P-110 Hepatocellular carcinoma in elderly patients: Final results of the Italian cohort of GIDEON study

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Characteristics of autoimmune hepatitis in patients who are not of European Caucasoid ethnic origin

Background: Significant diversity in disease severity has been identified for autoimmune disorders among different ethnic groups but there is a lack of data on autoimmune hepatitis (AIH) in populations other than those of European Caucasoid (EC) or Japanese extraction. Aims: To assess the clinical features, response to therapy, and eventual outcome in AIH patients of non-EC ethnicity. Methods: A retrospective review of a regularly updated database of patients with AIH referred to liver outpatient clinics at King's College Hospital, London, since 1983. Results: Twelve patients were identified (10 female; six African, five Asian, one Arabic; median age at presentation 30 years (range 12–58)) who satisfied international criteria for type 1 (11 cases) or type 2 (one case) AIH. Nine (75%) had cholestatic serum biochemistry and three (25%) had mild biliary changes on liver biopsy without definitive features of primary biliary cirrhosis or cholangiographic evidence of primary sclerosing cholangitis. Four showed a complete biochemical response to standard prednisolone with or without azathioprine therapy, three partial, and five no response. Four have required liver transplantation for intractable disease. By comparison with 180 EC patients with definite AIH attending during the same period, the non-EC patients were younger (p<0.05), presented with cholestatic biochemistry (p=0.014), and morphological biliary features more frequently (p<0.0005) and showed a poorer initial response to standard therapy (p<0.0005). Conclusions: Clinical expression of AIH in non-EC patients seems to differ in important respects from that in EC or Japanese patients. Management of such patients is challenging and may require alternative or more aggressive treatment strategies

Efficacy, safety and impact on quality of life of Sorafenib in elderly patients with advanced Hepatocellular carcinoma. Preliminary results of a Phase II study

Introduction: Sorafenib is the only systemic therapy that has prolonged the median survival and time to progression in patients with advanced hepatocellular carcinoma. Methods: The primary aim of this open prospective non-randomized phase II study was to assess efficacy and safety of sorafenib in a selected population of elderly patients with advanced hepatocellular carcinoma not previously treated. Secondary aims included quality of life (QoL) assessment using SF-36 questionnaire and changes of serum IL-6. All patients underwent multidimensional geriatric assessment (MGA) and accordingly were assigned to 3 different categories: fit, intermediate and frail. Scheduled sorafenib dose was 800 mg/day until disease progression or unacceptable toxicity. Efficacy was assessed every 3 months and defined as objective clinical response (RECIST) and disease-control rate (DCR), i.e. the percentage of patients who had a best-response (complete response, CR, or partial response, PR, or stable disease, SD) maintained for at least 28 days. Results: From January to November 2008 14 patients (M/F ratio, 12:2; mean age 70.7±3.1 years; range, 66−76) were enrolled and 13 were evaluable after 3 months: 28.6% had ECOG PS 0, 57.1% PS 1, and 14.3% PS 2. According to MGA, 3 patients were fit, 8 intermediate and 3 frail. At 3-month evaluation no CR/PR, 8/13 (61.5%) SD, 5/13 (38.5%) PD were observed. DCR was 75.0% (6/8 patients). The toxicity was moderate and the worst was grade 3: hand-foot and skin reactions (30.7%), hypertension (15.4%), diarrhea (30.7%), nausea and vomiting (7.7%), asthenia (15.4%). The treatment was interrupted for a mean of 9 days (range 4−19) due to toxicities in 84.6% of patients and restarted at a reduced dosage (400 mg/day) which was well tolerated. The mean dosage was 552 mg/day. QoL improved globally and in particular for: pain, energy, physical activity and patient perception of self-health status. Serum IL-6 were high at enrolment and did not change thereafter. At Novembrer 2008, 10/13 patients are alive. Conclusion: In elderly cancer patients with advanced hepatocellular carcinoma sorafenib demonstrated a good DCR, a moderate toxicity at 800 mg/day, an optimal acceptability at 400 mg/day and a significant improvement of quality of life