Abstract
BackgroundThe efficacy of hepatic arterial infusion chemotherapy (HAIC) for advanced hepatocellular carcinoma (HCC) remains unclear. We conducted a multi-center randomized phase II study comparing a sequential HAIC-sorafenib regimen versus sorafenib alone as an initial therapy for HCC.MethodsPatients were randomly assigned (ratio, 1:1) to receive sequential HAIC with cisplatin followed by sorafenib (HAIC group, n = 35) or sorafenib alone (sorafenib group, n = 33) as an initial therapy. The primary endpoint was the one-year survival rate. Secondary endpoint included overall survival (OS), the 2-year survival rate, the time-to-progression (TTP), the objective response rate (ORR), the disease control rate (DCR), and safety.ResultsFor the primary endpoint, the one-year survival rates were 46% in the HAIC group and 58% in the sorafenib group. The median OS period was 10.0 months (95% CI, 7.0–18.8) in the HAIC group and 15.2 months (95% CI, 8.2–19.7) in the sorafenib group (hazard ratio [HR], 1.08; 95% CI, 0.63 to 1.86, P = 0.78). The median TTP, ORR and DCR in the HAIC group were 2.8 months (95% CI, 1.7–5.5), 14.3, and 45.7%, respectively, while those in the sorafenib group were 3.9 months (95% CI, 2.3–6.8), 9.1, and 45.5%, respectively. No unexpected adverse events related to HAIC or sorafenib were observed in either group.ConclusionsSequential HAIC with cisplatin and sorafenib does not improve the survival benefit, compared with sorafenib alone, when used as an initial therapy for advanced HCC. However, this study was underpowered in regard to its primary and secondary endpoints, so the results should be interpreted with caution.Trial registrationUMIN ID 000006147, registration data: August 11, 2011.
Highlights
The efficacy of hepatic arterial infusion chemotherapy (HAIC) for advanced hepatocellular carcinoma (HCC) remains unclear
Sorafenib has been recommended as a first-line treatment for advanced-stage HCC patients, and for intermediate-stage patients who are not expected to benefit from transarterial chemoembolization (TACE) [6], the discontinuation rates because of drug-related adverse events (AEs) were over 40% in two prospective postmarketing surveillance studies performed in Japan [7, 8]
Our study examined whether sequential HAIC with cisplatin powder and sorafenib improve the survival benefit compared with sorafenib alone as an initial therapy for advanced HCC
Summary
The efficacy of hepatic arterial infusion chemotherapy (HAIC) for advanced hepatocellular carcinoma (HCC) remains unclear. Sorafenib has been recommended as a first-line treatment for advanced-stage HCC patients, and for intermediate-stage patients who are not expected to benefit from TACE [6], the discontinuation rates because of drug-related adverse events (AEs) were over 40% in two prospective postmarketing surveillance studies performed in Japan [7, 8]. HAIC has been used to treat patients with advanced HCC in Japan and other Asian countries as it has been shown to yield good disease control rates and is tolerated well [10,11,12,13,14]. The efficacy and tolerability of this formulation were found to be acceptable in patients with unresectable HCC [14]
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