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.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.
5.Association between alcohol consumption and subclinical atrial fibrillation
Ga‑In YU ; Daehoon KIM ; Hee Tae YU ; Tae‑Hoon KIM ; Il‑Young OH ; Jong Sung PARK ; Hyung‑Seob PARK ; Junbeom PARK ; Young Soo LEE ; Ki‑Woon KANG ; Jaemin SHIM ; Jung‑Hoon SUNG ; Eue‑Keun CHOI ; Boyoung JOUNG ;
International Journal of Arrhythmia 2023;24(3):20-
Background:
It has become important to identify and manage risk factors for subclinical atrial fibrillation (AF) with an increase in its detection rate. Thus, this research aimed to investigate whether alcohol consumption contrib‑ utes to the development of subclinical AF.
Methods:
This prospective study enrolled 467 patients without AF from a multicenter pacemaker registry. The incidence of subclinical AF (episodes of atrial rate > 220 beats per minute without symptoms) was compared between alcohol-drinking and non-drinking groups.
Results:
During followup (median 18 months), the incidence and risk of long-duration atrial high-rate episodes (AHRE) ≥ 24 h were increased in the alcohol group compared to the non-alcohol group [5.47 vs. 2.10 per 100 personyears, adjusted hazard ratio (HR), 2.83; 95% confidence interval (CI), 1.14–7.04; P = 0.03]. After propensity score match‑ ing, the incidence and risk of long-duration AHRE were higher in the alcohol group (6.97 vs. 1.27 per 100 personyears, adjusted HR, 7.84; 95% CI, 1.21–50.93; P = 0.03). The mean burden of long-duration subclinical AF was higher in the alcohol group than in the non-alcohol group (0.18 vs. 1.61% during follow-up, P = 0.08).
Conclusion
Alcohol consumption was associated with an increased risk of subclinical AF. Long-duration AHRE inci‑ dence and AHRE burden were higher in alcohol drinkers than in non-drinkers.
6.Resting heart rate and cardiovascular outcomes in patients with non‑paroxysmal atrial fibrillation: CODE‑AF registry
Hanjin PARK ; Hee Tae YU ; Tae‑Hoon KIM ; Junbeom PARK ; Jin‑Kyu PARK ; Ki‑Woon KANG ; Jaemin SHIM ; Jin‑Bae KIM ; Jun KIM ; Eue‑Keun CHOI ; HyungWook PARK ; Young Soo LEE ; Boyoung JOUNG
International Journal of Arrhythmia 2023;24(3):15-
Background:
The prognostic significance of resting heart rate and its therapeutic target in atrial fibrillation (AF) is uncertain. We sought to investigate the relationship between resting heart rate and cardiovascular outcomes in patients with non-paroxysmal AF (non-PAF).
Methods:
In this propensity score-weighted, multi-center prospective cohort study, 3217 patients with non-PAF were analyzed. Patients were categorized according to the baseline resting heart rate and cardiovascular outcomes were accessed for a median follow-up of 30 months. The primary outcome was a composite of cardiovascular death, heart failure hospitalization, and myocardial infarction/critical limb ischemia.
Results:
Freedom from primary outcome was longest among patients with resting heart rate 80–99 beats per minute (bpm) whereas shortest among those with ≤ 59 bpm (weighted log rank, p = 0.008). Compared with heart rate ≥ 100 bpm, resting heart rate 80–99 and 60–79 bpm was associated with reduced risk of primary outcome (weighted hazard ratio [WHR] 0.52, 95% confidence interval [CI] 0.32–0.84, p = 0.008 and WHR 0.58, 95% CI 0.37–0.92, p = 0.021 for heart rate 80–99 and 60–79 bpm, respectively). Using weighted restricted cubic spline curves, there was a U-shaped association between the resting heart rate and primary outcome with reduced risk of primary outcome in heart rate range of 68–99 bpm. This association was maintained regardless of atrioventricular node (AVN) blocker use or persistent/permanent AF (p for interaction 0.767 for AVN blocker use and 0.720 for AF type).
