- Email: [email protected]
696 HEPATIC HEMANGIOMA IN CELIAC DISEASE: A NEW POSSIBLE ASSOCIATION?
POSTERS the transplant disparity resolves after controlling for pre-treatment factors. 694 DIAGNOSTIC ACCURACY OF HCC BIOMARKERS DEPENDS ON THE ETIOLOGY OF LIVER DISEASE: AN INTERIM ANALYSIS 1 D. Bettinger1 , M. Schultheiß1 , J. Burk ¨ 2 , E. Panther1 , E. Knuppel ¨ , 3 R. Kuper ¨ , R. Thimme1 , H.E. Blum1 , H.C. Spangenberg1 . 1 Department of Medicine II, 2 Department of Diagnostic Radiology and Medical Physics, University Hospital Freiburg, Freiburg im Breisgau, 3 Wako Chemicals GmbH, Neuss, Germany E-mail: [email protected] Background and Aims: Hepatocellular carcinoma (HCC) is one of the leading causes for cancer related deaths worldwide. It is often diagnosed at advanced stages indicating the need of HCC surveillance programs. The usefulness of HCC biomarkers is limited as they may depend on the etiology of liver disease. The aim of this study was to determine the impact of different etiologies on diagnostic accuracy of alpha-fetoprotein (AFP), its subfraction AFPL3% and des-g-carboxyprothrombin (DCP). Patients and Methods: 175 patients with liver cirrhosis (CI) and 75 patients with confirmed HCC were enrolled in this prospective study. Patients were analyzed according their etiology of liver disease. Serum samples were collected and AFP, AFP-L3 and DCP were measured using a micro-total analysis system. Diagnostic accuracy was determined using ROC analyses and statistically significant differences in biomarker values were calculated using Mann-Whitney-U-tests. Results: ROC analyses of all patients revealed optimal cut-off values for AFP, AFP – L3% and DCP of 10 ng/ml, 10% and 2.87 ng/ml with an AUC of 0.745, 0.784 and 0.777 respectively. Sensitivity of AFP and DCP was 57% and 63% with specificity of 86% and 83%, respectively. Patients with viral hepatitis associated CI had higher median AFP values than patients with ASH/NAFLD (7.7 ng/ml vs. 3.6 ng/ml, p < 0.001) as a result of hepatic inflammation indicated by elevated aminotransferases which showed a positive correlation with AFP. DCP was higher in patients with ASH/NAFLD (0.79 ng/ml vs. 0.3 ng/ml, p < 0.001). In patients with viral hepatitis sensitivity and specificity of AFP was 67% and 63%, respectively, while DCP yielded sensitivity and specificity of 50% and 98%. In patients with ASH/NAFLD, sensitivity of AFP and DCP was 54% and 63% with specificity of 95% and 77%, respectively. Sensitivity and specificity of AFP-L3 did not differ significantly between these two etiologies. In both groups combination of all three markers showed the best diagnostic accuracy. Conclusion: AFP and DCP are influenced by the etiology of liver disease resulting in impaired diagnostic usefulness in HCC surveillance. Therefore combination of all markers may compensate the limitation of each marker and increase their diagnostic accuracy. 695 PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WITHOUT CIRRHOSIS HAD OFTEN UNDETECTABLE RISK FACTORS AND A MORE ADVANCED DISEASE AT DIAGNOSIS G. Brancaccio1 , M. Tommasini2 , F. Brunello3 , V. Di Marco4 , G. Pinzello5 , T. Stroffolini6 , F. Trevisani7 , G.B. Gaeta1 , Multicentre Italian Study Group. 1 Malattie Infettive, Unit` a Epatiti Virali, Universit` a di Napoli, Napoli, 2 Istituto Humanitas, Milano, 3 Gastroenterologia, Ospedale Molinette, Torino, 4 Gastroenterologia, Universit` a di Palermo, Palermo, 5 Ospedale Niguarda, Milano, 6 Policlinico Umberto I, Roma; Medicina Interna, Roma, 7 Universit` a di Bologna, Bologna, Italy E-mail: [email protected] Background and Aims: The vast majority of HCC cases develop in cirrhotic liver. We analyzed etiological factors and clinical presentation of HCC cases in non-cirrhotic liver retrieved from a nationwide study.
