from seven KGOG sites. This study included patients with platinum-sensitive recurrent epithelial ovarian cancer who received at least 2 previous courses of platinum-containing therapy and had been treated with a PARPi. Mucinous histology type was excluded. Patients who had responded to the last platinum regimen (either complete or partial response) were eligible to participate in this study. Forty-four patients will be recruited. All enrolled patients are treated with niraparib and bevacizumab for maintenance therapy until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint of the study is 6-month progression-free survival rate. Accrual is expected to be completed in 2022, followed by presentation of results in 2023.
6.Whole lung lavage using a rapid infusion system to treat a patient with pulmonary alveolar proteinosis
Seung Won RA ; Soon Eun PARK ; Hyung Kwan LEE ; Il Sang HAN ; Se Hun PARK
Yeungnam University Journal of Medicine 2020;37(1):67-72
Whole lung lavage (WLL) is a therapeutic procedure to remove accumulated material by infusing and draining the lungs with lavage fluid. This procedure has been regarded as the current standard of care to treat pulmonary alveolar proteinosis. However, the WLL protocol has not yet been standardized and the technique has been refined and modified a number of times. A rapid infusion system is a device used to infuse blood or other fluids at precise rates and normothermic conditions. This device is not typically used in WLL, which relies on the passive infusion of fluids using the gravitational force. However, in this study we performed WLL using a rapid infusion system, since we aimed to take advantage of its shorter operation time and greater degree of control over fluid volume and temperature. The patient’s symptoms improved without the occurrence of any complications.
7.Consensus statement on coronary intervention during the coronavirus disease 19 pandemic: from the Korean Society of Interventional Cardiology
Kwan Yong LEE ; Bong-Ki LEE ; Won-Jang KIM ; Se Hun KANG ; Taek Kyu PARK ; Song-Yi KIM ; Jung-Won SUH ; Chang-Hwan YOON ; Dong Heon YANG ; Sung Kee RYU ; Sang-Hyun KIM ; Sung Yun LEE ; In-Ho CHAE ;
The Korean Journal of Internal Medicine 2020;35(4):749-757
Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by the novel virus severe acute respiratory syndrome coronavirus 2. The first case developed in December, 2019 in Wuhan, China; several months later, COVID-19 has become pandemic, and there is no end in sight. This disaster is also causing serious health problems in the area of cardiovascular intervention. In response, the Korean Society of Interventional Cardiology formed a COVID-19 task force to develop practice guidelines. This special article introduces clinical practice guidelines to prevent secondary transmission of COVID-19 within facilities; the guidelines were developed to protect patients and healthcare workers from this highly contagious virus. We hope these guidelines help healthcare workers and cardiovascular disease patients around the world cope with the COVID-19 pandemic.
8.Consensus Statement on Coronary Intervention during the Coronavirus Disease 2019 (COVID-19) Pandemic: from the Korean Society of Interventional Cardiology (KSIC)
Kwan Yong LEE ; Bong-Ki LEE ; Won-Jang KIM ; Se Hun KANG ; Taek Kyu PARK ; Song-Yi KIM ; Jung-Won SUH ; Chang-Hwan YOON ; Dong Heon YANG ; Sung Kee RYU ; Sang-Hyun KIM ; Sung Yun LEE ; In-Ho CHAE ;
Korean Circulation Journal 2020;50(11):974-983
Coronavirus disease 2019 (COVID-19) is a highly contagious disease caused by the novel virus severe acute respiratory syndrome coronavirus-2. The first case developed in December, 2019 in Wuhan, China; several months later, COVID-19 has become pandemic, and there is no end in sight. This disaster is also causing serious health problems in the area of cardiovascular intervention. In response, the Korean Society of Interventional Cardiology formed a COVID-19 task force to develop practice guidelines. This special article introduces clinical practice guidelines to prevent secondary transmission of COVID-19 within facilities;the guidelines were developed to protect patients and healthcare workers from this highly contagious virus. We hope these guidelines help healthcare workers and cardiovascular disease patients around the world cope with the COVID-19 pandemic.
