The postoperative adjuvant combination therapy of sorafenib plus transarterial chemoembolization (TACE) proved to be superior to sorafenib alone in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT) after surgery in a phase 3 study.
Prof. Ming Kuang (The First Affiliated Hospital, China) and colleagues designed a phase 3 trial to assess the efficacy and safety of sorafenib plus TACE as a post-operative adjuvant treatment in patients with HCC and PVTT after surgery (N=158).1 Included patients were randomized 1:1 to sorafenib only or to sorafenib plus TACE. Recurrence-free survival (RFS) was the primary endpoint.
RFS was significantly improved in patients receiving the combination therapy compared with those receiving sorafenib only (median RFS, 16.8 months vs 12.6; HR, 0.57; Log-rank P=0.0024). The median overall survival was longer in patients in the sorafenib plus TACE arm than in patients in the sorafenib-only arm (30.4 months vs 22.5; HR, 0.57; Log-rank P=0.0174). Prof. Kuang added that sorafenib plus TACE was well tolerated and that the safety profiles of the 2 treatment regimens were similar.
The improved RFS and OS in patients receiving sorafenib and TACE indicate that this combination therapy may provide an effective strategy to control advanced HCC after surgery.
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