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.Effects of taurine and ginseng extracts on energy metabolism during exercise and their anti-fatigue properties in mice
Jisu KIM ; Suji BEAK ; Sanghyun AHN ; Byung Seok MOON ; Bom Sahn KIM ; Sang Ju LEE ; Seung Jun OH ; Hun-Young PARK ; Seung Hae KWON ; Chul Ho SHIN ; Kiwon LIM ; Kang Pa LEE
Nutrition Research and Practice 2022;16(1):33-45
BACKGROUND/OBJECTIVES:
Ginseng extract (GSE) and taurine (TR) are widely used antifatigue resources in functional foods. However, the mechanism underlying the antifatigue effects of GSE and TR are still unclear. Hence, we investigated whether GSE and TR have synergistic effects against fatigue in mice.MATERIALS/METHODS: L6 cells were treated with different concentrations of TR and GSE, and cell viability was determined using 2-(4-iodophenyl)-3-(4-nitrophenyl)-5-(2,4-disulfophenyl)-2H-tetrazolium. Oxidative stress was analyzed by immunocytochemistry using MitoTracker™ Red FM and an anti-8-oxoguanine antibody. Respiratory gas analysis was performed to investigate metabolism. Expression of an activated protein kinase was analyzed using immunohistochemistry. Gene expression of cluster of differentiation 36 and pyruvate dehydrogenase lipoamide kinase isozyme 4 was measured using reverse transcription– polymerase chain reaction. Mice were orally administered TR, GSE, or their combination for 30 days, and then fatigue-related parameters, including lactate, blood urea nitrogen, and glycogen, were measured after forced swimming.
RESULTS:
TR and GSE reduced oxidative stress levels in hydrogen peroxide-stimulated L6 cells and enhanced the oxygen uptake and lipid metabolism in mice after acute exercise. After oral administration of TR or GSE for 30 days, the fatigue-related parameters did not change in mice. However, the mice administered GSE (400 mg/kg/day) alone for 30 days could swim longer than those from the other groups. Further, no synergistic effect was observed after the swimming exercise in mice treated with the TR and GSE combination for 30 days.
CONCLUSIONS
Taken together, our data suggest that TR and GSE may exert antifatigue effects in mice after acute exercise by enhancing oxygen uptake and lipid oxidation.
5.Gorham-Stout Syndrome with Focal Segmental Glomerulosclerosis: A Case Report
Ji Hyun KIM ; You Sun KIM ; Seon Hee LIM ; Yo Han AHN ; Jung-Min KO ; Dong In SUH ; Kyoung Bun LEE ; Kyung Chul MOON ; Il-Soo HA ; Hae Il CHEONG ; Hee Gyung KANG
Childhood Kidney Diseases 2020;24(2):120-125
Gorham-Stout syndrome is a rare bone disorder characterized by progressive massive osteolysis and proliferation of vascular and lymphatic vessels. A 15-year-old boy was initially diagnosed with Gorham-Stout at the age of 8 years based on clinical and radiological findings. Following diagnosis, he was treated with pamidronate, interferon alfa, propranolol, oral corticosteroids, and sirolimus. He developed proteinuria at the age of 15 and progressed into the nephrotic range 2 years later. A renal biopsy revealed focal segmental glomerulosclerosis, not otherwise specified variant. The sequential increase in proteinuria associated with medications suggested that the focal segmental glomerulosclerosis may be caused by pamidronate and sirolimus, but cannot completely rule out the possibility of kidney involvement of GSS itself.
6.Cardiac Manifestations of Coronavirus Disease 2019 (COVID-19): a Multicenter Cohort Study
Minkwan KIM ; Jong-Ho NAM ; Jang-Won SON ; Sun Oh KIM ; Nak-Hoon SON ; Chul-Min AHN ; Chi Young SHIM ; Geu-Ru HONG ; In-Cheol KIM ; Jinwoo CHOI ; Seung-Mo KANG ; Yeoung Ho CHOI ; Hae Kyoung YOON ; Jae-Sun UHM ; In Hyun JUNG
Journal of Korean Medical Science 2020;35(40):e366-
Background:
This study aimed to investigate the cardiac manifestations of coronavirus disease 2019 (COVID-19).
Methods:
From February to March 2020, we prospectively and retrospectively enrolled consecutive patients diagnosed with COVID-19. Patient's data such as the demographic characteristics, symptoms, vital signs, laboratory and radiologic findings, electrocardiographic, and echocardiographic data, including the global longitudinal strain (GLS) of both ventricles, were obtained.
