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.

Proteinuria is associated with poor allograft and patient survival in kidney transplant recipients. However, the clinical relevance of spot urine protein-to-creatinine ratio (PCR) or albumin-to-creatinine ratio (ACR) as predictors of renal outcomes during the early postoperative period following kidney transplantation (KT) has not been determined. Methods: This single-center retrospective cohort study included 353 kidney transplant recipients who underwent KT between 2014 and 2017 and were followed up for more than 3 years. Among them, 186 and 167 recipients underwent living donor KT and deceased donor KT, respectively. The PCR and ACR were measured during the immediate postoperative period (within 7 days postoperatively), before discharge (2–3 weeks postoperatively), and 3–6 months postoperatively. Results: The median age of the patients was 51 years (interquartile range, 43–59 years), and 62.9% were male. An immediate postoperative PCR of ≥1 mg/mg was associated with old age, diabetes mellitus, high systolic blood pressure, delayed graft function, and donor factors (deceased donor KT, old age, and high serum creatinine concentrations). The PCR and ACR 3 to 6 months posttransplant were inversely associated with the estimated glomerular filtration rate at 1 year posttransplant. Deceased donor KT recipients with immediate postoperative PCR of ≥3 mg/mg showed a greater incidence of delayed graft function and lower estimated glomerular filtration rate before discharge than those with immediate postoperative PCR of <3 mg/mg. Conclusion: Early postoperative proteinuria is a useful biomarker to predict early renal outcomes after KT.

Purpose: This study aimed to determine the urodynamic characteristics of refractory enuresis and explored whether those characteristics can be managed through differential endoscopic injections with botulinum toxin. Methods: In total, 27 patients with nonmonosymptomatic enuresis who showed no response after conservative treatment for more than 12 months were included. The patients then underwent a videourodynamic study and received a differential endoscopic injection of botulinum toxin on the same day. Reduced capacity, detrusor overactivity, and bladder neck widening were the 3 major abnormal findings assessed during the filling phase, while sphincter hyperactivity was the only abnormality assessed during the emptying phase. An intravesical or intrasphincteric injection of botulinum toxin was attempted according to the videourodynamic study findings. Follow-up was conducted at 1, 3, 6, and 12 months after treatment. Results: The median age was 10 years (range, 7–31 years). Although 19 and 8 patients had a preoperative diagnosis of overactive bladder or dysfunctional voiding, respectively, the urodynamic diagnosis was different in more than half of the patients. Those showing detrusor overactivity benefited from intravesical botulinum toxin injection, whereas those with only sphincter hyperactivity benefited from both intravesical and intrasphincteric injections. Treatment resistance to botulinum toxin seemed to be attributable to bladder neck widening. Time had no apparent effect on efficacy, which persisted 6 months after the injection. More than 80% of the patients maintained the benefits of the injection after 1 year. Conclusions Videourodynamic studies were useful for identifying the reasons underlying refractory nonmonosymptomatic enuresis and helpful for determining the appropriate site of botulinum toxin injection.

Purpose: This study aimed to determine the urodynamic characteristics of refractory enuresis and explored whether those characteristics can be managed through differential endoscopic injections with botulinum toxin. Methods: In total, 27 patients with nonmonosymptomatic enuresis who showed no response after conservative treatment for more than 12 months were included. The patients then underwent a videourodynamic study and received a differential endoscopic injection of botulinum toxin on the same day. Reduced capacity, detrusor overactivity, and bladder neck widening were the 3 major abnormal findings assessed during the filling phase, while sphincter hyperactivity was the only abnormality assessed during the emptying phase. An intravesical or intrasphincteric injection of botulinum toxin was attempted according to the videourodynamic study findings. Follow-up was conducted at 1, 3, 6, and 12 months after treatment. Results: The median age was 10 years (range, 7–31 years). Although 19 and 8 patients had a preoperative diagnosis of overactive bladder or dysfunctional voiding, respectively, the urodynamic diagnosis was different in more than half of the patients. Those showing detrusor overactivity benefited from intravesical botulinum toxin injection, whereas those with only sphincter hyperactivity benefited from both intravesical and intrasphincteric injections. Treatment resistance to botulinum toxin seemed to be attributable to bladder neck widening. Time had no apparent effect on efficacy, which persisted 6 months after the injection. More than 80% of the patients maintained the benefits of the injection after 1 year. Conclusions Videourodynamic studies were useful for identifying the reasons underlying refractory nonmonosymptomatic enuresis and helpful for determining the appropriate site of botulinum toxin injection.

