650 SURVIVAL AND TOLERABILITY FOLLOWING Y-RESIN MICROSPHERE RADIOEMBOLISATION IN PATIENTS WITH UNRESECTABLE BCLC STAGE C HEPATOCELLULAR CARCINOMA (HCC)

650 SURVIVAL AND TOLERABILITY FOLLOWING Y-RESIN MICROSPHERE RADIOEMBOLISATION IN PATIENTS WITH UNRESECTABLE BCLC STAGE C HEPATOCELLULAR CARCINOMA (HCC)

POSTERS 648 TREATMENT OF HEPATOCELLULAR CARCINOMA WITH SORAFENIB: RESULTS IN THE REAL LIFE OF CHANGH COHORT I. Rosa1 , J. Denis2 , A.S. Dobrin3 , C. B...

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POSTERS 648 TREATMENT OF HEPATOCELLULAR CARCINOMA WITH SORAFENIB: RESULTS IN THE REAL LIFE OF CHANGH COHORT I. Rosa1 , J. Denis2 , A.S. Dobrin3 , C. Becker4 , R. Faroux5 , R. Bader6 , O. Danne7 , X. Causse8 , E. Diaz9 , G. Le Dreau ´ 10 , B. Condat11 , B. Marks12 , J. Henrion13 , F. Zerouala14 , T. Decaens15 , B. Lesgourgues16 , G. Bellaiche17 , H. Labadie18 , A. Pauwells19 , P. Renard20 , H. Hagege ` 1, CHANGH ANGH Study Group. 1 Hepatology, CHI Creteil, Cr´eteil, 2 Hepatology, CH de Corbeil Evry, Evry, 3 Hepatology, CHU Besancon, ¸ 4 Besancon, ¸ Hepatology, CH Lens, Lens, 5 Hepatology, CH la Roche sur Yon, La Roche sur Yon, 6 Hepatology, CH Mulhouse, Mulhouse, 7 Hepatology, CH de Pontoise, Pontoise, 8 Hepatology, Ch Orl´eans, Orl´eans, 9 Hepatology, CH Bethune, Bethune, 10 Hepatology, CH Lorient, Lorient, 11 Hepatology, CH Saint Camille, Bry sur Marne, 12 Hepatology, CH Valenciennes, Valencienne, France; 13 Hepatology, CH Jolimont, Jolimont, Belgium; 14 Hepatology, CH Meaux, Meaux, 15 Hepatology, CHU Henri Mondor, Cr´eteil, 16 Hepatology, CH Montfermeil, Montfermeil, 17 Hepatology, CH Aulnay/Bois, Aulnay / Bois, 18 Hepatology, CH Delafontaine, Saint Denis, 19 Hepatology, CH de Gonesse, Gonesse, 20 Hepatology, CH Argenteuil, Argenteuil, France E-mail: [email protected] Sorafenib is used in advanced or metastatic HCC. The aim of this study was to describe the characterics of the patients treated with sorafenib and to report the one year survival. Patients and Methods: The CHANGH cohort has permitted to include 1287 patients with first diagnosed HCC for a 18-months period. This work was conducted in 103 French hospitals. In this cohort, 186 patients received sorafenib. Results: 172 men and 15 women were treated with sorafenib, mean age 67 years. The aetiology of cirrhosis was alcohol in 69%, HCV infection in 16%, HBV infection in 15% and NASH in 13.5% of cases. HCC diagnosis was performed within a screening program in 14% of the patients. An histological diagnosis was obtained in 40% of cases. Presentation of HCC was a single tumour in 26%, mean size 82 mm. 18% of patients had <3 tumours. 44% of the HCC were multinodular, metastases were present in 16% and portal venous thrombosis in 43% of the cases. Patients were classified PS 0, 1, 2, 3, 4 in respectively 30, 42, 21, 4 and 2% of cases. The Child–Pugh score was A, B and C in respectively 63, 34 and 2.5% of cases. The one year follow up was obtained for 139 patients. 26% of them didn’t have received sorafenib because of a worsening of their clinical status. Overall survival was 16% at one year (median survival 16 weeks). The mean survival of the patients who had received the sorafenib was 22%, but median survival was 16%, similar to the median overall survival. Survival according to the Child–Pugh score was 22, 9 and 0% for respectively Child–Pugh A, B and C patients. Bleeding occurred in 9% of the treated patients: 7 oesophageal varices bleeding, 2 intra abdominal hemorrhages, one intracerebral bleeding and one severe epistaxis. Conclusion: Sorafenib is widely prescribed in advanced or metastatic HCC, but 26% of patients in whom the treatment was indicated didn’t receive it. In this real-life study, the one year overall survival was 22%, with an median survival of 16 weeks, poorer than the results of the literature. 649 LAPAROSCOPIC ULTRASOUND WITH RADIOFREQUENCY ABLATION OF HEPATIC TUMORS IN CIRRHOTIC PATIENTS I.A. Salama. Hepatobilary Surgery, National Liver Institute, Menoufia University, Shiben Elkom, Egypt E-mail: [email protected] Background: The optimal treatment for hepatocellular carcinoma (HCC) is surgical resection. However, only a small percentage of patients are operative candidates due to associated liver cirrhosis. Recent advances in laparoscopic ultrasound and Laparoscopy have greatly improved the accuracy in detecting intrahepatic tumors S262