Methods: A multicenter Italian cohort enrolled 1729 patients with HCC during a six month period, of whom 87 (4.7%) without underlying cirrhosis (NCP = no cirrhosis patients). An age and gender pair matched group of patients with underlying cirrhosis (n = 107) was retrieved from the main cohort (UCP = underlying cirrhosis patients). Diagnosis of HCC was assessed according to AASLD guidelines. Results: Mean age of NCP was 68.4±10.2 years, 97.7% were Caucasians. Diagnosis of HCC in normal liver was assessed by histology in 46 cases (58%) and by imaging and endoscopic procedures in 41. There were no differences in baseline characteristics between these two groups of patients. HCV infection was present in 32.2% of NCP and in 72.9% of UCP (p = 0.0001); overall, 54% of NCP were HBsAg and anti-HCV negative vs. only 15.9% of UC cases. Compared with UCP, serum cholesterol levels were higher in NC patients (185.1±43.8 vs. 162.6±43.5; p = 0.004); there were no differences in cigarette smoking, environmental toxic exposure, alfafetoprotein value, presence of comorbidities. Among NCP, virus-negative cases compared with virus-positive cases were more frequently alcohol users (45% vs. 20%; p = 0.0009) and had a higher BMI value (26.4±4 vs. 23.6±2.8; p = 0.008); 19 out of the 48 virus-negative patients (39.5%) had no indentified risk factor. 68% of cirrhotic patients were under ultrasonographic surveillance at least on yearly basis vs. 22% of NC patients (p = 0.001). At diagnosis, HCC was less frequently mononodular in NCP (16.7 vs 38.5%; p = 0.029). Conclusions: HCC in non cirrhotic liver accounted for 4.7% of HCC cases and was more advanced at diagnosis than in UC patients, possibly due to the low number of patients under ultrasonographic surveillance. Alcohol use and an elevated BMI were associated with HCC in NC patients, although in some of them no potential causative agents were identified. 696 HEPATIC HEMANGIOMA IN CELIAC DISEASE: A NEW POSSIBLE ASSOCIATION? S. Massironi1 , F. Branchi1,2 , R.E. Rossi1,2 , M. Fraquelli1 , L. Elli3 , M.T. Bardella3 , F. Cavalcoli1,2 , D. Conte1,2 . 1 Gastroenterology Unit II, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 2 Postgraduate School of Gastroenterology, Universit` a degli Studi di Milano, 3 Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy E-mail: [email protected] Background: Hepatic hemangioma (HH) is the most common benign mesenchymal tumor affecting the liver. Estimates of the prevalence of HH range widely, from 0.4 to 20%, with the highest prevalence rate at autopsy. Etiology remains partially unknown, although familial or genetic patterns of inheritance have been hypothesized, since hemangiomas have been described as part of defined clinical syndromes, such as Klippel-Trenaunay-Weber syndrome, Kasabach-Merritt syndrome, Osler-Rendu-Weber disease and Von Hippel-Lindau disease. No data on HH prevalence in celiac disease (CD) are available. Aim: To evaluate the possible association between HH and CD, in a series of celiac patients. Methods: From June 2010 to June 2011 a consecutive series of 97 histologically confirmed CD patients (18 M, 79 F, median age 41, range 17–84 years) underwent complete abdominal ultrasound (US). The US liver findings were compared with the ones of 681 nonceliac patients (309 M, 372 F, median age 53, range 18–89 years), free from known liver disease or previously detected HH, who performed US in the same period for aspecific gastroenteric symptoms (i.e. dyspepsia, abdominal pain, diarrhea). Results: 14 celiac patients (14.4%) showed US findings fully consistent with HH, compared with 35 (5.1%) in the control population (p = 0.0005). Prevalence of female sex was higher in
