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.The Korean Academy of Asthma Allergy and Clinical Immunology guidelines for sublingual immunotherapy
Gwanghui RYU ; Hye Mi JEE ; Hwa Young LEE ; Sung-Yoon KANG ; Kyunghoon KIM ; Ju Hee KIM ; Kyung Hee PARK ; So-Young PARK ; Myong Soon SUNG ; Youngsoo LEE ; Eun-Ae YANG ; Jin-Young MIN ; Eun Kyo HA ; Sang Min LEE ; Yong Won LEE ; Eun Hee CHUNG ; Sun Hee CHOI ; Young-Il KOH ; Seon Tae KIM ; Dong-Ho NAHM ; Jung Won PARK ; Jung Yeon SHIM ; Young Min AN ; Man Yong HAN ; Jeong-Hee CHOI ; Yoo Seob SHIN ; Doo Hee HAN ;
Allergy, Asthma & Respiratory Disease 2024;12(3):125-133
Allergen immunotherapy (AIT) has been used for over a century and has been demonstrated to be effective in treating patients with various allergic diseases. AIT allergens can be administered through various routes, including subcutaneous, sublingual, intralymphatic, oral, or epicutaneous routes. Sublingual immunotherapy (SLIT) has recently gained clinical interest, and it is considered an alternative treatment for allergic rhinitis (AR) and asthma. This review provides an overview of the current evidence-based studies that address the use of SLIT for treating AR, including (1) mechanisms of action, (2) appropriate patient selection for SLIT, (3) the current available SLIT products in Korea, and (4) updated information on its efficacy and safety. Finally, this guideline aims to provide the clinician with practical considerations for SLIT.
5.The Korean Academy of Asthma Allergy and Clinical Immunology guidelines for allergen immunotherapy
Hwa Young LEE ; Sung-Yoon KANG ; Kyunghoon KIM ; Ju Hee KIM ; Gwanghui RYU ; Jin-Young MIN ; Kyung Hee PARK ; So-Young PARK ; Myongsoon SUNG ; Youngsoo LEE ; Eun-Ae YANG ; Hye Mi JEE ; Eun Kyo HA ; Yoo Seob SHIN ; Sang Min LEE ; Eun Hee CHUNG ; Sun Hee CHOI ; Young-Il KOH ; Seon Tae KIM ; Dong-Ho NAHM ; Jung Won PARK ; Jung Yeon SHIM ; Young Min AN ; Doo Hee HAN ; Man Yong HAN ; Yong Won LEE ; Jeong-Hee CHOI ;
Allergy, Asthma & Respiratory Disease 2024;12(3):102-124
Allergen immunotherapy (AIT) is a causative treatment of allergic diseases in which allergen extracts are regularly administered in a gradually escalated doses, leading to immune tolerance and consequent alleviation of allergic diseases. The need for uniform practice guidelines in AIT is continuously growing as the number of potential candidates for AIT increases and new therapeutic approaches are tried. This updated version of the Korean Academy of Asthma Allergy and Clinical Immunology recommendations for AIT, published in 2010, proposes an expert opinion by specialists in allergy, pediatrics, and otorhinolaryngology. This guideline deals with the basic knowledge of AIT, including mechanisms, clinical efficacy, allergen standardization, important allergens in Korea, and special consideration in pediatrics. The article also covers the methodological aspects of AIT, including patient selection, allergen selection, schedule and doses, follow-up care, efficacy measurements, and management of adverse reactions. Although this guideline suggests the optimal dosing schedule, an individualized approach and modifications are recommended considering the situation for each patient and clinic.
6.Efficacy of the granisetron transdermal system for the control of nausea and vomiting induced by highly emetogenic chemotherapy: a multicenter, randomized, controlled trial
Der Sheng SUN ; Yoon Ho KO ; Jong Youl JIN ; In Sook WOO ; Suk Young PARK ; Yun Ae EOM ; Jin Hyoung KANG ; Hoon Kyo KIM
The Korean Journal of Internal Medicine 2023;38(3):406-416
Background/Aims:
We compared the efficacy of the granisetron transdermal system (GTS) with that of ondansetron for controlling chemotherapy-induced nausea and vomiting (CINV) in patients treated with highly emetogenic chemotherapy (HEC).
Methods:
We randomized a total of 389 patients to groups treated by GTS and ondansetron before HEC. The primary endpoint was the percentage of patients achieving complete response (CR; no retching/vomiting/rescue medication) of CINV from the time of chemotherapy initiation to 24 hours after the last administration of chemotherapy (prespecified non-inferiority margin of 15%). Quality of life (QoL) was also assessed using the Functional Living Index-Emesis (FLIE).