nodules, many of which were missed by preoperative imaging modality. Objective: Evaluation the safety and efficacy of laparoscopic Radiofrequency Ablation (RFA) guided with laparoscopic ultrasound in detecting and treatment of liver tumors in patient with liver cirrhosis. Methods: 72 patients with liver tumors (58 HCC, 9 metastatic Adencarcinoma, 2 neoendocrine metastasis, 3 other metastasis) were submitted to laparoscopic RFA under laparoscopic ultrasound guidance. 44 patients (61.1%) Child A and 28 patients (38.9%) Child B. Patients with large tumor (>6 cm), portal vein thrombosis, or Child C Class were excluded from the study. Results: Laparoscopic RFA were completed in all patients without any conversion rate. Laparoscopic ultrasound identified 19 new malignant lesions (18.4%) in comparison with the result of preoperative imaging. A total of 103 Lesions were treated by RFA (45 patients had one lesion, 23 patient had 2 lesions and 4 patients had 3 lesions) There was no mortality. Morbidity occurred in 4 patients (5.5%) 2 patients had liver abscesses, one patient had pleural effusion and one patient had postoperative bleeding necessitate blood transfusion and surgery. After a mean follow up of 14.3±11.6 months, a complete response with 100% necrosis was achieved in 69 of 72 patients examined (95.8%). 3 patients (4.1%) locally recurred at the RFA side and 7 patients (9.7%) had of new malignant nodules. Conclusion: Laparoscopic RFA guided with laparoscopic ultrasound is an excellent use of existing technology in improvement of safety and efficacy of detection and treatment of intrahepatic tumors in patients with liver cirrhosis. 650 SURVIVAL AND TOLERABILITY FOLLOWING 90 Y-RESIN MICROSPHERE RADIOEMBOLISATION IN PATIENTS WITH UNRESECTABLE BCLC STAGE ‘C’ HEPATOCELLULAR CARCINOMA (HCC) B. Sangro1 , G.M. Ettorre2 , R.C. Cianni3 , D. Gasparini4 , R. Golfieri5 , S. Ezzidin6 , F. Kolligs7 , F. Izzo8 , on behalf of the European Network on Radio-embolization with Yttrium 90 Microspheres (ENRY). 1 Liver Unit, Clinica Universitaria, Pamplona, Spain; 2 General Surgery and Transplantation Unit, San Camillo Hospital, Rome, 3 Radiology, Ospedale ’S.M.Goretti’, Latina, 4 Radiology, Azienda Ospedaliera ’Santa Maria della Misericordia’, Udine, 5 Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 6 Leitender Oberarzt der Nuklear Medizin, Universit¨ atsklinik Bonn, Bonn, 7 Department of Medicine II, LMU Klinikum der Universit¨ at M¨ unchen Campus Grosshadern, Munich, Germany; 8 Fondazione Pascale Cancer Institute, Naples, Italy E-mail: [email protected] Background and Aims: The European Network on Radioembolisation with 90 Y-resin microspheres (ENRY) conducted a retrospective analysis to better understand the safety profile and factors driving prognosis in patients with unresectable BCLC stage ‘C’ HCC. Methods: Kaplan–Meier analysis stratified by key prognostic indicators estimated overall survival in patients treated between 09/2003 and 12/2009. The nature and severity of all AEs were recorded up to day 90 post-radioembolisation. Differences in CTCAE (v3.0) grade from baseline to day 90 between cohorts were assessed by the Kruskal-Wallis test. Results: Of 183 consecutive patients with BCLC stage ‘C’, 145 (79.7%) were symptomatic with ECOG PS ‘1’ (59.3%) or ‘2’ (20.3%); 73 (39.9%) had branch (23.5%) or main (16.4%) portal vein occlusion (PVO); 46 (25.1%) were Child–Pugh class ‘B’; 75 (41.2%) had >5 liver nodules and 28 (15.3%) had extra-hepatic metastases. Median survivals following radioembolisation were similar in patients with and without PVO (10.2 [95% CI 7.7–11.8] vs. 9.3 months [7.4–11.4]; p = 0.826). Survival diminished with increasing symptomatic disease (ECOG ‘0’ vs. ‘1’ vs. ‘2’: 10.8 [6.5–11.9] vs. 10.0 [7.7–11.8] vs. 6.6