Non-variceal upper gastrointestinal bleeding (NVUGIB) refers to bleeding that develops in the gastrointestinal tract proximal to the ligament of Treitz. NVUGIB is an important cause for visiting the hospital and is associated with significant morbidity and mortality. Although European and Asian-Pacific guidelines have been published, there has been no previous guidelines regarding management of NVUGIB in Korea. Korea is a country with a high prevalence of Helicobacter pylori infection and patients have easy accessibility to receive endoscopy. Therefore, we believe that guidelines regarding management of NVUGIB are mandatory. The Korean Society of Gastroenterology reviewed recent evidence and recommends practical management guidelines on NVUGIB in Korea.

BACKGROUND: AND PURPOSE: The aim of this study was to determine the diagnostic performance and safety of a new ¹⁸F-labeled amyloid tracer, ¹⁸F-FC119S. METHODS: This study prospectively recruited 105 participants, comprising 53 with Alzheimer's disease (AD) patients, 16 patients with dementia other than AD (non-AD), and 36 healthy controls (HCs). In the first screening visit, the Seoul Neuropsychological Screening Battery cognitive function test was given to the dementia group, while HC subjects completed the Korean version of the Mini Mental State Examination. Individuals underwent ¹⁸F-FC119S PET, ¹⁸F-fluorodeoxyglucose (FDG) PET, and brain MRI. The diagnostic performance of ¹⁸F-FC119S PET for AD was compared to a historical control (comprising previously reported and currently used amyloid-beta PET agents), ¹⁸F-FDG PET, and MRI. The standardized uptake value (SUV) ratio (ratio of the cerebral cortical SUV to the cerebellar SUV) was measured for each PET data set to provide semiquantitative analysis. All adverse effects during the clinical trial periods were monitored. RESULTS: Visual assessments of the ¹⁸F-FC119S PET data revealed a sensitivity of 92% and a specificity of 84% in detecting AD. ¹⁸F-FC119S PET demonstrated equivalent or better diagnostic performance for AD detection than the historical control, ¹⁸F-FDG PET (sensitivity of 80.0% and specificity of 76.0%), and MRI (sensitivity of 98.0% and specificity of 50.0%). The SUV ratios differed significantly between AD patients and the other groups, at 1.44±0.17 (mean±SD) for AD, 1.24±0.09 for non-AD, and 1.21±0.08 for HC. No clinically significant adverse effects occurred during the trial periods. CONCLUSIONS ¹⁸F-FC119S PET provides high sensitivity and specificity in detecting AD and therefore may be considered a useful diagnostic tool for AD.

Skeletal cavernous hemangiomas are rare, benign tumors that may involve the supraorbital rim and orbital roof. However, such involvement is extremely rare. We report a case of skeletal cavernous hemangioma of the frontal bone involving the orbital roof and rim. En bloc excision and reconstruction, using a calvarial bone graft for the orbital roof and rim defect, was performed. It is important not only to perform total excision of skeletal cavernous hemangiomas, but to properly reconstruct the defects after the total excision since several complications can arise from an orbital roof and rim defect.
Frontal Bone* ; Hemangioma, Cavernous* ; Orbit* ; Transplants

BACKGROUND: The 30 mg pioglitazone tablet was recently introduced in Korea; no study has yet compared its glucose-lowering or weight gain effects to the 15 mg tablet in Korean patients with type 2 diabetes mellitus (T2DM). METHODS: The electronic medical records of 45 patients with T2DM with glycated hemoglobin (HbA1c) levels > 7.0%, despite taking 15 mg/day pioglitazone and a stable dose of other diabetes drugs for 3 months, were retrospectively reviewed. RESULTS: After dose up-titration, HbA1c levels decreased at 3- and 6-month follow-ups compared with baseline (8.5% at baseline vs. 8.2% at 3 months vs. 7.9% at 6 months; baseline vs. 3 months, P = 0.106; baseline vs. 6 months, P = 0.005; 3 months vs. 6 months, P = 0.096). In the subgroup analysis of 36 patients taking pioglitazone, sulfonylurea, and metformin, HbA1c levels also decreased at 3- and 6-month follow-ups compared with baseline (8.5 % vs. 8.2 % vs. 7.9%; baseline vs. 3 months, P = 0.289; baseline vs. 6 months, P = 0.014; 3 months vs. 6 months, P = 0.232). There was no significant body weight change (70.8 kg vs. 70.7 kg vs. 71.0 kg). CONCLUSION: Up-titrating from 15 mg to 30 mg of pioglitazone in patients with inadequate glycemic control (HbA1c > 9%) who were also taking sulfonylurea and metformin showed additive glucose-lowering effects without significant weight gain in Korean patients with T2DM.
Body Weight ; Body Weight Changes ; Diabetes Mellitus ; Diabetes Mellitus, Type 2* ; Electronic Health Records ; Follow-Up Studies ; Hemoglobin A, Glycosylated ; Humans ; Korea ; Metformin ; Retrospective Studies* ; Thiazolidinediones ; Weight Gain