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.Performance of ChatGPT on Solving Orthopedic Board-Style Questions: A Comparative Analysis of ChatGPT 3.5 and ChatGPT 4
Sung Eun KIM ; Ji Han LEE ; Byung Sun CHOI ; Hyuk-Soo HAN ; Myung Chul LEE ; Du Hyun RO
Clinics in Orthopedic Surgery 2024;16(4):669-673
Background:
The application of artificial intelligence and large language models in the medical field requires an evaluation of their accuracy in providing medical information. This study aimed to assess the performance of Chat Generative Pre-trained Transformer (ChatGPT) models 3.5 and 4 in solving orthopedic board-style questions.
Methods:
A total of 160 text-only questions from the Orthopedic Surgery Department at Seoul National University Hospital, conforming to the format of the Korean Orthopedic Association board certification examinations, were input into the ChatGPT 3.5 and ChatGPT 4 programs. The questions were divided into 11 subcategories. The accuracy rates of the initial answers provided by Chat GPT 3.5 and ChatGPT 4 were analyzed. In addition, inconsistency rates of answers were evaluated by regenerating the responses.
Results:
ChatGPT 3.5 answered 37.5% of the questions correctly, while ChatGPT 4 showed an accuracy rate of 60.0% (p < 0.001). ChatGPT 4 demonstrated superior performance across most subcategories, except for the tumor-related questions. The rates of inconsistency in answers were 47.5% for ChatGPT 3.5 and 9.4% for ChatGPT 4.
Conclusions
ChatGPT 4 showed the ability to pass orthopedic board-style examinations, outperforming ChatGPT 3.5 in accuracy rate. However, inconsistencies in response generation and instances of incorrect answers with misleading explanations require caution when applying ChatGPT in clinical settings or for educational purposes.
5.Isolated Polyethylene Insert Exchange for Instability after Total Knee Arthroplasty: Comparable Survival Rates and Range of Motion and Improved Clinical Scores Regardless of Hyperextension
Byung Sun CHOI ; Du Hyun RO ; Myung Chul LEE ; Hyuk-Soo HAN
Clinics in Orthopedic Surgery 2024;16(4):550-558
Background:
Isolated polyethylene insert exchange (IPIE) has not been established as a treatment option for hyperextension instability after primary total knee arthroplasty (TKA). The purpose of the study was to evaluate the survival rate and clinical outcomes of IPIE for the treatment of instability with or without hyperextension after TKA.
Methods:
This study retrospectively reviewed 46 patients who underwent IPIE for symptomatic prosthetic knee instability by dividing them into 2 groups based on the presence of hyperextension (without for group I and with for group IH). Patient demographics, clinical scores, radiographic data, range of motion (ROM), and surgical information were collected. Clinical failure was defined as a subsequent surgery following IPIE for any reason. The survival rate of IPIE and differences in demographics, clinical scores, and ROM were compared.
Results:
There were 46 patients (91% were women) with an average age of 70.1 years and a mean follow-up of 44.8 months. The average time between primary TKA and IPIE surgery was 6.5 ± 4.2 years, and during IPIE, 2 out of the 8 cruciate-retaining inserts were converted to “deep-dish“ ultracongruent inserts while the insert thickness increased from 11.9 ± 1.8 mm to 17.1 ± 3.1 mm. After IPIE surgery, a significantly thicker tibial insert was used in the group with hyperextension (15.39 ± 2.4 mm for group I, 18.3 ± 2.9 mm for group IH; p < 0.001 by independent t-test), and no significant differences were observed in the ROM and clinical scores before and after IPIE between the 2 groups. The overall survival rate for IPIE was 83% at 5 years and 57% at 10 years, and there were no statistically significant differences between the groups using the Cox proportional hazards regression model.
Conclusions
IPIE demonstrated an overall survival rate of 83% at 5 years with no difference in the recurrence of instability regardless of hyperextension. This study highlighted the effectiveness of using thicker inserts to resolve instability without significant differences in the ROM or clinical scores between the groups, suggesting its potential as a decision-making reference for surgeons.
