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.Cardiac Manifestations of Coronavirus Disease 2019 (COVID-19): a Multicenter Cohort Study
Minkwan KIM ; Jong-Ho NAM ; Jang-Won SON ; Sun Oh KIM ; Nak-Hoon SON ; Chul-Min AHN ; Chi Young SHIM ; Geu-Ru HONG ; In-Cheol KIM ; Jinwoo CHOI ; Seung-Mo KANG ; Yeoung Ho CHOI ; Hae Kyoung YOON ; Jae-Sun UHM ; In Hyun JUNG
Journal of Korean Medical Science 2020;35(40):e366-
Background:
This study aimed to investigate the cardiac manifestations of coronavirus disease 2019 (COVID-19).
Methods:
From February to March 2020, we prospectively and retrospectively enrolled consecutive patients diagnosed with COVID-19. Patient's data such as the demographic characteristics, symptoms, vital signs, laboratory and radiologic findings, electrocardiographic, and echocardiographic data, including the global longitudinal strain (GLS) of both ventricles, were obtained.
Results:
Forty patients (median age, 58 years; 50% men) were enrolled in the initial analysis. Patients were classified into severe and nonsevere groups based on the current guidelines. The 13 patients in the severe group were significantly older, had a greater prevalence of bilateral pneumonia and leukocytosis, and higher aspartate transaminase levels than patients in the nonsevere group. Patients in the severe group had a slightly lower left ventricular ejection fraction (LVEF) than those in the nonsevere group (median [interquartile range], 61.0% [58.5%, 62.3%] vs. 66.7% [60.6%, 69.8%], P = 0.015). In a subgroup of 34 patients in whom GLS could be analyzed, patients in the severe group had a significantly impaired left ventricular GLS (LVGLS) than those in the nonsevere group (−18.1% [−18.8%, −17.1%] vs. −21.7% [−22.9%, −19.9%], P = 0.001). There were no significant differences in total wall (RVGLS total , −19.3% [−23.9%, −18.4%] vs. −24.3% [−26.0%, −22.6%], P = 0.060) and free wall (RVGLS fw , −22.7% [−27.2%, −18.6%] vs. −28.8% [−30.4%, −24.1%], P = 0.066) right ventricle GLS (RVGLS).
Conclusion
Patients with severe COVID-19 had lower LVEF and LVGLS. RVGLS was not different between patients with severe and nonsevere COVID-19.
5.Keratoconjunctival Chemical Burn due to Chemical Light.
Jung Hyun PARK ; Nang Hee SONG ; Nam Chul CHI ; Jae Woong KOH
Journal of the Korean Ophthalmological Society 2010;51(9):1282-1286
PURPOSE: Chemical lights, also called Luminous Sticks, consist of a solution of diphenyl oxalate (C14H10O4) and hydrogen peroxide (H2O2). Human tissue can be damaged when the mixed solution contacts the human body. The authors report a single case of chemical injury of keratoconjunctiva by exposure to chemical lights. CASE SUMMARY: A 47-year-old man's right eye accidentally contacted the fluorescent material when breaking a Luminous Stick 7 days before being referred to our clinic. He had pain in the right eye and experienced visual loss. The patient's best corrected visual acuity in the right eye was 20/50. An ulcerative lesion with edema at the inferior bulbar and palpebral conjunctiva and coneal epithelial defect was observed upon biomicroscopic examination. The patient was hospitalized and antibiotics, steroids, mydriatic and artificial tear eye drops were applied for treatment. After 9 days of treatment, the best corrected visual acuity of the patient recovered to 20/20, and the conjunctiva and cornea were mostly healed. No complication was observed. CONCLUSIONS: Chemical lights are commonly used in concerts and festivals. If the contents contact the eyes when breaking he chemical lights, various chemical burns can occur and cause ophthalmologic complications. Since no regulations have been passed regarding chemical lights, safety education and supervision are considered to be necessary for children.
