1.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
2.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
3.The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
Bum Jun KIM ; Chi Hoon MAENG ; Bhumsuk KEAM ; Young-Hyuck IM ; Jungsil RO ; Kyung Hae JUNG ; Seock-Ah IM ; Tae Won KIM ; Jae Lyun LEE ; Dae Seog HEO ; Sang-We KIM ; Keunchil PARK ; Myung-Ju AHN ; Byoung Chul CHO ; Hoon-Kyo KIM ; Yoon-Koo KANG ; Jae Yong CHO ; Hwan Jung YUN ; Byung-Ho NAM ; Dae Young ZANG
Cancer Research and Treatment 2025;57(1):39-46
Purpose:
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods:
We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results:
From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion
Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
4.Quality of Acute Stroke Care within Emergency Medical Service System in Korea: Proposal for Severe Emergency Medical Center
Kyung Bok LEE ; Ji Sung LEE ; Jeong-Yoon LEE ; Jun Yup KIM ; Han-Yeong JEONG ; Seong-Eun KIM ; Jonguk KIM ; Do Yeon KIM ; Keon-Joo LEE ; Jihoon KANG ; Beom Joon KIM ; Tae Jung KIM ; Sang Joon AN ; Jang-Hyun BAEK ; Seongheon KIM ; Hyun-Wook NAH ; Jong Yun LEE, ; Jee-Hyun KWON ; Seong Hwan AHN ; Keun-Hwa JUNG ; Hee-Kwon PARK ; Tai Hwan PARK ; Jong-Moo PARK ; Yong-Jin CHO ; Im Seok KOH ; Soo Joo LEE ; Jae-Kwan CHA ; Joung-Ho RHA ; Juneyoung LEE ; Boung Chul LEE ; In Ok BAE ; Gui Ok KIM ; Hee-Joon BAE
Journal of the Korean Neurological Association 2023;41(1):18-30
Background:
Korea recently established 70 emergency medical service areas. However, there are many concerns that medical resources for stroke could not be evenly distributed through the country. We aimed to compare the treatment quality and outcomes of acute stroke among the emergency medical service areas.
Methods:
This study analyzed the data of 28,800 patients admitted in 248 hospitals which participated in the 8th acute stroke quality assessment by Health Insurance Review and Assessment Service. Individual hospitals were regrouped into emergency service areas according to the address of the location. Assessment indicators and fatality were compared by the service areas. We defined the appropriate hospital by the performance of intravenous thrombolysis.
Results:
In seven service areas, there were no hospitals which received more than 10 stroke patients for 6 months. In nine service areas, there were no patients who underwent intravenous thrombolysis (IVT). Among 167 designated emergency medical centers, 50 hospitals (29.9%) responded that IVT was impossible 24 hours a day. There are 97 (39.1%) hospitals that meet the definitions of appropriate hospital. In 23 service areas (32.9%) had no appropriate or feasible hospitals. The fatality of service areas with stroke centers were 6.9% within 30 days and 15.6% within 1 year from stroke onset than those without stroke centers (7.7%, 16.9%, respectively).
Conclusions
There was a wide regional gap in the medical resource and the quality of treatments for acute stroke among emergency medical service areas in Korea. The poststroke fatality rate of the service areas which have stroke centers or appropriate hospitals were significantly low.
5.Tear Film and Drainage after Selective Punctal Occlusion Using Polydioxanone Plugs in Dry Eye Patients
Sung Eun IM ; Hee Chul LEE ; Sang Soo KIM
Journal of the Korean Ophthalmological Society 2023;64(9):759-767
Purpose:
To assess changes in the tear film and delayed tear drainage after upper or lower, or combined upper and lower, punctal occlusion using dissolvable polydioxanone plugs in patients with dry eye.
Methods:
In total, 40 dry eye patients (80 eyes) were enrolled: four groups of 10 (20 eyes) with no, lower, upper, and lower and upper punctal occlusions. Dissolvable polydioxanone plugs were placed. The tear break-up time (tBUT) and the tear meniscus height (TMH) were measured, and the Schirmer I test and dye disappearance test (DDT) were performed at baseline and 2 weeks after the procedure.
