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.Prospective Evaluation of Various Ultrasound Parameters for Assessing Renal Allograft Rejection Subtypes: Elasticity and Dispersion as Diagnostic Tools
Yeji KWON ; Jongjin YOON ; Dae Chul JUNG ; Young Taik OH ; Kyunghwa HAN ; Minsun JUNG ; Byung Chul KANG
Yonsei Medical Journal 2025;66(4):249-258
Purpose:
Renal allograft rejection, either acute or chronic, is prevalent among many recipients. This study aimed to identify multiple Doppler ultrasound parameters for predicting renal allograft rejection.
Materials and Methods:
Between November 2021 and April 2022, 61 renal allograft recipients were studied prospectively after excluding two patients with dual transplants and seven with hydronephrosis. The analysis excluded 11 cases (10 due to missing Doppler data or pathology reports and one due to a high interquartile range/median dispersion value), resulting in a final analysis of 50 patients. Clinical characteristics, color Doppler imaging, superb microvascular imaging, and shear-wave imaging parameters were assessed by three experienced genitourinary radiologists. The Banff classification of the biopsy tissue served as the reference standard. Univariable and multivariable logistic regression, contingency matrices, and multiple machine-learning models were employed to estimate the associations.
Results:
Fifty kidney transplant recipients (mean age, 53.26±8.86 years; 29 men) were evaluated. Elasticity (≤14.8 kPa) demonstrated significant associations for predicting the combination of (borderline) T cell-mediated rejection (TCMR) categories (Banff categories 3 and 4) (p=0.006) and yielded equal or higher area under the receiver operating characteristics curve (AUC) values compared to various classifiers. Dispersion (>15.0 m/s/kHz) was the only significant factor for predicting the combination of nonTCMR categories (Banff categories 2, 5, and 6) (p=0.026) and showed equal or higher AUC values than multiple machine learning classifiers.
Conclusion
Elasticity (≤14.8 kPa) showed a significant association with the combination of (borderline) TCMR categories, whereas dispersion (>15.0 m/s/kHz) was significantly associated with the combination of non-TCMR categories in renal allografts.
4.Prospective Evaluation of Various Ultrasound Parameters for Assessing Renal Allograft Rejection Subtypes: Elasticity and Dispersion as Diagnostic Tools
Yeji KWON ; Jongjin YOON ; Dae Chul JUNG ; Young Taik OH ; Kyunghwa HAN ; Minsun JUNG ; Byung Chul KANG
Yonsei Medical Journal 2025;66(4):249-258
Purpose:
Renal allograft rejection, either acute or chronic, is prevalent among many recipients. This study aimed to identify multiple Doppler ultrasound parameters for predicting renal allograft rejection.
Materials and Methods:
Between November 2021 and April 2022, 61 renal allograft recipients were studied prospectively after excluding two patients with dual transplants and seven with hydronephrosis. The analysis excluded 11 cases (10 due to missing Doppler data or pathology reports and one due to a high interquartile range/median dispersion value), resulting in a final analysis of 50 patients. Clinical characteristics, color Doppler imaging, superb microvascular imaging, and shear-wave imaging parameters were assessed by three experienced genitourinary radiologists. The Banff classification of the biopsy tissue served as the reference standard. Univariable and multivariable logistic regression, contingency matrices, and multiple machine-learning models were employed to estimate the associations.
Results:
Fifty kidney transplant recipients (mean age, 53.26±8.86 years; 29 men) were evaluated. Elasticity (≤14.8 kPa) demonstrated significant associations for predicting the combination of (borderline) T cell-mediated rejection (TCMR) categories (Banff categories 3 and 4) (p=0.006) and yielded equal or higher area under the receiver operating characteristics curve (AUC) values compared to various classifiers. Dispersion (>15.0 m/s/kHz) was the only significant factor for predicting the combination of nonTCMR categories (Banff categories 2, 5, and 6) (p=0.026) and showed equal or higher AUC values than multiple machine learning classifiers.
Conclusion
Elasticity (≤14.8 kPa) showed a significant association with the combination of (borderline) TCMR categories, whereas dispersion (>15.0 m/s/kHz) was significantly associated with the combination of non-TCMR categories in renal allografts.
5.Prospective Evaluation of Various Ultrasound Parameters for Assessing Renal Allograft Rejection Subtypes: Elasticity and Dispersion as Diagnostic Tools
Yeji KWON ; Jongjin YOON ; Dae Chul JUNG ; Young Taik OH ; Kyunghwa HAN ; Minsun JUNG ; Byung Chul KANG
Yonsei Medical Journal 2025;66(4):249-258
Purpose:
Renal allograft rejection, either acute or chronic, is prevalent among many recipients. This study aimed to identify multiple Doppler ultrasound parameters for predicting renal allograft rejection.
Materials and Methods:
Between November 2021 and April 2022, 61 renal allograft recipients were studied prospectively after excluding two patients with dual transplants and seven with hydronephrosis. The analysis excluded 11 cases (10 due to missing Doppler data or pathology reports and one due to a high interquartile range/median dispersion value), resulting in a final analysis of 50 patients. Clinical characteristics, color Doppler imaging, superb microvascular imaging, and shear-wave imaging parameters were assessed by three experienced genitourinary radiologists. The Banff classification of the biopsy tissue served as the reference standard. Univariable and multivariable logistic regression, contingency matrices, and multiple machine-learning models were employed to estimate the associations.
Results:
Fifty kidney transplant recipients (mean age, 53.26±8.86 years; 29 men) were evaluated. Elasticity (≤14.8 kPa) demonstrated significant associations for predicting the combination of (borderline) T cell-mediated rejection (TCMR) categories (Banff categories 3 and 4) (p=0.006) and yielded equal or higher area under the receiver operating characteristics curve (AUC) values compared to various classifiers. Dispersion (>15.0 m/s/kHz) was the only significant factor for predicting the combination of nonTCMR categories (Banff categories 2, 5, and 6) (p=0.026) and showed equal or higher AUC values than multiple machine learning classifiers.
Conclusion
Elasticity (≤14.8 kPa) showed a significant association with the combination of (borderline) TCMR categories, whereas dispersion (>15.0 m/s/kHz) was significantly associated with the combination of non-TCMR categories in renal allografts.
6.Prospective Evaluation of Various Ultrasound Parameters for Assessing Renal Allograft Rejection Subtypes: Elasticity and Dispersion as Diagnostic Tools
Yeji KWON ; Jongjin YOON ; Dae Chul JUNG ; Young Taik OH ; Kyunghwa HAN ; Minsun JUNG ; Byung Chul KANG
Yonsei Medical Journal 2025;66(4):249-258
Purpose:
Renal allograft rejection, either acute or chronic, is prevalent among many recipients. This study aimed to identify multiple Doppler ultrasound parameters for predicting renal allograft rejection.
Materials and Methods:
Between November 2021 and April 2022, 61 renal allograft recipients were studied prospectively after excluding two patients with dual transplants and seven with hydronephrosis. The analysis excluded 11 cases (10 due to missing Doppler data or pathology reports and one due to a high interquartile range/median dispersion value), resulting in a final analysis of 50 patients. Clinical characteristics, color Doppler imaging, superb microvascular imaging, and shear-wave imaging parameters were assessed by three experienced genitourinary radiologists. The Banff classification of the biopsy tissue served as the reference standard. Univariable and multivariable logistic regression, contingency matrices, and multiple machine-learning models were employed to estimate the associations.
Results:
Fifty kidney transplant recipients (mean age, 53.26±8.86 years; 29 men) were evaluated. Elasticity (≤14.8 kPa) demonstrated significant associations for predicting the combination of (borderline) T cell-mediated rejection (TCMR) categories (Banff categories 3 and 4) (p=0.006) and yielded equal or higher area under the receiver operating characteristics curve (AUC) values compared to various classifiers. Dispersion (>15.0 m/s/kHz) was the only significant factor for predicting the combination of nonTCMR categories (Banff categories 2, 5, and 6) (p=0.026) and showed equal or higher AUC values than multiple machine learning classifiers.
Conclusion
Elasticity (≤14.8 kPa) showed a significant association with the combination of (borderline) TCMR categories, whereas dispersion (>15.0 m/s/kHz) was significantly associated with the combination of non-TCMR categories in renal allografts.
7.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.
8.Prospective Evaluation of Various Ultrasound Parameters for Assessing Renal Allograft Rejection Subtypes: Elasticity and Dispersion as Diagnostic Tools
Yeji KWON ; Jongjin YOON ; Dae Chul JUNG ; Young Taik OH ; Kyunghwa HAN ; Minsun JUNG ; Byung Chul KANG
Yonsei Medical Journal 2025;66(4):249-258
Purpose:
Renal allograft rejection, either acute or chronic, is prevalent among many recipients. This study aimed to identify multiple Doppler ultrasound parameters for predicting renal allograft rejection.
Materials and Methods:
Between November 2021 and April 2022, 61 renal allograft recipients were studied prospectively after excluding two patients with dual transplants and seven with hydronephrosis. The analysis excluded 11 cases (10 due to missing Doppler data or pathology reports and one due to a high interquartile range/median dispersion value), resulting in a final analysis of 50 patients. Clinical characteristics, color Doppler imaging, superb microvascular imaging, and shear-wave imaging parameters were assessed by three experienced genitourinary radiologists. The Banff classification of the biopsy tissue served as the reference standard. Univariable and multivariable logistic regression, contingency matrices, and multiple machine-learning models were employed to estimate the associations.
