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Efficacy and safety of sorafenib in combination with gemcitabine in patients with advanced hepatocellular carcinoma: A multicenter, open‐label, single‐arm phase II study
Author(s) -
Srimuninnimit Vichien,
Sriuranpong Virote,
Suwanvecho Suthida
Publication year - 2014
Publication title -
asia‐pacific journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.73
H-Index - 29
eISSN - 1743-7563
pISSN - 1743-7555
DOI - 10.1111/ajco.12191
Subject(s) - sorafenib , medicine , gemcitabine , hepatocellular carcinoma , regimen , clinical endpoint , adverse effect , neutropenia , oncology , phases of clinical research , liver function , response evaluation criteria in solid tumors , gastroenterology , surgery , clinical trial , chemotherapy
Aims Currently, the only standard systemic treatment for advanced hepatocellular carcinoma is sorafenib monotherapy. The study was conducted to assess the efficacy and safety of the novel combination of sorafenib and gemcitabine in the treatment of advanced hepatocellular carcinoma. Methods Between M arch 2008 and O ctober 2010, patients with advanced pathologically proven hepatocellular carcinoma who had not received previous systemic therapy and had C hild– P ugh liver function class A or B received sorafenib plus gemcitabine. Treatment included 4‐week cycle of gemcitabine (1000 mg/m 2 days 1, 8, 15) to the maximum of six cycles together with sorafenib (400 mg twice daily). Patient continued sorafenib until disease progression or withdrawal from other reasons. The primary end point is progression‐free survival. Results Forty‐five patients were enrolled in this study. The median progression‐free survival was 3.7 months (95% CI 3.5–3.8). The overall response rate was 4% with no complete responses and the disease control rate was 66%. The median overall survival (OS) was 11.6 months (95% CI 7.4–15.9). The median time to progression was 3.6 months (95% CI 3.4–3.7). The most frequently reported grade 3/4 treatment‐related adverse events included thrombocytopenia 33%, neutropenia 16% and hand‐foot skin reaction 13%. The study regimen was well tolerated. Conclusion The combination of sorafenib and gemcitabine in advanced hepatocellular carcinoma is generally well tolerated and has modest clinical efficacy. The median OS is up to 1 year. However, well‐designed randomized controlled trials with a sorafenib alone comparator arm are needed to confirm this finding.