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.Development and Validation of the Korean Version of Hand-Foot Skin Reaction and Quality of Life Questionnaire (HF-QoL-K).
Se Hyun NAM ; Hyun Jin CHOI ; Woo Dae KANG ; Seok Mo KIM ; Myong Cheol LIM ; Sang Yoon PARK ; Jung Sup KIM ; Byoung Gie KIM ; Duk Soo BAE ; Jeong won LEE ; Tae Joong KIM ; Taejong SONG
Journal of Korean Medical Science 2016;31(12):1969-1975
Given the growing number of cancer patients and the resulting increase in the administration of chemotherapeutic agents, convenient and effective methods for measuring the symptoms and quality of life associated with the hand-foot syndrome (HFS) are needed. Therefore, the aim of this study was to develop and validate the Korean version of the hand-foot skin reaction and quality of life questionnaire (HF-QoL-K), comprising a 20-item symptom domain and an 18-item daily activity domain. After we developed the HF-QoL-K, 209 Korean patients with gynecologic cancer who were undergoing chemotherapeutic agents relating the HFS were asked to fill in the questionnaire. The content validity, internal consistency reliability, and test-retest reliability were evaluated. The internal validity index, Cronbach’s alpha coefficient, and intra-class correlation coefficient of the HF-QoL-K were 0.90, 0.958, and 0.825 (95% confidence interval [CI], 0.774–0.865), respectively. The scatter plot (Pearson correlation coefficient, 0.826) and the Bland-Altman plot for test-retest reliability were also acceptable. The HF-QoL-K instrument is a valid and reliable questionnaire for the measurement of the symptoms and quality of life in Korean cancer patients suffering HFS.
Drug Therapy
;
Hand-Foot Syndrome
;
Humans
;
Quality of Life*
;
Reproducibility of Results
;
Skin*
5.Prognostic Value of Elevated Homocysteine Levels in Korean Patients with Coronary Artery Disease: A Propensity Score Matched Analysis.
Sung Woo KWON ; Jong Youn KIM ; Young Ju SUH ; Dae Hyung LEE ; Young Won YOON ; Byoung Kwon LEE ; Young Hak JUNG ; Eui Young CHOI ; Bum Kee HONG ; Se Joong RIM ; Hyuck Moon KWON
Korean Circulation Journal 2016;46(2):154-160
BACKGROUND AND OBJECTIVES: We sought to determine whether an elevated homocysteine (Hcy) level is associated with a worse prognosis in Korean patients with coronary artery disease (CAD). SUBJECTS AND METHODS: A total of 5839 patients (60.4% male, mean age 61.3±11.2 years) with CAD were enrolled from 2000 to 2010 at Gangnam Severance Hospital. CAD was diagnosed by invasive coronary angiography. Laboratory values including Hcy level were obtained on the day of coronary angiography and analyses were performed shortly after sampling. Patients were divided into two groups according to their Hcy levels. Baseline risk factors, coronary angiographic findings, length of follow-up, and composite endpoints including cardiac death (CD) and non-fatal myocardial infarction (NFMI) were recorded. 1:1 propensity score matched analysis was also performed. RESULTS: Over a mean follow-up period of 4.4±2.5 years, there were 132 composite endpoints (75 CD and 57 NFMI) with an event rate of 2.3%. Mean Hcy level was 9.9±4.3 µmol/L (normal Hcy 7.9±1.5 µmol/L and elevated Hcy 13.9±5.1 µmol/L). Kaplan-Meier survival analysis showed an association of elevated Hcy level with worse prognosis (p<0.0001). In addition, a multivariate Cox regression analysis showed an association of elevated Hcy level with worse prognosis for both the entire cohort (hazard ratio [HR] 2.077, 95% confidence interval [CI] 1.467-2.941, p<0.0001) and the propensity score matched cohort (HR 1.982, 95% CI 1.305-3.009, p=0.001). CONCLUSION: Elevated Hcy level is associated with worse outcomes in Korean patients with CAD.
