Effect of macroscopic vascular invasion (MVI), extrahepatic spread (EHS), and ECOG performance status (ECOG PS) on outcome in patients with advanced hepatocellular carcinoma (HCC) treated with sorafenib: Analysis of two phase III, randomized, double-blind trials
Authors: J. Bruix, A. Cheng, Y. Kang, C. Tsao, S. Qin, G. Lentini, J. Zou, A. Nadel, K. Burock, D. Voliotis, J. M. Llovet
Journal: Journal of Clinical Oncology (2009)

4580^ Background: The landmark phase III SHARP trial (Llovet et al, N Engl J Med, 2008) showed that sorafenib is effective and safe for the treatment of advanced HCC. These results were confirmed in an Asian population in the phase III Asia-Pacific (AP) study (Cheng et al, Lancet Oncol, 2009). We compared outcomes of sorafenib treatment in patients enrolled in the SHARP and AP trials with known baseline predictors of poor prognosis. Methods: Patients with advanced, unresectable, measurable HCC, ECOG PS 0–2, Child-Pugh A, and no prior systemic therapy for HCC were randomized to sorafenib 400 mg BID or placebo (SHARP: N=602; AP: N=226). Patients in the AP study had more evolved disease and a predominance of hepatitis B infection. Endpoints included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 days from first demonstration of response), and safety. Results: Efficacy results are shown in the table . The incidence of grade 3/4 drug-related adverse events (AEs) across subgroups in each study was consistent with the overall population for each study. The most common grade 3/4 AEs in all sorafenib populations were hand-foot skin reaction and diarrhea. Conclusions: Sorafenib is effective and safe for the treatment of advanced HCC in patients globally, irrespective of baseline ECOG PS and presence or absence of MVI and/or EHS. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .