M. De Luca

990 PEGINTERFERON ALPHA-2A PLUS RIBAVIRIN VERSUS PEGINTERFERON ALPHA-2B PLUS RIBAVIRIN IN NAIVE PATIENTS WITH CHRONIC HEPATITIS C VIRUS INFECTION: RESULTS OF A PROSPECTIVE RANDOMISED TRIAL

are presented in tables 1 and 2. Serious adverse events occurred in 12 patients of the budesonide group and 14 patients of the prednisone group. Conclusion: In this largest AIH-trial, ever conducted, 3mg tid oral budesonide is superior to oral prednisone each in combination with AZA in inducing biochemical remission in active autoimmune hepatitis with significantly less steroid specific side effects (SSSE).

Probiotics and atopic dermatitis. A new strategy in atopic dermatitis

Over the last few decades, the prevalence of atopic dermatitis has been increasing from 2% to 100%, with 90% of cases within 5 years of age versus 6% between 6 and 10 years and 2% after 10 years, and environmental factors may possibly play an important role in this increase as in other atopic diseases. Many findings suggest an important role of atopy in atopic dermatitis; moreover, 40% of children with atopic dermatitis have food allergy and the removal of the food allergen from the patients diet leads to a significant clinical improvement. In a possible scenario, IgE-bearing dendritic cells are likely to process allergens acquired in the gastrointestinal tract, circulate to the skin and activate local T cells. Cultures of beneficial live microorganisms characteristic of the commensal microflora are administered with probiotic functional foods in order to provide a microbial challenge for the maturation of gut-associated lymphoid tissue, which the infant often lacks. The probiotic effects are attributed to normalisation of the increased intestinal permeability and balancing gut microecology, improvement of the immunological defence barrier (IgA) of the intestine, alleviation of the intestinal inflammatory response, and downregulation of proinflammatory cytokines characteristic of local and systemic allergic inflammation.

Safety and efficacy of subcutaneous hepatitis B immunoglobulin after liver transplantation: an open single-arm prospective study.

Life‐long hepatitis B immunoglobulin (HBIG) administration is a main component of prophylactic strategy to prevent hepatitis B virus (HBV) reinfection after liver transplantation (LT). Long‐term effects of HBIG treatment are known only for intravenous (IV) and intramuscular formulations. To evaluate safety and efficacy of self‐administered SC HBIG, 135 LT patients receiving a 48‐week treatment were analyzed. The dose of HBIG was 500 IU or 1000 IU if body weight was <75 kg or ≥75 kg, respectively. Patients were switched from the monthly IV HBIG treatment to weekly SC HBIG 2–3 weeks after the last IV dosage. All patients were able to SC self‐injection after a single training. The treatment was effective in maintaining trough anti‐HBs levels >100 IU/L. No severe drug‐related side effects occurred. Fifteen injection‐site small hematomas and four cases of mild itch occurred. At the end of the study, anti‐HBs median titer was 232 IU/L (115–566 IU/L) and 97.8% of patients had an anti‐HBs level >150 IU/L. Due to high mean level of anti‐HBs titers observed during this study, individualized treatment schedules should be further investigated. In conclusion, SC HBIG for long‐term prophylaxis of post‐LT HBV reinfection resulted safe, well accepted, and effective in maintaining adequate anti‐HBs levels.

P.1.1: PREDICTIVE FACTORS FOR TUMOR CONTROL AMONG HEPATOCELLULAR CARCINOMA PATIENTS TREATED WITH SORAFENIB

Background and aim: Sorafenib is a multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma (HCC). However, the predictive factors of outcome among treated patients have not been fully investigated. Aim of this study was to identify factors predictive for tumor control among patients with advanced HCC treated with sorafenib. Material and methods: All consecutive HCC patients treated with sorafenib at our Unit from October 2008 to October 2010 were evaluated. All patients received 800 mg/day of sorafenib until progression or unacceptable toxicities. Overall survival (OS) and time to progression (TTP) were estimated by using Kaplan-Meier curves. TTP was considered as a marker of tumor control. Univariate analysis included age, gender, etiology, AFP, Child-Pugh class, MELD, alanine aminotransferase (ALT), alkaline phosphatase, bilirubin, albumin, ascites, metastasis, portal vein thrombosis, oesophageal varices, effects related to VEGF inhibition: rash, arterial hypertension, bleeding, and hand-foot syndrome (HFS). To detect factors independently related to TTP, multivariate analysis by Cox’s model was done. Results: We treated 101 patients (median age 67 years; 81 males; 98 cirrhotics; Child A/B: 79/19; 55 macrovascular invasion; 39 extrahepatic spread). Median therapy duration was 4 (range 1-16) months. Median OS was 10 (95% CI 4.5-15.5) months. TTP was 9 (95%CI 3.7-14.3) months. Complete/partial response occurred in 21% of patients and stable disease in 19%. At univariate analysis, the variables significantly related to TTP were: female sex (14 months vs 6 months, p=.05), no portal thrombosis (13 months vs 6 months, p=.04), ALT =60UI (15 months vs 6 months, p=.02), no ascites (11 months vs 2 months, p=.003), and occurrence of HFS (16 months vs 5 months, p<0.000). At multivariate analysis, no ascites (p=.02; HR 2.7, 95%CI 1.2-6.0) and occurrence of HFS (p<.000; HR 8.9, 95%CI 3.3-23.8) were independently related to TTP. Conclusions: In sorafenib treated patients, the absence of ascites and the occurrence of HFS are predictive factors for longer TTP. HFS was the only symptom related to inhibition of VEGF predicting tumor control.

