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.Identification of Single Nucleotide Polymorphisms as Biomarkers for Recurrent Pregnancy Loss in Korean Women
Hye In KIM ; Eun A CHOI ; Eun Chan PAIK ; Soohyeon PARK ; Yu Im HWANG ; Jae Hoon LEE ; Seok Kyo SEO ; SiHyun CHO ; Young Sik CHOI ; Byung Seok LEE ; Jimyeong PARK ; Sanghoo LEE ; Kyoung-Ryul LEE ; Bo Hyon YUN
Journal of Korean Medical Science 2022;37(46):e336-
Background:
Single nucleotide polymorphisms (SNPs) are reportedly associated with repeated abortion. Thus, genetic analysis based on race is the key to developing accurate diagnostic tests. This study analyzed the genetic polymorphisms of recurrent pregnancy loss (RPL) patients among Korean women compared to the controls.
Methods:
In 53 women of RPL group and 50 controls, the genetic analysis was performed.The genotype distribution and allele frequency were analyzed statistically for the difference between the two groups. The association between each SNP marker and RPL risk was analyzed.
Results:
The genotypes of LEPR, endothelial nitric oxide synthase (eNOS), KDR, miR-27a, miR-449b, and tumor necrosis factor-alpha (TNF-α) were analyzed using odds ratio (OR) with 95% confidence intervals (CIs). Only the AG genotype of miR-449b (A>G) polymorphism showed significant association with the risk of RPL when compared to the AA genotype (OR, 2.39). The combination of GG/AG+GG/CA+AA genotypes for eNOS/ miR-449b/TNF-α was associated with 7.36-fold higher risk of RPL (OR, 7.36). The GG/ AG+GG combination for eNOS/miR-449b showed 2.43-fold higher risk for RPL (OR, 2.43). The combination of AG+GG/CA+AA genotypes for miR-449b/TNF-α showed a significant association with the risk of RPL (OR, 7.60). From the haplotype-based analysis, the G-G-A haplotype of eNOS/miR-449b/TNF-α and the G-A haplotype of miR-449b/TNF-α were associated with increased risk of RPL (OR, 19.31; OR, 22.08, respectively).
Conclusion
There is a significant association between the risk of RPL and miR-449b/TNF-αcombination, and therefore, genetic analysis for specific combined genotypes can be an important screening method for RPL in Korean women.
5.Use of Gemcitabine plus Carboplatin is Associated with Poor Outcomes in Urothelial Carcinoma Patients with Chronic Kidney Disease Stage 4-5
Hyung-Don KIM ; Hyeon-Su IM ; Jwa Hoon KIM ; Hyehyun JEONG ; Shin Kyo YOON ; Inkeun PARK ; Jae Lyun LEE
Cancer Research and Treatment 2021;53(4):1166-1173
Purpose:
This study aimed to investigate the clinical outcomes with gemcitabine-carboplatin (GCb), the standard treatment for patients with advanced urothelial carcinoma (UC) who are ineligible for cisplatin-based regimens, in advanced UC patients with a glomerular filtration rate (GFR) < 30 mL/min.
Materials and Methods:
A retrospective cohort study involving GCb-treated advanced UC patients with GFR < 60 mL/min (n=89) was performed. Clinical outcomes were compared between subgroups with GFR < 30 mL/min and GFR ≥ 30 mL/min but < 60 mL/min.
Results:
Most baseline characteristics were comparable between the two subgroups. Patients with GFR < 30 mL/min had a significantly lower objective response rate (12.5%) compared to those with higher GFR levels (56.7%) (p=0.004). The number of GCb cycles was significantly lower in patients with GFR < 30 mL/min (median 2 cycles) than in those with higher GFR levels (median 6 cycles) (p=0.002). Compared to those with GFR ≥ 30 mL/min but < 60 mL/min, patients with GFR < 30 mL/min showed significantly worse progression-free survival (PFS) and overall survival (OS) (p < 0.001 for both). Further stratification of patient subgroups according to their GFR (i.e., GFR ≥ 45 mL/min but < 60 mL/min vs. GFR ≥ 30 mL/min but < 45 mL/min vs. GFR < 30 mL/min) revealed significantly different PFS and OS (p < 0.001 for both).
