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/AIMS: To optimize efficacy of National Liver Cancer Screening Program (NLCSP) for subjects with chronic hepatitis B (CHB), it is needed to know the incidence of liver cancer and its predisposing factors in the program. METHODS: From January 2010 to December 2014, all the hepatitis B surface antigen (HBsAg) positive participants who received at least two or more abdominal ultrasonography under NLCSP were retrospectively enrolled in a single tertiary hospital. Annual incidence of primary liver cancer was calculated and related clinical factors were investigated. RESULTS: During 5 years, 541 subjects were enrolled. Mean age was 53 years old and 292 subjects (54%) were receiving antiviral agents. Liver cirrhosis (LC) was diagnosed in 212 (39.2%). Mean follow-up time was 2.36 years and 15 hepatocellular carcinoma and 1 intrahepatic cholangiocarcinoma were diagnosed. Annual incidence of primary liver cancer was 9.8 per 1,000 patient year. Cumulative incidence at 1, 3, and 5 year was 0.6%, 2.6%, and 6.4%, respectively. In multivariate analyses, LC (hazard ratio [HR] 8.74, 95% confidence interval [CI] 1.97–38.71, P=0.024), age (HR 1.08, 95% CI 1.01–1.15, P=0.024) were significantly associated with cancer development. CONCLUSIONS: Despite of high rate of oral antiviral therapy, incidence of primary liver cancer is not low in CHB patients in Korea. Old age and presence of LC are independently associated with higher risk of cancer development during surveillance. This study could be used as baseline data for quality control of NLCSP.
Antiviral Agents ; Carcinoma, Hepatocellular ; Causality ; Cholangiocarcinoma ; Follow-Up Studies ; Hepatitis B Surface Antigens ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Incidence* ; Korea ; Liver Cirrhosis ; Liver Neoplasms* ; Liver* ; Mass Screening* ; Multivariate Analysis ; Quality Control ; Retrospective Studies ; Tertiary Care Centers ; Ultrasonography

Since laparoscopic liver resection was first introduced in 2001, Korean surgeons have chosen a laparoscopic procedure as one of the treatment options for benign or malignant liver disease. We distributed and analyzed a nationwide questionnaire to members of the Korean Laparoscopic Liver Surgery Study Group (KLLSG) in order to evaluate the current status of laparoscopic liver resection in Korea. Questionnaires were sent to 24 centers of KLLSG. The questionnaire consisted of operative procedure, histological diagnosis of liver lesions, indications for resection, causes of conversion to open surgery, and postoperative outcomes. A laparoscopic liver resection was performed in 416 patients from 2001 to 2008. Of 416 patients, 59.6% had malignant tumors, and 40.4% had benign diseases. A total laparoscopic approach was performed in 88.7%. Anatomical laparoscopic liver resection was more commonly performed than non-anatomical resection (59.9% vs 40.1%). The anatomical laparoscopic liver resection procedures consisted of a left lateral sectionectomy (29.3%), left hemihepatectomy (19.2%), right hemihepatectomy (6%), right posterior sectionectomy (4.3%), central bisectionectomy (0.5%), and caudate lobectomy (0.5%). Laparoscopy-related serious complications occurred in 12 (2.8%) patients. The present study findings provide data in terms of indication, type and method of liver resection, and current status of laparoscopic liver resection in Korea.
*Hepatectomy/statistics & numerical data ; Humans ; *Laparoscopy/statistics & numerical data ; Liver/*surgery ; Liver Diseases/pathology/surgery ; Liver Neoplasms/pathology/surgery ; Postoperative Complications/epidemiology ; Questionnaires ; Republic of Korea

No abstract available.
Chest Pain ; Echocardiography ; Esophageal Achalasia ; Heart Atria ; Humans ; Thorax

No abstract available.
Hypertrophy ; Obesity ; Obesity, Abdominal

BACKGROUND/AIMS: As bacterial resistance to antimicrobial agents has grown due to the increasing use of antimicrobial agents, we sought to evaluate the suitability of ceftriaxone usage (representative of third generation cephalosporins) at 10 university hospitals in Korea. METHODS: We prospectively evaluated the appropriateness of antibiotic usage in 400 adult patients who received ceftriaxone between February 1, 2006 and June 30, 2006. Drug utilization evaluation (DUE) methods were based on standards set forth by the American Society of Hospital Pharmacists. The DUE criteria used in this study were modified to be more suitable in our hospital setting: justification of drug use, critical and process indications, complications, and outcome measures. RESULTS: The average patient age was 64.4 years. The utilization of ceftriaxone was appropriate in 262 cases (65.5%) for the justification of use, while inappropriate use was observed in 138 cases (34.5%). Common reasons for inappropriate use of ceftriaxone included continued empiric use for presumed infections, prophylactic perioperative injection, and empiric therapy for fever. Most of the critical indications showed a high rate of suitability (66.5-98.5%). Complications occurred in 37 cases (9.3%). With respect to outcome measures, clinical responses were observed in 60.7% of cases, while only 15.7% of cases showed evidence of infection eradication via negative cultures. CONCLUSIONS: Appropriate use (65.5%) of ceftriaxone was higher than inappropriate use (34.5%) at university hospitals in Korea. Inappropriate utilization, however, including continued empiric use for presumed infections and prophylactic perioperative injection remained high. Intensification of educational programs and antibiotic control systems for ceftriaxone is needed to improve the suitability of antimicrobial use.
Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anti-Bacterial Agents/*therapeutic use ; Ceftriaxone/adverse effects/*therapeutic use ; Child ; Child, Preschool ; *Drug Utilization Review ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Treatment Outcome

