studies

420A AASLD ABSTRACTS HEPATOLOGY, October, 2015
was 53 +/-0.6 days. By multivariate analysis, factors related
to all causes of death were patients’ age >60 years (OR=1.2,
95%CI; 1.1-1.3), length of hospital stay of >7 days (OR=1.1,
95%CI; 1.02-1.2), male (OR=1.3, 95%CI; 1.2-1.4), living
in Northern part of Thailand (OR=1.5, 95%CI; 1.3-1.8) and
presence of complications during admission (OR=1.3, 95%CI;
1.1-1.5. CONCLUSIONS: The disease burden of patients with
cholangiocarcinoma in Thailand is significant with 0.65% of
in-patients with GI. diseases and high mortality rate of 14%.
Disclosures:
The following authors have nothing to disclose: Sombat Treeprasertsuk, Kittiyod
Poovorawan, Ngamphol Soonthornworasiri, Roongruedee Chaiteerakij, Pisaln
Mairiang, Kookwan Sawadpanich, Varocha Mahachai, Kamthorn Phaosawasdi
417
Short-term preoperative treatment with sorafenib for
patients with resectable hepatocellular carcinoma (HCC):
results of the BIOSHARE neoadjuvant phase II study
from GERCOR IRC
Mohamed Bouattour 1 , Laetitia Fartoux 2 , Olivier Rosmorduc 2 , Eric
Vibert 3 , Charlotte E. Costentin 4 , Olivier Soubrane 5 , Olivier Scatton
6 , Maxime Ronot 7 , Laurent Castera 1 , Muriel Garnier 8 , Armand
De Gramont 8 , Jacques Belghiti 5 , Valerie Paradis 9 , Annemilaï
Tijeras-Raballand 10 , Alexandra Hadengue 11 , David Brusquant 11 ,
Benoist Chibaudel 11 , Eric Raymond 8 , Sandrine Faivre 8 ; 1 Hepatology,
Beaujon University Hospital, Clichy, France; 2 Hepatology,
Saint-Antoine University Hospital, Paris, France; 3 Hepato-Biliary
Surgery, Paul-Brousse University Hospital, Villejuif,, France; 4 Hepatology,
Henri-Mondor University Hospital, Creteil, France; 5 Hepato-Biliary
Surgery, Beaujon University Hospital, Clichy, France;
6 Hepato-Biliary Suregry, Saint-Antoine University Hospital, Paris,
France; 7 Radiology, Beaujon University Hospital, Clichy, France;
8 Medical Oncology, Centre Hospitalo-Univesitaire Vaudois
(CHUV), Lauzanne, Switzerland; 9 Pathology, Beaujon University
Hospital, Clichy, France; 10 AREC FILIA RESEARCH,, Paris, France;
11 GERCOR, Paris, France
Background. Neoadjuvant therapy offers the opportunity of
investigating new agents in early stage and allows direct
access to tumor biology. This open-label, multicenter, phase
II study aimed at investigating the activity of sorafenib including
radiological, pathological and molecular changes in tumor
from patients with operable HCC. Patients and methods. A preoperative
treatment consisting of 400 mg bid orally sorafenib
was administered for 4 consecutive weeks followed by surgery
1 week after sorafenib discontinuation. Primary endpoints
were antitumor activity and histological changes between
paired biopsies and plasma biomarkers, from baseline and
post sorafenib treatment. Secondary endpoints were safety
profile, R0 surgery and post-surgical complications. Residual
disease characteristics were analyzed on surgical specimens.
Results. Among 30 patients enrolled, 28 were evaluable for
safety and 25 patients (21 men; median age: 61.5 years)
were evaluable for the primary endpoint. All evaluable patients
were Child Pugh A, 14 (56%) with chronic liver disease, 9
(36%) with cirrhosis and 2 patient (8%) with no underlying
liver disease. The baseline median tumor size was 37 mm
(17-220 mm) and 21 patients (84%) had a single lesion. The
median duration and dosing of sorafenib for evaluable patients
were 28 days (21-35d) and 793 mg/day (477 – 843 mg/
day) respectively. Overall, the safety profile of preoperative
sorafenib was good. According to RECIST criteria, all patients
showed stable disease after 4 weeks of sorafenib. Among 14
patients evaluated according to mRECIST and Choi criteria,
objective responses were observed for 4 (29%) and 7 (50%)
patients respectively. All evaluable patients went on liver resection;
median hospitalization duration was 8 days (4-59d) and
no unexpected postoperative complication was observed. R0
tumor resection was achieved in 22 patients (88%). Surgical
specimen showed macrovascular and microvascular invasion
as well as satellite nodules in 12%, 48%, and 36% respectively.
Intratumor necrosis was observed in 13 patients of 20
evaluable patients. Biomarkers from pre- and post-treatment
tissue (Vimentin, CK19, E-Cadherin, N-Cadherin, CK7, MIB1,
CD31, VEGF, CD133, CA9, p-S6, c-MET, CXCR4) and plasma
(VEGF-C, Ang2, PlGF, c-KIT, SDF-1, HGF, TGFb1) are currently
assessed and will be presented during the meeting. Conclusion.
Preoperative BIOSHARE trial showed appropriate safety
regarding both tolerance to sorafenib and surgical procedures.
Short-term neoadjuvant treatment with sorafenib showed promising
efficacy in terms of tumor response (mRECIST and Choi)
and will allow detailed evaluation of molecular changes in
patient tumor tissues.
Disclosures:
Mohamed Bouattour - Advisory Committees or Review Panels: Bayer Schering
Pharma; Speaking and Teaching: Bayer Schering Pharma
Olivier Rosmorduc - Advisory Committees or Review Panels: Syrtex, IPSEN;
Speaking and Teaching: Bayer
Laurent Castera - Speaking and Teaching: Gilead, BMS, Janssen, Echosens,
Abbvie, Biopredictive
The following authors have nothing to disclose: Laetitia Fartoux, Eric Vibert,
Charlotte E. Costentin, Olivier Soubrane, Olivier Scatton, Maxime Ronot, Muriel
Garnier, Armand De Gramont, Jacques Belghiti, Valerie Paradis, Annemilaï
Tijeras-Raballand, Alexandra Hadengue, David Brusquant, Benoist Chibaudel,
Eric Raymond, Sandrine Faivre
418
Analytic Morphomics Predicts Survival in Patients with
Hepatocellular Carcinoma Treated with Transarterial
Chemoembolization
Neehar D. Parikh 1,3 , Amit G. Singal 2 , Peng Zhang 3 , Venkat Krishnamurthy
3 , Pranab Barman 1 , Akbar K. Waljee 1,4 , Grace L. Su 1,3 ;
1 Division of Gastroenterology, University of Michigan, Ann Arbor,
MI; 2 Division of Digestive and Liver Diseases, Parkland Health and
Hospital System, Dallas, TX; 3 VA Ann Arbor Healthcare System,
Ann Arbor, MI; 4 Veterans Affairs Center for Clinical Management
Research, VA Ann Arbor Healthcare System, Ann Arbor, MI
The prognosis of patients with hepatocellular carcinoma (HCC)
undergoing transarterial chemoembolization (TACE) is often
uncertain. The existing HCC staging criteria are limited in their
ability to predict survival after therapy. Analytic morphomics
has been shown to predict patient outcomes in cirrhosis and
other disease states. We aimed to determine the ability of
analytic morphomics to predict outcome after TACE for HCC.
We included patients from a single center (Ann Arbor VA Medical
Center) who had TACE as the primary treatment for their
HCC and who had a CT chest or abdomen prior to therapy.
Analytic morphomic measurements were taken at the bottom of