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.
5.TGFβ1-Induced Transglutaminase-2 Triggers Catabolic Response in Osteoarthritic Chondrocytes by Modulating MMP-13
Jae-Young PARK ; Hyun Cheol BAE ; Sung Hee PYO ; Myung Chul LEE ; Hyuk-Soo HAN
Tissue Engineering and Regenerative Medicine 2021;18(5):831-840
Background:
Transforming growth factor beta 1 (TGFβ1) plays an essential role in maintaining cartilage homeostasis. TGFβ1 is known to upregulate anabolic processes in articular cartilage, but the role of TGFβ1 in chondrocyte catabolism remains unclear. Thus, we examined whether TGFβ1 increases catabolic processes in the osteoarthritic joint via transglutaminase 2 (TG2). In this study, we investigated whether interplay between TGFβ1 and TG2 mediates chondrocyte catabolism and cartilage degeneration in osteoarthritis.
Methods:
To investigate the role of TGFβ1 and TG2 in osteoarthritis, we performed immunostaining to measure the levels of TGFβ1 and TG2 in 6 human non-osteoarthritic and 16 osteoarthritic joints. We conducted quantitative reverse transcription polymerase chain reaction and western blot analysis to investigate the relationship between TGFβ1 and TG2 in chondrocytes and determined whether TG2 regulates the expressions of matrix metalloproteinase (MMP)-13, type II, and type X collagen. We also examined the extent of cartilage degradation after performing anterior cruciate ligament transection (ACLT) and destabilization of the medial meniscus (DMM) surgery in TG2 knock-out mice.
Results:
We confirmed the overexpression of TGFβ1 and TG2 in human osteoarthritic cartilage compared with non-osteoarthritic cartilage. TGFβ1 treatment significantly increased the expression of TG2 via p38 and ERK activation. TGFβ1-induced TG2 also elevated the level of MMP-13 and type X collagen via NF-κB activation in chondrocytes. Cartilage damage after ACLT and DMM surgery was less severe in TG2 knock-out mice compared with wild-type mice.
Conclusion
TGFβ1 modulated catabolic processes in chondrocytes in a TG2-dependent manner. TGFβ1-induced TG2 might be the therapeutic target for treating cartilage degeneration and osteoarthritis.
6.TGFβ1-Induced Transglutaminase-2 Triggers Catabolic Response in Osteoarthritic Chondrocytes by Modulating MMP-13
Jae-Young PARK ; Hyun Cheol BAE ; Sung Hee PYO ; Myung Chul LEE ; Hyuk-Soo HAN
Tissue Engineering and Regenerative Medicine 2021;18(5):831-840
Background:
Transforming growth factor beta 1 (TGFβ1) plays an essential role in maintaining cartilage homeostasis. TGFβ1 is known to upregulate anabolic processes in articular cartilage, but the role of TGFβ1 in chondrocyte catabolism remains unclear. Thus, we examined whether TGFβ1 increases catabolic processes in the osteoarthritic joint via transglutaminase 2 (TG2). In this study, we investigated whether interplay between TGFβ1 and TG2 mediates chondrocyte catabolism and cartilage degeneration in osteoarthritis.
Methods:
To investigate the role of TGFβ1 and TG2 in osteoarthritis, we performed immunostaining to measure the levels of TGFβ1 and TG2 in 6 human non-osteoarthritic and 16 osteoarthritic joints. We conducted quantitative reverse transcription polymerase chain reaction and western blot analysis to investigate the relationship between TGFβ1 and TG2 in chondrocytes and determined whether TG2 regulates the expressions of matrix metalloproteinase (MMP)-13, type II, and type X collagen. We also examined the extent of cartilage degradation after performing anterior cruciate ligament transection (ACLT) and destabilization of the medial meniscus (DMM) surgery in TG2 knock-out mice.
Results:
We confirmed the overexpression of TGFβ1 and TG2 in human osteoarthritic cartilage compared with non-osteoarthritic cartilage. TGFβ1 treatment significantly increased the expression of TG2 via p38 and ERK activation. TGFβ1-induced TG2 also elevated the level of MMP-13 and type X collagen via NF-κB activation in chondrocytes. Cartilage damage after ACLT and DMM surgery was less severe in TG2 knock-out mice compared with wild-type mice.
Conclusion
TGFβ1 modulated catabolic processes in chondrocytes in a TG2-dependent manner. TGFβ1-induced TG2 might be the therapeutic target for treating cartilage degeneration and osteoarthritis.