Results:
Forty patients (median age, 58 years; 50% men) were enrolled in the initial analysis. Patients were classified into severe and nonsevere groups based on the current guidelines. The 13 patients in the severe group were significantly older, had a greater prevalence of bilateral pneumonia and leukocytosis, and higher aspartate transaminase levels than patients in the nonsevere group. Patients in the severe group had a slightly lower left ventricular ejection fraction (LVEF) than those in the nonsevere group (median [interquartile range], 61.0% [58.5%, 62.3%] vs. 66.7% [60.6%, 69.8%], P = 0.015). In a subgroup of 34 patients in whom GLS could be analyzed, patients in the severe group had a significantly impaired left ventricular GLS (LVGLS) than those in the nonsevere group (−18.1% [−18.8%, −17.1%] vs. −21.7% [−22.9%, −19.9%], P = 0.001). There were no significant differences in total wall (RVGLS total , −19.3% [−23.9%, −18.4%] vs. −24.3% [−26.0%, −22.6%], P = 0.060) and free wall (RVGLS fw , −22.7% [−27.2%, −18.6%] vs. −28.8% [−30.4%, −24.1%], P = 0.066) right ventricle GLS (RVGLS).
Conclusion
Patients with severe COVID-19 had lower LVEF and LVGLS. RVGLS was not different between patients with severe and nonsevere COVID-19.
7.Reninoma: a rare cause of curable hypertension
Ji Hye KIM ; Ji Hyun KIM ; Myung Hyun CHO ; Eujin PARK ; Hye Sun HYUN ; Yo Han AHN ; Hee Gyung KANG ; Kyung Chul MOON ; Il Soo HA ; Hae Il CHEONG
Korean Journal of Pediatrics 2019;62(4):144-147
The most common type of refractory hypertension found in children is secondary hypertension, which is a potentially curable disease. Reninoma, a renin-secreting juxtaglomerular cell tumor, is a rare cause of severe hypertension that is usually diagnosed in adolescents and young adults. Surgical resection of the tumor completely cures the hypertension of patients with reninoma. The typical clinical presentation of reninoma includes hypokalemia, metabolic alkalosis, and features secondary to the increased activation of the renin-angiotensin system without renal artery stenosis. We report a case of reninoma in a female adolescent with a typical clinical presentation, in which surgical removal of the tumor completely cured hypertension. We discuss here the clinical features, imaging studies, and immunohistochemical examination of the tumor used to establish the diagnosis of reninoma and for the management of the condition.
Adolescent
;
Alkalosis
;
Child
;
Diagnosis
;
Humans
;
Hypertension
;
Hypertension, Renal
;
Hypokalemia
;
Juxtaglomerular Apparatus
;
Renal Artery Obstruction
;
Renin
;
Renin-Angiotensin System
;
Young Adult
8.Comparison of Cortical Ring Allograft and Plate Fixation with Autologous Iliac Bone Graft for Anterior Cervical Discectomy and Fusion
Jae Chul LEE ; Hae Dong JANG ; Joonghyun AHN ; Sung Woo CHOI ; Deokwon KANG ; Byung Joon SHIN
Asian Spine Journal 2019;13(2):258-264
STUDY DESIGN: A retrospective cohort study. PURPOSE: To compare the clinical and radiological outcomes of patients who underwent anterior cervical discectomy and fusion (ACDF) supplemented with plate fixation using allograft with those who underwent ACDF using tricortical iliac autograft. OVERVIEW OF LITERATURE: As plate fixation is becoming popular, it is reported that ACDF using allograft may have similar outcomes compared with ACDF using autograft. METHODS: Forty-one patients who underwent ACDF supplemented with plate fixation were included in this study. We evaluated 24 patients who used cortical ring allograft filled with demineralized bone matrix (DBM) (group A) and 17 patients who used tricortical iliac autograft (group B). In radiological evaluations, fusion rate, subsidence of grafted material, cervical lordosis, fused segmental lordosis, and radiological adjacent segment degeneration (ASD) were observed and analyzed with preoperative and postoperative plain radiographs. Clinical outcomes were evaluated using the Neck Disability Index score, Odom criteria, and Visual Analog Scale score of neck and upper extremity pain. Radiological union was determined by dynamic radiographs using cutoff values of 1 mm of interspinous motion as the indication of pseudarthrosis. RESULTS: There was no significant difference in the fusion rate, graft subsidence, cervical lordosis, fused segmental lordosis, and ASD incidence between the groups. Operative time was shorter in group A (136 min) than in group B (141 min), but it was not significant (p>0.05). Blood loss was greater in group B (325 mL) than in group A (210 mL, p=0.013). There was no difference in the clinical outcomes before and after surgery. CONCLUSIONS: In ACDF with plate fixation, cortical ring allograft filled with DBM group showed similar radiological and clinical outcomes compared with those of the autograft group. If the metal plate is reinforced, using cortical ring allograft could be a viable alternative to autograft.