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POSTERS CD than in the control population (p < 0.001). The two group were indeed similar for age and presence of steatosis (37% of celiac patients and 32.3% in the control subjects, p = n.s.). HH in celiac patients had a median diameter of 1.3 cm (range 0.6–6.8 cm) and presented as a single lesion in 12/14 patients (86%) and as multiple lesions in the other two (14%), with a hyperechoic aspect in 13 patients (93%) without significant differences with control subjects. Conclusions: The prevalence of HH in the setting of CD seems to be higher compared to general population. Although mechanisms underlying this association are still far to be clearly understood, genetic, autoimmune, hormonal or metabolic processes could play an important role. 697 KIR2DL5 AND HLA-BW4I80 ARE ASSOCIATED WITH LONGER OVERALL SURVIVAL IN PATIENTS UNDERGOING LIVER RESECTION FOR HEPATOCELLULAR CARCINOMA E. Cariani1 , M. Pilli2 , A. Zerbini3 , C. Rota1 , A. Olivani2 , D. Canetti2 , P. Zanelli4 , A. Zanetti4 , C. Ferrari2 , G. Missale2 . 1 Clinical PathologyToxicology, Ospedale Civile S. Agostino-Estense, Modena, 2 U.O. Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria di Parma, Parma, 3 Clinical Microbiology Laboratory, Azienda Ospedaliera ASMN-IRCCS, Reggio Emilia, 4 U.O. Genetica Medica, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy E-mail: [email protected] Background and Aims: Killer cell immunoglobulin-like receptors (KIRs) are related to the activation and inhibition of natural killer cells and may play an important role in the innate response against cancer and infections. KIRs have been shown to influence the development of hepatocellular carcinoma (HCC) in post-hepatitic liver cirrhosis. Aim of our study was to evaluate if KIRs can influence HCC disease recurrence and overall survival in patients that had undergone curative resection. Methods: KIR genotyping (2DL1, 2DL2, 2DL3, 2DL5, 2DS1, 2DS2, 2DS3, 2DS5, 3DL1, 3DS1) was performed by PCR with gene-specific primer pairs in a cohort of 41 patients undergoing liver resection for HCC, that were also typed for HLA-Bw4 and -Bw6 supertypes. Liver cirrhosis was due to HCV infection in 29/41 (70.7%) of our patient cohort. Results: KIR2DL5 genotype was significantly (p = 0.016) associated with longer survival (KIR2DL5 negative: 50% overall survival (OS) 29 months, 75% OS 18 months; KIR2DL5 positive: 50% OS undefined, 75% OS 85 months). The HLA-Bw4I80 genotype was also overrepresented in patients with better survival (p = 0.046, 75% survival: 73 months for Bw4I80-positive patients and 15 months for Bw4I80 negatives), whereas Bw4T80 was predictive of worse prognosis (p = 0.026, 75% survival: 18 months for Bw4T80-positive patients and 78 months for Bw4T80 negatives). Conclusions: KIR2DL5 and HLA-Bw4I80 genes association with HCC prognosis supports a role for natural killer (NK) cell activation in HCC progression. 698 ASSOCIATION OF POLYMORPHISM IN MICRORNA 604 WITH SUSCEPTIBILITY TO PERSISTENT HEPATITIS B VIRUS INFECTION AND DEVELOPMENT OF HEPATOCELLULAR CARCINOMA IN PATIENTS WITH CHRONIC HEPATITIS B J.Y. Cheong1 , S.S. Kim1 , Y.J. Kim2 , S.W. Cho1 . 1 Ajou University School of Medicine, Suwon, 2 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea E-mail: [email protected] Background: Polymorphisms in microRNA may be associated with tumorigenesis or immune control of infection. We evaluated the mircoRNA 604 (miR-604) polymorphism can influence the S276