Anti-Bacterial Agents
;
Biphenyl Compounds
;
Burns, Chemical
;
Child
;
Conjunctiva
;
Cornea
;
Edema
;
Eye
;
Holidays
;
Human Body
;
Humans
;
Hydrogen Peroxide
;
Light
;
Middle Aged
;
Ophthalmic Solutions
;
Organization and Administration
;
Social Control, Formal
;
Steroids
;
Tears
;
Ulcer
;
Visual Acuity
6.Recommendation guideline of Korean Society of Gynecologic Oncology and Colposcopy for quadrivalent human papillomavirus vaccine.
Byoung Gie KIM ; Nak Woo LEE ; Seung Cheol KIM ; Young Tae KIM ; Yong Man KIM ; Chan Joo KIM ; Sang Yoon PARK ; Yong Sang SONG ; Jae Kwan LEE ; Won Chul LEE ; Nam Hoon CHO ; Chi Hum CHO ; Soo Young HUR ; Jong Sup PARK ; Kyu Wan LEE
Korean Journal of Gynecologic Oncology 2007;18(4):259-283
Genital HPV infection is the most common sexually transmitted infection, but the majority of infections are self-limited. However, persistent infection with high-risk types can cause cervical cancer in women, which is the most common female genital cancer in Korea. In addition, HPV infection is the cause of genital warts and is associated with other anogenital cancers. The HPV vaccine is composed of the HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein in yeast using recombinant DNA technology produces noninfectious virus-like particles (VLP) that resemble HPV virions. The quadrivalent HPV vaccine is a mixture of four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18 combined with an aluminum adjuvant. Clinical trials indicate that the vaccine has high efficacy in preventing persistent HPV infection, cervical cancer precursor lesions, vaginal and vulvar cancer precursor lesions, and genital warts caused by HPV types 6, 11, 16, or 18 among females who have not already been infected with the respective HPV type. The recommended age for primary vaccination of Korean females is 15-17 years, considering sexual debut and duration of protection of the vaccine. Vaccine can be administered as young as age 9 years. Catch-up vaccination is recommended for females aged 18-26 years who have not been previously vaccinated. Vaccination is not a substitute for routine cervical cancer screening, and vaccinated females should have cervical cancer screening as recommended.
Aluminum
;
Capsid Proteins
;
Colposcopy*
;
Condylomata Acuminata
;
DNA, Recombinant
;
Female
;
Human papillomavirus 6
;
Humans*
;
Korea
;
Mass Screening
;
Uterine Cervical Neoplasms
;
Vaccination
;
Virion
;
Vulvar Neoplasms
;
Yeasts
7.Follicular Variant of Papillary Thyroid Carcinoma: Clinical Features and Surgical Strategy.
Seung Chul LEE ; Jong Ho YOON ; Ji Sup YUN ; Kee Hyun NAM ; Chi Young LIM ; Woong Youn CHUNG ; Cheong Soo PARK
Journal of the Korean Surgical Society 2007;73(5):366-371
PURPOSE: The follicular variant of papillary thyroid carcinoma (FVPTC) is difficult to diagnose and there is continuous debate regarding the optimal extent of surgery. METHODS: One hundred sixty three patients (17 male, 146 female; mean age 43.3 years), who underwent a thyroidectomy with a final diagnosis of FVPTC were divided into the total thyroidectomy group (Group I, n=74) and the less- than total thyroidectomy group (Group II, n=89). The two groups were compared with respect to the various clinicopathological characteristics. The mean follow up duration was 64.9 months (13~247 months). RESULTS: Group I showed a significantly higher sensitivity than Group II for the diagnosis. The age of the patients in Group I was significantly older than those in Group II. The frequency of multifocality, capsular invasion, and the incidence of a cervical lymph node metastasis were significantly higher in Group I. Therefore, Group I had a higher proportion of stage III and IV. The percentage of high risk patients according to the AMES (Age, distant Metastasis, Extent of primary tumor, and tumor Size) category and MACIS (distant Metastasis, Age, Completeness of primary surgical resection, extrathyroidal Invasion, and tumor Size) score was significantly higher in Group I. However, there was a similar rate of locoregional recurrence, distant metastasis, and survival in the two groups. CONCLUSION: When a diagnosis of FVPTC is made preoperatively or intraoperatively, definitive thyroid cancer surgery can be applied using the corresponding extent of surgery for an ordinary papillary thyroid carcinoma. However, if no definitive diagnosis is made, then a less-than total thyroidectomy is recommended as the initial surgery, and a complete thyroidectomy is reserved only for high-risk patients.
