Quanguo Liu1, Yajie Dai. 1. School of Medicine, Southeast University, Nanjing, China.
Abstract
PURPOSE: To explore the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in the treatment of advanced hepatocellular carcinoma. METHODS:118 patients with advanced hepatocellular carcinoma treated in our hospital from June 2014 to June 2016 were collected and randomly divided into the Sorafenib+TACE group (treated with Sorafenib combined with TACE, n=59) and the TACE group (n=59). The clinical efficacy, the changes in levels of serum vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF) and alpha fetoprotein (AFP) before and after treatment, adverse reactions and postoperative survival of patients were observed and recorded. RESULTS: The objective response rate (ORR) and the disease control rate (DCR) were 55.9% (33/59) and 86.4% (51/59) in the Sorafenib+TACE group, and 37.3% (22/59) and 67.8% (40/59) in the TACE group. Both ORR and DCR in the Sorafenib+TACE group were significantly superior to those in the TACE group (p=0.022, p=0.027). Main adverse reactions after treatment included myelosuppression, fever, rash, gastrointestinal reactions, hepatalgia, hypertension and hand-foot syndrome, mostly of grade I-II, which were all improved after dose reduction and symptomatic treatment. The incidence rates of rash, diarrhea, hypertension and hand-foot syndrome in the Sorafenib+TACE group were obviously higher than those in the TACE group (p<0.001, p=0.002, p=0.002, p<0.001). The levels of serum VEGF, bFGF and AFP declined significantly in both groups after treatment compared with those before treatment (p=0.013, p<0.001, p<0.001), while they were evidently lower in the Sorafenib+TACE group than in the TACE group after treatment (p<0.001, p=0.016, p<0.001). Follow-up results showed that the overall survival in the Sorafenib+TACE group was significantly longer than in the TACE group (p=0.030). CONCLUSION: Compared with TACE alone, Sorafenib combined with TACE can significantly improve ORR and DCR, obviously reduce the levels of serum VEGF, bFGF and AFP, and prolong the survival of patients with advanced hepatocellular carcinoma, while the adverse reactions are tolerable, so it is worthy of clinical popularization and application.
RCT Entities:
PURPOSE: To explore the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in the treatment of advanced hepatocellular carcinoma. METHODS: 118 patients with advanced hepatocellular carcinoma treated in our hospital from June 2014 to June 2016 were collected and randomly divided into the Sorafenib+TACE group (treated with Sorafenib combined with TACE, n=59) and the TACE group (n=59). The clinical efficacy, the changes in levels of serum vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF) and alpha fetoprotein (AFP) before and after treatment, adverse reactions and postoperative survival of patients were observed and recorded. RESULTS: The objective response rate (ORR) and the disease control rate (DCR) were 55.9% (33/59) and 86.4% (51/59) in the Sorafenib+TACE group, and 37.3% (22/59) and 67.8% (40/59) in the TACE group. Both ORR and DCR in the Sorafenib+TACE group were significantly superior to those in the TACE group (p=0.022, p=0.027). Main adverse reactions after treatment included myelosuppression, fever, rash, gastrointestinal reactions, hepatalgia, hypertension and hand-foot syndrome, mostly of grade I-II, which were all improved after dose reduction and symptomatic treatment. The incidence rates of rash, diarrhea, hypertension and hand-foot syndrome in the Sorafenib+TACE group were obviously higher than those in the TACE group (p<0.001, p=0.002, p=0.002, p<0.001). The levels of serum VEGF, bFGF and AFP declined significantly in both groups after treatment compared with those before treatment (p=0.013, p<0.001, p<0.001), while they were evidently lower in the Sorafenib+TACE group than in the TACE group after treatment (p<0.001, p=0.016, p<0.001). Follow-up results showed that the overall survival in the Sorafenib+TACE group was significantly longer than in the TACE group (p=0.030). CONCLUSION: Compared with TACE alone, Sorafenib combined with TACE can significantly improve ORR and DCR, obviously reduce the levels of serum VEGF, bFGF and AFP, and prolong the survival of patients with advanced hepatocellular carcinoma, while the adverse reactions are tolerable, so it is worthy of clinical popularization and application.