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.Relationship Between Suicide Attempts and Peripheral Blood Markers in Patients Who Visited the Emergency Department
Seok-Ho CHOI ; Seo-Hyun CHOI ; Seri MAENG ; Jae Nam BAE ; Jeong-Seop LEE ; Won-Hyoung KIM ; Yangsik KIM
Journal of the Korean Society of Biological Psychiatry 2024;31(2):40-50
Objectives:
We investigate relationship between suicide attempts and peripheral blood inflammatory markers in patients visiting the emergency department (ED) for psychiatric consultations, aiming to identify potential biomarkers for predicting suicide risk.
Methods:
We retrospectively reviewed medical records of 569 patients who were referred to psychiatric consultation at the ED from January 1, 2022 to December 31, 2022. Demographic and clinical characteristics and various blood test markers were analyzed. Analyses were performed to compare differences in blood markers between suicide attempters and non-attempters and among those with varying histories of suicide attempts.
Results:
Among 569 patients, 398 (69.9%) had attempted suicide. Significant differences in leukocytes, lymphocytes, eosinophils, red blood cells (RBCs), lactate dehydrogenase (LDH), and ketone bodies were observed between suicide attempters and non-attempters. Further analysis revealed that patients with a history of suicide attempts had higher lymphocyte and eosinophil counts but lower LDH and ketone body levels. An increasing frequency of past suicide attempts correlated with higher lymphocyte and eosinophil count and lower neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune inflammatory index, glucose, LDH, and ketone body levels.
Conclusions
We identify blood markers associated with suicide attempts, indicating that leukocyte, lymphocyte, eosinophil, RBC count, LDH, and ketone body levels could serve as potential biomarkers for assessing suicide risk. Findings underscore importance of biological assessments in conjunction with psychological evaluations in predicting and preventing suicide attempts. Further research is needed to validate these biomarkers and understand mechanisms.
5.Relationship Between Suicide Attempts and Peripheral Blood Markers in Patients Who Visited the Emergency Department
Seok-Ho CHOI ; Seo-Hyun CHOI ; Seri MAENG ; Jae Nam BAE ; Jeong-Seop LEE ; Won-Hyoung KIM ; Yangsik KIM
Journal of the Korean Society of Biological Psychiatry 2024;31(2):40-50
Objectives:
We investigate relationship between suicide attempts and peripheral blood inflammatory markers in patients visiting the emergency department (ED) for psychiatric consultations, aiming to identify potential biomarkers for predicting suicide risk.
Methods:
We retrospectively reviewed medical records of 569 patients who were referred to psychiatric consultation at the ED from January 1, 2022 to December 31, 2022. Demographic and clinical characteristics and various blood test markers were analyzed. Analyses were performed to compare differences in blood markers between suicide attempters and non-attempters and among those with varying histories of suicide attempts.
Results:
Among 569 patients, 398 (69.9%) had attempted suicide. Significant differences in leukocytes, lymphocytes, eosinophils, red blood cells (RBCs), lactate dehydrogenase (LDH), and ketone bodies were observed between suicide attempters and non-attempters. Further analysis revealed that patients with a history of suicide attempts had higher lymphocyte and eosinophil counts but lower LDH and ketone body levels. An increasing frequency of past suicide attempts correlated with higher lymphocyte and eosinophil count and lower neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune inflammatory index, glucose, LDH, and ketone body levels.
Conclusions
We identify blood markers associated with suicide attempts, indicating that leukocyte, lymphocyte, eosinophil, RBC count, LDH, and ketone body levels could serve as potential biomarkers for assessing suicide risk. Findings underscore importance of biological assessments in conjunction with psychological evaluations in predicting and preventing suicide attempts. Further research is needed to validate these biomarkers and understand mechanisms.
6.Relationship Between Suicide Attempts and Peripheral Blood Markers in Patients Who Visited the Emergency Department
Seok-Ho CHOI ; Seo-Hyun CHOI ; Seri MAENG ; Jae Nam BAE ; Jeong-Seop LEE ; Won-Hyoung KIM ; Yangsik KIM
Journal of the Korean Society of Biological Psychiatry 2024;31(2):40-50
Objectives:
We investigate relationship between suicide attempts and peripheral blood inflammatory markers in patients visiting the emergency department (ED) for psychiatric consultations, aiming to identify potential biomarkers for predicting suicide risk.
Methods:
We retrospectively reviewed medical records of 569 patients who were referred to psychiatric consultation at the ED from January 1, 2022 to December 31, 2022. Demographic and clinical characteristics and various blood test markers were analyzed. Analyses were performed to compare differences in blood markers between suicide attempters and non-attempters and among those with varying histories of suicide attempts.