Diagnosis
;
Female
;
Follow-Up Studies
;
Humans
;
Incidence
;
Lymph Nodes
;
Male
;
Neoplasm Metastasis
;
Recurrence
;
Thyroid Gland*
;
Thyroid Neoplasms*
;
Thyroidectomy
8.Changes of Cholesterol Level after Treatment in Bipolar Patients.
Ji Min NAM ; Tae Suk KIM ; Jung Jin KIM ; Chang Uk LEE ; Soo Jung LEE ; Chul LEE ; In Ho PAIK ; Chi Un PAE
Korean Journal of Psychopharmacology 2005;16(6):507-512
OBJECTIVES: Cholesterol interacts with serotonin and it has been found to be associated with some clinical symptoms of mood disorders. There is a paucity of data on first onset bipolar patients and from Asian population. In this study, we compared the total choelsterol (TC) level between the bipolar I patients with a single manic episode (BPSM) and the normal controls, and investigated the relationship between the TC level and treatment response in the BPSM. METHODS: Twenty-five BPSM and thirty normal controls were enrolled in this study. The pretreatment and posttreatment TC levels in the BPSM were measured and comapred to that of normal controls. Young Mania Rating Scale (YMRS) was used for assessing symptom severity in the BPSM. RESULTS: The TC level was significantly lower in the BPSM than in the controls. There were negative correlations between the YMRS scores and the pretreatment TC level in the BPSM. The posttreatment TC level was significantly higher than the pretreatment TC level in the BPSM. CONCLUSION: This study suggests that the TC level can be changed after treatment in bipolar manic patients, although more studies involving different ethnic groups will be needed. Further longitudinal studies will be needed to examine the change of total cholesterol level according to the clinical course of bipolar disorder.
Asian Continental Ancestry Group
;
Bipolar Disorder
;
Cholesterol*
;
Ethnic Groups
;
Humans
;
Mood Disorders
;
Serotonin
9.Establishment of a bovine leukemia virus-free dairy herd in Korea.
Guk Hyun SUH ; Jeong Chi LEE ; Chai Yong LEE ; Tai Young HUR ; Dong Soo SON ; Byeong Seog AHN ; Nam Chul KIM ; Chung Gil LEE
Journal of Veterinary Science 2005;6(3):227-230
In view of the high prevalence rate of bovine leukemia virus (BLV)infections in cattle over the entire country, a large dairy farm in Chungnam province was chosen and 'test and segregate' program was instituted. On July 1999, ELISA test was performed on 491 animals on the farm and only 163 cattle (139 adult cows, 18 female and 6 male calves)were BLV-seronegative. From February 2000 through April 2004, the seronegative group was placed in barns 1,500 to 2,000 m from seropositive group and thereafter tested at 3-to 5-month intervals by ELISA. Animals seroconverted in consecutive tests were removed from the seronegative group immediately after the detection of anti-BLV antibodies. The changes in management were aimed at preventing iatrogenic transfer of blood between cattle. Replacement heifers imported from other countries and calves born at the farm were repeatedly tested by ELISA, and only seronegative animals were introduced into the group. As of April 2004, there were 311 cattle in the BLV seronegative group of the farm. Twent y four cows of the initial 139 adult cows were seroconverted in 2000, and no seropositive animals were found since February 2001. Follow up of the group, from which all seropositive cattle were moved to a separate location, revealed no recurrence of BLV infection for three years. The approach in the present study might be valuable for Korean producers who would like to move toward a BLV-negative status.