7.Clinical and Radiological Changes after Microfracture of Knee Chondral Lesions in Middle-Aged Asian Patients
Jong Keun KIM ; Rupesh VAIDYA ; Su Keon LEE ; JeongSeok YU ; Jae Young PARK ; Du Hyun RO ; Myung Chul LEE ; Hyuk Soo HAN
Clinics in Orthopedic Surgery 2019;11(3):282-290
BACKGROUND: Although microfracture is widely accepted as an effective treatment option for knee chondral lesions, little is known about the deterioration of clinical outcomes and radiological progression in middle-aged patients. Therefore, this study was conducted to evaluate the clinical and radiological changes after microfracture of knee chondral lesions in middle-aged Asian patients. METHODS: A total of 71 patients were included in the study. They were between the ages of 40 and 60 years and underwent arthroscopic microfracture for localized full-thickness cartilage defects of the knee from January 2000 to September 2015. The recovery status of chondral lesions was assessed by using the magnetic resonance observation of cartilage repair tissue (MOCART) score in postoperative magnetic resonance imaging (MRI). Clinical and radiological results were reviewed, and survival rate with conversion to arthroplasty or osteotomy as an end point was evaluated. RESULTS: The mean age of the patients at surgery was 51.3 ± 4.7 years (range, 40 to 60 years), and the mean follow-up period was 7.2 ± 2.6 years (range, 1.0 to 17.4 years). The MOCART scores of 32 patients at mean postoperative 2.1 years showed three cases (9%) of full recovery, two cases (7%) of hyperplastic recovery, 23 cases (70%) with more than 50% filling, and four cases (14%) with less than 50% filling. Clinical scores improved significantly at 1 year after surgery (p < 0.05); however, the scores deteriorated over time after postoperative 1 year, and the mean values reached preoperative levels at postoperative 10 years. Significant radiological progression of arthritis (Kellgren-Lawrence grade) was observed at 5 years after surgery. Four patients underwent total knee arthroplasty during follow-up. CONCLUSIONS: Most patients showed more than 50% of defect filling at 2 years after surgery on MRI. Clinical results of microfracture of knee chondral lesion showed the best improvement at postoperative 1 year but gradually worsened thereafter until postoperative 10 years. Radiological progression of arthritis was observed from 5 years after surgery.
Arthritis
;
Arthroplasty
;
Arthroplasty, Replacement, Knee
;
Asian Continental Ancestry Group
;
Cartilage
;
Follow-Up Studies
;
Humans
;
Knee
;
Magnetic Resonance Imaging
;
Osteotomy
;
Survival Rate
;
Treatment Outcome
8.High incidence of subsequent re-operation following treatments for medial meniscus tears combined with anterior cruciate ligament reconstruction: second-look arthroscopic study
Sang Gyun KIM ; Soo Hyun KIM ; Jung Heum BAEK ; Jae Gyoon KIM ; Ki Mo JANG ; Hong Chul LIM ; Ji Hoon BAE
The Journal of Korean Knee Society 2019;31(4):e11-
BACKGROUND:
The Multicenter Orthopaedic Outcomes Network (MOON) group recently reported that medial meniscus (MM) repairs are associated with more frequent re-operations when compared to lateral meniscus (LM) repairs. The purpose of this study was to compare the meniscal healing and the incidence of subsequent re-operation of medial and lateral meniscal tears that occurred concurrently with anterior cruciate ligament (ACL) injuries.
METHODS:
We retrospectively reviewed patients who underwent second-look arthroscopy after primary ACL reconstruction (ACLR) between June 2005 to December 2016. The healing of meniscal tears following repair or left in situ, and re-tear following partial meniscectomy, were evaluated via second-look arthroscopy and compared between medial and lateral meniscus. Moreover, the incidence of subsequent meniscal re-operation after the index ACLR were investigated and compared between medial and lateral meniscus. Subsequent meniscal re-operation was performed in cases of the following three symptomatic meniscus tears: re-tears at the meniscectomy site; new tears; and failed healing of repaired or left in situ meniscus.
RESULTS:
There were 148 meniscal tears in 121 patients at index ACLR. There were 62 MM tears, 38 LM tears, and 24 bilateral meniscus tears. At second-look arthroscopy, the “successful healing†rate for tears following repair was higher in LM tears (91.2%) compared to MM tears (80.0%), although it was not statistically significant (p > 0.05). No significant differences were observed in the healing of left in situ tears or re-tear of meniscectomy site between medial and lateral meniscus. Patients with MM tears combined with ACL injuries had a higher incidence of subsequent meniscal re-operation compared to patients with LM tears (25.6% vs 16.1%, p = 0.025).
