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.Prevention of Cytomegalovirus Infection in Solid Organ Transplant Recipients:Guidelines by the Korean Society of Infectious Diseases and the Korean Society for Transplantation
Kyungmin HUH ; Sang-Oh LEE ; Jungok KIM ; Su Jin LEE ; Pyoeng Gyun CHOE ; Ji-Man KANG ; Jaeseok YANG ; Heungsup SUNG ; Si-Ho KIM ; Chisook MOON ; Hyeri SEOK ; Hye Jin SHI ; Yu Mi WI ; Su Jin JEONG ; Wan Beom PARK ; Youn Jeong KIM ; Jongman KIM ; Hyung Joon AHN ; Nam Joong KIM ; Kyong Ran PECK ; Myoung Soo KIM ; Sang Il KIM
Infection and Chemotherapy 2024;56(1):101-121
Cytomegalovirus (CMV) is the most important opportunistic viral pathogen in solid organ transplant (SOT) recipients.The Korean guideline for the prevention of CMV infection in SOT recipients was developed jointly by the Korean Society for Infectious Diseases and the Korean Society of Transplantation. CMV serostatus of both donors and recipients should be screened before transplantation to best assess the risk of CMV infection after SOT. Seronegative recipients receiving organs from seropositive donors face the highest risk, followed by seropositive recipients. Either antiviral prophylaxis or preemptive therapy can be used to prevent CMV infection. While both strategies have been demonstrated to prevent CMV infection post-transplant, each has its own advantages and disadvantages. CMV serostatus, transplant organ, other risk factors, and practical issues should be considered for the selection of preventive measures. There is no universal viral load threshold to guide treatment in preemptive therapy. Each institution should define and validate its own threshold.Valganciclovir is the favored agent for both prophylaxis and preemptive therapy. The evaluation of CMV-specific cellmediated immunity and the monitoring of viral load kinetics are gaining interest, but there was insufficient evidence to issue recommendations. Specific considerations on pediatric transplant recipients are included.
3.The Korean Organ Transplantation Registry (KOTRY): an overview and summary of the kidney-transplant cohort
Hee Jung JEON ; Tai Yeon KOO ; Man Ki JU ; Dong-Wan CHAE ; Soo Jin Na CHOI ; Myoung Soo KIM ; Jung-Hwa RYU ; Jong Cheol JEON ; Curie AHN ; Jaeseok YANG ;
Kidney Research and Clinical Practice 2022;41(4):492-507
As the need for a nationwide organ-transplant registry emerged, a prospective registry, the Korean Organ Transplantation Registry (KOTRY), was initiated in 2014. Here, we present baseline characteristics and outcomes of the kidney-transplant cohort for 2014 through 2019. Methods: The KOTRY consists of five organ-transplant cohorts (kidney, liver, lung, heart, and pancreas). Data and samples were prospectively collected from transplant recipients and donors at baseline and follow-up visits; and epidemiological trends, allograft outcomes, and patient outcomes, such as posttransplant complications, comorbidities, and mortality, were analyzed. Results: From 2014 to 2019, there were a total of 6,129 registered kidney transplants (64.8% with living donors and 35.2% with deceased donors) with a mean recipient age of 49.4 ± 11.5 years, and 59.7% were male. ABO-incompatible transplants totaled 17.4% of all transplants, and 15.0% of transplants were preemptive. The overall 1- and 5-year patient survival rates were 98.4% and 95.8%, respectively, and the 1- and 5-year graft survival rates were 97.1% and 90.5%, respectively. During a mean follow-up of 3.8 years, biopsy-proven acute rejection episodes occurred in 17.0% of cases. The mean age of donors was 47.3 ± 12.9 years, and 52.6% were male. Among living donors, the largest category of donors was spouses, while, among deceased donors, 31.2% were expanded-criteria donors. The mean serum creatinine concentrations of living donors were 0.78 ± 0.62 mg/dL and 1.09 ± 0.24 mg/dL at baseline and 1 year after kidney transplantation, respectively. Conclusion: The KOTRY, a systematic Korean transplant cohort, can serve as a valuable epidemiological database of Korean kidney transplants.
