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.Five-Year Overall Survival and Prognostic Factors in Patients with Lung Cancer: Results from the Korean Association of Lung Cancer Registry (KALC-R) 2015
Da Som JEON ; Ho Cheol KIM ; Se Hee KIM ; Tae-Jung KIM ; Hong Kwan KIM ; Mi Hyung MOON ; Kyongmin Sarah BECK ; Yang-Gun SUH ; Changhoon SONG ; Jin Seok AHN ; Jeong Eun LEE ; Jeong Uk LIM ; Jae Hyun JEON ; Kyu-Won JUNG ; Chi Young JUNG ; Jeong Su CHO ; Yoo-Duk CHOI ; Seung-Sik HWANG ; Chang-Min CHOI ; ;
Cancer Research and Treatment 2023;55(1):103-111
Purpose:
This study aimed to provide the clinical characteristics, prognostic factors, and 5-year relative survival rates of lung cancer diagnosed in 2015.
Materials and Methods:
The demographic risk factors of lung cancer were calculated using the KALC-R (Korean Association of Lung Cancer Registry) cohort in 2015, with survival follow-up until December 31, 2020. The 5-year relative survival rates were estimated using Ederer II methods, and the general population data used the death rate adjusted for sex and age published by the Korea Statistical Information Service from 2015 to 2020.
Results:
We enrolled 2,657 patients with lung cancer who were diagnosed in South Korea in 2015. Of all patients, 2,098 (79.0%) were diagnosed with non–small cell lung cancer (NSCLC) and 345 (13.0%) were diagnosed with small cell lung cancer (SCLC), respectively. Old age, poor performance status, and advanced clinical stage were independent risk factors for both NSCLC and SCLC. In addition, the 5-year relative survival rate declined with advanced stage in both NSCLC (82%, 59%, 16%, 10% as the stage progressed) and SCLC (16%, 4% as the stage progressed). In patients with stage IV adenocarcinoma, the 5-year relative survival rate was higher in the presence of epidermal growth factor receptor (EGFR) mutation (19% vs. 11%) or anaplastic lymphoma kinase (ALK) translocation (38% vs. 11%).
Conclusion
In this Korean nationwide survey, the 5-year relative survival rates of NSCLC were 82% at stage I, 59% at stage II, 16% at stage III, and 10% at stage IV, and the 5-year relative survival rates of SCLC were 16% in cases with limited disease, and 4% in cases with extensive disease.
3.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.
4.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.Analysis of Factors Related to Growth and Growth Patterns of Unruptured Intracranial Aneurysms
Jonggu LEE ; Min Ho KONG ; Jung Hee KIM ; Se Youn JANG ; Sunghoon KIM ; Soono HONG ; Kwan Young SONG
Korean Journal of Neurotrauma 2022;18(1):45-55
Objective:
The goal of the present study was to identify factors related to the growth and growth patterns of unruptured intracranial aneurysms (UIAs).
Methods:
Between January 2011 and December 2018, a total of 275 patients were diagnosed with UIAs in our institution. Of them, 91 patients were evaluated using computed tomography angiography, magnetic resonance angiography, or digital subtraction angiography. Aneurysm size, morphology, location, and its changes were investigated. Patient factors, including gender, history of stroke, smoking, hypertension, diabetes mellitus, and excessive alcohol consumption, were studied to identify factors associated with aneurysm growth.
Results:
A total of 91 patients (121 aneurysms) with a mean follow-up duration of 37.2±23.9 months and a mean age of 64.0±11.4 years were included. The growth of unruptured aneurysms was identified in 23 patients (27 aneurysms, 22.3%). Regarding morphology, the diffuse growth pattern was the most common (12 aneurysms in 10 patients, 44.4%). Univariate analysis showed that patients with multiple aneurysms (p=0.010), history of stroke (p=0.021), and aneurysm location in the posterior circulation (p=0.029) were significantly associated with aneurysm growth.
Conclusion
The growth of an UIA is associated with the history of stroke, posterior location, and multiplicity. Considering the risk of unruptured aneurysm growth, patients with such risk factors should receive additional attention during follow-up.
7.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.
8.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.
9.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.
10.The Usefulness of a Wearable Device in Daily Physical Activity Monitoring for the Hospitalized Patients Undergoing Lumbar Surgery
Dong Hwan KIM ; Kyoung Hyup NAM ; Byung Kwan CHOI ; In Ho HAN ; Tae Jin JEON ; Se Young PARK
Journal of Korean Neurosurgical Society 2019;62(5):561-566
OBJECTIVE: Functional outcomes have traditionally been evaluated and compared using subjective surveys, such as visual analog scores (VAS), the Oswestry disability index (ODI), and Short Form-36 (SF-36), to assess symptoms and quality of life. However, these surveys are limited by their subjective natures and inherent bias caused by differences in patient perceptions of symptoms. The Fitbit Charge® (Fitbit Inc., San Francisco, CA, USA) provides accurate and objective measures of physical activity. The use of this device in patients after laminectomy would provide objective physical measures that define ambulatory function, activity level, and degree of recovery. Therefore, the present study was conducted to identify relationships between the number of steps taken by patients per day and VAS pain scores, prognoses, and postoperative functional outcomes.METHODS: We prospectively investigated 22 consecutive patients that underwent laminectomy for spinal stenosis or a herniated lumbar disc between June 2015 and April 2016 by the same surgeon. When patients were admitted for surgery and first visited after surgery, preoperative and postoperative functional scores were recorded using VAS scores, ODI scores, and SF-36. The VAS scores and physical activities were recorded daily from postoperative day (POD) 1 to POD 7. The relationship between daily VAS scores and daily physical activities were investigated by simple correlation analysis and the relationship between mean number of steps taken and ODI scores after surgery was subjected to simple regression analysis. In addition, Wilcoxon’s signed-rank test was used to investigate the significance of pre-to-postoperative differences in VAS, ODI, and SF-36 scores.RESULTS: Pre-to-postoperative VAS (p<0.001), ODI (p<0.001), SF-36 mental composite scores (p=0.009), and SF-36 physical composite scores (p<0.001) scores were found to be significantly different. Numbers of steps taken from POD 1 to POD 7 were negatively correlated with daily VAS scores (r=-0.981, p<0.001). In addition, the mean number of steps from POD 3 to POD 7 and the decrease in ODI conducted one month after surgery were statistically significant (p=0.029).CONCLUSION: Wearable devices are not only being used increasingly by consumers as lifestyle devices, but are also progressively being used in the medical area. This is the first study to demonstrate the usefulness of a wearable device for checking patient physical activity and predicting pain and prognosis after laminectomy. Based on our experience, the wearable device used to provide measures of physical activity in the present study has the potential to provide objective information on pain severity and prognosis.
Bias (Epidemiology)
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Humans
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Laminectomy
;
Life Style
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Motor Activity
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Prognosis
;
Prospective Studies
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Quality of Life
;
Spinal Stenosis
;
Visual Analog Scale

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