Treatment with transarterial chemoembolization and Nexavar improved progression-free survival compared with transarterial chemoembolization alone in patients with unresectable hepatocellular carcinoma, according to a study published in Gut.
Masatoshi Kudo, MD, PhD, from the Kindai University Faculty of Medicine in Japan, and colleagues explained that because of the high tumor recurrence rate after TACE, the procedure is usually repeated many times, which can lead to deterioration of liver function.
To explore the safety and efficacy of combination therapy with Nexavar (sorafenib, Bayer), Kudo and colleagues randomly assigned patients with unresectable HCC to receive either TACE with sorafenib (n = 80) or TACE alone (n = 76).
The researchers defined progression as untreatable, or “unTACEable,” progression such as the inability for a patient to further receive or benefit from TACE for reasons including intrahepatic tumor progression, invasion or extrahepatic spread, transient deterioration of liver function to Child-Pugh C, or macrovascular invasion.
Median PFS was longer in the TACE plus sorafenib group than the TACE only group (25.2 vs. 13.5 months; HR = 0.59; 95% CI, 0.41-0.87).
Among TACE naive group, the researchers observed no difference between median PFS based on unTACEable progression in either group. However, among those with one to two previous treatments with TACE, median PFS was longer in the combination group that the TACE alone group (HR = 0.57; 95% CI, 0.33-0.99).
Kudo and colleagues noted that adverse events occurred more often in the combination group, likely due to treatment with sorafenib, but none of the events were unexpected and rates of grade 3 and grade 4 adverse events were relatively low.
“These findings differ markedly from those of previous trials testing the combination of TACE plus sorafenib in patients with HCC,” they wrote. “In contrast to [three previous] negative trials, the present trial assessed the efficacy of TACE plus sorafenib using an endpoint more suitable for a TACE combination trial, with this endpoint being consistent with those used in clinical practice.”
The researchers concluded that pre-treatment with sorafenib 2 weeks to 3 weeks before initial TACE enhanced the treatment effect of TACE through tumor vessel normalization leading to homogenous distribution of lipiodol mixed with anticancer drugs and gelatin sponge particle within the tumors. – by Talitha Bennett
Disclosures: Kudo reports honoraria from Bayer, Eisai, Merck Sharp & Dohme, and Ajinomoto; consulting or advisory roles with Kowa, Merck Sharp & Dohme, Bristol-Myers Squibb, Bayer, Chugai and Taiho; and has received funding from Chugai, Otuka, Takeda, Taiho, Sumitomo Dainippon, Daiichi Sankyo, Merck Sharp & Dohme, Eisai, Bayer and AbbVie. Please see the full study for all other authors’ relevant financial disclosures.