6.Fixed-Bearing and Higher Postoperative Knee Flexion Angle as Predictors of Satisfaction in Asian Patients Undergoing Posterior-Stabilized Total Knee Arthroplasty
Sung Eun KIM ; Byung Sun CHOI ; Du Hyun RO ; Myung Chul LEE ; Hyuk-Soo HAN
Clinics in Orthopedic Surgery 2024;16(5):733-740
Background:
Patient-reported satisfaction following total knee arthroplasty (TKA) can be affected by various factors. This study aimed to assess patient satisfaction rates and identify factors related to patients, surgery, and postoperative knee motion associated with satisfaction in posterior-stabilized TKA among Asian patients.
Methods:
A retrospective cross-sectional study was conducted in patients with primary osteoarthritis who underwent TKA and had a follow-up period of over 2 years. Patient satisfaction was measured using a 5-point Likert scale, and the patients were divided into satisfied and dissatisfied groups. The factors potentially affecting satisfaction were collected, including demographics, comorbidities, surgical options, and knee motion. Univariate and multivariate regression analyses were performed.
Results:
Of the 858 patients included, 784 (91.4%) were satisfied and 74 (8.6%) were dissatisfied. Fixed-bearing implants and higher postoperative knee flexion angles were associated with satisfaction (odds ratio [OR], 2.366; p = 0.001 and OR, 1.045; p < 0.001, respectively), whereas cerebrovascular disease was related to dissatisfaction (OR, 0.403; p = 0.005). The regression model demonstrated moderate predictability (R2 = 0.112).
Conclusions
Fixed-bearing implants and higher postoperative knee flexion angles were associated with patient satisfaction following TKA, whereas cerebrovascular disease was associated with dissatisfaction. The identification of these factors could help improve surgical outcomes and patient satisfaction following TKA.
7.Disease Awareness, Medical Use Behavior, Diagnosis and Treatment Status, Quality of Life and Comorbidities in Primary Cicatricial Alopecia Patients: A Multicenter Survey
Seo Won SONG ; Dong Geon LEE ; Hoon KANG ; Bark-Lynn LEW ; Jee Woong CHOI ; Ohsang KWON ; Yang Won LEE ; Beom Joon KIM ; Young LEE ; Jin PARK ; Moon-Bum KIM ; Do Young KIM ; Sang Seok KIM ; Byung Cheol PARK ; Sang Hoon LEE ; Gwang Seong CHOI ; Hyun-Tae SHIN ; Chang Hun HUH ; Yong Hyun JANG ; Soo Hong SEO ; Jiehyun JEON ; Hyun Sun PARK ; Chong Hyun WON ; Min Sung KIM ; Byung In RO ; Ji Hyun LEE ; Ji Hae LEE ; Dong Soo YU ; Yu Ri WOO ; Hyojin KIM ; Jung Eun KIM
Korean Journal of Dermatology 2024;62(4):206-217
Background:
Primary cicatricial alopecia (PCA) is a rare disease that causes irreversible destruction of hair follicles and affects the quality of life (QOL).
Objective:
We aimed to investigate the disease awareness, medical use behavior, QOL, and real-world diagnosis and treatment status of patients with PCA.
Methods:
A self-administered questionnaire was administered to patients with PCA and their dermatologists. Patients aged between 19 and 75 years who visited one of 27 dermatology departments between September 2021 and September 2022 were included.
Results:
In total, 274 patients were included. The male-to-female ratio was 1:1.47, with a mean age of 45.7 years. Patients with neutrophilic and mixed PCA were predominantly male and younger than those with lymphocytic PCA. Among patients with lymphocytic PCA, lichen planopilaris was the most common type, and among those with neutrophilic PCA, folliculitis decalvans was the most common type. Among the total patients, 28.8% were previously diagnosed with PCA, 47.0% were diagnosed with PCA at least 6 months after their first hospital visit, 20.0% received early treatment within 3 months of disease onset, and 54.4% received steady treatment. More than half of the patients had a moderate to severe impairment in QOL. Topical/intralesional steroid injections were the most common treatment. Systemic immunosuppressants were frequently prescribed to patients with lymphocytic PCA, and antibiotics were mostly prescribed to patients with neutrophilic PCA.