Results:
Among 569 patients, 398 (69.9%) had attempted suicide. Significant differences in leukocytes, lymphocytes, eosinophils, red blood cells (RBCs), lactate dehydrogenase (LDH), and ketone bodies were observed between suicide attempters and non-attempters. Further analysis revealed that patients with a history of suicide attempts had higher lymphocyte and eosinophil counts but lower LDH and ketone body levels. An increasing frequency of past suicide attempts correlated with higher lymphocyte and eosinophil count and lower neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune inflammatory index, glucose, LDH, and ketone body levels.
Conclusions
We identify blood markers associated with suicide attempts, indicating that leukocyte, lymphocyte, eosinophil, RBC count, LDH, and ketone body levels could serve as potential biomarkers for assessing suicide risk. Findings underscore importance of biological assessments in conjunction with psychological evaluations in predicting and preventing suicide attempts. Further research is needed to validate these biomarkers and understand mechanisms.
7.Relationship Between Suicide Attempts and Peripheral Blood Markers in Patients Who Visited the Emergency Department
Seok-Ho CHOI ; Seo-Hyun CHOI ; Seri MAENG ; Jae Nam BAE ; Jeong-Seop LEE ; Won-Hyoung KIM ; Yangsik KIM
Journal of the Korean Society of Biological Psychiatry 2024;31(2):40-50
Objectives:
We investigate relationship between suicide attempts and peripheral blood inflammatory markers in patients visiting the emergency department (ED) for psychiatric consultations, aiming to identify potential biomarkers for predicting suicide risk.
Methods:
We retrospectively reviewed medical records of 569 patients who were referred to psychiatric consultation at the ED from January 1, 2022 to December 31, 2022. Demographic and clinical characteristics and various blood test markers were analyzed. Analyses were performed to compare differences in blood markers between suicide attempters and non-attempters and among those with varying histories of suicide attempts.
Results:
Among 569 patients, 398 (69.9%) had attempted suicide. Significant differences in leukocytes, lymphocytes, eosinophils, red blood cells (RBCs), lactate dehydrogenase (LDH), and ketone bodies were observed between suicide attempters and non-attempters. Further analysis revealed that patients with a history of suicide attempts had higher lymphocyte and eosinophil counts but lower LDH and ketone body levels. An increasing frequency of past suicide attempts correlated with higher lymphocyte and eosinophil count and lower neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio, platelet-to-lymphocyte ratio, systemic immune inflammatory index, glucose, LDH, and ketone body levels.
Conclusions
We identify blood markers associated with suicide attempts, indicating that leukocyte, lymphocyte, eosinophil, RBC count, LDH, and ketone body levels could serve as potential biomarkers for assessing suicide risk. Findings underscore importance of biological assessments in conjunction with psychological evaluations in predicting and preventing suicide attempts. Further research is needed to validate these biomarkers and understand mechanisms.
8.A Nationwide Study on HER2-Low Breast Cancer in South Korea: Its Incidence of 2022 Real World Data and the Importance of Immunohistochemical Staining Protocols
Min Chong KIM ; Eun Yoon CHO ; So Yeon PARK ; Hee Jin LEE ; Ji Shin LEE ; Jee Yeon KIM ; Ho-chang LEE ; Jin Ye YOO ; Hee Sung KIM ; Bomi KIM ; Wan Seop KIM ; Nari SHIN ; Young Hee MAENG ; Hun Soo KIM ; Sun Young KWON ; Chungyeul KIM ; Sun-Young JUN ; Gui Young KWON ; Hye Jeong CHOI ; So Mang LEE ; Ji Eun CHOI ; Ae Ri AN ; Hyun Joo CHOI ; EunKyung KIM ; Ahrong KIM ; Ji-Young KIM ; Jeong Yun SHIM ; Gyungyub GONG ; Young Kyung BAE
Cancer Research and Treatment 2024;56(4):1096-1104
Purpose:
Notable effectiveness of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)–low advanced breast cancer (BC) has focused pathologists’ attention. We studied the incidence and clinicopathologic characteristics of HER2-low BC, and the effects of immunohistochemistry (IHC) associated factors on HER2 IHC results.
Materials and Methods:
The Breast Pathology Study Group of the Korean Society of Pathologists conducted a nationwide study using real-world data on HER2 status generated between January 2022 and December 2022. Information on HER2 IHC protocols at each participating institution was also collected.
