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.

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.

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.

Background: Aortic dissection (AD) is one of the most catastrophic diseases and is associated with high morbidity and mortality. The aim of this study is to investigate the hospital incidence and mortality rates of thoracic AD in Korea using a nationwide database. Methods: We conducted a nationwide population-based study using the health claims data of the National Health Insurance Service in Korea. From 2005 to 2016, adult patients newly diagnosed with AD were included. All patients were divided into the following four subgroups by treatment: type A surgical repair (TASR), type B surgical repair (TBSR), thoracic endovascular aortic repair (TEVAR), and medical management (MM). The incidence rate, mortality rate, and risk factors of in-hospital mortality were evaluated. Results: In total, 18,565 patients were newly diagnosed with AD (TASR, n = 4,319 [23.3%];TBSR, n = 186 [1.0%]; TEVAR, n = 697 [3.8%]; MM, n = 13,363 [72.0%]). The overall AD incidence rate was 3.76 per 100,000 person-years and exhibited a gradual increase during the study period (3.29 to 4.82, P < 0.001). The overall in-hospital mortality rate was 10.84% and remained consistent (P = 0.57). However, the in-hospital mortality rate decreased in the TASR subgroup (18.23 to 11.27%, P = 0.046). An older age, the female sex, hypertension, and chronic kidney disease were independent risk factors for in-hospital mortality. Conclusion The incidence of thoracic AD has gradually increased in Korea. The in-hospital mortality in the TASR subgroup decreased over the decade, although the overall mortality of AD patients did not change.

OBJECTIVE: Assessing the severity of injury and predicting outcomes are essential in traumatic brain injury (TBI). However, the respiratory rate and Glasgow Coma Scale (GCS) of the Revised Trauma Score (RTS) are difficult to use in the prehospital setting. This investigation aimed to develop a new prehospital trauma score for TBI (NTS-TBI) to predict mortality and disability.METHODS: We used a nationwide trauma database on severe trauma cases transported by fire departments across Korea in 2013 and 2015. NTS-TBI model 1 used systolic blood pressure < 90 mmHg, peripheral capillary oxygen saturation < 90% measured via pulse oximeter, and motor component of GCS. Model 2 comprised variables of model 1 and age >65 years. We assessed discriminative power via area under the curve (AUC) value for in-hospital mortality and disability defined according to the Glasgow Outcome Scale with scores of 2 or 3. We then compared AUC values of NTS-TBI with those of RTS.RESULTS: In total, 3,642 patients were enrolled. AUC values of NTS-TBI models 1 and 2 for mortality were 0.833 (95% confidence interval [CI], 0.815 to 0.852) and 0.852 (95% CI, 0.835 to 0.869), respectively, while AUC values for disability were 0.772 (95% CI, 0.749 to 0.796) and 0.784 (95% CI, 0.761 to 0.807), respectively. AUC values of NTS-TBI model 2 for mortality and disability were higher than those of RTS (0.819 and 0.761, respectively) (P < 0.01).CONCLUSION: Our NTS-TBI model using systolic blood pressure, motor component of GCS, oxygen saturation, and age was feasible for prehospital care and showed outstanding discriminative power for mortality.
Anoxia ; Area Under Curve ; Blood Pressure ; Brain Injuries ; Capillaries ; Fires ; Glasgow Coma Scale ; Glasgow Outcome Scale ; Hospital Mortality ; Humans ; Hypotension ; Korea ; Mortality ; Observational Study ; Oxygen ; Quality Improvement ; Respiratory Rate