Conclusion
The use of GCb is discouraged in advanced UC patients with GFR < 30 mL/min. Alternative therapeutic approaches with better efficacy are warranted for these patients.
6.Selecting coronavirus disease 2019 patients with negligible risk of progression: early experience from non-hospital isolation facility in Korea
Pyoeng Gyun CHOE ; Eun Kyo KANG ; Sun Young LEE ; Boram OH ; Dahae IM ; Hyo Yeon LEE ; Hyemin JUNG ; Chang Kyung KANG ; Min Sun KIM ; Wan Beom PARK ; Eun Hwa CHOI ; BeLong CHO ; Myoung-don OH ; Nam Joong KIM
The Korean Journal of Internal Medicine 2020;35(4):765-770
Background/Aims:
As the novel coronavirus (coronavirus disease 2019 [COVID-19]) outbreak progresses rapidly, staying home is recommended for suspected patients; however, the safety of this recommendation is uncertain. In Korea, non-hospital facilities called “living and treatment centers (LTCs)” have been established since 5 March 2020. The LTCs provided a unique opportunity to evaluate the safety of selection criteria for low-risk groups.
Methods:
Between 5 March and 9 April 2020, patients with COVID-19 who met the following criteria were admitted to the LTC; alert, age below 65 years old, no underlying disease or well-controlled underlying disease, body temperature below 38.0°C, whether taking antipyretics or not, and no dyspnea. Patients were closely observed by doctors or nurses’ interviews twice a day and transferred to hospitals when symptoms worsened.
Results:
A total of 113 patients were admitted to the LTC; 52.2% were female, with a median age of 25 years (interquartile range, 21.5 to 39.5). Of 113 patients, 54 (47.8%) were asymptomatic at diagnosis, and 15 (13.3%) had no symptoms until they were released from isolation. During the follow-up period, two (1.8%) patients were transferred to a hospital but did not progress to severe status during hospitalization.
Conclusions
The risk of progression was negligible in COVID-19 patients who met the admission criteria for LTC at the time of diagnosis. LTCs could be a safe alternative considering shortage of hospital beds.
7.Native T1 Mapping Demonstrating Apical Thrombi in Eosinophilic Myocarditis Associated with Churg-Strauss Syndrome.
Kyongmin Sarah BECK ; Soh Yong JEONG ; Kyo Young LEE ; Kiyuk CHANG ; Jung Im JUNG
Korean Circulation Journal 2016;46(6):882-885
Eosinophilic myocarditis is a disease characterized by eosinophilic infiltration of the myocardium, consisting of acute necrotic stage, thrombotic stage, and fibrotic stage. Although T1 mapping has been increasingly used in various cardiac pathologies, there has been no report of T1 mapping in eosinophilic myocarditis. We report a case of 75-year-old female with eosinophilic myocarditis, whose cardiac magnetic resonance imaging included native T1 mapping, in which apical thrombi were distinctly seen as areas with decreased T1 values, next to areas of inflammation seen as increased T1 value in subendocardium.
Aged
;
Churg-Strauss Syndrome*
;
Eosinophils*
;
Female
;
Humans
;
Inflammation
;
Magnetic Resonance Imaging
;
Myocarditis*
;
Myocardium
;
Necrosis
;
Pathology
;
Thrombosis
8.An Unusual Presentation of Pulmonary Mucosa-Associated Lymphoid Tissue Lymphoma as Diffuse Pulmonary Infiltrates with Spontaneous Regression.
Hye Seon KANG ; Hea Yon LEE ; Seung Joon KIM ; Seok Chan KIM ; Young Kyoon KIM ; Gyeong Sin PARK ; Kyo Young LEE ; Jung Im JUNG ; Ji Young KANG
Cancer Research and Treatment 2015;47(4):943-948
A 57-year-old woman presented with cough and dyspnea for 2 months. Computed tomography of the chest showed diffuse ground-glass opacities in both lungs. Histologic examination via thoracoscopic lung biopsy revealed atypical lymphoproliferative lesion. Her symptoms and radiologic findings of the chest improved just after lung biopsy without any treatment. Therefore, she was discharged and monitored at an outpatient clinic. Two months later, pulmonary mucosa-associated lymphoid tissue (MALT) lymphoma was confirmed by the detection of API2-MALT1 translocation in fluorescent in situ hybridization analysis. Although the lung lesions resolved spontaneously, she received chemotherapy due to bone marrow involvement in her staging workup. Pulmonary MALT lymphoma is rare. Nodular or consolidative patterns are the most frequent radiologic findings. Although the disease has an indolent growth, it rarely resolves without treatment. We report an unusual case of pulmonary MALT lymphoma with diffuse interstitial abnormalities on image and spontaneous regression on clinical course.