Conclusion
This study provides information on the disease awareness, medical use behavior, QOL, diagnosis, and treatment status of Korean patients with PCA. This can help dermatologists educate patients with PCA to understand the necessity for early diagnosis and steady treatment.
9.Does intradiscal steroid injection accelerate the histological degeneration of the human disc?
Jin Hwan KIM ; Sunhee CHANG ; Byung Ho KIM ; Gyu Heon LEE ; Sung Tan CHO
Osteoporosis and Sarcopenia 2024;10(3):108-113
Objectives:
Intradiscal steroid injection (ISI) use has been proven as a low-risk and rapid treatment for disc degeneration disease (DDD). However, the histological effects of steroids on human discs remain poorly understood. The purpose of this study is to investigate whether ISI induces histologic degeneration of the disc.
Methods:
In this study, a histological analysis was carried out on the nucleus pulposus obtained from 150 patients who underwent posterior lumbar interbody fusion. Among these individuals, 59 received ISI before the surgery, while 91 did not. After staining with hematoxylin and eosin, the histological classification was performed based on chondrocyte proliferation (C1, C2, and C3) and granular matrix change (M1 and M2). Logistic regression analysis was used to identify the main factors influencing chondrocyte proliferation and granular matrix change.Additionally, histological differences between the ISI group and the non-ISI group were analyzed.
Results:
Chondrocyte proliferation and granular matrix changes were not significantly different between the ISI and non-ISI groups. The logistic regression analysis indicated that age is the most significant risk factor for both chondrocyte proliferation (P = 0.02) and granular matrix changes (P < 0.01).
Conclusions
The most crucial factor in disc degeneration is age. ISI does not accelerate the histological degeneration of chondrocyte proliferation and granular matrix. Therefore, the ISI could be considered as a histologically safe alternative in patients with DDD.
10.mTOR Plays an Important Role in the Stemness of Human Fetal Cartilage Progenitor Cells (hFCPCs)
Him-Cha SHIN ; Jiyoung KIM ; So Ra PARK ; Byung Hyune CHOI
Tissue Engineering and Regenerative Medicine 2024;21(2):309-318
BACKGROUND:
Mammalian target of rapamycin (mTOR) is known to regulate self-renewal ability and potency of embryonic stem cells (ESCs) and adult stem cells in opposite manners. However, its effects vary even among adult stem cells and are not reported in fetal stem/progenitor cells. This study investigated the role of mTOR in the function of human fetal cartilage-derived progenitor cells (hFCPCs).
METHODS:
mTOR activity in hFCPCs was first examined via the level of phosphor-mTOR until passage 19, together with doubling time of cells and senescence-associated b-galactosidase (SA-bGal). Then, the effect of 100 nM rapamycin, the inhibitor of mTOR, was investigated on self-renewal ability, proliferation rate and osteogenic/adipogenic potential of hFCPCs in vitro. Expression of stemness genes (Oct-4, Sox2 and Nanog) and cell cycle regulators (CDK4 and Cyclin D1) was measured at mRNA or protein levels.
RESULTS:
mTOR activity was maintained constantly at high levels in hFCPCs until passage 19, while their proliferation rate was decreasing from 48 h at passage 13 to 70 h at passage 9 and senescent cells were observed at passage 18 (8.3 ± 1.2%) and 19 (15.6 ± 1.9%). Inhibition of mTOR in hFCPCs impaired their colony forming frequency (CFU-F) by 4 folds, while showing no change in their doubling time and expression of CDK4 and Cyclin D1. Upon mTOR inhibition, Oct4 expression decreased by 2 folds and 4 folds at the mRNA and protein levels, respectively, while that of Sox2 and Nanog did not change significantly. Finally, mTOR inhibition reduced osteogenic and adipogenic differentiation of hFCPCs in vitro.
CONCLUSION
This study has shown that mTOR plays an important role in the self-renewal ability of hFCPCS but not in their proliferation, The effect of mTOR appears to be associated with Oct-4 expression and important in the osteogenic and adipogenic differentiation ability of hFCPCs.

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