9.Predictive Factors for Efficacy of AST-120 Treatment in Diabetic Nephropathy: a Prospective Single-Arm, Open-Label, Multi-Center Study
You Cheol HWANG ; Se Won KIM ; Kyu Yeon HUR ; Bong Soo CHA ; In Joo KIM ; Tae Sun PARK ; Sei Hyun BAIK ; Kun Ho YOON ; Kwan Woo LEE ; In Kyu LEE ; Moon Kyu LEE
Journal of Korean Medical Science 2019;34(15):e117-
BACKGROUND: Removal of uremic toxins such as indoxyl sulfate by AST-120 is known to improve renal function and delay the initiation of dialysis in patients with advanced chronic kidney disease. However, it is unclear whether the addition of AST-120 to conventional treatments is effective in delaying the progression of renal dysfunction in patients with diabetic nephropathy. METHODS: A total of 100 patients with type 2 diabetes and renal dysfunction (serum creatinine levels ranging from 1.5 to 3.0 mg/dL) were recruited from eight centers in Korea and treated with AST-120 (6 g/day) for 24 weeks. The primary endpoint was improvement in renal function measured as the gradient of the reciprocal serum creatinine level (1/sCr) over time (i.e., the ratio of 1/sCr time slope for post- to pre-AST-120 therapy). A response was defined as a ratio change of the regression coefficient of 1/sCr ≤ 0.90. RESULTS: Renal function improved in 80.3% of patients (61/76) after 24 weeks of AST-120 treatment. There were no differences between responder and non-responder groups in baseline characteristics except for diastolic blood pressure (73.5 ± 9.5 mmHg in the responder group vs. 79.3 ± 11.1 mmHg in the non-responder group; P = 0.046). Serum lipid peroxidation level decreased significantly in the responder group (from 2.25 ± 0.56 μmol/L to 1.91 ± 0.72 μmol/L; P = 0.002) but not in the non-responder group. CONCLUSION: The addition of AST-120 to conventional treatments may delay the progression of renal dysfunction in diabetic nephropathy. The antioxidant effect of AST-120 might contribute to improvement in renal function.
Antioxidants
;
Blood Pressure
;
Creatinine
;
Diabetic Nephropathies
;
Dialysis
;
Humans
;
Indican
;
Korea
;
Lipid Peroxidation
;
Oxidative Stress
;
Prospective Studies
;
Renal Insufficiency, Chronic
10.Long-Term Outcomes of Adult Lung Transplantation Recipients: A Single-Center Experience in South Korea
Kyung Wook JO ; Sang Bum HONG ; Dong Kwan KIM ; Sung Ho JUNG ; Hyeong Ryul KIM ; Se Hoon CHOI ; Geun Dong LEE ; Sang Oh LEE ; Kyung Hyun DO ; Eun Jin CHAE ; In Cheol CHOI ; Dae Kee CHOI ; In Ok KIM ; Seung Il PARK ; Tae Sun SHIM
Tuberculosis and Respiratory Diseases 2019;82(4):348-356
BACKGROUND: Recently, the number of lung transplants in South Korea has increased. However, the long-term outcome data is limited. In this study, we aimed to investigate the long-term outcomes of adult lung transplantation recipients. METHODS: Among the patients that underwent lung transplantation at a tertiary referral center in South Korea between 2008 and 2017, adults patient who underwent deceased-donor lung transplantation with available follow-up data were enrolled. Their medical records were retrospectively reviewed. RESULTS: Through eligibility screening, we identified 60 adult patients that underwent lung (n=51) or heart-lung transplantation (n=9) during the observation period. Idiopathic pulmonary fibrosis (46.7%, 28/60) was the most frequent cause of lung transplantation. For all the 60 patients, the median follow-up duration for post-transplantation was 2.6 years (range, 0.01–7.6). During the post-transplantation follow-up period, 19 patients (31.7%) died at a median duration of 194 days. The survival rates were 75.5%, 67.6%, and 61.8% at 1 year, 3 years, and 5 years, respectively. Out of the 60 patients, 8 (13.3%) were diagnosed with chronic lung allograft dysfunction (CLAD), after a mean duration of 3.3±2.8 years post-transplantation. The CLAD development rate was 0%, 17.7%, and 25.8% at 1 year, 3 years, and 5 years, respectively. The most common newly developed post-transplantation comorbidity was the chronic kidney disease (CKD; 54.0%), followed by diabetes mellitus (25.9%). CONCLUSION: Among the adult lung transplantation recipients at a South Korea tertiary referral center, the long-term survival rates were favorable. The proportion of patients who developed CLAD was not substantial. CKD was the most common post-transplantation comorbidity.
Adult
;
Allografts
;
Comorbidity
;
Diabetes Mellitus
;
Follow-Up Studies
;
Heart-Lung Transplantation
;
Humans
;
Idiopathic Pulmonary Fibrosis
;
Korea
;
Lung Transplantation
;
Lung
;
Mass Screening
;
Medical Records
;
Renal Insufficiency, Chronic
;
Retrospective Studies
;
Survival Rate
;
Tertiary Care Centers

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