98080-114

A randomized phase III trial comparing sorafenib plus best supportive care (BSC) versus BSC alone in Child-Pugh B patients (pts) with advanced hepatocellular carcinoma (HCC): The BOOST study.

Subcategory: 
Category: 
Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
General Poster Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 

TPS4151

Citation: 

J Clin Oncol 30, 2012 (suppl; abstr TPS4151)

Author(s): 

Bruno Daniele, Massimo Di Maio, Ciro Gallo, Antonio Gasbarrini, Giacomo Carteni, Giovan Giuseppe Di Costanzo, Antonio Craxi, Giuseppe Cabibbo, Luigi Bolondi, Alessandro Granito, Gabriele Missale, Antonio Frassoldati, Mario Angelico, Mario Roselli, Gennaro Daniele, Francesco Perrone; G. Rummo Hospital, Benevento, Italy; Clinical Trials Unit, National Cancer Institute, Napoli, Italy; Medical Statistics, Second University, Napoli, Italy; Policlinico Universitario Agostino Gemelli, Roma, Italy; Azienda Ospedaliero di Rilievo Nazionale A. Cardarelli, Naples, Italy; Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone, Palermo, Italy; Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi, Bologna, Italy; Azienda Ospedaliero-Universitaria di Parma, Parma, Italy; Az. Ospedaliera Universitaria Arcispedale Sant'Anna di Ferrara, Ferrara, Italy; Azienda Ospedaliera Universitaria Policlinico Tor Vergata, Roma, Italy; National Cancer Institute, Naples, Italy


Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures

Abstract: 

Background: The efficacy of sorafenib in pts with advanced HCC has been demonstrated in two randomized phase III trials (Llovet JM, NEJM 2008;359:378; Cheng AL, Lancet Oncol 2009;10:25), both restricted to pts with well-preserved liver function (Child-Pugh A). Child-Pugh B (CPB) pts, that represent a relevant proportion of pts with advanced HCC in clinical practice, were not eligible. Despite this limitation, the marketing authorization of sorafenib by the main regulatory agencies was not restricted to Child A pts. CPB pts are different in terms of prognosis, and are potentially different in terms of balance between treatment efficacy and toxicity. Large observational studies [Marrero JA, ASCO 2011 (abstr 4001)] are producing quite reassuring data about sorafenib tolerability in CPB pts, but the real efficacy of the drug in this setting remains substantially unknown, due to the lack of randomized trials. Methods: BOOST (B Child HCC patients – Optimization Of Sorafenib Treatment) is a randomized phase III trial comparing sorafenib + best supportive care (BSC) vs. BSC alone in CPB pts with advanced HCC. Pts are eligible if older than 18, with ECOG performance status 0-2. Pts assigned to experimental arm receive sorafenib 400 mg twice daily, with dose reductions and interruptions according to toxicity. Overall survival (OS) is the primary endpoint. In order to demonstrate a Hazard Ratio of death 0.70 in favor of sorafenib (2-month improvement in median OS, from 4.5 to 6.5 months), with 80% power and α 0.05, 320 pts have to be randomized, 160 per arm. The BOOST trial (ClinicalTrials.gov Identifier NCT01405573; Eudract number 2009-013870-42) is approved by the Ethical Committee of the National Cancer Institute, Napoli, Italy, as coordinating centre, and is currently under evaluation by several other Institutions. BOOST is a non-profit, academic trial. The trial has received a financial support by Italian Ministry of Health (FARM84SA2X), although the support is not enough to supply sorafenib to participating centers. BOOST is partially supported by AIRC (grant IG2009-9316). The study is open to all international Centers wishing to participate.