susceptibility to persistence of hepatitis B virus (HBV) infection and the progression to hepatocellular carcinoma (HCC) in chronic HBV infected patients. Methods: A total of 1,439 individuals having either past or present evidence of HBV infection were enrolled in Ajou University hospital and Seoul National University Hospital. Subjects were divided into 4 groups; 1. spontaneously recovery from HBV infection (n = 404), 2. chronic HBV carrier without cirrhosis (n = 313), 3. chronic HBV carrier with cirrhosis (n = 305), 4. hepatocellular carcinoma (n = 417). We genotyped miR-604 genome region polymorphism (rs2368392) using the TaqMan® assay in the ABI prism 7900HT sequence detection system. Results: The CC genotype of miR-604 rs2368392 was prevailed (46.4%) and T allele frequency was 0.326 in all the subjects. The chronicity of HBV infection was higher in subjects with miR-604 T allele compared with subjects with C allele (OR, 1.19; CI, 1.00– 1.42; P = 0.05 in a co-dominant model, and OR, 1.26; CI, 1.00–1.60; P = 0.05 in a dominant model), implying that the patients with miR604 T allele may have a higher risk for HBV persistence. In contrast, miR-604 T allele showed protective effect for HCC development (OR, 0.80; CI, 0.65–0.98; P = 0.03 in a co-dominant model, and OR, 0.58; CI, 0.38–0.91; P = 0.02 in a recessive model). There was no significant association between miR-604 polymorphism and the risk of cirrhosis development in chronic HBV carrier. Conclusion: The T allele at miR-604 rs2368392 may be a risk factor for HBV persistence after infection, but may be protective factor for HCC development in patients with chronic HBV infection. 699 OBSERVED PATTERNS OF SYSTEMIC THERAPY USE IN HEPATOCELLULAR CARCINOMA (HCC) PATIENTS FROM THE MULTINATIONAL HCC BRIDGE STUDY: RESULTS OF A SECOND INTERIM ANALYSIS M. Colombo1 , L. Roberts2 , M. Schwartz3 , F. Degos4 , M. Sherman5 , P.-J. Chen6 , M. Chen7 , J.-W. Park8 , M. Kudo9 , P. Johnson10 , B. Huang11 , S. Wagner12 , L. Orsini13 . 1 Ospedale Maggiore, Milan, Italy; 2 Mayo Clinic, Rochester, MN, 3 Mount Sinai Medical Center, New York, NY, USA; 4 Hˆ opital Beaujon, Clichy, France; 5 University of Toronto, Toronto, ON, Canada; 6 National Taiwan University, Taiwan, Taiwan R.O.C.; 7 Sun Yat-sen University, Guangzhou, China; 8 National Cancer Center, Goyang, Republic of Korea; 9 Kinki University, Osaka, Japan; 10 University of Birmingham, Birmingham, UK; 11 Outcome Sciences, Cambridge, MA, 12 Bristol-Myers Squibb, Princeton, NJ, 13 Bristol-Myers Squibb, Wallingford, CT, USA E-mail: [email protected] Background and Aims: Treatment options for patients with advanced HCC remain limited, particularly with respect to systemic therapy. Here we present a second interim analysis of the HCC BRIDGE study, the first global, large-scale, observational study to document real-life HCC patient experience from diagnosis to death, focusing on the patient cohort that received systemic treatment. Methods: This longitudinal cohort study includes HCC patients newly diagnosed between January 2005 and June 2011 and treated at major medical centers in North America, Europe, and Asia, with data collected retrospectively and prospectively as recorded in patient charts. This analysis will include second interim data from the cohort of patients treated with systemic therapy across all regions. Results: As of July 2011 (first interim analysis), 12,442 patients were enrolled, of whom 1536 (12%) had received systemic treatment. Similar to the pattern of risk factors seen by region in the overall study population, the predominant risk factors in the systemically treated cohort were HCV in North America and Europe and HBV in Asia. In the systemically treated cohort, Child-Pugh status at
Journal of Hepatology 2012 vol. 56 | S225–S388