4.Analysis of the Switching Patterns of Biologics and Their Efficacy after Switching in Moderate-to-Severe Psoriasis Patients
Su Min LEE ; Byeong Chang KO ; Sang Woo AHN ; Ji An UH ; Jung Eun SEOL ; Hyojin KIM ; Soo Kyung LEE ; Myoung Shin KIM ; Un Ha LEE ; So Hee PARK ; So Young JUNG ; Hai-Jin PARK
Korean Journal of Dermatology 2022;60(7):420-428
Background:
Biologics-experienced patients are more likely to show a lower response to biologics than that of biologic-naïve patients. However, no consensus on switching biologics exists.
Objective:
We aimed to investigate the switching patterns and efficacy of the switched biologics in patients with moderate-to-severe psoriasis in actual clinical practice.
Methods:
This multicenter retrospective study included 37 patients with a history of switching biologics. We analyzed the reasons for switching, the switching patterns, and psoriasis area and severity index (PASI) 75 response rates after switching biologics. We also analyzed the factors affecting the PASI75 response rate to the second biologic.
Results:
The reasons for switching baseline biologics were primary failure in five patients (13.5%), secondary failure in 28 patients (75.7%), and adverse events in four patients (10.8%). The second biologics prescribed mostly include interleukin (IL)-23 inhibitor in twenty-four patients (64.9%), IL-17 inhibitor in eight patients (21.6%), tumor necrosis factor-α inhibitor in three patients (8.1%), and IL-12/23 inhibitor in two patients (5.4%). A total of 46% of patients (17/37) switched biologics from IL-12/23 inhibitors to IL-23 inhibitors. The PASI75 response rates at the primary endpoint of the second and third biologics were 89.2% and 88.8%, respectively. Our study found that female sex and obesity were associated with the primary failure of the second biologic.
Conclusion
Secondary failure was the most common reason for switching baseline biologics. Korean dermatologists prefer different classes of biologics while switching. The PASI75 response rates at the primary endpoints of the second and third biologics were relatively satisfactory.
5.Safety and efficacy of nilotinib in adult patients with chronic myeloid leukemia: a post-marketing surveillance study in Korea
Seo-Yeon AHN ; Sang Kyun SON ; Gyu Hyung LEE ; Inho KIM ; June-Won CHEONG ; Won Sik LEE ; Byung Soo KIM ; Deog-Yeon JO ; Chul Won JUNG ; Chu Myoung SEONG ; Jae Hoon LEE ; Young Jin YUH ; Min Kyoung KIM ; Hun-Mo RYOO ; Moo-Rim PARK ; Su-Hee CHO ; Hoon-Gu KIM ; Dae Young ZANG ; Jinny PARK ; Hawk KIM ; Seryeon LEE ; Sung-Hyun KIM ; Myung Hee CHANG ; Ho Sup LEE ; Chul Won CHOI ; Jihyun KWON ; Sung-Nam LIM ; Suk-Joong OH ; Inkyung JOO ; Dong-Wook KIM
Blood Research 2022;57(2):144-151
Background:
Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea.
Methods:
An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response.
Results:
During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients).
Conclusion
This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
6.A Study on Global Nursing Practice Education Experience
Eun Sil CHO ; Myoung Hee SEO ; Soo Ok YOU ; Ok Hee AHN ; Myeoung Hi SONG
Journal of Korean Academy of Community Health Nursing 2021;32(4):485-496
Purpose:
This study attempted to obtain basic data for developing a global nursing practice education program.
Methods:
The data collection period was from July 2 to 11, 2020. The study participants were professors with experience in design, operation and management of global nursing practice education or experts with experience in international cooperation projects, and 8 people who agreed to participate in focus group interview (FGI). FGI was conducted twice in total and the directed content analysis method was applied.
Results:
The categories of ‘practice design’ are ‘growing as a global nursing leader’ and ‘working together towards one goal’. The categories of ‘practice operation’ are ‘watching, listening, and performing’, ‘self-directed organizing from preparation to finishing’, and ‘learning the value of participation rather than grades’. The category of 'practice management' is 'one's own weight to carry'.