Conclusion
Resting heart rate was associated with cardiovascular outcomes in patients with non-PAF and those with resting heart rate between 68 and 99 bpm had lower risk of adverse cardiovascular events regardless of AVN blocker use or persistent/permanent AF.
7.Association of transport time interval with neurologic outcome in out-of-hospital cardiac arrest patients without return of spontaneous circulation on scene and the interaction effect according to prehospital airway management
Yonghoon JANG ; Tae Han KIM ; Sun Young LEE ; Young Sun RO ; Ki Jeong HONG ; Kyoung Jun SONG ; Sang Do SHIN
Clinical and Experimental Emergency Medicine 2022;9(2):93-100
Objective:
This study analyzed the association of transport time interval (TTI) with survival rate and neurologic outcome in out-of-hospital cardiac arrest (OHCA) patients without return of spontaneous circulation (ROSC) and the interaction effect of TTI according to prehospital airway management.
Methods:
A retrospective observational study based on the nationwide OHCA database from January 2013 to December 2017 was designed. Emergency medical service (EMS)-treated OHCA patients aged ≥18 years were included. TTI was categorized into four groups of quartiles (≤4, 5–7, 8–11, ≥12 minutes). The primary outcome was favorable neurologic outcome at discharge. The secondary outcome was survival to discharge from the hospital. Multivariable logistic regression was used to analyze outcomes according to TTI. A different effect of TTI according to the administration of prehospital EMS advanced airway was evaluated.
Results:
In total, 83,470 patients were analyzed. Good neurologic recovery decreased as TTI increased (1.0% for TTI ≤4 minutes, 0.9% for TTI 5–7 minutes, 0.6% for TTI 8–11 minutes, and 0.5% for TTI ≥12 minutes; P for trend <0.05). The adjusted odds ratio of prolonged TTI (≥12 minutes) was 0.73 (95% confidence interval, 0.57–0.93; P<0.01) for good neurologic recovery. However, the negative effect of prolonged TTI on neurological outcome was insignificant when advanced airway or entotracheal intubation were performed by EMS providers (adjusted odds ratio, 1.17; 95% confidence interval, 0.42–3.29; P=0.76).
Conclusion
EMS TTI was negatively associated with the neurologic outcome of OHCA without ROSC on scene. When advanced airway was performed on scene, TTI was insignificantly associated with the outcome.
8.Association between the number of prehospital defibrillation attempts and neurologic outcomes in out-of-hospital cardiac arrest patients without on-scene return of spontaneous circulation
Seulki CHOI ; Tae Han KIM ; Ki Jeong HONG ; Joo JEONG ; Young Sun RO ; Kyoung Jun SONG ; Sang Do SHIN
Clinical and Experimental Emergency Medicine 2021;8(1):21-29
Objective:
Delivery of prehospital defibrillation for shockable rhythms by emergency medical service providers is crucial for successful resuscitation in out-of-hospital cardiac arrest (OHCA) patients. The optimal range of prehospital defibrillation attempts for refractory shockable rhythms is unknown. This study evaluated the association between the number of prehospital defibrillation attempts and neurologic outcomes in OHCA patients.
Methods:
A retrospective observational study was conducted using the nationwide OHCA registry. Adult OHCA patients who were treated by emergency medical service providers due to presumed cardiac origin with initial shockable rhythm were enrolled from 2013 to 2016. The final analysis was performed on patients without on-scene return of spontaneous circulation. The number of prehospital defibrillation attempts was categorized as follows: 2–3, 4–5, and ≥6 attempts. The primary outcome was a good neurologic recovery at hospital discharge. Multivariate logistic regression analysis was performed to evaluate the association between neurologic outcomes and the number of prehospital defibrillation attempts.
Results:
A total of 4,513 patients were included in the final analysis. The numbers of patients for whom 2–3, 4–5, and ≥6 defibrillation attempts were made were 2,720 (60.3%), 1,090 (24.2%), and 703 (15.5%), respectively. Poorer outcomes were associated with ≥6 defibrillation attempts: survival to hospital discharge (adjusted odds ratio, 0.38; 95% confidence interval, 0.21–0.65) and good neurologic recovery (adjusted odds ratio, 0.42; 95% confidence interval, 0.21–0.84).
