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.
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.
['Kondo|Masaaki|M|http://orcid.org/0000-0002-6063-4561', 'Morimoto|Manabu|M|', 'Kobayashi|Satoshi|S|', 'Ohkawa|Shinichi|S|', 'Hidaka|Hisashi|H|', 'Nakazawa|Takahide|T|', 'Aikata|Hiroshi|H|', 'Hatanaka|Takeshi|T|', 'Takizawa|Daichi|D|', 'Matsunaga|Kotaro|K|', 'Okuse|Chiaki|C|', 'Suzuki|Michihiro|M|', 'Taguri|Masataka|M|', 'Ishibashi|Takako|T|', 'Numata|Kazushi|K|', 'Maeda|Shin|S|', 'Tanaka|Katsuaki|K|']
D000368:Aged D000369:Aged, 80 and over D000970:Antineoplastic Agents D000971:Antineoplastic Combined Chemotherapy Protocols D006528:Carcinoma, Hepatocellular D002945:Cisplatin D005260:Female D005500:Follow-Up Studies D006499:Hepatic Artery D006801:Humans D007261:Infusions, Intra-Arterial D008113:Liver Neoplasms D008297:Male D008875:Middle Aged D000077157:Sorafenib D015996:Survival Rate D016896:Treatment Outcome
Hepatic arterial infusion chemotherapy Sorafenib Hepatocellular carcinoma Cisplatin Sequential treatment