Cohort Studies
;
Coronary Angiography
;
Coronary Artery Disease*
;
Coronary Vessels*
;
Death
;
Follow-Up Studies
;
Homocysteine*
;
Humans
;
Male
;
Myocardial Infarction
;
Prognosis
;
Propensity Score*
;
Risk Factors
6.Comparison of Cable Method and Miniaci Method Using Picture Archiving and Communication System in Preoperative Planning for Open Wedge High Tibial Osteotomy
Seong Dae YOON ; GuoFeng ZHANG ; Hee June KIM ; Byoung Joo LEE ; Hee Soo KYUNG
The Journal of Korean Knee Society 2016;28(4):283-288
PURPOSE: The purpose was to compare the accuracy of Miniaci method using picture archiving and communication system (PACS) with a cable method in high tibial osteotomy (HTO). MATERIALS AND METHODS: This study analyzed 47 patients (52 knees) with varus deformity and medial osteoarthritis. From 2007 to 2013, patients underwent HTO using either a cable method (20 knees) or Miniaci method based on a PACS image (32 knees). In the cable method, the 62.5% point of the mediolateral tibial plateau width was located using an electrocautery cord under fluoroscopy (cable group). The Miniaci method used preoperative radiographs to shift the weight bearing axis (PACS group). Full-length lower limb radiographs obtained preoperatively and at the sixth postoperative week were used to compare the percentage of crossing point of the weight bearing line on the tibial plateau with respect to the medial border. RESULTS: The weight bearing line on the tibial plateau was corrected from a preoperative 11.0±7.0% to a postoperative 47.2±7.4% in the cable group and from 12.7±4.9% to 59.5±5.3% in the PACS group. The mechanical femorotibial angle was corrected from varus 8.9±3.7° to valgus 0.3±4.0° in the cable group and from varus 9.0±3.3° to valgus 2.9±2.6° in the PACS group. CONCLUSIONS: In HTO, correction based on the Miniaci method using a PACS was more accurate than correction using the cable method.
Congenital Abnormalities
;
Electrocoagulation
;
Fluoroscopy
;
Humans
;
Knee
;
Lower Extremity
;
Methods
;
Osteoarthritis
;
Osteotomy
;
Planning Techniques
;
Weight-Bearing
7.Asian Society of Gynecologic Oncology International Workshop 2014.
Jeong Yeol PARK ; Hextan Yuen Sheung NGAN ; Won PARK ; Zeyi CAO ; Xiaohua WU ; Woong JU ; Hyun Hoon CHUNG ; Suk Joon CHANG ; Sang Yoon PARK ; Sang Young RYU ; Jae Hoon KIM ; Chi Heum CHO ; Keun Ho LEE ; Jeong Won LEE ; Suresh KUMARASAMY ; Jae Weon KIM ; Sarikapan WILAILAK ; Byoung Gie KIM ; Dae Yeon KIM ; Ikuo KONISHI ; Jae Kwan LEE ; Kung Liahng WANG ; Joo Hyun NAM
Journal of Gynecologic Oncology 2015;26(1):68-74
The Asian Society of Gynecologic Oncology International Workshop 2014 on gynecologic oncology was held in Asan Medical Center, Seoul, Korea on the 23rd to 24th August 2014. A total of 179 participants from 17 countries participated in the workshop, and the up-to-date findings on the management of gynecologic cancers were presented and discussed. This meeting focused on the new trends in the management of cervical cancer, fertility-sparing management of gynecologic cancers, surgical management of gynecologic cancers, and recent advances in translational research on gynecologic cancers.
Female
;
Fertility Preservation/methods
;
Genital Neoplasms, Female/*therapy
;
Humans
;
Ovarian Neoplasms/therapy
;
Translational Medical Research/methods
;
Uterine Cervical Neoplasms/therapy
8.Two-Stage Revision for Infected Total Knee Arthroplasty: Based on Autoclaving the Recycled Femoral Component and Intraoperative Molding Using Antibiotic-Impregnated Cement on the Tibial Side.
Byoung Joo LEE ; Hee Soo KYUNG ; Seong Dae YOON
Clinics in Orthopedic Surgery 2015;7(3):310-317
BACKGROUND: The purpose of this study was to determine the degree of infection control and postoperative function for new articulating metal-on-cement spacer. METHODS: A retrospective study of 19 patients (20 cases), who underwent a two-stage revision arthroplasty using mobile cement prosthesis, were followed for a minimum of 2 years. This series consisted of 16 women and 3 men, having an overall mean age of 71 years. During the first stage of revision, the femoral implant and all the adherent cement was removed, after which it was autoclaved before replacement. The tibial component was removed and a doughy state, antibiotic-impregnated cement was inserted on the tibial side. To achieve joint congruency, intraoperative molding was performed by flexing and extending the knee joint. Each patient was evaluated clinically and radiologically. The clinical assessments included range of motion, and the patients were scored as per the Hospital for Special Surgery (HSS) and Knee Society (KS) criteria. RESULTS: The mean range of knee joint motion was 70degrees prior to the first stage operation and 72degrees prior to the second stage revision arthroplasty; following revision arthroplasty, it was 113degrees at the final follow-up. The mean HSS score and KS knee and function scores were 86, 82, and 54, respectively, at the final follow-up. The success rate in terms of infection eradication was 95% (19/20 knees). No patient experienced soft tissue contracture requiring a quadriceps snip. CONCLUSIONS: This novel technique provides excellent radiological and clinical outcomes. It offers a high surface area of antibiotic-impregnated cement, a good range of motion between first and second stage revision surgery for the treatment of chronic infection after total knee arthroplasty, and is of a reasonable cost.
