The use of single‐agent sorafenib in the treatment of advanced hepatocellular carcinoma patients with underlying Child‐Pugh B liver cirrhosis

Abstract

BACKGROUND: This study explored the efficacy, tolerability, and survival benefits of using sorafenib in patients with Child‐Pugh class B (CPB) cirrhosis. METHODS: Patients with advanced hepatocellular carcinoma who were treated with sorafenib at Queen Mary Hospital, Hong Kong, China, were analyzed retrospectively. Treatment outcomes were analyzed according to their respective Child‐Pugh status. Patients with CPB disease were further divided into CPB7 (those with a score of 7) and CPB8‐9 (a score of 8 or 9) subgroups. RESULTS: The baseline demographic parameters were comparable between 108 patients with Child‐Pugh class A (CPA) disease and 64 CPB patients. Both clinical benefit rate (21.3% vs 32.4% vs 14.8%; P = .23) and progression‐free survival (median: 3.2 months vs 3.2 months vs 2.3 months; P = .26) were similar among CPA, CPB7, and CPB8‐9 groups, respectively. The overall survival was different among these groups (P = .002) and showed a trend toward worse outcome in CPB patients: the median was 6.1, 5.4, and 2.7 months among CPA, CPB7, and CPB8‐9 patients, respectively. The commonest grade 3/4 adverse events were hand‐foot syndrome (13.5%), diarrhea (9.9%), and rash (7.0%). Grade 3/4 leukopenia, thrombocytopenia, and anemia occurred in 2.9%, 5.3%, and 8.8% of the patients, respectively. Overall, the 3 groups of patients experienced similar incidence of most of these adverse events. Nonetheless, CPB patients experienced more anemia (P = .01), gastrointestinal bleeding (P = .02), and hepatic encephalopathy (P = .02). CONCLUSIONS: CPA and CPB patients tolerated sorafenib similarly and derived similar clinical and progression‐free survival benefit. Among CPB patients, most benefits were observed in patients with a score of 7. Nevertheless, CPB patients were more susceptible to developing cirrhotic complications, and thus more vigilant surveillance is needed. Cancer 2012. © 2012 American Cancer Society.

Sorafenib With and Without Transarterial Chemoembolization for Advanced Hepatocellular Carcinoma With Main Portal Vein Tumor Thrombosis: A Retrospective Analysis

“…The most likely interpretation was the small sample size in the subgroups CP-6 and CP-7 (CP-6: n 5 12 vs. n 5 11; CP-7: n 5 10 vs. n 5 10). Those results demonstrated a trend indicating that sorafenib monotherapy might be more suitable for HCC patients with MPVTT and in the CP-6 or CP-7 subgroups than combination therapy of sorafenib and TACE, for the following reasons: (a) The combination therapy may exacerbate liver ischemic damage in patients with MPVTT; (b) a poor hepatic reserve increases the risk for irreversible hepatotoxicity after TACE caused by chemotherapy drugs and lipiodol or embolization agents, especially in the patients with MPVobstruction [9,25,26]; (c) patients with a CP score of 6 or 7 tolerated sorafenib well and benefited from it [27]. This finding is important and a large prospective trial should be explored to confirm it.…”

Systemic therapies for hepatocellular carcinoma

“…TTP was 4 and 2 months (p = 0.0045), while OS was 8.4 and 3.2 months (p = 0.0007) in patients with CPA and CPB, respectively. Another retrospective study by Chiu et al explored the efficacy, tolerability, and survival benefits of sorafenib in 64 patients with CPB liver function (15). The patients with CPB were divided into CPB7 (with a CPB score of 7) and CPB8-9 (with a CPB score of 8 and 9) subgroups and compared with those with CPA.…”

Adoption of Sorafenib for the Treatment of Advanced-Stage Hepatocellular Carcinoma in Oncology Practices in the United States

“…While the incidence of HCC continues to rise, the overall 5-year survival rate remains extremely low at <12% [2]. Though diagnosis with early-stage HCC provides opportunities for several potentially curative treatment options [4], presentation with advanced HCC (Barcelona Clinic Liver Cancer [BCLC] Stage C) was historically met with limited treatment options and poor prognosis [5]. Until recently, there was no systemic therapy demonstrated to effectively treat individuals with advanced HCC [6].…”

“…Since the approval of sorafenib, studies have focused primarily on the safety and efficacy of this new molecular-targeted therapy in single-institution, clinical settings [5,13,14]. While these studies have each demonstrated clinical benefit in treating advanced HCC [5,13,14], others note the need to balance this opportunity with the potential for side effects and high treatment costs in the community setting [15,16].…”

“…While these studies have each demonstrated clinical benefit in treating advanced HCC [5,13,14], others note the need to balance this opportunity with the potential for side effects and high treatment costs in the community setting [15,16]. Specifically, treatment with sorafenib may cause a higher incidence of adverse drug reactions, such as hand-foot skin reactions, hypertension, and diarrhea, as well as an estimated USD 10,000-15,000/month in drug-related treatment costs [8,17,18,19,20].…”