Efficacy and safety of sorafenib (Sor) in patients (Pts) with advanced hepatocellular carcinoma (HCC): Subgroup analyses of the SHARP trial by baseline (BL) transaminase (ALT/AST)/α-fetoprotein (AFP) and bilirubin (bil) levels.

Raoul, J.L.; Sherman, Morris; Nadel, Andrea; Lentini, Giuseppe; Moscovici, M.; Voliotis, D.; Meinhardt, Gerold; Bruix, Jordi; Llovet, Josep M.

doi:10.1200/jco.2010.28.15_suppl.4051

Cited by 7 publications

(7 citation statements)

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“…In another phase 1 trial, there was infrequent incidence of grade 3 hyperbilirubinemia (4% of patients), but it appeared to be independent of the dose level and resolved spontaneously 16. Another study also noticed although sorafenib could cause elevation of bilirubin, the change was transient 17. Therefore, there is no concrete evidence yet to support the causal relationship between the administration of sorafenib in patients with CPB cirrhosis and the development of significant hyperbilirubinemia.…”

Section: Discussionmentioning

confidence: 99%

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

Chiu

Tang

Yao

et al. 2012

Cancer

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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.

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Section: Discussionmentioning

confidence: 99%

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

Chiu

Tang

Yao

et al. 2012

Cancer

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“…These data support a timely switch to sorafenib therapy to prevent deterioration of liver function with inappropriate TACE use; this is critical for safe follow-on treatment with sorafenib. Liver dysfunction with sorafenib has also been occasionally reported, although the incidence is not significantly higher compared with placebo [73], and is usually reversible with drug discontinuation, in contrast to that emerging after TACE. With the recent approval of regorafenib, it will be increasingly important to critically monitor the treatment for HCC, so that when a patient's disease becomes refractory to TACE, the switch to sorafenib-regorafenib sequential therapy is performed in a timely manner [7].…”

Section: Impact Of Tace On Liver Functionmentioning

confidence: 99%

Patient Selection for Transarterial Chemoembolization in Hepatocellular Carcinoma: Importance of Benefit/Risk Assessment

2018

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Background: Liver cancer is the second most common cause of cancer-related death, with hepatocellular carcinoma (HCC) accounting for most primary liver cancers and most commonly arising from a history of advanced chronic liver disease. Among the available therapies, transarterial chemoembolization (TACE) is the most widely utilized and is considered the first-line treatment recommended for patients staged as intermediate HCC (Barcelona Clinic Liver Cancer stage B). If applied correctly, TACE can produce survival benefits without adversely affecting hepatic functional reserve. Summary: The aim of this nonsystematic review is to evaluate the evidence supporting TACE, with a special interest in intermediate HCC, for which this treatment is recommended in first line. However, intermediate HCC represents a broad and heterogeneous group of patients, not all of whom will benefit from TACE. This review highlights the importance of appropriate patient selection for initial TACE and for retreatment. It also evaluates evidence for the treatment of patients who become refractory to TACE. Some patients may, in fact, benefit from early switch (i.e., after 1 or 2 TACE treatments) to systemic therapies rather than continuing retreatments with TACE in order to preserve liver function, thus allowing sequential first- and second-line drug therapies. Key Messages: Careful assessment of an individual patient's benefit/risk ratio is recommended before any TACE session is considered to ensure optimal long-term outcomes in intermediate HCC.

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“…Overall, sorafenib prolonged time to progression (TTP) by 1.4-2.7 months and OS by 2-3 months. Subgroup analyses revealed that the survival benefits of sorafenib get across to patients with different etiologies of HCC, with or without extrahepatic spread and vascular invasion, as well as other risk factors [28][29][30][31][32][33].…”

Section: Sorafenibmentioning

confidence: 99%

Molecular targeted therapy for advanced hepatocellular carcinoma: current status and future perspectives

2010

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Sorafenib, a multikinase inhibitor targeting vascular endothelial growth factor (VEGF)-mediated angiogenesis, is the first drug found to prolong survival of patients with advanced hepatocellular carcinoma (HCC). This advance has shifted the paradigm of systemic treatment for HCC toward molecular targeted therapy (MTT). However, the disease-stabilizing effect of VEGF signaling-targeted MTT normally lasts only for a few months, suggesting a rapid emergence of resistance in the majority of patients. To overcome the resistance to VEGF signaling-targeted MTT, strategies incorporating inhibition of either compensatory pro-angiogenic pathways or recruitment of bone marrow-derived circulating endothelial progenitors, as well as suppression of other oncogenic pathways, are currently being investigated. The combination of multiple molecular targeted agents or the use of multi-target agents may enhance the efficacy at the expense of increased toxicities. To facilitate the development of MTT for HCC, current methodologies for pharmacodynamic assessment, patient selection and target identification need to be improved. Patient selection according to the individual molecular signature of the tumor and correlative biomarker studies are encouraged while planning a clinical trial of novel MTT.

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Efficacy and safety of sorafenib (Sor) in patients (Pts) with advanced hepatocellular carcinoma (HCC): Subgroup analyses of the SHARP trial by baseline (BL) transaminase (ALT/AST)/α-fetoprotein (AFP) and bilirubin (bil) levels.

Cited by 7 publications

References 0 publications

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

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

Patient Selection for Transarterial Chemoembolization in Hepatocellular Carcinoma: Importance of Benefit/Risk Assessment

Molecular targeted therapy for advanced hepatocellular carcinoma: current status and future perspectives

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