*Animal Husbandry
;
Animals
;
Antibodies, Viral/*blood
;
Cattle
;
Enzootic Bovine Leukosis/*prevention&control
;
Female
;
Korea
;
Leukemia Virus, Bovine/*isolation&purification
;
Male
;
Prevalence
10.The role of mesenchymal stem cells in hematopoietic stem cell transplantation.
Sung Kyu PARK ; Jong Ho WON ; Soo Jeong PARK ; Nak Gyun CHUNG ; Dae Chul JEONG ; Chan Kyu KIM ; Nam Su LEE ; Kyu Taeg LEE ; Hyun Soo KIM ; Dae Sik HONG ; Chi Wha HAN ; Hee Sook PARK
Korean Journal of Medicine 2003;65(3):277-288
BACKGROUND: Human bone marrow contains mesenchymal stem cells (MSCs) which are capable of differentiation into a number of mesenchymal cell lineages when stimulated under appropriate conditions. Many studies indicate that the bone marrow stroma is damaged following bone marrow transplantation. Animal models suggest that the transplantation of healthy stromal elements, including MSCs, may enhance the ability of the bone marrow microenvironment to support hematopoiesis after stem cell transplantation. However, it remains to be seen whether transplantation of MSCs has significant value and pre-culture of hematopoietic stem cells with MSCs prior to transplantation changes their engraftment. METHODS: We investigated the differentiation potential and the potential plasticity of MSCs. And we also studied whether they have any effects on hematopoietic engraftment in xenotransplantation animal model. RESULTS: Culture-expanded human MSCs exhibited a spindle-shaped fibroblastic morphology and were differentiated into adipocytes, osteoblasts, and chondrocytes in specific culture conditions. In xenograft animal model, human ex vivo expanded marrow-derived MSCs were cotransplantated with human CD34+ cells into NOD/SCID mice and demonstrated about a two-fold increase in bone marrow engraftment as determined by human CD45+ and CD34+ expression as compared to transplantation of CD34+ cells alone. Also MSCs resulted in a two-fold to three-fold increase in bone marrow engraftment of CD45+- CD33+ cells and CD45+- CD13+ cells, whereas no such effect were observed in engraftment of CD45+- CD3+ cells and CD45+- CD19+ cells. To determine the homing and engraftment of MSCs, we performed cotransplantation of human CD34+ cells with ex vivo expanded human MSCs that had been retrovirally transduced with GFP transgene into NOD/SCID mice. Expression of GFP was found in the bone marrow of 1 of 5 NOD/SCID mice by DNA-PCR analysis. Using DNA-PCR, we found human beta2-microglobulin expression in liver, spleen, thymus, lung, heart, kidney, and small intestine. CONCLUSION: These results suggest that MSCs are capable of enhancing hematopoietic engraftment and they also may possess therapeutic value for the repair of damaged mesenchymal tissues following hematopoietic stem cell transplantation.
Adipocytes
;
Animals
;
Bone Marrow
;
Bone Marrow Transplantation
;
Cell Lineage
;
Chondrocytes
;
Fibroblasts
;
Heart
;
Hematopoiesis
;
Hematopoietic Stem Cell Transplantation*
;
Hematopoietic Stem Cells*
;
Heterografts
;
Humans
;
Intestine, Small
;
Kidney
;
Liver
;
Lung
;
Mesenchymal Stromal Cells*
;
Mice
;
Models, Animal
;
Osteoblasts
;
Plastics
;
Spleen
;
Stem Cell Transplantation
;
Thymus Gland
;
Transgenes
;
Transplantation, Heterologous
;
Zidovudine

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