Results:
Fifty kidney transplant recipients (mean age, 53.26±8.86 years; 29 men) were evaluated. Elasticity (≤14.8 kPa) demonstrated significant associations for predicting the combination of (borderline) T cell-mediated rejection (TCMR) categories (Banff categories 3 and 4) (p=0.006) and yielded equal or higher area under the receiver operating characteristics curve (AUC) values compared to various classifiers. Dispersion (>15.0 m/s/kHz) was the only significant factor for predicting the combination of nonTCMR categories (Banff categories 2, 5, and 6) (p=0.026) and showed equal or higher AUC values than multiple machine learning classifiers.
Conclusion
Elasticity (≤14.8 kPa) showed a significant association with the combination of (borderline) TCMR categories, whereas dispersion (>15.0 m/s/kHz) was significantly associated with the combination of non-TCMR categories in renal allografts.
9.Robotic surgery may lead to reduced postoperative inflammatory stress in colon cancer: a propensity score–matched analysis
Eun Ji PARK ; Gyong Tae NOH ; Yong Joon LEE ; Min Young PARK ; Seung Yoon YANG ; Yoon Dae HAN ; Min Soo CHO ; Hyuk HUR ; Kang Young LEE ; Byung Soh MIN
Annals of Coloproctology 2024;40(6):594-601
Purpose:
Robot-assisted surgery is readily applied to every type of colorectal surgeries. However, studies showing the safety and feasibility of robotic surgery (RS) have dealt with rectal cancer more than colon cancer. This study aimed to investigate how technical advantages of RS can translate into actual clinical outcomes that represent postoperative systemic response.
Methods:
This study retrospectively reviewed consecutive cases in a single tertiary medical center in Korea. Patients with primary colon cancer who underwent curative resection between 2006 and 2012 were included. Propensity score matching was done to adjust baseline patient characteristics (age, sex, body mass index, American Society of Anesthesiologists physical status, tumor profile, pathologic stage, operating surgeon, surgery extent) between open surgery (OS), laparoscopic surgery (LS), and RS groups.
Results:
After propensity score matching, there were 66 patients in each group for analysis, and there was no significant differences in baseline patient characteristics. Maximal postoperative leukocyte count was lowest in the RS group and highest in the OS group (P=0.021). Similar results were observed for postoperative neutrophil count (P=0.024). Postoperative prognostic nutritional index was highest in the RS group and lowest in the OS group (P<0.001). The time taken to first flatus and soft diet resumption was longest in the OS group and shortest in the RS group (P=0.001 and P<0.001, respectively). Among all groups, other short-term postoperative outcomes such as hospital stay and complications did not show significant difference, and oncological survival results were similar.
Conclusion
Better postoperative inflammatory indices in the RS group may correlate with their faster recovery of bowel motility and diet resumption compared to LS and OS groups.
10.Robotic surgery may lead to reduced postoperative inflammatory stress in colon cancer: a propensity score–matched analysis
Eun Ji PARK ; Gyong Tae NOH ; Yong Joon LEE ; Min Young PARK ; Seung Yoon YANG ; Yoon Dae HAN ; Min Soo CHO ; Hyuk HUR ; Kang Young LEE ; Byung Soh MIN
Annals of Coloproctology 2024;40(6):594-601
Purpose:
Robot-assisted surgery is readily applied to every type of colorectal surgeries. However, studies showing the safety and feasibility of robotic surgery (RS) have dealt with rectal cancer more than colon cancer. This study aimed to investigate how technical advantages of RS can translate into actual clinical outcomes that represent postoperative systemic response.
Methods:
This study retrospectively reviewed consecutive cases in a single tertiary medical center in Korea. Patients with primary colon cancer who underwent curative resection between 2006 and 2012 were included. Propensity score matching was done to adjust baseline patient characteristics (age, sex, body mass index, American Society of Anesthesiologists physical status, tumor profile, pathologic stage, operating surgeon, surgery extent) between open surgery (OS), laparoscopic surgery (LS), and RS groups.
Results:
After propensity score matching, there were 66 patients in each group for analysis, and there was no significant differences in baseline patient characteristics. Maximal postoperative leukocyte count was lowest in the RS group and highest in the OS group (P=0.021). Similar results were observed for postoperative neutrophil count (P=0.024). Postoperative prognostic nutritional index was highest in the RS group and lowest in the OS group (P<0.001). The time taken to first flatus and soft diet resumption was longest in the OS group and shortest in the RS group (P=0.001 and P<0.001, respectively). Among all groups, other short-term postoperative outcomes such as hospital stay and complications did not show significant difference, and oncological survival results were similar.
Conclusion
Better postoperative inflammatory indices in the RS group may correlate with their faster recovery of bowel motility and diet resumption compared to LS and OS groups.

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