Entity

Time filter

Source Type

Yanggu, South Korea

Bruix J.,University of Barcelona | Takayama T.,Nihon University | Mazzaferro V.,Liver Unit | Chau G.-Y.,Taipei Veterans General Hospital | And 17 more authors.
The Lancet Oncology | Year: 2015

Background: There is no standard of care for adjuvant therapy for patients with hepatocellular carcinoma. This trial was designed to assess the efficacy and safety of sorafenib versus placebo as adjuvant therapy in patients with hepatocellular carcinoma after surgical resection or local ablation. Methods: We undertook this phase 3, double-blind, placebo-controlled study of patients with hepatocellular carcinoma with a complete radiological response after surgical resection (n=900) or local ablation (n=214) in 202 sites (hospitals and research centres) in 28 countries. Patients were randomly assigned (1:1) to receive 400 mg oral sorafenib or placebo twice a day, for a maximum of 4 years, according to a block randomisation scheme (block size of four) using an interactive voice-response system. Patients were stratified by curative treatment, geography, Child-Pugh status, and recurrence risk. The primary outcome was recurrence-free survival assessed after database cut-off on Nov 29, 2013. We analysed efficacy in the intention-to-treat population and safety in randomly assigned patients receiving at least one study dose. The final analysis is reported. This study is registered with ClinicalTrials.gov, number NCT00692770. Findings: We screened 1602 patients between Aug 15, 2008, and Nov 17, 2010, and randomly assigned 1114 patients. Of 556 patients in the sorafenib group, 553 (>99%) received the study treatment and 471 (85%) terminated treatment. Of 558 patients in the placebo group, 554 (99%) received the study treatment and 447 (80%) terminated treatment. Median duration of treatment and mean daily dose were 12.5 months (IQR 2.6-35.8) and 577 mg per day (SD 212.8) for sorafenib, compared with 22.2 months (8.1-38.8) and 778.0 mg per day (79.8) for placebo. Dose modification was reported for 497 (89%) of 559 patients in the sorafenib group and 206 (38%) of 548 patients in the placebo group. At final analysis, 464 recurrence-free survival events had occurred (270 in the placebo group and 194 in the sorafenib group). Median follow-up for recurrence-free survival was 8.5 months (IQR 2.9-19.5) in the sorafenib group and 8.4 months (2.9-19.8) in the placebo group. We noted no difference in median recurrence-free survival between the two groups (33.3 months in the sorafenib group vs 33.7 months in the placebo group; hazard ratio [HR] 0.940; 95% CI 0.780-1.134; one-sided p=0.26). The most common grade 3 or 4 adverse events were hand-foot skin reaction (154 [28%] of 559 patients in the sorafenib group vs four [<1%] of 548 patients in the placebo group) and diarrhoea (36 [6%] vs five [<1%] in the placebo group). Sorafenib-related serious adverse events included hand-foot skin reaction (ten [2%]), abnormal hepatic function (four [<1%]), and fatigue (three [<1%]). There were four (<1%) drug-related deaths in the sorafenib group and two (<1%) in the placebo group. Interpretation: Our data indicate that sorafenib is not an effective intervention in the adjuvant setting for hepatocellular carcinoma following resection or ablation. Funding: Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals. © 2015 Elsevier Ltd. Source


Oh H.S.,Woosong University | Yoon Chang S.W.,Samsung | Choi J.S.,Incheon National University | Park E.S.,Severance Hospital | Jin H.Y.,Ajou University
American Journal of Infection Control | Year: 2013

Background: Costs of postexposure treatment of sharps injuries (SIs) in health care workers (HCWs) are an economic burden in many countries. This study analyzed the costs associated with SIs in HCWs in the Republic of Korea. Methods: Between October 1, 2005, and February 28, 2006, general information on SIs among HCWs and the direct costs (eg, laboratory, pharmacy, medical and surgical treatments) and indirect costs eg, (loss of working days) were collected prospectively from 34 hospitals nationwide. Results: A total of 700 SIs were documented, 505 of which (72.1%) generated costs. The average costs per SI were pharmacy, 123,091 won (US$129); laboratory tests, 66,958 won ($70); medical services, 26,332 won ($28); and medical treatments, 9,377 won ($10). The average costs of preventive measures were 160,274 won ($168) for hepatitis B virus (HBV), 127,858 won ($134) for hepatitis C virus (HCV), and 139,552 won ($146) for HIV. Of the laboratory tests, 32.9% were HBV-related, 29.4% were HCV-related, and 19.8% were HIV-related. Of postexposure prophylaxes, 34.9% were HB immunoglobulin and 31.4% were HBV vaccines. We estimated that 7,057.5 SIs generated costs, at a total annual cost of 844,587,577 won ($884,385). Conclusions: The direct costs of managing SIs among HCWs constitute an economic burden in Korea. More aggressive and comprehensive preventive measures of SIs should be adopted. © 2013 by Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved. Source