Results:
The per protocol analysis included 152 (47.80%) and 166 patients (52.20%) in the GTS and ondansetron groups, respectively. In the full analysis set, the most common diagnosis, regimen, and period of chemotherapy were lung cancer (149 patients, 40.27%), cisplatin-based regimen (297 patients, 80.27%), and 1 day chemotherapy (221 patients, 59.73%). The CR rates were 86.84% and 90.36% in the GTS and ondansetron groups, respectively; the treatment difference was −3.52% (95% confidence interval, −10.52 to 3.48) and met the primary endpoint, indicating that GTS was not inferior to ondansetron. Patient satisfaction, assessed on the FLIE, showed significantly higher scores in the GTS group compared to the ondansetron group (mean ± standard deviation, 1,547.38 ± 306.00 and 1,494.07 ± 312.05 mm, respectively; p = 0.0449).
Conclusions
GTS provided effective, safe, and well-tolerated control of CINV and improved the QoL in HEC.
7.Risk Factors and Patterns of Locoregional Recurrence after Radical Nephrectomy for Locally Advanced Renal Cell Carcinoma
Gyu Sang YOO ; Won PARK ; Hongryull PYO ; Byong Chang JEONG ; Hwang Gyun JEON ; Minyong KANG ; Seong Il SEO ; Seong Soo JEON ; Hyun Moo LEE ; Han Yong CHOI ; Byung Kwan PARK ; Chan Kyo KIM ; Sung Yoon PARK ; Ghee Young KWON
Cancer Research and Treatment 2022;54(1):218-225
Purpose:
We aimed to investigate the risk factors and patterns of locoregional recurrence (LRR) after radical nephrectomy (RN) in patients with locally advanced renal cell carcinoma (RCC).
Materials and Methods:
We retrospectively analyzed 245 patients who underwent RN for non-metastatic pT3-4 RCC from January 2006 to January 2016. We analyzed the risk factors associated with poor locoregional control using Cox regression. Anatomical mapping was performed on reference computed tomography scans showing intact kidneys.
Results:
The median follow-up duration was 56 months (range, 1 to 128 months). Tumor extension to renal vessels or the inferior vena cava (IVC) and Fuhrman’s nuclear grade IV were identified as independent risk factors of LRR. The 5-year actuarial LRR rates in groups with no risk factor, one risk factor, and two risk factors were 2.3%, 19.8%, and 30.8%, respectively (p < 0.001). The locations of LRR were distributed as follows: aortocaval area (n=2), paraaortic area (n=4), retrocaval area (n=5), and tumor bed (n=11). No LRR was observed above the celiac axis (CA) or under the inferior mesenteric artery (IMA).
Conclusion
Tumor extension to renal vessels or the IVC and Fuhrman’s nuclear grade IV were the independent risk factors associated with LRR after RN for pT3-4 RCC. The locations of LRR after RN for RCC were distributed in the tumor bed and regional lymphatic area from the bifurcation of the CA to that of the IMA.
8.A Real Situation Experimental Study on The Thermal Protection Performance of Firefighter Clothes and Gloves.
Won Jae LEE ; Gu Hyun KANG ; Yong Soo JANG ; Wonhee KIM ; Hyun Young CHOI ; Jae Guk KIM ; MinJi KIM ; Kyo SEO ; Do hee KIM ; Joo young LEE ; Jung Yoon CHOI
Journal of Korean Burn Society 2018;21(1):17-21
PURPOSE: This study aimed to evaluate the thermal protective function of firefighter clothes and gloves through real scale fire simulations. METHODS: Firstly, the fire simulation by real scale flame was performed for firefighter clothes. A manikin equipped with firefighter clothes was directly exposed to flames which energy average is 84 Kw/m2. for 22 seconds. Heat flux gauges attached on the body measured surface temperature elevation. Secondly, we also performed the other fire simulation by hot plate exposure to firefighter gloves. Firefighter gloves with heat flux gauges exposed hot plate which temperature is 300℃ in both dry and moist conditions. Primary outcome was surface temperature change of manikin body (first simulation) and hand (second simulation) over times. RESULTS: In the first flame simulation, the surface temperature of face and shoulders elevated more rapidly comparing with the other body surface area when initial period of flame shutter open. After 18sec of shutter open, the surface temperature of upper trunk elevated rapildy. After shutter closure, high surface temperature kept continuously on right side of face and left shoulder. In the second hot plate simulation, fingers and palms showed higher surface temperature than the other areas of hands in the both dry and wet conditions. CONCLUSION: This study suggests that the real scale flame enables firefighter clothes to lose their heat protective function suddenly after 18 seconds. Additionally, the protective function of firefighter gloves were relatively weaker in the palmar side of fingers than the other parts of hand. There should be additional study for evaluate thermal protection performance of firefighter clothes. And, further effort for reinforce palmar side of fingers of firefighter gloves should be done.
Body Surface Area
;
Clothing*
;
Fingers
;
Firefighters*
;
Fires
;
Hand
;
Hot Temperature
;
Humans
;
Manikins
;
Patient Simulation
;
Shoulder
9.Factors Affecting Endoscopic Curative Resection of Gastric Cancer in the Population-Based Screening Era.