Conclusion
Six or more prehospital defibrillation attempts were associated with poorer neurologic outcomes in OHCA patients with an initial shockable rhythm who were unresponsive to on-scene defibrillation and resuscitation.
9.Association between the number of prehospital defibrillation attempts and neurologic outcomes in out-of-hospital cardiac arrest patients without on-scene return of spontaneous circulation
Seulki CHOI ; Tae Han KIM ; Ki Jeong HONG ; Joo JEONG ; Young Sun RO ; Kyoung Jun SONG ; Sang Do SHIN
Clinical and Experimental Emergency Medicine 2021;8(1):21-29
Objective:
Delivery of prehospital defibrillation for shockable rhythms by emergency medical service providers is crucial for successful resuscitation in out-of-hospital cardiac arrest (OHCA) patients. The optimal range of prehospital defibrillation attempts for refractory shockable rhythms is unknown. This study evaluated the association between the number of prehospital defibrillation attempts and neurologic outcomes in OHCA patients.
Methods:
A retrospective observational study was conducted using the nationwide OHCA registry. Adult OHCA patients who were treated by emergency medical service providers due to presumed cardiac origin with initial shockable rhythm were enrolled from 2013 to 2016. The final analysis was performed on patients without on-scene return of spontaneous circulation. The number of prehospital defibrillation attempts was categorized as follows: 2–3, 4–5, and ≥6 attempts. The primary outcome was a good neurologic recovery at hospital discharge. Multivariate logistic regression analysis was performed to evaluate the association between neurologic outcomes and the number of prehospital defibrillation attempts.
Results:
A total of 4,513 patients were included in the final analysis. The numbers of patients for whom 2–3, 4–5, and ≥6 defibrillation attempts were made were 2,720 (60.3%), 1,090 (24.2%), and 703 (15.5%), respectively. Poorer outcomes were associated with ≥6 defibrillation attempts: survival to hospital discharge (adjusted odds ratio, 0.38; 95% confidence interval, 0.21–0.65) and good neurologic recovery (adjusted odds ratio, 0.42; 95% confidence interval, 0.21–0.84).
Conclusion
Six or more prehospital defibrillation attempts were associated with poorer neurologic outcomes in OHCA patients with an initial shockable rhythm who were unresponsive to on-scene defibrillation and resuscitation.
10.Management of isolated para-aortic lymph node recurrence after surgery for colorectal cancer
Young Il KIM ; In Ja PARK ; Jin Hong PARK ; Tae Won KIM ; Jun Soo RO ; Seok Byung LIM ; Chang Sik YU ; Jin Cheon KIM
Annals of Surgical Treatment and Research 2020;98(3):130-138
PURPOSE:
The rare incidence of isolated para-aortic lymph node (PALN) recurrence of colorectal cancer has precluded the formulation of treatment guidelines. This study evaluated and compared the effects of different treatment modalities on survival outcomes in patients with PALN recurrence.
METHODS:
Patients diagnosed with isolated PALN recurrence after curative resection for primary colorectal cancer from January 2004 to December 2014 were evaluated retrospectively. Patients with isolated recurrence were selected using imaging modalities. Overall survival (OS) and survival after recurrence (SAR) were analyzed and compared between different treatments using the Kaplan-Meier method.
RESULTS:
The median OS was 64 months with a median follow-up time of 50 months. Of the 46 patients with PALN recurrence, 35 (76.1%) had isolated recurrences. Of these 35 patients, 16 underwent PALN resection and 19 received chemotherapy. Median SAR was significantly longer in patients who did than did not undergo resection (71 months vs. 39 months, P = 0.017). Median OS tended to be longer in patients who did than did not undergo resection (77 months vs. 62 months, P = 0.055). SAR was similar in patients who received radiotherapy and those who underwent resection (34 months vs. 46 months, P = 0.146). Three of 16 patients (18.8%) who underwent resection were found to be recurrence-free.
CONCLUSION
Surgical resection of isolated PALN recurrence may benefit patients, with favorable survival outcomes and by providing definitive diagnosis for proper treatment planning.

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