Conclusion
Global nursing practice education aims one goal - growing as a global nursing leader - and is self-directed course from preparation to an end with watching, listening and performing together. It is about learning the value of participation rather than grades. This can be used as basic data for the design, operation and management of global nursing practice education in the future.
7.Enlarged lymph nodes diagnosed with Langerhans cell histiocytosis found in a direct inguinal hernia: a case report
Jong Hyuk YUN ; Myoung Won SON ; Geum Jong SONG ; Hye In AHN ; Sang Ho BAE ; Moon Soo LEE
Journal of Minimally Invasive Surgery 2021;24(4):223-226
It is unusual that an unexpected mass is encountered within a hernia sac. This report describes a patient diagnosed with Langerhans cell histiocytosis (LCH) after surgery for an inguinal hernia. A 64-year-old male patient presented with inguinal mass over a 1-year period. Direct inguinal hernias were found in both sides, and enlarged lymph nodes were found in both hernia sacs. Laparoscopic totally extraperitoneal repair was done, and one enlarged lymph node within inguinal hernia sac was excised for diagnostic purposes.Microscopic findings showed the distinctive cytologic features of Langerhans cells and immunohisto chemical staining are positive for CD1a and S-100. LCH is a rare disorder, and the involvement of the lymph nodes with no other sites of disease is uncommon. To the best of our knowledge, this is the first report of LCH within an inguinal hernia sac. Multidisciplinary approach should be considered to provide better detection and treatment.
8.The pre-hospital analysis of intentional taking poison in Gangwon-do
Woong Chan AHN ; Jun Hwi CHO ; Joong Bum MOON ; Chan Woo PARK ; Myoung Cheol SHIN ; Ka Eul KIM ; Joon Yeol LEE ; Yoon Soo PARK ; Byoung Seon HWANG ; Go Eum YANG ; Hui Young LEE ; Min Soo KIM ; In Kook CHUN ; Taek Geun OHK
Journal of the Korean Society of Emergency Medicine 2020;31(1):23-38
Objective:
This study examined the characteristics of the patients taking poison intentionally at the pre-hospital stage to prevent it at the community level.
Methods:
We retrospectively reviewed the data that had been reported to fire stations from January 2017 to December 2018. This data included sex, age, occupation, the season of the year, time, place, methods, alcohol ingestion, transferred to the hospital or not, and we examined how taking poison had an effect on the suicide success rate.
Results:
The subjects were a total of 1,356 patients who had been reported to fire stations due to intentionally taking poison. Forty-five point five percent of them were male, and 54.5% were female. The most common method of intentional taking poison was sedatives (58.3%), followed by pesticides (24.6%), antidepressants (19.0%), and other methods (12.6%). The home place was preferred more than any other places. The suicide success rate was 2.1% in males and 1.4% in females. For the age groups, those patients 40-64 years old tried taking poison much more than the other age groups. In the aspect of the season of the year, summer was the highest season for taking poison, at 30.3%. The daytime was more preferred than the night time.
Conclusion
In this study, we analyzed the characteristics of the pre-hospital intentional poisoning cases according to gender, age, occupation, season of the year, time, and between the transferred and the untransferred groups. Efforts should be made in cooperation with the community to prevent suicide attempts by intentionally taking poison.