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POSTERS months [5.5–20.8]) and extra-hepatic spread (no EHD vs. EHD: 10.2 [8.2–11.7] vs. 7.4 months [4.3–13.1]) but these differences were not statistically significant (p = 0.926 and p = 0.137, respectively). Survival was similar by Child–Pugh class (‘A’ vs. ‘B’: 9.7 [8.2– 13.1] vs. 10.0 months [6.1–14.5]; p = 0.668); but differed by number of nodules <5 vs. ≥5 (10.3 [7.6–14.5] vs. 9.3 months [7.0–10.7]; p = 0.020), pre-treatment ascites (7.4 [4.8–9.9] vs. 10.4 months [8.2–11.8]; p = 0.007) and total bilirubin >1.5 mg/dL (8.3 [5.5–10.3] vs. 10.4 months [7.6–13.1]; p = 0.009). Fatigue was common postradioembolisation (112 patients; 61.2%), mostly as grade 1 (84.9% of cases), and affected a significantly higher proportion with ECOG ‘1’–‘2’ than ECOG ‘0’ (69.9% vs. 27.0%; p < 0.001). Other AEs included: nausea and/or vomiting (31.0%); abdominal pain (28.4%), fever (12.0%) and gastrointestinal ulcer (4.4%). Grade 3/4 changes in bilirubin were observed in 6.0% of patients (p = 0.002). No other significant changes were observed in LFTs including: albumin, prothrombin, ALT and platelet counts. Conclusions: Radioembolisation was well-tolerated in patients with BCLC ‘C’ disease with no significant differences for the defining characteristics (PVO, PS, and EHD). 651 THE MORTALITY AND COMPLICATION RATES OF HEPATECTOMY, RADIOFREQUENCY ABLATION, AND TRANS-CATHETER ARTERIAL EMBOLIZATION FOR LIVER TUMORS: ANALYSIS OF JAPANESE NATIONWIDE DATABASE M. Sato1 , R. Tateishi1 , H. Yasunaga2 , H. Horiguchi2 , H. Yoshida1 , S. Matsuda3 , K. Koike1 . 1 Department of Gastroenterology, 2 Department of Health Management and Policy, The University of Tokyo, Bunkyo-Ku, 3 Department of Preventive Medicine and Community Health, University of Occupational and Environmental Health, Kitakyushu, Japan E-mail: [email protected] Background and Aims: Reported mortality and complication rates of therapeutic procedures for liver tumors were substantially heterogeneous among studies due to study design and small sample size. We investigated the mortality and complication rates of hepatectomy, radiofrequency ablation (RFA), and transcatheter arterial embolization (TAE) in large number of samples using a Japanese nationwide database named Diagnosis Procedure Combination (DPC) system. Methods: Data were derived from the DPC database between July 1 and December 31 of 2007 and 2008. We identified 59231 patients diagnosed as malignant liver neoplasms who underwent hepatectomy (n = 9044), RFA (n = 13000), or TAE (n = 37187). We analyzed in-hospital mortality and complication rate for each procedure first. Then we assessed the relationship between mortality rates and various factors including patient characteristics and hospital procedure volume. Results: The number of in-hospital death in patients who underwent hepatectomy, RFA, and TAE was 176, 31 and 383, respectively. The crude in-hospital mortality rates with 95% confidence interval (CI) of hepatectomy, RFA, and TAE were 1.95% (1.67–2.25), 0.24% (0.16–0.34), and 1.03% (0.93–1.14), respectively. The post-procedural complication rate, of hepatectomy, RFA, and TAE was 13.61% (12.91–14.34), 4.38% (4.03–4.74), and 5.16% (4.94– 5.40), respectively. Significant factors associated with increased mortality rate by logistic regression analyses were older age, patients with hepatocellular carcinoma (vs. metastatic liver tumor), extensive resection, lower hospital volume, and patients with chronic renal disease for hepatectomy (Table); the cardiac comorbidity for RFA (Odds ratio [OR] = 6.07, p = 0.001); and lower hospital volume (OR = 1.60, p < 0.001) for TAE. Conclusions: Mortality and complication rates of therapeutic procedures for liver tumors were acceptably low in Japan. However

