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
Authors: Yang T. , Qin S. , Tak W. , Yu S. , Tsao C. , Kim J. , Burock K. , Zou J. , Voliotis D. , Cheng A. 
Published: August 2020

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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]

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