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.Early efficacy and safety of statin therapy in Korean patients with hypercholesterolemia: Daegu and Gyeongbuk Statin Registry
Han Joon BAE ; Yun-Kyeong CHO ; Hyoung-Seob PARK ; Hyuck-Jun YOON ; Hyungseop KIM ; Seongwook HAN ; Seung-Ho HUR ; Yoon-Nyun KIM ; Kwon-Bae KIM ; Jae-Kean RYU ; Deug Young NAH ; Chang-Wook NAM
The Korean Journal of Internal Medicine 2020;35(2):342-350
Background/Aims:
To date, prospective data are limited on efficacy and safety profiles of statin therapy in Korean hypercholesterolemic patients. Hence, the aim of this study was to evaluate the practice patterns of statin therapy and its efficacy and safety through the prospective Daegu and Gyeongbuk statin registry.
Methods:
Statin naïve patients who were prescribed statins according to the criteria of Korean Guidelines for Management of Dyslipidemia were enrolled. Clinical and laboratory evaluations were performed at baseline and at week 8, where the efficacy was assessed with the same guidelines.
Results:
Of 908 patients, atorvastatin and rosuvastatin were most frequently prescribed statins (63.1% and 29.3%, respectively). High intensity statins (atorvastatin 40 mg or rosuvastatin 20 mg) were prescribed in 24.7% of all patients and in 79.5% of high and very high risk groups. The total and low density lipoprotein (LDL) cholesterol levels decreased from 203.7 ± 43.0 to 140.6 ± 28.6 mg/dL and 134.4 ± 35.7 to 79.5 ± 21.3 mg/dL, respectively. The achievement rate of the LDL target goal was 98.6% in low risk, 95.0% in moderate risk, 88.1% in high risk, and 42.1% in very high risk patients (59.7% in overall). There was no significant difference in the efficacy between atorvastatin and rosuvastatin. Adverse events were observed in 12.0% of patients and led to 1.4% of treatment cessation.
Conclusions
The efficacy of the usual starting dose of statins in daily practice was relatively insufficient for Korean hypercholesterolemic patients with high or very high risks. Short-term adverse events of statin therapy were not common in Korean patients with a low discontinuation rate.
5.The Implication of Cardiac Injury Score on In-hospital Mortality of Coronavirus Disease 2019
In-Cheol KIM ; Jin Eun SONG ; Hee Jung LEE ; Jeong-Ho PARK ; Miri HYUN ; Ji Yeon LEE ; Hyun Ah KIM ; Yong Shik KWON ; Jae Seok PARK ; Jong-Chan YOUN ; Jongmin HWANG ; Cheol Hyun LEE ; Yun-Kyeong CHO ; Hyoung-Seob PARK ; Hyuck-Jun YOON ; Chang-Wook NAM ; Seongwook HAN ; Seung-Ho HUR ; Howard J. EISEN ; Hyungseop KIM
Journal of Korean Medical Science 2020;35(39):e349-
Background:
s: The severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has spread worldwide. Cardiac injury after SARS-CoV-2 infection is a major concern. The present study investigated impact of the biomarkers indicating cardiac injury in coronavirus disease 2019 (COVID-19) on patients' outcomes.
Methods:
This study enrolled patients who were confirmed to have COVID-19 and admitted at a tertiary university referral hospital between February 19, 2020 and March 15, 2020. Cardiac injury was defined as an abnormality in one of the following result markers: 1) myocardial damage marker (creatine kinase-MB or troponin-I), 2) heart failure marker (N-terminal-pro B-type natriuretic peptide), and 3) electrical abnormality marker (electrocardiography). The relationship between each cardiac injury marker and mortality was evaluated. Survival analysis of mortality according to the scoring by numbers of cardiac injury markers was also performed.
Results:
A total of 38 patients with COVID-19 were enrolled. Twenty-two patients (57.9%) had at least one of cardiac injury markers. The patients with cardiac injuries were older (69.6 ± 14.9 vs. 58.6 ± 13.9 years old, P = 0.026), and were more male (59.1% vs. 18.8%, P = 0.013).They showed lower initial oxygen saturation (92.8 vs. 97.1%, P = 0.002) and a trend toward higher mortality (27.3 vs. 6.3%, P = 0.099). The increased number of cardiac injury markers was significantly related to a higher incidence of in-hospital mortality which was also evidenced by Kaplan-Meier survival analysis (P = 0.008).
Conclusion
The increased number of cardiac injury markers is related to in-hospital mortality in patients with COVID-19.
6.Accuracy of implantable loop recorders for detecting atrial tachyarrhythmias after atrial fibrillation catheter ablation
Hyun Jun CHO ; Cheol Hyun LEE ; Jongmin HWANG ; Hyoung‑Seob PARK ; Sang‑Woong CHOI ; In‑Cheol KIM ; Yun‑Kyeong CHO ; Hyuck‑Jun YOON ; Hyungseop KIM ; Chang‑Wook NAM ; Seung‑Ho HUR ; Byung Chun JUNG ; Yoon Nyun KIM ; Seongwook HAN
International Journal of Arrhythmia 2020;21(2):e6-
Background:
Implantable loop recorders (ILRs) can provide an enhanced possibility to detect atrial fibrillation (AF), but the accuracy, especially the positive predictive value (PPV), is controversial. This study aimed to evaluate the accuracy of ILRs for detecting AF through a comparison with Holter.