the safety of procedure was affected by patient and therapeutic characteristics. Table: Logistic regression analysis-hepatectomy Factors

OR

Age; ≤59 60–69 70–79 ≥80 Number of cases per year; high (≥51) Intermediate (18–50) Low (≤17)

1.00 1.80 2.95 2.34 1.00 1.46 2.43

95% CI

p

1.02–3.19 1.72–5.04 1.14–4.78

0.04 <0.001 0.02

0.97–2.21 1.65–3.58

0.07 <0.001

652 MULTIPOLAR RADIOFREQUENCY ABLATION (MRFA) FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMA (HCC) IN PATIENTS WITH CIRRHOSIS: PRELIMINARY EXPERIENCE IN 109 PATIENTS O. Seror1 , G. Nkontchou2 , M. Aout3 , A. Mahmoudi2 , N. GanneCarrie´ 2 , V. Grando2 , I. Baghad2 , P. Nahon2 , J.C. Trinchet2 , N. Sellier1 , D. Roulot2 , E. Vicaut3 , M. Beaugrand2 . 1 Radiology Unit, 2 Liver Unit, Hˆ opital Jean Verdier, 3 Clinical Research Unit, Hˆ opital Lariboisi`ere, Bondy, France E-mail: [email protected] Multipolar radiofrequency ablation (MRFA) is a new percutaneous technique consisting in simultaneous insertion in the liver of 2 up to 4 bipolar electrodes surrounding the tumor. This technique “no touch technique” allows ablation without direct punction of tumors up to 45 mm in diameter. Potential advantages are a lower local recurrence rate by achieving a larger safety margin and a reduction of intra hepatic distant metastasis by avoiding spreading of tumoral cells. From November 2006 to February 2010, 109 cirrhotic patients (82 males, mean age 65 years (44–82) with cirrhosis (Child– Pugh A/B: 91/18) with HCC (uni/multinodular 86/23) were treated with MRFA. Median size of the tumor were 25 mm (10–45). All patients were treated under general anesthesia by the same operator, under US guidance using bipolar electrodes (CelonProSurge; Celon Medical Instruments) simultaneously activated. Patients were closely followed every 3 months by US, CT/MRI and serum AFP. Results: A complete ablation was obtained in 108 patients (99%) after one (n = 102) or 2 (n = 6) sessions. The mean number of electrodes used was 3 (2–4), 20 to 330 kJ were delivered per session (mean 106 kJ), during 10 to 55 mm (mean 27). Two patients died during the first 3 months one from pneumonia (6 weeks), the second from bacterial peritonitis (4 weeks). We cannot exclude the responsibility of the procedure in the later. Two severe complications were observed: jaundice (1) and abundant pleural effusion (1). After a median follow-up of 18 months (mean 19.8±12.11 months), two local recurrence occurred and 29 patients developed distant recurrences. At the end point, 17 patients have died from HCC progression (8); liver failure including severe sepsis (5), non liver causes (4) and 4 have been transplanted. The 3-year recurrence and survival rates were 39% and 69% respectively. Conclusion: MRFA is well tolerated and bears a low morbidity despite larger areas of ablation. Local recurrence rate is markedly reduced in comparison with series using monopolar techniques but the distant recurrence rate is similar. MRFA achieves a better local control than conventional technique in the treatment of HCC in the treatment of HCC.

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