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.

Objectives: . The relationships among positional obstructive sleep apnea (POSA), obstructive sleep apnea (OSA), and periodic limb movements during sleep (PLMS) remain unclear. We investigated these relationships with respect to the severity of OSA and explored the underlying mechanisms. Methods: . We retrospectively reviewed 6,140 eligible participants who underwent full-night diagnostic polysomnography at four clinical centers over a 5-year period, utilizing event-synchronized analysis. We evaluated the periodic limb movement index (PLMI) and the periodic limb movement with arousal index (PLMAI). The impacts of POSA on the PLMI, PLMAI, and PLMS were analyzed in relation to the severity of OSA. Results: . The mean PLMI, the mean PLMAI, and the prevalence of PLMS were significantly lower in participants with severe OSA compared to the mild and moderate OSA groups. The mean PLMI among those with mild OSA exceeded that of control participants. Furthermore, the mean PLMI (4.8±12.7 vs. 2.6±9.8 events/hr, P<0.001), the mean PLMAI (0.9±3.7 vs. 0.5±3.3 events/hr, P<0.001), and the prevalence of PLMS (11% vs. 5.3%, P<0.001) were higher in patients with POSA than in those with non-positional OSA. This PLMS finding was particularly pronounced among those with severe OSA (odds ratio [OR], 1.554; 95% confidence interval [CI], 1.065–2.267) and was less evident in the mild (OR, 0.559; 95% CI, 0.303–1.030) and moderate (OR, 1.822; 95% CI, 0.995–3.339) groups. Conclusion . Patients with POSA, especially those with severe OSA, exhibit a comparatively high prevalence of PLMS. In cases involving prominent PLMS, the diagnosis and treatment of POSA and OSA should be considered.

Background/Aims: CD40 agonists are thought to generate antitumor effects on pancreatic cancer via macrophages and T cells. We aimed to investigate the role of CD40 agonists in the differentiation of macrophages and treatment of human pancreatic adenocarcinoma. Methods: Immunohistochemistry was performed on paraffin-embedded surgical blocks from patients with pancreatic cancers to evaluate macrophage phenotypes and their relationship with survival. The effects of CD40 agonists on macrophage phenotypes and human pancreatic cancer were evaluated utilizing cell cocultures and organotypic slice cultures. Results: CD163 + (predominant in M2 macrophages) and FOXP3 + (predominant in regulatory T cells) expression levels in the tumors were significantly lower in patients with stage IB pancreatic cancer than in those with stage II or III disease (p=0.002 and p=0.003, respectively). Patients with high CD163 + expression had shorter overall survival than those with low CD163 + expression (p=0.002). In vitro treatment of THP-1 macrophages with a CD40 agonist led to an increase in HLA-DR + (predominant in M1 macrophages) and a decrease in CD163 + expression in THP-1 cells. Cell cocultures showed that CD40 agonists facilitate the suppression of PANC-1 human pancreatic cancer cells by THP-1 macrophages. Organotypic slice cultures showed that CD40 agonists alter the pancreatic cancer microenvironment by shifting the macrophage phenotype toward M1 (increase HLA-DR + and decrease CD163 + expression), decreasing the abundance of regulatory T cells, and increasing tumor cell apoptosis. Conclusions CD163 is related to advanced human pancreatic cancer stages and shorter overall survival. CD40 agonists alter macrophage phenotype polarization to favor the M1 phenotype and suppress human pancreatic cancer.

In cryptogenic stroke patients, early detection of new-onset atrial fibrillation (AF) and recurrent stroke is required to prevent poor clinical outcomes. Therefore, we investigated the predictors of new-onset AF and recurrent stroke in cryptogenic stroke patients without previously diagnosed AF. In total, 390 patients who were diagnosed with stroke and non-sustained atrial tachycardia (NSAT) on 24-hour Holter monitoring were followed up to assess new-onset AF and recurrent stroke. The 5-year event-free survival as well as the predictors of recurrent stroke or new-onset AF were investigated. Based on receiver operating characteristic analysis, frequent premature atrial contractions (PACs) were defined as PACs >44 beats/day. The median follow-up period was 35 months. The composite event rate was 11.5%. In Kaplan-Meier analysis, the 5-year cumulative incidence of composite events was higher in cryptogenic stroke patients with frequent PACs than in those without frequent PACs. Multivariate analysis revealed that current smoking, increased left atrial volume index, and frequent PACs were poor prognostic predictors of composite event, and frequent PACs were an independent poor prognostic factor of new-onset AF in cryptogenic stroke patients. Therefore, frequent PACs might be associated with poor clinical outcomes (new-onset AF and recurrent stroke) in cryptogenic stroke patients with concomitant NSAT.

Background: Detection of arrhythmias is crucial for the treatment of cardiovascular diseases.However, conventional devices do not provide sufficient diagnostic accuracy while patients should suffer from bothersome diagnostic process. We sought to evaluate diagnostic capability and safety of the new adhesive electrocardiogram (ECG) monitoring device in patients who need ECG monitoring during admission. Methods: We enrolled 10 patients who admitted to Seoul National University Bundang Hospital and required continuous ECG monitoring between October 31, 2019 and December 18, 2019. New adhesive ECG monitoring device and conventional ECG monitoring device were simultaneously applied to the patients and maintained for 48 hours. From each patient, 48 pairs of ECG signal were collected and analyzed by two cardiologists independently.Discrepancy of diagnosis and frequency of noise or signal loss were compared between the two devices. Results: From analyzable ECG data, discrepancy of arrhythmia diagnosis was not observed between the two devices. Noise rate was higher in conventional ECG monitoring device (2.5% vs. 17.3%, P < 0.001) and signal loss was not observed in new adhesive device while there was 9.4% of signal losses in conventional Holter recorder group. The new device was well-tolerated among 48 hours of monitoring period and no adverse event was observed. Conclusion A newer adhesive ECG monitoring device demonstrated similar diagnostic accuracy compared to conventional ECG monitoring device.