Yoon Gwon MUN ; Myung Gyu CHOI ; Chul Hyun LIM ; Han Hee LEE ; Dong Hoon KANG ; Jae Myung PARK ; Kyo Young SONG
Clinical Endoscopy 2018;51(5):478-484
BACKGROUND/AIMS: Since population-based screening for gastric cancer in Korea was implemented, endoscopic treatment of early gastric cancer has become increasingly popular. This study investigates factors affecting endoscopic curative resection of early gastric cancer in population-based screening for gastric cancer. METHODS: We retrospectively reviewed data of patients with newly diagnosed gastric cancer who underwent treatment at Seoul St. Mary’s Hospital. All patients completed questionnaires about clinical information, including interval between surveillance tests for gastric cancer. RESULTS: Of 469 gastric cancer patients, 147 (31.3%) had undergone curative endoscopic resection, 260 (55.4%) had undergone curative surgical resection, and 62 (13.3%) underwent non-curative resection or were in an inoperable state. Patients with curative endoscopic resection had fewer alarm symptoms/signs than other groups. In multivariate analysis, regular surveillance endoscopy was the only factor predicting curative endoscopic resection (odds ratio [OR], 6.099; 95% confidence interval [CI], 2.532–14.933). In addition, patients undergoing gastric cancer screening had a significantly higher rate of endoscopic curative resection compared with subjects who had never been screened. (1-year interval: OR, 49.969; 95% CI, 6.340–393.827, 2-year interval: OR, 15.283; 95% CI, 1.833–127.406, over 2-year interval: OR, 10.651; 95% CI, 1.248–90.871). Shorter screening test intervals were associated with higher rates of endoscopic curative resection. CONCLUSIONS: Regular surveillance testing was the independent factor predicting curative endoscopic resection of gastric cancer.
Early Detection of Cancer
;
Endoscopy
;
Humans
;
Korea
;
Mass Screening*
;
Multivariate Analysis
;
Retrospective Studies
;
Seoul
;
Stomach Neoplasms*
10.Practice patterns in the management of threatened preterm labor in Korea: A multicenter retrospective study.
Han Sung HWANG ; Sung Hun NA ; Sung Eun HUR ; Soon Ae LEE ; Kyung A LEE ; Geum Joon CHO ; Kwan Young OH ; Chan Hee JIN ; Seung Mi LEE ; Jae Eun SHIN ; Kyo Hoon PARK ; Ji Young LIM ; Suk Joo CHOI ; Joon Ho LEE ; Sae Kyung CHOI ; Jae Yoon SHIM ; Yun Sung JO ; Gyu Yeon CHOI ; Young Han KIM ; Ki Cheol KIL ; Jong Woon KIM ; Dong Wook KWAK ; Yun Dan KANG ; Young Ju KIM
Obstetrics & Gynecology Science 2015;58(3):203-209
OBJECTIVE: This study aimed to examine clinical practice patterns in the management of pregnant women admitted with threatened preterm labor (TPL) in Korea. METHODS: Data from women admitted with a diagnosis of TPL were collected from 22 hospitals. TPL was defined as regular uterine contractions with or without other symptoms such as pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show and cervical changes. Data on general patient information, clinical characteristics at admission, use of tocolytics, antibiotics, and corticosteroids, and pregnancy outcomes were collected using an online data collections system. RESULTS: A total of 947 women with TPL were enrolled. First-line tocolysis was administered to 822 (86.8%) patients. As a first-line tocolysis, beta-agonists were used most frequently (510/822, 62.0%), followed by magnesium sulfate (183/822, 22.3%), calcium channel blockers (91/822, 11.1%), and atosiban (38/822, 4.6%). Of the 822 women with first-line tocolysis, second-line tocolysis were required in 364 (44.3%). Of 364 with second-line, 199 had third-line tocolysis (37.4%). Antibiotics were administered to 29.9% of patients (284/947) with single (215, 22.7%), dual (26, 2.7%), and triple combinations (43, 4.5%). Corticosteroids were administered to 420 (44.4%) patients. Betamethasone was administered to 298 patients (71.0%), and dexamethasone was administered to 122 patients (29.0%). CONCLUSION: Practice patterns in the management of TPL in Korea were quite various. It is needed to develop standardized practice guidelines for TPL management.
Adrenal Cortex Hormones
;
Anti-Bacterial Agents
;
Back Pain
;
Betamethasone
;
Calcium Channel Blockers
;
Dexamethasone
;
Diagnosis
;
Female
;
Humans
;
Korea
;
Magnesium Sulfate
;
Muscle Cramp
;
Obstetric Labor, Premature*
;
Physician's Practice Patterns
;
Pregnancy
;
Pregnancy Outcome
;
Pregnant Women
;
Premature Birth
;
Retrospective Studies*
;
Tocolysis
;
Tocolytic Agents
;
Uterine Contraction
;
Vaginal Discharge

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