CONCLUSIONS
There was a trend for the successful healing rate to be higher in LM repairs than MM repairs. Subsequent meniscal re-operations after ACLR were more frequent in patients with medial meniscal tears concurrently with ACL injuries in comparison to patients with lateral meniscal tears.LEVEL OF STUDY: Level IV, retrospective case series.
9.Evaluation of mandibular cortical bone ratio on computed tomography images in patients taking bisphosphonates
Maxillofacial Plastic and Reconstructive Surgery 2018;40(1):17-
BACKGROUND: Bisphosphonate (BP) has the ability to thicken the cortical bone. In addition, it has been reported that the cortical bone thickened by BP has relation to the medication-related osteonecrosis of the jaw (MRONJ). Therefore, the objective of this article is to analyze the ratio as well as thickness of cortical bone in the mandible using computed tomography (CT) and to evaluate it as the predictive factor of MRONJ. METHODS: The thickness of the cortical bone was measured on a paraxial view of the CT showing the mental foramen in 95 patients: 33 patients with MRONJ (3 males, 30 females), 30 patients taking BP without MRONJ (2 males, 28 females), and 32 controls (9 males, 28 females). Also, the ratios of the cortical bone to the total bone were obtained using the measured values. Based on these results, we compared the difference of mandibular cortical bone ratio between the three groups. RESULTS: The average cortical bone thickness was measured as 3.81 mm in patients with MRONJ, 3.39 mm in patients taking BP without MRONJ, and 3.23 mm in controls. There was only a significant difference between patients with MRONJ and controls (P < 0.05). On the other hand, the average mandibular cortical bone ratio was measured as 37.9% in patients with MRONJ, 27.9% in patients taking BP without MRONJ, and 23.3% in controls. There was a significant difference between all groups (P < 0.05). CONCLUSION: The mandibular cortical bone ratio is large in order of patients with MRONJ, patients taking BP without MRONJ, and controls. This result suggests that the mandibular cortical bone ratio would be very useful to predict the development of MRONJ.
Diphosphonates
;
Hand
;
Humans
;
Jaw
;
Male
;
Mandible
;
Osteonecrosis
10.The work–life balance and psychosocial well-being of South Korean workers
Jae Won YANG ; Chunhui SUH ; Chae Kwan LEE ; Byung Chul SON
Annals of Occupational and Environmental Medicine 2018;30(1):38-
BACKGROUND: It is challenging to balance work and life, and little attention has been paid to the work–life balance and psychosocial well-being of South Koreans. We assessed the association between work–life balance and psychosocial well-being among paid Korean workers. METHODS: This study was based on data from the fourth Korean Working Conditions Survey. We evaluated only paid workers, which constituted 30,649 of the total of 50,007 subjects surveyed. Poor work–life balance was defined based on the goodness of fit between working hours and social commitments. Well-being was measured using the World Health Organization WHO-5 index. Poisson regression with robust variances was used to calculate the estimated prevalence ratios (PRs) with confidence intervals. RESULTS: Poor work–life balance was associated with poor psychosocial well-being (PR = 1.25; 95% CI 1.21 to 1.28) even after adjusting for work-related and individual characteristics. Poor well-being was associated with low-level job autonomy (PR = 1.06; 95% CI 1.03 to 1.09), working for ≥53 h per week (PR = 1.10; 95% CI 1.06 to 1.14), blue-collar status (PR = 1.16; 95% CI 1.11 to 1.21), low-level support at work (PR = 1.32; 95% CI 1.29 to 1.36), age ≥ 50 years (PR = 1.21; 95% CI 1.15 to 1.26), the female gender (95% CI PR = 1.04; 95% CI 1.01 to 1.07), and cohabitation (living with somebody) (PR = 1.08; 95% CI 1.04 to 1.12). Good well-being was associated with high-intensity work (PR = 0.96; 95% CI 0.94 to 0.99), being the secondary earner in a household (PR = 0.82; 95% CI 0.79 to 0.85), and higher income (PR = 0.75; 95% CI 0.71 to 0.79). CONCLUSION: Work–life balance was associated with psychosocial well-being after adjusting for both work-related and individual characteristics.
Family Characteristics
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Female
;
Humans
;
Prevalence
;
World Health Organization

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