Methods: A multicenter Italian cohort enrolled 1729 patients with HCC during a six month period, of whom 87 (4.7%) without underlying cirrhosis (NCP = no cirrhosis patients). An age and gender pair matched group of patients with underlying cirrhosis (n = 107) was retrieved from the main cohort (UCP = underlying cirrhosis patients). Diagnosis of HCC was assessed according to AASLD guidelines. Results: Mean age of NCP was 68.4±10.2 years, 97.7% were Caucasians. Diagnosis of HCC in normal liver was assessed by histology in 46 cases (58%) and by imaging and endoscopic procedures in 41. There were no differences in baseline characteristics between these two groups of patients. HCV infection was present in 32.2% of NCP and in 72.9% of UCP (p = 0.0001); overall, 54% of NCP were HBsAg and anti-HCV negative vs. only 15.9% of UC cases. Compared with UCP, serum cholesterol levels were higher in NC patients (185.1±43.8 vs. 162.6±43.5; p = 0.004); there were no differences in cigarette smoking, environmental toxic exposure, alfafetoprotein value, presence of comorbidities. Among NCP, virus-negative cases compared with virus-positive cases were more frequently alcohol users (45% vs. 20%; p = 0.0009) and had a higher BMI value (26.4±4 vs. 23.6±2.8; p = 0.008); 19 out of the 48 virus-negative patients (39.5%) had no indentified risk factor. 68% of cirrhotic patients were under ultrasonographic surveillance at least on yearly basis vs. 22% of NC patients (p = 0.001). At diagnosis, HCC was less frequently mononodular in NCP (16.7 vs 38.5%; p = 0.029). Conclusions: HCC in non cirrhotic liver accounted for 4.7% of HCC cases and was more advanced at diagnosis than in UC patients, possibly due to the low number of patients under ultrasonographic surveillance. Alcohol use and an elevated BMI were associated with HCC in NC patients, although in some of them no potential causative agents were identified. 696 HEPATIC HEMANGIOMA IN CELIAC DISEASE: A NEW POSSIBLE ASSOCIATION? S. Massironi1 , F. Branchi1,2 , R.E. Rossi1,2 , M. Fraquelli1 , L. Elli3 , M.T. Bardella3 , F. Cavalcoli1,2 , D. Conte1,2 . 1 Gastroenterology Unit II, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, 2 Postgraduate School of Gastroenterology, Universit` a degli Studi di Milano, 3 Center for Prevention and Diagnosis of Celiac Disease, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy E-mail: [email protected] Background: Hepatic hemangioma (HH) is the most common benign mesenchymal tumor affecting the liver. Estimates of the prevalence of HH range widely, from 0.4 to 20%, with the highest prevalence rate at autopsy. Etiology remains partially unknown, although familial or genetic patterns of inheritance have been hypothesized, since hemangiomas have been described as part of defined clinical syndromes, such as Klippel-Trenaunay-Weber syndrome, Kasabach-Merritt syndrome, Osler-Rendu-Weber disease and Von Hippel-Lindau disease. No data on HH prevalence in celiac disease (CD) are available. Aim: To evaluate the possible association between HH and CD, in a series of celiac patients. Methods: From June 2010 to June 2011 a consecutive series of 97 histologically confirmed CD patients (18 M, 79 F, median age 41, range 17–84 years) underwent complete abdominal ultrasound (US). The US liver findings were compared with the ones of 681 nonceliac patients (309 M, 372 F, median age 53, range 18–89 years), free from known liver disease or previously detected HH, who performed US in the same period for aspecific gastroenteric symptoms (i.e. dyspepsia, abdominal pain, diarrhea). Results: 14 celiac patients (14.4%) showed US findings fully consistent with HH, compared with 35 (5.1%) in the control population (p = 0.0005). Prevalence of female sex was higher in