Results:
Total 11,416 patients from 25 institutions included in this study. Of these patients, 40.7% (range, 6.0% to 76.3%) were classified as HER2-zero, 41.7% (range, 10.5% to 69.1%) as HER2-low, and 17.5% (range, 6.7% to 34.0%) as HER2-positive. HER2-low tumors were associated with positive estrogen receptor and progesterone receptor statuses (p < 0.001 and p < 0.001, respectively). Antigen retrieval times (≥ 36 minutes vs. < 36 minutes) and antibody incubation times (≥ 12 minutes vs. < 12 minutes) affected on the frequency of HER2 IHC 1+ BC at institutions using the PATHWAY HER2 (4B5) IHC assay and BenchMark XT or Ultra staining instruments. Furthermore, discordant results between core needle biopsy and subsequent resection specimen HER2 statuses were observed in 24.1% (787/3,259) of the patients.
Conclusion
The overall incidence of HER2-low BC in South Korea concurs with those reported in previously published studies. Significant inter-institutional differences in HER2 IHC protocols were observed, and it may have impact on HER2-low status. Thus, we recommend standardizing HER2 IHC conditions to ensure precise patient selection for targeted therapy.
9.A Multicenter, Prospective, Observational Study to Evaluate Ethanol-Induced Symptoms in Patients Receiving Docetaxel Chemotherapy
Young-Woong WON ; Jin-Hyoung KANG ; Jung Hye KWON ; Dong-Hoe KOO ; Jung Hun KANG ; Chi Hoon MAENG ; Hee Kyung AHN ; Sung Yong OH ; Dae-Won LEE ; Joohyuk SOHN ; So Yeon OH ; Kyung Hee LEE ; Su-Jin KOH ; Keun Seok LEE ; Chan-Kyu KIM ; Ji-Yeon KIM ; Jun Ho JI ; Sung-Bae KIM ; Joo Young HA ; Ho Young KIM
Cancer Research and Treatment 2023;55(4):1096-1103
Purpose:
Several previous studies and case reports have reported ethanol-induced symptoms in patients receiving anticancer drugs containing ethanol. Most docetaxel formulations contain ethanol as a solvent. However, there are insufficient data on ethanol-induced symptoms when docetaxel-containing ethanol is administered. The primary purpose of this study was to investigate the frequency and pattern of ethanol-induced symptoms during and after docetaxel administration. The secondary purpose was to explore the risk factors for ethanol-induced symptoms.
Materials and Methods:
This was a prospective, multicenter, observational study. The participants filled out ethanol-induced symptom questionnaire on the day of chemotherapy and the following day.
Results:
Data from 451 patients were analyzed. The overall occurrence rate of ethanol-induced symptoms was 44.3% (200/451 patients). The occurrence rate of facial flushing was highest at 19.7% (89/451 patients), followed by nausea in 18.2% (82/451 patients), and dizziness in 17.5% (79/451 patients). Although infrequent, unsteady walking and impaired balance occurred in 4.2% and 3.3% of patients, respectively. Female sex, presence of underlying disease, younger age, docetaxel dose, and docetaxel-containing ethanol amount were significantly associated with the occurrence of ethanol-induced symptoms.
Conclusion
The occurrence of ethanol-induced symptoms was not low in patients receiving docetaxel-containing ethanol. Physicians need to pay more attention to the occurrence of ethanol-induced symptoms and prescribe ethanol-free or low-ethanol-containing formulations to high-risk patients.
10.Current Trends in Liquid Biopsy Technology for Early Diagnosis of Metastatic Renal Cell Carcinoma
Jeong Yoon SUH ; Se Jung MAENG ; Mirinae KIM ; Su Jeong KANG ; Young Wook CHOI ; In Ho CHANG
Korean Journal of Urological Oncology 2022;20(4):223-234
Clear cell renal cell carcinoma (ccRCC) is a disease with a wide variety of clinical progressions such as the rate of disease progression or the degree of metastasis. About 30% of ccRCC patients suffer from metastatic diseases, and about 30% develop metastasis after diagnosis. In the case of metastatic RCC, early prediction of the disease is important because of the poor prognosis, but ccRCC-specific molecular markers for clinical use are not available yet. As an alternative, liquid biopsy, which can find molecules released from tumor tissues in circulating blood and obtain information on metastatic dissemination and recurrence of ccRCC, is emerging. In this article, we will introduce molecules such as cell free DNA, cell free RNA, protein, and exosomes available as circulating biomarkers for liquid biopsy. We will also introduce some promising technologies that can compensate for the limitations of liquid biopsy.

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