Ambulatory Care Facilities
;
Biopsy
;
Bone Marrow
;
Cough
;
Drug Therapy
;
Dyspnea
;
Female
;
Humans
;
In Situ Hybridization, Fluorescence
;
Lung
;
Lymphoid Tissue
;
Lymphoma
;
Lymphoma, B-Cell, Marginal Zone*
;
Middle Aged
;
Neoplasm Regression, Spontaneous
;
Thorax
9.Incidence of Retinal Lesions before and after Refractive Surgery and Preoperative Prophylactic Laser Treatment.
Min Kyo KIM ; Hoon LEE ; Hyung Keun LEE ; Kyoung Yul SEO ; Eung Kweon KIM ; Tae Im KIM
Journal of the Korean Ophthalmological Society 2015;56(11):1671-1676
PURPOSE: We investigated the incidence of retinal lesions before and after surgery and the percentage of preoperative prophylactic laser treatment in patients who underwent corneal refractive surgery or phakic intraocular lens implantation (pIOLi). METHODS: The medical records of patients who underwent refractive surgery from January 2005 to June 2013 were reviewed retrospectively. We investigated the incidence and type of retinal lesions identified during the preoperative examination. Additionally, the percentage of preoperative prophylactic laser treatment and the incidence of postoperative newly developed retinal lesions were analyzed. RESULTS: A total of 894 eyes of 466 subjects (laser in situ keratomileusis [LASIK] 225 eyes, 117 subjects; laser-assisted subepithelial keratectomy [LASEK] or photorefractive keratectomy [PRK] 450 eyes, 231 subjects; pIOLi 219 eyes, 121 subjects) were enrolled in the present study. Retinal lesions were found in 268 eyes (29.98%) and of those, 144 eyes (16.11%) received prophylactic laser treatment. Postoperative newly developed retinal lesions were detected in 8 cases (LASEK or PRK, 5 cases; pIOLi, 3 cases) during the follow-up period. There was a significant correlation between preoperative spherical equivalent and the presence of retinal lesions. CONCLUSIONS: The patient population of refractive surgery is largely myopic and thus particularly vulnerable to retinal lesions. Additionally, a considerable number of patients required preoperative prophylactic laser treatment. Therefore, both surgeons and patients should be aware of the risks of developing postoperative retinal lesions.
Follow-Up Studies
;
Humans
;
Incidence*
;
Keratectomy, Subepithelial, Laser-Assisted
;
Medical Records
;
Myopia
;
Phakic Intraocular Lenses
;
Photorefractive Keratectomy
;
Refractive Surgical Procedures*
;
Retinaldehyde*
;
Retrospective Studies
10.Solitary Fibrous Tumor of the Pleura Manifesting as an Air-Containing Cystic Mass: Radiologic and Histopathologic Correlation.
Ji Eun BAEK ; Myeong Im AHN ; Kyo Young LEE
Korean Journal of Radiology 2013;14(6):981-984
Solitary fibrous tumor (SFT) is a rare mesenchymal neoplasm that typically presents as a well-defined lobular soft tissue mass commonly arising from the pleura. We report an extremely rare case of an SFT containing air arising from the right major fissure in a 58-year-old woman. Chest CT showed an ovoid air-containing cystic mass with an internal, homogeneously enhancing solid nodule. To our knowledge, this is the first case in the literature. The histopathologic findings were correlated with the radiologic findings, and the mechanism of air retention within the tumor is discussed.
Cysts/*diagnosis
;
Diagnosis, Differential
;
Female
;
Follow-Up Studies
;
Humans
;
Middle Aged
;
Pleura/*pathology/radiography/radionuclide imaging
;
Positron-Emission Tomography/*methods
;
Solitary Fibrous Tumor, Pleural/*diagnosis/surgery
;
Thoracic Surgery, Video-Assisted
;
Tomography, X-Ray Computed/*methods

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