629 SAFETY AND EFFECTIVENESS OF TREATMENT WITH SORAFENIB IN ELDERLY CIRRHOTIC PATIENTS AFFECTED BY ADVANCED HEPATOCELLULAR CARCINOMA

RISK STRATIFICATION USING OCTREOTIDE TEST FOR PATIENTS WITH GASTRO-ENTERO-PANCREATIC NEUROENDOCRINE TUMORS: RESULTS OF PROSPECTIVE VALIDATION OF THE TEST S. Massironi 1, M.P. Spampatti 2 , R.E. Rossi∗ ,2, D. Conte2, C. Ciafardini 2 , M. Peracchi 2 1Fondazione Irccs Ca’ Granda Ospedale Maggiore Policlinico Milano, Milano, Italy; 2Dipartimento di Scienze Mediche, Universita degli Studi di Milano, Milan, Milano, Italy

P.1.66: SAFETY AND EFFECTIVENESS OF TREATMENT WITH SORAFENIB IN ELDERLY CIRRHOTIC PATIENTS AFFECTED BY ADVANCED HEPATOCELLULAR CARCINOMA

RISK STRATIFICATION USING OCTREOTIDE TEST FOR PATIENTS WITH GASTRO-ENTERO-PANCREATIC NEUROENDOCRINE TUMORS: RESULTS OF PROSPECTIVE VALIDATION OF THE TEST S. Massironi 1, M.P. Spampatti 2 , R.E. Rossi∗ ,2, D. Conte2, C. Ciafardini 2 , M. Peracchi 2 1Fondazione Irccs Ca’ Granda Ospedale Maggiore Policlinico Milano, Milano, Italy; 2Dipartimento di Scienze Mediche, Universita degli Studi di Milano, Milan, Milano, Italy

P.1.97: SORAFENIB FOR THE TREATMENT OF ADVANCED HEPATOCELLULAR CARCINOMA: EFFECTIVENESS AND IMPACT OF ADVERSE EFFECTS IN DAILY CLINICAL PRACTICE

Background and aim: Colorectal cancer (CRC) represents the second leading cause of cancer mortality in Europe. Evidence from several scientific studies suggests that screening for the early detection and removal of cancerous lesions can reduce its incidence and mortality and improve patients’ quality of life. The main literature on this topic refers to the American context, which is extremely different from the Italian one. The aim is to propose the results of a cost-effectiveness analysis of a screening program in Italy using as case-study the experience of a CRC screening program started in 2005 in the Province of Ferrara, to determine the full cost of the screening program and to compare the costs-effectiveness of FOBT and colonoscopy. Material and methods: A micro-costing analysis is used to identify and evaluate all the costs involved in each phase of the screening program, following an activity-based costing approach to consider all the activities carried out in the assistance process. The effectiveness of the diagnostic instrument used, FOBT combined with colonoscopy, is valued in terms of early detected lesions and years of life gained. Finally, we use the cost and effectiveness data collected to estimate the costs for year of life gained using a MISCAN-COLON Model. Results: The preliminary results show that, after the screening implementation, a huge number of new cases of hyperplasic polyps, dysplastic adenomas and carcinomas are detected. Moreover, early diagnosis allows the diagnosis of colorectal cancer at the earliest Dukes’ stages. The results of the Model show that the screening program will reduce mortality of 11% and prevent almost 1,100 deaths, with 12,741 years of life gained in a period of time of 30 years. Comparing the costs born in the first wave of the screening with the number of years potentially saved, the model shows that the incremental cost-effectiveness ratio of the program is almost €5,315 for life year. Conclusions: This study shows the economic benefits of the screening program estimated in similar studies conducted in other countries (Sonnenberg, 2000). Besides, the paper highlights the importance of implementing a screening program not only for the effects that prevention can have in clinical terms, but also for the economic impact of such a policy in terms of long-term sustainability of healthcare systems.