Comparison of efficacy between TACE combined with apatinib and TACE alone in the treatment of intermediate and advanced hepatocellular carcinoma: A single-center randomized controlled trial.

Comparison of efficacy between TACE combined with apatinib and TACE alone in the treatment of intermediate and advanced hepatocellular carcinoma: A single-center randomized controlled trial.

Cancer Biol Ther. 2017 May 26;:0

Authors: Lu W, Jin XL, Yang C, Du P, Jiang FQ, Ma JP, Yang J, Xie P, Zhang Z

Abstract
OBJECTIVE: This study was designed to compare the clinical efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with apatinib and TACE alone in the treatment of intermediate and advanced hepatocellular carcinoma (HCC).
METHODS: From March 2015 to August 2015, a total of 44 patients with moderate and advanced HCC, who were admitted in the Navy General Hospital of China, were included into this study. These patients were randomly divided into two groups: group A and group B. Patients in group A underwent TACE alone, while patients in group B underwent the combined treatment of TACE with apatinib. Differences in preoperative general data between these two groups were not statistically significant (P>0.05). All patients were followed up for 12-18 months. Changes in alpha-fetal protein (AFP) at three months after treatment and the objective response rate (ORR) at three, six, nine and twelve months after treatment were compared between these two groups. Furthermore, progression-free survival (PFS) and the incidence of adverse reactions were also compared between these two groups.
RESULTS: AFP levels in groups A and B significantly decreased after three months of treatment, compared with the levels before treatment, and the differences were statistically significant (P<0.05). However, at three months after treatment, the difference between these two groups was not statistically significant (P>0.05). ORR at three, six, nine and twelve months after treatment was 36.36%, 27.27%, 13.64% and 9.09%, respectively, in group A; and 60%, 50%, 45% and 35%, respectively, in group B. At three and six months after treatment, the differences between these two groups were not statistically significant (P>0.05); while at nine and twelve months after treatment, the differences between these two groups were statistically significant (P<0.05). The median PFS was 6.0 months in group A and 12.5 months in group B, and the difference was statistically significant (P<0.05). The incidences of complications were related to oral apatinib, such as hypertension, hand-foot syndrome and proteinuria, were higher in group B than in group A, and the differences were statistically significant (P<0.05). These symptoms all alleviated after symptomatic treatments.
CONCLUSIONS: For intermediate and advanced HCC, the long-term curative effect of TACE combined with apatinib is better than that of TACE alone. The former can obviously prolong the PFS of patients and has a confirmed safety.

PMID: 28548587 [PubMed - as supplied by publisher]

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