BACKGROUND/AIMS: The prevalence of malignancies associated with human immunodeficiency virus (HIV) is rapidly increasing. The aim of the present study was to identify clinical features associated with malignancies in South Korean patients infected with HIV. METHODS: From January 1990 to June 2007, we reviewed an electronic database containing pathological reports obtained from HIV-infected patients and then retrospectively analyzed a total of 27 malignancy cases treated at four different institutions. RESULTS: Among 683 patients infected with HIV, malignant diseases were diagnosed in 27 cases (4.0%). Twenty-five of these patients were male, and the median age was 48 (range; 24-76). At the time of diagnosis, the median CD4+ lymphocyte count was 42/uL (range 3-339). Acquired immune deficiency syndrome (AIDS)-defining malignancies were diagnosed in 13 patients (48%) and non-AIDS-defining malignancies were diagnosed in 14 patients (52%). Two patients each were diagnosed with AIDS-defining and non-AIDS-defining malignancies during the pre-highly active anti-retroviral therapy (HARRT) period. In contrast, 11 patients (48%) and 12 patients (52%) were diagnosed with AIDS-defining and non-AIDS-defining malignancies during the HARRT period, respectively. Among AIDS-defining malignancies, non-Hodgkins lymphoma was the most frequently observed (9/13), followed by Kaposi's sarcoma (4/13). Among the 9 patients with non-Hodgkins lymphoma, diffuse large B-cell lymphoma was most common (5/9), followed by primary CNS lymphoma (3/9) and Burkitt's lymphoma (1/9). Gastrointestinal (GI) malignancies [i.e., gastric cancer (3/14), rectal cancer (3/14), and esophageal cancer (1/14)] and hepatocellular carcinoma (3/14) were the most commonly observed among the non-AIDS-defining malignancies. Other observed non-AIDS-defining malignancies were thyroid cancer (1/14), tonsillar cancer (1/14), angiosarcoma (1/14), and eccrine cancer (1/14). Finally, median CD4+ lymphocyte counts at the time of diagnosis were significantly different (18 vs. 114/uL, p=0.001) between AIDS-defining malignancies and non-AIDS-defining malignancies. CONCLUSIONS: Malignancies were diagnosed in 4.0% of patients infected with HIV. This study showed similar rates of incidence between AIDS-defining and non-AIDS-defining malignancies. Non-Hodgkins lymphoma was the most frequently observed malignancy, whereas GI malignancies and hepatocellular carcinoma were common among non-AIDS-defining malignancies.
Acquired Immunodeficiency Syndrome ; Burkitt Lymphoma ; Carcinoma, Hepatocellular ; Electronics ; Electrons ; Esophageal Neoplasms ; Hemangiosarcoma ; HIV ; Humans ; Incidence ; Lymphocyte Count ; Lymphoma ; Lymphoma, B-Cell ; Lymphoma, Non-Hodgkin ; Male ; Prevalence ; Rectal Neoplasms ; Retrospective Studies ; Sarcoma, Kaposi ; Stomach Neoplasms ; Thyroid Neoplasms ; Tonsillar Neoplasms

OBJECTIVE: In order to elucidate the retrogressive degeneration of orofacial cleft, the fissured tissues of prenatal and postnatal cleft lip and palate were examined by histological and immunohistochemical methods. DESIGN: Totally 42 cases of prenatal (n=17) and postnatal (n=25) cleft lip and/or palate were examined in comparison with 10 cases of normal lip and oral mucosa using immunohistochemical stainings of MMP-3, MMP-9, MMP-10, cathepsin G, PCNA, E-cadherin, TGase 2, HSP-70, vWF, and VEGF. MAIN OUTCOME MEASURES: In the fissured tissue the sebaceous glands were strongly positive for PCNA and grew into the underlying fibromuscular tissue (24/42). Some hyperplastic sebaceous glands of prenatal cleft lip produced infundibular follicular cyst (9/17). The skin and mucosal epithelia from the postnatal cleft lip and palate (10/25) showed severe basal hyperplasia (11/25) and melanocyte infiltration (7/25). RESULTS: The immunostaining of MMP-3 and HSP-70 were strongly positive in the hyperplastic sebaceous glands and nearby atrophying muscle bundles of the fissured tissue, while MMP-9, MMP-10, and cathepsin G were almost negative. The immunoreactions of the other antibodies used in this study were similar between in the fissured tissues and in the normal controls. CONCLUSIONS: These data suggest that the over-expression of MMP-3 is closely related to the sebaceous gland hyperplasia, epithelial dysplasia, and the muscle degeneration, and that the over-expression of MMP-3 in the fissured tissue may continuously aggravate the cleft condition in the later life.
Adult ; Antibodies ; Cadherins ; Cathepsin G ; Cleft Lip* ; Follicular Cyst ; Humans ; Hyperplasia ; Lip ; Melanocytes ; Mouth Mucosa ; Outcome Assessment (Health Care) ; Palate* ; Proliferating Cell Nuclear Antigen ; Sebaceous Glands ; Skin ; Vascular Endothelial Growth Factor A