Impact of prior surgical resection with curative intent on the efficacy and safety of sorafenib in patients with advanced hepatocellular carcinoma (HCC): Subset analysis of the Asia-Pacific (AP) study

Abstract

e15518^ Background: The multinational, phase III, randomized, double-blind, placebo-controlled AP study demonstrated that sorafenib is effective and safe for the treatment of advanced HCC in patients from the AP region (Cheng, et al. Lancet Oncol, 2009). Surgical resection with curative intent is a commonly used procedure for the treatment of HCC; however, tumor recurrence occurs in the majority of patients. Hence, it is of interest to analyze the efficacy and safety of sorafenib in patients who had undergone prior partial hepatectomy. Methods: Patients (N=226) with advanced HCC, ECOG PS 0–2, Child-Pugh class A, and no prior systemic therapy were randomized 2:1 to receive either sorafenib 400 mg BID or placebo. End points included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 d from first demonstration of response), time-to-progression (TTP), and safety. Results: Of 226 patients enrolled, 70 had previously undergone partial hepatectomy. Median TTP, OS, and DCR by subset are shown in the table. The safety profile of sorafenib in patients with and without prior hepatectomy was similar to that reported for the total study population. The most common grade 3/4 adverse events in the sorafenib groups were hand-foot skin reaction and diarrhea. Conclusions: Sorafenib was safe for the treatment of advanced HCC in patients from the AP region, whether or not they had undergone prior surgical resection. Sorafenib treatment resulted in similar TTP in patients with and without a history of prior partial hepatectomy, and the magnitude of TTP was similar in both groups to that in the overall population. Due to small sample size, further study is warranted. [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 .