Journal of Hepatology 2012 vol. 56 | S225–S388
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POSTERS CD than in the control population (p < 0.001). The two group were indeed similar for age and presence of steatosis (37% of celiac patients and 32.3% in the control subjects, p = n.s.). HH in celiac patients had a median diameter of 1.3 cm (range 0.6–6.8 cm) and presented as a single lesion in 12/14 patients (86%) and as multiple lesions in the other two (14%), with a hyperechoic aspect in 13 patients (93%) without significant differences with control subjects. Conclusions: The prevalence of HH in the setting of CD seems to be higher compared to general population. Although mechanisms underlying this association are still far to be clearly understood, genetic, autoimmune, hormonal or metabolic processes could play an important role. 697 KIR2DL5 AND HLA-BW4I80 ARE ASSOCIATED WITH LONGER OVERALL SURVIVAL IN PATIENTS UNDERGOING LIVER RESECTION FOR HEPATOCELLULAR CARCINOMA E. Cariani1 , M. Pilli2 , A. Zerbini3 , C. Rota1 , A. Olivani2 , D. Canetti2 , P. Zanelli4 , A. Zanetti4 , C. Ferrari2 , G. Missale2 . 1 Clinical PathologyToxicology, Ospedale Civile S. Agostino-Estense, Modena, 2 U.O. Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria di Parma, Parma, 3 Clinical Microbiology Laboratory, Azienda Ospedaliera ASMN-IRCCS, Reggio Emilia, 4 U.O. Genetica Medica, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy E-mail: [email protected] Background and Aims: Killer cell immunoglobulin-like receptors (KIRs) are related to the activation and inhibition of natural killer cells and may play an important role in the innate response against cancer and infections. KIRs have been shown to influence the development of hepatocellular carcinoma (HCC) in post-hepatitic liver cirrhosis. Aim of our study was to evaluate if KIRs can influence HCC disease recurrence and overall survival in patients that had undergone curative resection. Methods: KIR genotyping (2DL1, 2DL2, 2DL3, 2DL5, 2DS1, 2DS2, 2DS3, 2DS5, 3DL1, 3DS1) was performed by PCR with gene-specific primer pairs in a cohort of 41 patients undergoing liver resection for HCC, that were also typed for HLA-Bw4 and -Bw6 supertypes. Liver cirrhosis was due to HCV infection in 29/41 (70.7%) of our patient cohort. Results: KIR2DL5 genotype was significantly (p = 0.016) associated with longer survival (KIR2DL5 negative: 50% overall survival (OS) 29 months, 75% OS 18 months; KIR2DL5 positive: 50% OS undefined, 75% OS 85 months). The HLA-Bw4I80 genotype was also overrepresented in patients with better survival (p = 0.046, 75% survival: 73 months for Bw4I80-positive patients and 15 months for Bw4I80 negatives), whereas Bw4T80 was predictive of worse prognosis (p = 0.026, 75% survival: 18 months for Bw4T80-positive patients and 78 months for Bw4T80 negatives). Conclusions: KIR2DL5 and HLA-Bw4I80 genes association with HCC prognosis supports a role for natural killer (NK) cell activation in HCC progression. 698 ASSOCIATION OF POLYMORPHISM IN MICRORNA 604 WITH SUSCEPTIBILITY TO PERSISTENT HEPATITIS B VIRUS INFECTION AND DEVELOPMENT OF HEPATOCELLULAR CARCINOMA IN PATIENTS WITH CHRONIC HEPATITIS B J.Y. Cheong1 , S.S. Kim1 , Y.J. Kim2 , S.W. Cho1 . 1 Ajou University School of Medicine, Suwon, 2 Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea E-mail: [email protected] Background: Polymorphisms in microRNA may be associated with tumorigenesis or immune control of infection. We evaluated the mircoRNA 604 (miR-604) polymorphism can influence the S276
susceptibility to persistence of hepatitis B virus (HBV) infection and the progression to hepatocellular carcinoma (HCC) in chronic HBV infected patients. Methods: A total of 1,439 individuals having either past or present evidence of HBV infection were enrolled in Ajou University hospital and Seoul National University Hospital. Subjects were divided into 4 groups; 1. spontaneously recovery from HBV infection (n = 404), 2. chronic HBV carrier without cirrhosis (n = 313), 3. chronic HBV carrier with cirrhosis (n = 305), 4. hepatocellular carcinoma (n = 417). We genotyped miR-604 genome region polymorphism (rs2368392) using the TaqMan® assay in the ABI prism 7900HT sequence detection system. Results: The CC genotype of miR-604 rs2368392 was prevailed (46.4%) and T allele frequency was 0.326 in all the subjects. The chronicity of HBV infection was higher in subjects with miR-604 T allele compared with subjects with C allele (OR, 1.19; CI, 1.00– 1.42; P = 0.05 in a co-dominant model, and OR, 1.26; CI, 1.00–1.60; P = 0.05 in a dominant model), implying that the patients with miR604 T allele may have a higher risk for HBV persistence. In contrast, miR-604 T allele showed protective effect for HCC development (OR, 0.80; CI, 0.65–0.98; P = 0.03 in a co-dominant model, and OR, 0.58; CI, 0.38–0.91; P = 0.02 in a recessive model). There was no significant association between miR-604 polymorphism and the risk of cirrhosis development in chronic HBV carrier. Conclusion: The T allele at miR-604 rs2368392 may be a risk factor for HBV persistence after infection, but may be protective factor for HCC development in patients with chronic HBV infection. 699 OBSERVED PATTERNS OF SYSTEMIC THERAPY USE IN HEPATOCELLULAR CARCINOMA (HCC) PATIENTS FROM THE MULTINATIONAL HCC BRIDGE STUDY: RESULTS OF A SECOND INTERIM ANALYSIS M. Colombo1 , L. Roberts2 , M. Schwartz3 , F. Degos4 , M. Sherman5 , P.-J. Chen6 , M. Chen7 , J.-W. Park8 , M. Kudo9 , P. Johnson10 , B. Huang11 , S. Wagner12 , L. Orsini13 . 1 Ospedale Maggiore, Milan, Italy; 2 Mayo Clinic, Rochester, MN, 3 Mount Sinai Medical Center, New York, NY, USA; 4 Hˆ opital Beaujon, Clichy, France; 5 University of Toronto, Toronto, ON, Canada; 6 National Taiwan University, Taiwan, Taiwan R.O.C.; 7 Sun Yat-sen University, Guangzhou, China; 8 National Cancer Center, Goyang, Republic of Korea; 9 Kinki University, Osaka, Japan; 10 University of Birmingham, Birmingham, UK; 11 Outcome Sciences, Cambridge, MA, 12 Bristol-Myers Squibb, Princeton, NJ, 13 Bristol-Myers Squibb, Wallingford, CT, USA E-mail: [email protected] Background and Aims: Treatment options for patients with advanced HCC remain limited, particularly with respect to systemic therapy. Here we present a second interim analysis of the HCC BRIDGE study, the first global, large-scale, observational study to document real-life HCC patient experience from diagnosis to death, focusing on the patient cohort that received systemic treatment. Methods: This longitudinal cohort study includes HCC patients newly diagnosed between January 2005 and June 2011 and treated at major medical centers in North America, Europe, and Asia, with data collected retrospectively and prospectively as recorded in patient charts. This analysis will include second interim data from the cohort of patients treated with systemic therapy across all regions. Results: As of July 2011 (first interim analysis), 12,442 patients were enrolled, of whom 1536 (12%) had received systemic treatment. Similar to the pattern of risk factors seen by region in the overall study population, the predominant risk factors in the systemically treated cohort were HCV in North America and Europe and HBV in Asia. In the systemically treated cohort, Child-Pugh status at
Journal of Hepatology 2012 vol. 56 | S225–S388