Method and results:
Thirteen patients who underwent AF ablation were enrolled. ILRs were implanted in all patients, who were scheduled to have Holter monitorings after the procedure. The incidence of AF was compared between the two modalities and analyzed for any correlations. A total of 51 Holters (67,985.5 min) and concomitant ILRs were available for the comparison. The judgment of the presence of AF did not perfectly correlate between the ILR and Holter (Kappa = 0.866, P < 0.001). In the ILR data, the sensitivity of detecting AF on the Holter was 81.6% (95% confidence interval [CI] 0.812–0.820; P < 0.001). The specificity was 99.9% (95% CI 0.998–0.999; P < 0.001). When the ILR detected AF, the PPV was 99.5% (95% CI 0.994–0.995), but the ILR did not detect AF, and the negative predictive value was 94.2% (95% CI 0.941–0.944). A separate analysis of AF/atrial tachycardia (AT) showed that the AT detection rate of the ILR was 2.3%.
Conclusion
The ILR had a low false positive value and high PPV for AF events. However, it was limited in identifying AT.
7.Effect of carvedilol on premature ventricular complexes originating from the ventricular outflow tract
Jongmin HWANG ; Kyoungmin LEE ; Seongwook HAN ; Han‑Joon BAE ; Sang Woong CHOI ; Cheol Hyun LEE ; In‑Cheol KIM ; Yun‑Kyeong CHO ; Hyoung‑Seob PARK ; Hyuck‑Jun YOON ; Hyungseop KIM ; Chang‑Wook NAM ; Seung‑Ho HUR
International Journal of Arrhythmia 2020;21(2):e7-
Background:
Carvedilol is one of the most effective beta-blockers in reducing ventricular tachyarrhythmias and mortality in patients with heart failure. One of the possible antiarrhythmic mechanisms of carvedilol is the suppression of store overload-induced Ca2+ release, especially for the triggered activity.
Objectives:
Premature ventricular complex (PVC) originating from the ventricular outflow tract (OT) is the most common form of idiopathic PVC, and its main mechanism is related to triggered activity. We evaluate the efficacy of carvedilol to suppress the OT PVC.
Methods:
The electronic medical records at our hospital were screened to identify OT PVC patients treated with carvedilol. Clinical, electrocardiographic, and Holter monitoring studies were reviewed.
Results:
A total of 25 patients who underwent Holter monitoring before and after carvedilol administration were found and enrolled. The mean age of the patients was 54.9 ± 13.9 years, and the mean dose of carvedilol was 18.2 ± 10.2 mg (sustained release formulation, 8/16/32 mg). The 24-h burden of PVC in 18 (72%) of 25 patients was significantly reduced from 12.2 ± 9.7% to 4.4 ± 6.7% (P = 0.006). In seven patients, the burden of PVC was changed from 7.1 ± 6.1% to 9.8 ± 8.4% (P = 0.061). There was no difference in age, carvedilol dose, duration of treatment, ventricular function, and left atrial size between responding and non-responding groups.
Conclusion
In this retrospective pilot study, treatment with carvedilol showed PVC suppression in 72% of patients. Now, we are conducting a prospective, randomized, multicenter study to evaluate the effect of carvedilol on OT PVC (Clinical trial registration: FOREVER trial, Clinical-Trials.gov: NCT03587558).
8.Optical Coherence Tomography: Defined Plaque Erosion after Removal of a Coronary Guidewire
Sang Woong CHOI ; Seung Ho HUR ; Cheol Hyun LEE ; Yun Kyeong CHO ; Hyuck Jun YOON ; Chang Wook NAM ; Kwon Bae KIM
Korean Circulation Journal 2019;49(9):879-881
No abstract available.
Tomography, Optical Coherence
10.Trends and Cut-Point Changes in Obesity Parameters by Age Groups Considering Metabolic Syndrome
Hyung Jun PARK ; Young Ho HONG ; Yun Jung CHO ; Ji Eun LEE ; Jae Moon YUN ; Hyuktae KWON ; Sang Hyuck KIM
Journal of Korean Medical Science 2018;33(7):e47-
BACKGROUND: Non-communicable diseases (NCDs) are an important issue worldwide. Obesity has a close relationship with NCDs. Various age-related changes should be considered when evaluating obesity. METHODS: National representative cohort data from the National Health Insurance Service National Sample Cohort from 2012 to 2013 were used. Sex-specific and age group-specific (10-year intervals) means for body mass index (BMI), waist circumference (WC), and waist-to-height ratio (WtHR) were calculated. Optimal cut-points for obesity parameters were defined as the value predicting two or more components of metabolic syndrome (except WC). RESULTS: The mean value and optimal cut-point for BMI decreased with age for men. The mean BMI value for women increased with age, but optimal cut-points showed no remarkable difference. The mean WC of men increased with age, but the optimal cut-points were similar for age groups. For women, the mean value and optimal cut-point for WC increased with age. Regarding WtHR, the mean value and optimal cut-point increased with age for men and women. Differences across age groups were larger for women. CONCLUSION: The mean values of the obesity indices and the optimal cut-points were changed according to age groups. This study supports the necessity of applying age group-specific cut-points for the various obesity parameters.
Body Mass Index
;
Cohort Studies
;
Female
;
Humans
;
Male
;
National Health Programs
;
Obesity
;
Waist Circumference

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