Results:
Compared to the control group, all three test groups exhibited significant changes in the tBUT, the DDT test, and the TMH after polydioxanone plug placement (all p < 0.05). The group with both upper and lower punctal occlusions exhibited more delayed tear drainage than the other test groups. A lower punctal occlusion significantly delayed tear drainage to a greater extent than did an upper punctal occlusion (p = 0.010).
Conclusions
In dry eye patients, a polydioxanone plug improved the tBUT and TMH, and the DDT score. The tear drainage delay increased in the order: both, lower, and upper punctal occlusion(s).
6.2020 Clinical Practice Guideline for Percutaneous Transthoracic Needle Biopsy of Pulmonary Lesions: A Consensus Statement and Recommendations of the Korean Society of Thoracic Radiology
Soon Ho YOON ; Sang Min LEE ; Chul Hwan PARK ; Jong Hyuk LEE ; Hyungjin KIM ; Kum Ju CHAE ; Kwang Nam JIN ; Kyung Hee LEE ; Jung Im KIM ; Jung Hee HONG ; Eui Jin HWANG ; Heekyung KIM ; Young Joo SUH ; Samina PARK ; Young Sik PARK ; Dong-Wan KIM ; Miyoung CHOI ; Chang Min PARK
Korean Journal of Radiology 2021;22(2):263-280
Percutaneous transthoracic needle biopsy (PTNB) is one of the essential diagnostic procedures for pulmonary lesions. Its role is increasing in the era of CT screening for lung cancer and precision medicine. The Korean Society of Thoracic Radiology developed the first evidence-based clinical guideline for PTNB in Korea by adapting pre-existing guidelines. The guideline provides 39 recommendations for the following four main domains of 12 key questions: the indications for PTNB, pre-procedural evaluation, procedural technique of PTNB and its accuracy, and management of post-biopsy complications. We hope that these recommendations can improve the diagnostic accuracy and safety of PTNB in clinical practice and promote standardization of the procedure nationwide.
7.Retrospective study on prevalence of recurrent inguinal hernia: a large-scale multi-institutional study
Chul Seung LEE ; Ji Hoon KIM ; Byung Jo CHOI ; Jae Im LEE ; Sang Chul LEE ; Yoon Suk LEE ; Seong Taek OH ; Hyung Jin KIM
Annals of Surgical Treatment and Research 2020;98(1):51-55
PURPOSE:
We conducted a multi-institutional analysis to establish the epidemiological characteristics of recurrent inguinal hernia following hernia repair in patients across 4 institutions in Korea.
METHODS:
The retrospectively reviewed data included patient characteristics, hernia location, year of primary operation, type of hernia, timing of recurrence, primary operation type, and whether a mesh was used.
RESULTS:
Among 4,604 patients who underwent hernia repair surgery, 255 patients (5.5%; 13 females and 242 males; mean age, 63 years) were found to have recurrent hernia from January 2010 to April 2017. Recurrent indirect inguinal and direct hernias were observed in 47.1% and 49.4% of the patients, respectively. The recurrence of hernias within 1 year of surgery was the highest at 17.25%. Early and late recurrences was observed in 23.5% and 66.5% of the patients, respectively. Among the patients, 81.6% underwent open hernia repair at the time of initial surgery.
CONCLUSION
Recurrence of hernia is most common in the first year after the initial surgery, and 23.5% of recurrent inguinal hernia was developed within 2 years. Patients underwent surgery after an average of 116 months (median value, 64 months) following the first operation. In patients with recurrent hernia, direct hernia was seen more frequent than indirect hernia whereas indirect hernia occurred more in patients with primary hernia.
8.Real-World Experience of Nivolumab in Non-small Cell Lung Cancer in Korea
Sun Min LIM ; Sang-We KIM ; Byoung Chul CHO ; Jin Hyung KANG ; Myung-Ju AHN ; Dong-Wan KIM ; Young-Chul KIM ; Jin Soo LEE ; Jong-Seok LEE ; Sung Yong LEE ; Keon Uk PARK ; Ho Jung AN ; Eun Kyung CHO ; Tae Won JANG ; Bong-Seog KIM ; Joo-Hang KIM ; Sung Sook LEE ; Im-II NA ; Seung Soo YOO ; Ki Hyeong LEE
Cancer Research and Treatment 2020;52(4):1112-1119
Purpose:
The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program.