Allografts
;
Animals
;
Autografts
;
Bone Matrix
;
Cohort Studies
;
Diskectomy
;
Humans
;
Incidence
;
Lordosis
;
Neck
;
Operative Time
;
Pseudarthrosis
;
Retrospective Studies
;
Transplants
;
Upper Extremity
;
Visual Analog Scale
9.A score for decision making during percutaneous coronary intervention in acute myocardial infarction patients with multivessel disease
Hae Chang JEONG ; Joon Ho AHN ; Min Chul KIM ; Doo Sun SIM ; Keun Ho PARK ; Young Joon HONG ; Ju Han KIM ; Myung Ho JEONG ; Ki Bae SEUNG ; Kiyuk CHANG ; Youngkeun AHN
The Korean Journal of Internal Medicine 2019;34(2):324-334
BACKGROUND/AIMS:
The optimal percutaneous coronary intervention (PCI) strategy in patients with acute myocardial infarction (AMI) with multivessel disease (MVD) is uncertain. This study was designed to develop a novel and simple tool for assessing an individualized and optimized PCI strategy in AMI patients with MVD.
METHODS:
In total, 5,025 patients with AMI from nine centers at two universities were enrolled in the prospective Convergent Registry of Catholic and Chonnam University for Acute Myocardial Infarction (COREA-AMI) registry from January 2004 through December 2009. From among them, we selected 2,630 patients with MVD who were treated by culprit-only or multivessel (MV) PCI. We investigated major adverse cardiac events (MACEs) during a 1-year clinical follow-up. Using a subgroup analysis, we extracted variables for use in the culprit only versus multivessel revascularization (CONVERSE) score, which showed a preference for MV PCI rather than culprit-only PCI for treating MVD.
RESULTS:
The CONVERSE score was constructed using eight independent variables (1 point for each variable): age > 65 years, hypertension, diabetes mellitus, high Killip class (III or IV), low left ventricular ejection fraction (≤ 50%), low creatinine clearance (≤ 60 mL/min), high level of high-sensitivity C-reactive protein (≥ 2.0 mg/L), and left anterior descending artery or left main as the nonculprit vessel. The incidence of MACEs increased linearly with the CONVERSE score. The receiver operating characteristic curve showed that the cutoff value was 3 points.
CONCLUSIONS
The results suggest that patients with a CONVERSE score of 3 or more should undergo MV PCI.
10.False Positive Diagnosis of Hepatocellular Carcinoma in Liver Resection Patients.
Hongeun LEE ; Jeong Hee YOON ; Hyeyoung KIM ; Nam Joon YI ; Suk Kyun HONG ; Kyung Chul YOON ; Hyo Sin KIM ; Sung Woo AHN ; Jin Young CHOI ; YoungRok CHOI ; Hae Won LEE ; Ju Yeon YI ; Kyoung Bun LEE ; Kwang Woong LEE ; Kyung Suk SUH
Journal of Korean Medical Science 2017;32(2):315-320
The diagnosis of hepatocellular carcinoma (HCC) is based on imaging studies particularly in high-risk patients without histologic confirmation. This study evaluated the prevalence and characteristics of false-positively diagnosed HCC in a liver resection cohort for HCC. A retrospective review was performed of 837 liver resection cases for clinically diagnosed HCC between 2005 and 2010 at our institute. High-risk patients with tumors > 1 cm with one or two image findings consistent with HCC and tumors < 1 cm with two or more image findings consistent with HCC with persistently increased serum alpha-fetoprotein (AFP) levels above the normal range with underlying inhibited hepatitis activity underwent liver resection. The false-positive rate was 2.2% (n = 18). Of the 18 patients, 7 patients (0.8%) were diagnosed with benign conditions (one each of hemangioma, inflammation, cortical adenoma, dysplastic nodule, angiomyolipoma, bile duct adenoma, and non-neoplastic liver parenchyme) and 11 patients (1.3%) were diagnosed with malignancies (cholangiocarcinoma [n = 6], hepatoblastoma [n = 2], and one each of lymphoepithelioma-like carcinoma, ovarian cystadenocarcinoma, and nasopharynx carcinoma metastasis). The clinical characteristics of pathologically diagnosed HCC patients were similar (P > 0.05) compared to non-HCC patients except for higher rate of history of alcoholism (P < 0.05) observed in non-HCC patients. Four of 18 non-HCC patients (22.2%) showed diagnostic discordance on the dynamic imaging study. Despite the recent progression in diagnostic imaging techniques, 2.2% of cases were false-positively diagnosed as HCC in a liver resection patient cohort; and the final diagnosis was benign disease in 0.8% of liver resection patients clinically diagnosed with HCC.
Adenoma
;
Adenoma, Bile Duct
;
Alcoholism
;
alpha-Fetoproteins
;
Angiomyolipoma
;
Carcinoma, Hepatocellular*
;
Cohort Studies
;
Cystadenocarcinoma
;
Diagnosis*
;
Diagnostic Imaging
;
Hemangioma
;
Hepatitis
;
Hepatoblastoma
;
Humans
;
Inflammation
;
Liver*
;
Nasopharynx
;
Prevalence
;
Reference Values
;
Retrospective Studies

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