J.H. Geschwind

Society of Interventional Radiology Interventional Oncology Task Force: Interventional oncology research vision statement and critical assessment of the State of Research Affairs

THE Research Subcommittee of the Society of Interventional Radiology (SIR) Interventional Oncology Task Force has undertaken preparation of a vision statement and critical assessment of the state of affairs of research in interventional oncology as a first step in advancing the research agenda of interventional oncology under the aegis of SIR. This document was refined over multiple consensus meetings and adopted by the global SIR Interventional Oncology Task Force at its February 2005 meeting. Further input has been provided by the SIR Foundation during review before publication. In addition to this document, we further envision additional strategy and tactic documents on clinical trials and basic/ translational research, which will include specific milestones to be achieved over the course of our 10-year vision.

Systematic review of catheter-based intra-arterial therapies in hepatocellular carcinoma: state of the art and future directions

Intra-arterial therapies (IATs) play a pivotal role in the management of patients with primary and secondary liver malignancies. The unique advantages of these treatments are their ability to selectively deliver a high dose of anticancer treatment while preserving healthy liver tissue. The proven efficacy of these catheter-based locoregional therapies in a highly systemic chemoresistant cancer such as hepatocellular carcinoma (HCC), along with the minimally invasive nature of these treatments, quickly yielded wide acceptance in the medical community and revolutionized the field of Interventional Oncology. In this article, we describe the clinical rationale and background of catheter-based IATs. We provide an overview of clinical achievements of these treatments alone and in combination with sorafenib in patients with HCC.

Second interim analysis of GIDEON (Global Investigation of Therapeutic Decisions in Unresectable HCC and of Its Treatment with Sorafenib): U.S. versus global perspective on patient and disease characteristics, treatment history, and sorafenib use.

278 Background: GIDEON is a global, prospective, noninterventional study of patients (pts) treated with sorafenib (SOR) for unresectable hepatocellular carcinoma (uHCC). Regions evaluated included US, Europe, Japan, Asia Pacific, and Latin America. Detailed regional data were presented by Kudo et al (ILCA 2011, abstr 0-030). Data from the second US interim analysis are compared to global results. METHODS Eligible pts had uHCC and were treated with SOR. Demographics, disease etiology, treatment history, and SOR dosing were compared in a descriptive, preplanned subgroup analysis. RESULTS Global and US safety populations comprised 1571 and 313 pts, respectively. In the US, hepatitis B was less common (18% vs 37% global) whereas hepatitis C was more frequent (53% vs 32% global). Alcoholic liver disease etiology was higher in US pts (41% vs 29% global). US pts were diagnosed with later-stage disease, but fewer US pts had documented BCLC and Child-Pugh status. Fewer US pts had an ECOG PS 0 at start of SOR (28% vs 40% global). Rates of prior surgery and locoregional treatment were similar in US (11% and 49%, respectively) and global pts (19% and 55%, respectively). US pts treated with TACE (n = 116) underwent fewer TACE procedures (≥3: 13.8% vs 38.9% global); most (59%) TACE-treated pts in the US received 1 treatment. In US vs global pts, median time from prior surgery to start of SOR was 10 months (range 1-61) vs 14 months (range 1-181) and median time from last TACE to start of SOR was 3.2 months vs 3.1 months. CONCLUSIONS Disease characteristics and treatment patterns for pts with uHCC in the US differ from those in the global population. US pts enrolled in GIDEON (ie, receiving SOR) have differing etiologies of liver disease and have a greater proportion of hepatic dysfunction, likely accounting for worse performance status. [Table: see text].

Prospective phase II study of chemoembolization with drug-eluting beads for hepatic neuroendocrine metastases: Interim analysis.

331 Background: To evaluate safety and efficacy of transarterial chemoembolization with doxorubicin eluting beads (DEB-TACE) in 30 patients with hepatic neuroendocrine metastases (NET) in a prospective phase II study. We report the interim analysis on 10 patients. Methods: Patients who met inclusion criteria (NET liver-dominant metastases, ECOG 0-1, treatment naive) underwent up to 4 DEB-TACE sessions (100-300 micron beads loaded with up to 100mg of doxorubicin) within a 6-month period. Statistical plan included interim analysis of initial 10 patients to assess therapeutic efficacy (defined as objective response≥50%). Tumor response was assessed by MR imaging 1 month after treatment using contrast-enhancement (EASL) and tumor size (RECIST). Safety was assessed by NCI Common Terminology Criteria. Results: DEB-TACE was successfully performed in 10 patients (22 targeted lesions). Patient characteristics included mean age 65 yrs; ECOG 0/1 (6/4); carcinoid syndrome (n=2); tumor burden range (4-75%), and mean t...