Aged
;
Anti-Bacterial Agents/*administration & dosage/*therapeutic use
;
Arthroplasty, Replacement, Knee/*adverse effects/*instrumentation/methods
;
Bone Cements/*therapeutic use
;
Female
;
Humans
;
Male
;
Middle Aged
;
Prosthesis-Related Infections/*surgery
;
Range of Motion, Articular/physiology
;
Reoperation/*instrumentation/methods
;
Retrospective Studies
;
Treatment Outcome
9.Biplanar Open Wedge High Tibial Osteotomy in the Medial Compartment Osteoarthritis of the Knee Joint: Comparison between the Aescula and TomoFix Plate.
Hee Soo KYUNG ; Byoung Joo LEE ; Joon Woo KIM ; Seong Dae YOON
Clinics in Orthopedic Surgery 2015;7(2):185-190
BACKGROUND: The purpose of this study was to compare the results of Aescula and TomoFix plates used for biplanar open wedge high tibial osteotomy in medial osteoarthritis of the knee joint with varus deformity. METHODS: A consecutive series of 50 cases of biplanar open wedge high tibial osteotomy were evaluated retrospectively. Group A contained 25 cases treated by using the Aescula plate, and group T contained 25 cases treated by using the TomoFix plate. Full weight-bearing was permitted at 6 weeks after surgery in group A and at 2 weeks in group T. Clinical evaluations were performed at the final follow-up by using postoperative knee scores and functional scores. Radiographic analysis included postoperative mechanical femur-tibia angle, change in posterior tibial slope angle, and complications related to implants. The mean follow-up periods were 30 months in group A and 26 months in group T. RESULTS: The knee and functional scores were improved at the final follow-up in both groups (p < 0.05), but no differences were observed between the two groups (p > 0.05). An acceptable correction angle was obtained in 52% of group A and in 84% of group T (p = 0.015). Change in posterior tibial slope angle was larger in group A than in group T (p < 0.001), showing better maintenance of posterior tibial slope in group T. In group A, there were 3 cases of screw loosening and 4 cases of delayed union. In addition, there were residual varus deformities in 7 cases (6 in group A and 1 in group T). CONCLUSIONS: This study shows that firm fixation using a TomoFix plate for open wedge high tibial osteotomy produces better radiologic results and a low complication rate than those of the Aescula spacer plate.
*Bone Plates
;
Equipment Design
;
Humans
;
Osteoarthritis, Knee/*surgery
;
Osteotomy/*methods
;
Retrospective Studies
;
Tibia/*surgery
10.Clinical Application of Exhaled Nitric Oxide Measurements in a Korean Population.
Woo Jung SONG ; Ji Won KWON ; Eun Jin KIM ; Sang Min LEE ; Sae Hoon KIM ; So Yeon LEE ; Sang Heon KIM ; Heung Woo PARK ; Yoon Seok CHANG ; Woo Kyung KIM ; Jung Yeon SHIM ; Ju Hee SEO ; Byoung Ju KIM ; Hyo Bin KIM ; Dae Jin SONG ; Gwang Cheon JANG ; An Soo JANG ; Jung Won PARK ; Ho Joo YOON ; Joo Shil LEE ; Sang Heon CHO ; Soo Jong HONG
Allergy, Asthma & Immunology Research 2015;7(1):3-13
Nitric oxide (NO) is a biologic mediator of various physiologic functions. Recent evidence suggests the clinical utility of fractional exhaled NO (FeNO) as a biomarker for assessing asthma and other respiratory diseases. FeNO methodologies have been recently standardized by international research groups and subsequently validated in several Korean population studies. Normal ranges for FeNO have been reported for various ethnic groups, and the clinical utility has been widely evaluated in asthma and various respiratory diseases. Based on current evidence including most of Korean population data, this position paper aims to introduce the methodological considerations, and provide the guidance for the proper clinical application of FeNO measurements in Korean populations.
Asthma
;
Ethnic Groups
;
Humans
;
Nitric Oxide*
;
Reference Values

Result Analysis
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