OBJECTIVE: Head elevation at an angle of 30° during cardiopulmonary resuscitation (CPR) was hemodynamically beneficial compared to supine position in a previous porcine cardiac arrest experimental study. However, survival benefit of head-up elevation during CPR has not been clarified. This study aimed to assess the effect of head-up tilt position during CPR on 24-hour survival in a porcine cardiac arrest experimental model.METHODS: This was a randomized experimental trial using female farm pigs (n=18, 42±3 kg) sedated, intubated, and paralyzed on a tilting surgical table. After surgical preparation, 15 minutes of untreated ventricular fibrillation was induced. Then, 6 minutes of basic life support was performed in a position randomly assigned to either head-up tilt at 30° or supine with a mechanical CPR device, LUCAS-2, and an impedance threshold device, followed by 20 minutes of advanced cardiac life support in the same position. Primary outcome was 24-hour survival, analyzed by Fisher exact test.RESULTS: In the 8 pigs from the head-up tilt position group, one showed return of spontaneous circulation (ROSC); all eight pigs expired within 24 hours. In the eight pigs from the supine position group, six had the ROSC; six pigs survived for 24 hours and two expired. The head-up position group showed lower 24-hour survival rate and lower ROSC rate than supine position group (P<0.01).CONCLUSION: The use of head-up tilt position with 30 degrees during CPR showed lower 24-hour survival than the supine position.
Advanced Cardiac Life Support ; Agriculture ; Animal Experimentation ; Cardiopulmonary Resuscitation ; Electric Impedance ; Female ; Head ; Heart Arrest ; Humans ; Models, Theoretical ; Supine Position ; Survival Rate ; Swine ; Ventricular Fibrillation

OBJECTIVE: This study aimed to achieve expert consensus for the evaluation of Emergency medical system operation fund (EMSOF) support projects using the Delphi method in Korea. METHODS: The Delphi study was performed in June 2018. Experts who are members of the policy committee of the Korean Society of Emergency Medicine (KSEM) participated in the study. Respondents were asked to express their level of agreement of appropriateness for the following 6 categories for 21 projects: project contents, amount of support, indicators, performance, overall evaluation, and need to maintain. With a possible score of 9 points, the project categories were classified into 3 groups, inappropriate, moderate and appropriate, based on the median score of the respondents' ratings in each question. RESULTS: Sixteen of the 18 policy committee members participated in the survey. Their average professional work years were 8.2 years. All 21 projects were evaluated as appropriate for content. Amount of support and indicators were evaluated as moderate. Only 5 out of the 21 projects were evaluated as having appropriate indicators. No projects were evaluated as ineffective. Comprehensive evaluation of the projects was evaluated as moderate, and no project was evaluated as inappropriate in fund support. CONCLUSION: Overall, the contents of the EMSOF assistance project were rated high; however, there was a disagreement on the amount of support and evaluation indicators for each project. The results of this study are expected to be used as basic data to improve the use of EMSOF.
Committee Membership ; Consensus ; Delphi Technique ; Emergencies ; Emergency Medicine ; Financial Management ; Korea ; Methods ; Resource Allocation ; Surveys and Questionnaires

PURPOSE: We investigated whether irinotecan plus capecitabine improved progression-free survival (PFS) compared with capecitabine alone in patients with human epidermal growth factor 2 (HER2) negative and anthracycline and taxane pretreated metastatic breast cancer (MBC). MATERIALS AND METHODS: A total of 221 patients were randomly assigned to irinotecan (80 mg/m2, days 1 and 8) and capecitabine (1,000 mg/m2 twice a day, days 1-14) or capecitabine alone (1,250 mg/m2 twice a day, days 1-14) every 3 weeks. The primary endpoint was PFS. RESULTS: There was no significant difference in PFS between the combination and monotherapy arm (median, 6.4 months vs. 4.7 months; hazard ratio [HR], 0.84; 95% confidence interval [CI], 0.63 to 1.11; p=0.84). In patients with triple-negative breast cancer (TNBC, n=90), the combination significantly improved PFS (median, 4.7 months vs. 2.5 months; HR, 0.58; 95% CI, 0.37 to 0.91; p=0.02). Objective response rate was numerically higher in the combination arm, though it failed to reach statistical significance (44.4% vs. 33.3%, p=0.30). Overall survival did not differ between arms (median, 20.4 months vs. 24.0 months; p=0.63). While grade 3 or 4 neutropenia was more common in the combination arm (39.6% vs. 9.0%), hand-foot syndrome was more often observed in capecitabine arm. Quality of life measurements in global health status was similar. However, patients in the combination arm showed significantly worse symptom scales especially in nausea/vomiting and diarrhea. CONCLUSION: Irinotecan plus capecitabine did not prove clinically superior to single-agent capecitabine in anthracycline- and taxane-pretreated HER2 negative MBC patients. Toxicity profiles of the two groups differed but were manageable. The role of added irinotecan in patients with TNBC remains to be elucidated.
Arm ; Breast Neoplasms* ; Breast* ; Capecitabine* ; Diarrhea ; Disease-Free Survival ; Epidermal Growth Factor ; Global Health ; Hand-Foot Syndrome ; Humans ; Neutropenia ; Quality of Life ; Triple Negative Breast Neoplasms ; Weights and Measures