BACKGROUND: Left atrial (LA) remodeling develops as a result of longstanding pressure overload. However, determinants and clinical outcome of excessive remodeling, so called giant left atrium (GLA), are not clear. METHODS: Clinical characteristics of patients with GLA (antero-posterior diameter higher than 65 mm), including echo-Doppler parameters, and follow-up clinical outcomes from a tertiary referral hospital were investigated. RESULTS: Among 68519 consecutive primary patients who underwent echocardiography over a period of 10 years, data from 163 GLA cases (0.24%) were analyzed. Main causes were significant rheumatic mitral stenosis (n = 58, 36%); other causes comprised significant rheumatic mitral regurgitation (MR; n = 10, 6%), mitral valve (MV) prolapse or congenital mitral valvular disease (MVD) (n = 20, 12%), and functional MR (n = 25, 15%). However, mild rheumatic MV disease (n = 4, 3%) or left ventricular (LV) systolic or diastolic dysfunction without significant MR (n = 46, 28%) were also causes of GLA. During median follow-up of 22 months, 42 cases (26%) underwent composite events. MV surgery was related to lower rate of composite events. In multivariate analysis, MV surgery, elevated pulmonary arterial systolic pressure, and increased LA volume index were independent predictors of future events (p < 0.05) regardless of underlying diseases or history of MV surgery. CONCLUSION: Although rheumatic MVD with atrial fibrillation is the main contributor to GLA, longstanding atrial fibrillation with LV dysfunction but without MVD also could be related to GLA. Even in GLA state, accurate measurement of LA volume is crucial for risk stratification for future events, regardless of underlying disease.
Atrial Fibrillation ; Blood Pressure ; Echocardiography ; Follow-Up Studies ; Heart Atria* ; Humans ; Mitral Valve ; Mitral Valve Insufficiency ; Mitral Valve Stenosis ; Multivariate Analysis ; Prognosis* ; Prolapse ; Tertiary Care Centers

The General Rules for the Study of Primary Liver Cancer was published in June 2001 as the first edition. Since then, the 5th edition of the General Rules for the Study of Primary Liver Cancer was published by the 17th Committee of the Korean Liver Cancer Association based on the most recent data. The 5th edition of the General Rules for the Study of Primary Liver Cancer ranged over numerous topics such as anatomy, medical assessment of the patients, staging of hepatocellular carcinoma, description of the image findings, summary of hepatic resection, description of the surgical specimens, liver transplantation, reporting the pathological findings, pathological examinations of liver specimen, non-surgical treatment, radiotherapy, and assessment of tumor response after non-surgical treatment of hepatocellular carcinoma. The 5th General Rules for the Study of Primary Liver Cancer will not only become the basis of academic development for liver cancer studies in Korea, but also serve as the primary form of national liver cancer data accumulation based on standardized rules.
Carcinoma, Hepatocellular ; Humans ; Korea ; Liver Neoplasms* ; Liver Transplantation ; Liver* ; Radiotherapy

BACKGROUND AND OBJECTIVES: We sought to determine whether an elevated homocysteine (Hcy) level is associated with a worse prognosis in Korean patients with coronary artery disease (CAD). SUBJECTS AND METHODS: A total of 5839 patients (60.4% male, mean age 61.3±11.2 years) with CAD were enrolled from 2000 to 2010 at Gangnam Severance Hospital. CAD was diagnosed by invasive coronary angiography. Laboratory values including Hcy level were obtained on the day of coronary angiography and analyses were performed shortly after sampling. Patients were divided into two groups according to their Hcy levels. Baseline risk factors, coronary angiographic findings, length of follow-up, and composite endpoints including cardiac death (CD) and non-fatal myocardial infarction (NFMI) were recorded. 1:1 propensity score matched analysis was also performed. RESULTS: Over a mean follow-up period of 4.4±2.5 years, there were 132 composite endpoints (75 CD and 57 NFMI) with an event rate of 2.3%. Mean Hcy level was 9.9±4.3 µmol/L (normal Hcy 7.9±1.5 µmol/L and elevated Hcy 13.9±5.1 µmol/L). Kaplan-Meier survival analysis showed an association of elevated Hcy level with worse prognosis (p<0.0001). In addition, a multivariate Cox regression analysis showed an association of elevated Hcy level with worse prognosis for both the entire cohort (hazard ratio [HR] 2.077, 95% confidence interval [CI] 1.467-2.941, p<0.0001) and the propensity score matched cohort (HR 1.982, 95% CI 1.305-3.009, p=0.001). CONCLUSION: Elevated Hcy level is associated with worse outcomes in Korean patients with CAD.
Cohort Studies ; Coronary Angiography ; Coronary Artery Disease* ; Coronary Vessels* ; Death ; Follow-Up Studies ; Homocysteine* ; Humans ; Male ; Myocardial Infarction ; Prognosis ; Propensity Score* ; Risk Factors