POSTERS significantly associated with overall survival (OS) on univariate analysis and therefore included in multivariate analysis. Only Child– Pugh stage and HAP-Score were independent prognostic factors. The median OS for HAP A/B/C/D was 26/18/14/10 months (p < 0.0001). Conclusions: We could validate the HAP-score in an independent cohort of HCC patients treated with TACE. The HAP-score discriminates four different prognostic subgroups. Its clinical usefulness is limited by only 2 treatment options being available for this group of patients (TACE and drug treatment). A simplified score could be a useful tool for the selection of HCC patients for TACE. P984 EFFICACY OF SORAFENIB ACCORDING TO THE NUMBER OF PRIOR TACE PROCEDURES IN HEPATOCELLULAR CARCINOMA PATIENTS R. Sacco1 , A. Romano1 , M. Bertini1 , S. Metrangolo1 , G. Parisi1 , M. Bertoni1 , G. Federici1 , A. Scaramuzzino1 , V. Mismas1 , B. Ginanni2 , I. Bargellini2 , L. Fornaro3 , G. Masi3 , G. Bresci1 , ITA.LI.CA. Group. 1 Gastroenterology, 2 Radiology, 3 Oncology, Pisa University Hospital, Pisa, Italy E-mail:
[email protected] Background and Aims: It has been suggested that sorafenib should be initiated as early as possible in patients with HCC who failed transarterial chemoembolization; the correlation between the efficacy of sorafenib and the number of prior TACE has not been documented. We analyzed the correlation between the efficacy of sorafenib and the number of prior TACE procedures in HCC patients included in the Nation-wide Italian database ITA.LI.CA. Methods: ITA.LI.CA. database contains 5136 HCC patients. Patients treated with sorafenib were included. We considered as endpoints: overall survival, time to progression and disease control rate. These endpoints were compared in patients with no TACE, one and ≥2 prior TACE procedures. Results: 321 patients received sorafenib (271 males; age 65±11 years; 225 in BCLC-C stage). Of these, 201 received no TACE (187 were in BCLC-C stage), 60 one TACE and 60 ≥2 TACE. Median OS was significantly longer in patients who received one single TACE procedure, with respect to those with no or ≥2 TACE procedure(s) (19 months with one TACE versus 11 months with no TACE and 12 months for ≥2 TACE; p < 0.05). No differences among groups were observed in TTP (one TACE: 4 months; no TACE: 4 months; ≥2 TACE: 5 months; p=not significant), but patients with only one TACE prior to sorafenib treatment had an improved DCR (one TACE: 34%; no TACE: 24%; ≥2 TACE: 28%; p < 0.05). Conclusions: This analysis suggests that HCC patients starting sorafenib after one single TACE procedure present improved OS and DCR with respect to those who received ≥2 TACE procedures. P985 CONCOMITANT VERSUS SEQUENTIAL TREATMENT WITH TACE AND SORAFENIB IN HEPATOCELLULAR CARCINOMA PATIENTS R. Sacco1 , A. Romano1 , I. Bargellini2 , B. Ginanni2 , V. Mismas1 , C. Vivaldi3 , C. Caparello3 , G. Musettini3 , G. Masi3 , L. Faggioni2 , G. Bresci1 , ITA.LI.CA. Group. 1 Gastroenterology, 2 Radiology, 3 Oncology, Pisa University Hospital, Pisa, Italy E-mail:
[email protected] Background and Aims: A therapeutic strategy based on the concomitant – rather than sequential – administration of TACE and sorafenib for the treatment of patients with HCC gained particular interest. In this field-practice study, we compare the clinical outcomes associated with the concomitant and the sequential strategy, in HCC patients included in the Nation-wide Italian database ITA.LI.CA. Methods: ITA.LI.CA. contains data of 5136 HCC patients. Patients treated with TACE and sorafenib, either sequentially or in combination, were included in this analysis. These endpoints were
considered: overall survival, time to progression, disease control rate. Data reported in patients who received concomitant treatment were compared with those observed in patients on sequential treatment. Results: 128 patients were observed (98 males; age 44.7 years; 107 in BCLC-B stage). Of these, 17 received concomitant treatment with TACE and sorafenib, whereas the sequential strategy was applied to 111 subjects. Median OS was significantly longer in patients on concomitant treatment than in those receiving the sequential strategy (25 months vs 12 months; p < 0.01). A similar finding was observed for TTP (6 months vs 4 months; p < 0.05) and for DCR (30% vs 25%; p < 0.05). One patient treated with the concomitant strategy and two patients on the sequential therapy experienced a complete response. No relevant safety warnings were reported. Conclusions: Although the different sample size of the two groups hampers the analysis, the results of this large, field-practice study lend some support to the effectiveness and safety of sorafenib in combination with TACE rather than after the failure of this locoregional therapy. P986 MANAGEMENT OF HCC BY TRANSARTERIAL CHEMOEMBOLIZATION CONVENTIONAL AND BEADS DOXORUBICIN ´ Giraldez1 , J.M. Sousa1 , V. Nacarino2 , V. Ciria1 , M.T. Ferrer1 , A. ´ Iglesias2 , J. Peiro´ 2 , J.M. Pascasio1 . 1 Gastroenterology, 2 Hospital A. Virgen del Roc´ıo, Seville, Spain E-mail:
[email protected] Background and Aims: Transarterial chemoembolization (TACE) is a locoregional therapy for hepatocellular carcinoma (HCC). The use of microspheres of doxorubicin (DEB-TACE) versus conventional TACE (cTACE) has been recently proposed. Objetive: To analyze the impact of DEB-TACE versus cTACE in the management of patients with HCC in a tertiary hospital. Methods: Retrospective study of 102 patients with liver cirrhosis and HCC who underwent TACE in our hospital. Baseline descriptive analyses and survival curves (Kaplan Meier) were performed. Logrank test was used to survival comparisons. Results: Cirrhosis was related to HCV (42.5%) and alcohol (24.5%) in most cases. Most patients were male (79%), Child A (60%), mean age 62 and 69.6% had a single HCC. There were no baseline significant differences in both groups. 41 patients (40%) underwent DEB-TACE modality. 76 patients responded to first TACE session. Post-TACE syndrome was significantly less frequent in the DEB-TACE group (14.8% vs. 39.1%). The median survival as definitive treatment or pre-LT was 629 and 827 days, respectively. As definitive therapy 1-, 2- and 3-years survival was 73.5%, 32.4% and 17.6% with cTACE versus 23.8%, 19% and 12.7% with DEB-TACE. As bridging therapy, 1-, 2- and 3-years post-transplant survival was 94.7%, 89.2% and 77.6% with cTACE versus 66.7%, 57.1%, 57.1% with DEB-TACE. There were no significant differences in tumor-related death rates in both scenarios. Conclusions: DC-Beads is a safe therapy, useful in the whole spectrum of HCC cirrhotic patients. Although it seems to give no survival advantage, tumor-related deaths were not higher in both conventional and DC-Beads groups.
Journal of Hepatology 2014 vol. 60 | S361–S522
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