Final phase 2 results testify to the clinical advantage of TACE plus sorafenib in unresectable HCC

Key clinical point: Although treatment with transarterial chemoembolization (TACE) plus sorafenib does not significantly increase overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC) relative to TACE alone, it does offer a clinically meaningful OS prolongation.

Major finding: Patients receiving TACE plus sorafenib vs. TACE monotherapy showed a median OS of 36.2 months vs. 30.8 months (hazard ratio 0.861; P = .40). Despite being nonsignificant, the benefit (ΔOS 5.4 months) was clinically meaningful.

Study details: The data represent the final results of the multicenter, prospective phase 2 TACTICS trial including 156 patients aged >20 years with unresectable HCC having a life expectancy of ≥12 weeks who were randomly assigned to TACE plus sorafenib (n = 80) or TACE alone (n = 76).

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Disclosures: The study was sponsored by Bayer Yakuhin Ltd., Japan. Some authors reported serving as speakers/advisory consultants for and receiving grants, personal fees, and consulting/advisory fees from various sources including Bayer. M Kudo is the Editor-in-Chief of Liver Cancer, and some others are its editorial board members.

Source: Kudo M et al. Final results of TACTICS: A randomized, prospective trial comparing transarterial chemoembolization plus sorafenib to transarterial chemoembolization alone in patients with unresectable hepatocellular carcinoma. Liver Cancer. 2022 (Feb 10). Doi: 10.1159/000522547