Kim J.S.,Chungbuk National University | Chae Y.,Severance Hospital | Ha Y.-S.,Chungbuk National University | Ha Y.-S.,Urologic | And 4 more authors.
Clinical Genitourinary Cancer | Year: 2012

Introduction: Aberrant methylation of promoter CpG islands is an important inactivation mechanism of tumor suppressors and tumor-related genes. Ras association domain family 1A (RASSF1A) promoter hypermethylation was shown to be associated with bladder cancer (BC), but its prognostic value remains unclear. The aim of the present study was to investigate the value of RASSF1A methylation as a prognostic marker in BC. Materials and Methods: Primary BC tissues were obtained from 301 patients and included 186 specimens of nonmuscle invasive bladder cancer (NMIBC) and 115 specimens of muscle invasive bladder cancers (MIBC). RASSF1A hypermethylation was assessed using methylation-specific polymerase chain reaction (MS-PCR). The association between RASSF1A hypermethylation and clinicopathologic features, and the prognostic significance of RASSF1A hypermethylation were evaluated by Kaplan-Meier and multivariate Cox regression analyses. Results: RASSF1A promoter hypermethylation was detected in 33.6% of BCs and occurred more frequently in MIBC (46.1%) than in NMIBC (25.8%) (P <.001). In NMIBC, RASSF1A methylation was associated with advanced tumor stage (P =.026) and high grade (P <.001). Among patients with recurrent NMIBC, RASSF1A methylation was associated with shorter time to progression by Kaplan-Meier analysis (log-rank test; P =.004) and identified as an independent predictor of cancer progression by multivariate Cox regression analysis (hazard ratio [HR], 8.559; P =.014). Conclusions: Our results suggest that methylated RASSF1A may be a potential prognostic marker in patients with recurrent NMIBC. © 2012 Elsevier Inc. All rights reserved. Source


Yun S.J.,Chungbuk National University | Ha Y.S.,Chungbuk National University | Chae Y.,Severance Hospital | Kim J.S.,Chungbuk National University | And 2 more authors.
Annals of Oncology | Year: 2012

Background: The gene encoding human 8-oxoguanine glycosylase 1 (hOGG1) is involved in DNA base excision repair from oxidatively damaged DNA. A case-control study was conducted to evaluate the correlation between the susceptibility and clinicopathological outcomes of prostate cancer (CaP) and hOGG1 genotype. Patients and methods: Subjects were recruited from 266 CaP patients and 266 age-matched benign prostatic hyperplasia patients. The hOGG1 codon 326 genotype was determined by peptide nucleic acid-mediated PCR clamping and compared with Gleason score and tumor stage. Results: The Cys allele at codon 326 of hOGG1 was associated with an increased risk of CaP in comparison with the Ser allele (P = 0.005). Gleason scores of 8 or higher were observed more often in patients with the mutant genotypes Ser/Cys and Cys/Cys than in those with a wild-type genotype (P = 0.045), and the Cys/Cys homozygous genotype was associated with a significantly higher risk of metastatic disease in comparison with the Ser/Ser genotype (P = 0.017). Conclusions: These results suggest that hOGG1 is associated with the susceptibility to CaP and its aggressive clinicopathological characteristics. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source


Lee H.-M.,Yonsei University | Chun J.-H.,Severance Hospital
Journal of the Korean Medical Association | Year: 2012

Recently many hospitals in Korea have become interested in JCI (Joint Commission International) accreditation. As the medical market opens to medical tourism and to attract foreign patients, JCI accreditation has become the prime object. It is compatible with government policy for upgrading the medical industry and necessary to strengthen compatibility with foreign hospitals. JCI accreditation means that the medical services provided by a hospital are equivalent in quality and patient safety to medical services internationally. It also means that the hospital is reliable in treating patients according to international policies and regulations. The most important meaning of JCI accreditation is that the staff in the hospital have promised to provide safe patient care according to the hospital policies and bylaws made and approved by the staff members. During the process for JCI accreditation, the hospital staff's concept regarding patient safety has been changed and many of them are now voluntarily involved in quality improvement and patient safety activities in the hospital. © Korean Medical Association. Source

Discover hidden collaborations