PURPOSE: BioPATH is a non-interventional study evaluating the relationship of molecular biomarkers (PTEN deletion/downregulation, PIK3CA mutation, truncated HER2 receptor [p95HER2], and tumor HER2 mRNA levels) to treatment responses in Asian patients with HER2+ advanced breast cancer treated with lapatinib and other HER2-targeted agents. MATERIALS AND METHODS: Female Asian HER2+ breast cancer patients (n=154) who were candidates for lapatinib-based treatment following metastasis and having an available primary tumor biopsy specimen were included. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, overall survival on lapatinib, correlation between biomarker status and PFS for any previous trastuzumab-based treatment, and conversion/conservation rates of the biomarker status between tissue samples collected at primary diagnosis and at recurrence/metastasis. Potential relationships between tumor mRNA levels of HER2 and response to lapatinib-based therapy were also explored. RESULTS: p95HER2, PTEN deletion/downregulation, and PIK3CA mutation did not demonstrate any significant co-occurrence pattern and were not predictive of clinical outcomes on either lapatinib-based treatment or any previous trastuzumab-based therapy in the metastatic setting. Proportions of tumors positive for p95HER2 expression, PIK3CA mutation, and PTEN deletion/down-regulation at primary diagnosis were 32%, 31.2%, and 56.2%, respectively. Despite limited availability of paired samples, biomarker status patterns were conserved in most samples. HER2 mRNA levels were not predictive of PFS on lapatinib. CONCLUSION: The prevalence of p95HER2 expression, PIK3CA mutation, and PTEN deletion/downregulation at primary diagnosis were similar to previous reports. Importantly, no difference was observed in clinical outcome based on the status of these biomarkers, consistent with reports from other studies.
Asian Continental Ancestry Group ; Biomarkers ; Biopsy ; Breast Neoplasms ; Breast ; Diagnosis ; Disease-Free Survival ; Female ; Humans ; Neoplasm Metastasis ; Prevalence ; RNA, Messenger ; Trastuzumab

PURPOSE: As there were few previous studies with a small number of subjects, the purpose of this was to evaluate the prognostic significance of ¹⁸F-FDG PET/CT in patients with distal bile duct cancer undergoing curative surgery.METHODS: The study included 40 patients (M/F = 24:16; age 68.0 ± 8.0 years) who underwent preoperative ¹⁸F-FDG PET/CT followed by curative surgical resection. The participant's age, sex, Eastern Cooperative Oncology Group performance-status score, baseline serum CA 19-9 level, stage, pathologic T and N stages, tumor size, tumor grade, tumor growth pattern, R0 resection, and adjuvant therapy were included as clinicopathological variables for predicting overall survival. The PET variables were maximum standardized uptake value (SUV(max)), average SUV (SUV(avg)), metabolic tumor volume (MTV), and total lesion glycolysis (TLG) of the tumor. The Kaplan-Meyer method and Cox proportional hazards model were used for the survival analysis.RESULTS: A total of 15 of 40 patients (37.5%) died during the follow-up period. In univariate analysis, low SUVmax (≤ 2.7, p = 0.0005) and low SUV(avg) (≤ 2.6, p = 0.0034) were significant predictors of poor overall survival. In multivariate analyses, only low SUV(max) (HR = 6.7016, 95% CI 1.9961–22.4993, p = 0.0047) was an independent prognostic factor associated with poor overall survival.CONCLUSION: The SUVmax of the primary tumor measured by ¹⁸F-FDG PET/CT was an independent significant prognostic factor for overall survival in patients with distal bile duct cancer. However, different results from a previous study warrant further large sample-sized study.
Bile Duct Neoplasms ; Bile Ducts ; Bile ; Cholangiocarcinoma ; Follow-Up Studies ; Glycolysis ; Humans ; Methods ; Multivariate Analysis ; Positron-Emission Tomography and Computed Tomography ; Prognosis ; Proportional Hazards Models ; Tumor Burden