Materials and Methods:
Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected.
Results:
Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data.
Conclusion
This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.
9.Dexamethasone Interferes with Autophagy and Affects Cell Survival in Irradiated Malignant Glioma Cells
Alfred KOMAKECH ; Ji-Hye IM ; Ho-Shin GWAK ; Kyue-Yim LEE ; Jong Heon KIM ; Byong Chul YOO ; Heesun CHEONG ; Jong Bae PARK ; Ji Woong KWON ; Sang Hoon SHIN ; Heon YOO
Journal of Korean Neurosurgical Society 2020;63(5):566-578
Objective:
: Radiation is known to induce autophagy in malignant glioma cells whether it is cytocidal or cytoprotective.Dexamethasone is frequently used to reduce tumor-associated brain edema, especially during radiation therapy. The purpose of the study was to determine whether and how dexamethasone affects autophagy in irradiated malignant glioma cells and to identify possible intervening molecular pathways.
Methods:
: We prepared p53 mutant U373 and LN229 glioma cell lines, which varied by phosphatase and tensin homolog (PTEN) mutational status and were used to make U373 stable transfected cells expressing GFP-LC3 protein. After performing cell survival assay after irradiation, the IC50 radiation dose was determined. Dexamethasone dose (10 µM) was determined from the literature and added to the glioma cells 24 hours before the irradiation. The effect of adding dexamethasone was evaluated by cell survival assay or clonogenic assay and cell cycle analysis. Measurement of autophagy was visualized by western blot of LC3-I/LC3-II and quantified by the GFP-LC3 punctuated pattern under fluorescence microscopy and acridine orange staining for acidic vesicle organelles by flow cytometry.
Results:
: Dexamethasone increased cell survival in both U373 and LN229 cells after irradiation. It interfered with autophagy after irradiation differently depending on the PTEN mutational status : the autophagy decreased in U373 (PTEN-mutated) cells but increased in LN229 (PTEN wild-type) cells. Inhibition of protein kinase B (AKT) phosphorylation after irradiation by LY294002 reversed the dexamethasone-induced decrease of autophagy and cell death in U373 cells but provoked no effect on both autophagy and cell survival in LN229 cells. After ATG5 knockdown, radiation-induced autophagy decreased and the effect of dexamethasone also diminished in both cell lines. The diminished autophagy resulted in a partial reversal of dexamethasone protection from cell death after irradiation in U373 cells; however, no significant change was observed in surviving fraction LN229 cells.
Conclusion
: Dexamethasone increased cell survival in p53 mutated malignant glioma cells and increased autophagy in PTENmutant malignant glioma cell but not in PTEN-wildtype cell. The difference of autophagy response could be mediated though the phosphatidylinositol 3-kinase/AKT/mammalian target of rapamycin signaling pathway.
10.Cohort Profile: Firefighter Research on the Enhancement of Safety and Health (FRESH), a Prospective Cohort Study on Korean Firefighters
Yun Tae KIM ; Woo Jin KIM ; Jee Eun CHOI ; Mun joo BAE ; Heeseon JANG ; Chan Joo LEE ; Hye Jeong LEE ; Dong Jin IM ; Byoung Seok YE ; Mi Ji KIM ; Yeoju JEONG ; Sung Soo OH ; Young Chul JUNG ; Eun Seok KANG ; Sungha PARK ; Seung Koo LEE ; Ki Soo PARK ; Sang Baek KOH ; Changsoo KIM
Yonsei Medical Journal 2020;61(1):103-109
40 years or new hires with less than 1 year of service.]]>
Brain
;
Cardiovascular Diseases
;
Cohort Studies
;
Firefighters
;
Follow-Up Studies
;
Health Surveys
;
Hospitals, University
;
Humans
;
Killer Cells, Natural
;
Korea
;
Magnetic Resonance Imaging
;
Mental Disorders
;
Mental Health
;
Neuropsychological Tests
;
Polycyclic Hydrocarbons, Aromatic
;
Prospective Studies
;
Republic of Korea
;
Risk Factors

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