Journal Article

Randomized, phase II trial of sequential hepatic arterial infusion chemotherapy and sorafenib versus sorafenib alone as initial therapy for advanced hepatocellular carcinoma: SCOOP-2 trial

Suzuki, Michihiro, Kondo, Masaaki, Morimoto, Manabu, Ishibashi, Takako, Tanaka, Katsuaki, Aikata, Hiroshi, Numata, Kazushi, Maeda, Shin, Hidaka, Hisashi, Kobayashi, Satoshi, Okuse, Chiaki, Takizawa, Daichi, Nakazawa, Takahide, Ohkawa, Shinichi, Matsunaga, Kotaro, Taguri, Masataka, Hatanaka, Takeshi

2019

Overview

Background The 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. Methods Patients 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. Results For 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. Conclusions Sequential 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 registration UMIN ID 000006147 , registration data: August 11, 2011.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Aged / Aged, 80 and over / Analysis / Antineoplastic agents / Antineoplastic Agents - administration & dosage / Antineoplastic Agents - adverse effects / Antineoplastic Agents - therapeutic use / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Biomedical and Life Sciences / Biomedicine / Cancer / Cancer Research / Cancer therapies / Cancer treatment / Carcinoma / Carcinoma, Hepatocellular - drug therapy / Carcinoma, Hepatocellular - mortality / Chemotherapy / Cisplatin / Cisplatin - administration & dosage / Cisplatin - adverse effects / Cisplatin - therapeutic use / Clinical trials / Diagnosis / Disease / Disease control / Drug dosages / Experimental therapeutics and drug development / Female / Follow-Up Studies / Health Promotion and Disease Prevention / Hepatic arterial infusion chemotherapy / Hepatic Artery / Hepatocellular carcinoma / Hospitals / Humans / Infusions, Intra-Arterial / Inhibitor drugs / Liver cancer / Liver Neoplasms - drug therapy / Liver Neoplasms - mortality / Male / Medical prognosis / Medicine/Public Health / Middle Aged / Oncology / Operating systems (Software) / Patient outcomes / Registration / Research Article / Sequential treatment / Sorafenib / Sorafenib - administration & dosage / Sorafenib - adverse effects / Sorafenib - therapeutic use / Studies / Surgical Oncology / Survival Rate / Targeted cancer therapy / Treatment Outcome / Tumors / Veins & arteries