9.Dummy Run of Quality Assurance Program before Prospective Study of Hippocampus-Sparing Whole-Brain Radiotherapy and Simultaneous Integrated Boost for Multiple Brain Metastases from Non-small Cell Lung Cancer: Korean Radiation Oncology Group (KROG) 17-06 Study
Eunah CHUNG ; Jae Myoung NOH ; Kyu Chan LEE ; Jin Hee KIM ; Weon Kuu CHUNG ; Yang Gun SUH ; Jung Ae LEE ; Ki Ho SEOL ; Hong Gyun WU ; Yeon Sil KIM ; O Kyu NOH ; Jae Won PARK ; Dong Soo LEE ; Jihae LEE ; Young Suk KIM ; Woo Yoon PARK ; Min Kyu KANG ; Sunmi JO ; Yong Chan AHN
Cancer Research and Treatment 2019;51(3):1001-1010
PURPOSE: Lung Cancer Subcommittee of Korean Radiation Oncology Group (KROG) has recently launched a prospective clinical trial (KROG 17-06) of hippocampus-sparing whole brain radiotherapy (HS-WBRT) with simultaneous integrated boost (SIB) in treating multiple brain metastases from non-small cell lung cancer. In order to improve trial quality, dummy run studies among the participating institutions were designed. This work reported the results of two-step dummy run procedures of the KROG 17-06 study. MATERIALS AND METHODS: Two steps tested hippocampus contouring variability and radiation therapy planning compliance. In the first step, the variation of the hippocampus delineation was investigated for two representative cases using the Dice similarity coefficients. In the second step, the participating institutions were requested to generate a HS-WBRT with SIB treatment plan for another representative case. The compliance of the treatment plans to the planning protocol was evaluated. RESULTS: In the first step, the median Dice similarity coefficients of the hippocampus contours for two other dummy run cases changed from 0.669 (range, 0.073 to 0.712) to 0.690 (range, 0.522 to 0.750) and from 0.291 (range, 0.219 to 0.522) to 0.412 (range, 0.264 to 0.598) after providing the hippocampus contouring feedback. In the second step, with providing additional plan priority and extended dose constraints to the target volumes and normal structures, we observed the improved compliance of the treatment plans to the planning protocol. CONCLUSION: The dummy run studies demonstrated the notable inter-institutional variability in delineating the hippocampus and treatment plan generation, which could be decreased through feedback from the trial center.
Brain
;
Carcinoma, Non-Small-Cell Lung
;
Compliance
;
Hippocampus
;
Lung Neoplasms
;
Neoplasm Metastasis
;
Prospective Studies
;
Radiation Oncology
;
Radiotherapy
10.Epigenetic inactivation of RUNX3 in colorectal cancer
Eung Jin SHIN ; Han Jo KIM ; Myoung Won SON ; Tae Sung AHN ; Hyun Yong LEE ; Dae Ro LIM ; Sang Byung BAE ; Seob JEON ; Hyungjoo KIM ; Dongjun JEONG ; Moon Soo LEE ; Dong Sun KIM ; Jeong Se NOH ; Moo Jun BAEK
Annals of Surgical Treatment and Research 2018;94(1):19-25
PURPOSE: Emerging evidence indicates that runt-related transcription factor 3 (RUNX3) is an important tumor suppressor gene in several cancer types, including colorectal cancer (CRC). However, the clinical significance of RUNX3 inactivation in CRC remains unclear. The aim of this study was to examine the correlation between clinicopathologic factors and RUNX3 hypermethylation/expression in CRC. METHODS: Sixty-two CRC patients who were treated at the Soonchunhyang University College of Medicine were recruited in this study. The hypermethylation of CpG islands in the RUNX3 promoter and the expression of RUNX3 mRNA were identified by methylation-specific polymerase chain reaction (PCR) and reverse transcriptase-PCR, respectively. The expression of RUNX3 was determined by immunohistochemical staining. RESULTS: Of the 62 CRC tissue samples, 20 (32.3%) presented hypermethylated RUNX3 promoters. Aberrant RUNX3 hypermethylation was found to be associated with vascular (P = 0.006) and lymphatic (P = 0.002) invasion. Hypermethylation of RUNX3 was associated with poor survival outcomes (P = 0.038). However, expression of RUNX3 was not a prognostic factor (P = 0.363). CONCLUSION: Hypermethylation of RUNX3 may be a predictor of a poor prognosis in CRC.
Colorectal Neoplasms
;
Core Binding Factor Alpha 3 Subunit
;
CpG Islands
;
Epigenomics
;
Genes, Tumor Suppressor
;
Humans
;
Immunohistochemistry
;
Methylation
;
Polymerase Chain Reaction
;
Prognosis
;
RNA, Messenger
;
Transcription Factor 3

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