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
Masaaki Kondo,
Manabu Morimoto,
Satoshi Kobayashi,
Shinichi Ohkawa,
Hisashi Hidaka,
Takahide Nakazawa,
Hiroshi Aikata,
Takeshi Hatanaka,
Daichi Takizawa,
Kotaro Matsunaga,
Chiaki Okuse,
Michihiro Suzuki,
Masataka Taguri,
Takako Ishibashi,
Kazushi Numata,
Shin Maeda,
Katsuaki Tanaka
Affiliations
Masaaki Kondo
Gastroenterological Center, Yokohama City University Medical Center 4-57
Manabu Morimoto
Gastroenterological Center, Yokohama City University Medical Center 4-57
Satoshi Kobayashi
Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center Hospital; 1-1-2
Shinichi Ohkawa
Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center Hospital; 1-1-2
Hisashi Hidaka
Gastroenterology Division of Internal Medicine, Kitasato University Hospital; 1-15-1
Takahide Nakazawa
Gastroenterology Division of Internal Medicine, Kitasato University Hospital; 1-15-1
Hiroshi Aikata
Department of Gastroenterology and Metabolism, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University; 1-2-3
Takeshi Hatanaka
Department of Internal Medicine, Isesaki Municipal Hospital; 12-1
Daichi Takizawa
Department of Internal Medicine, Isesaki Municipal Hospital; 12-1
Kotaro Matsunaga
Division of Gastroenterology and Hepatology, Department of Internal Medicine, St Marianna University School of Medicine; 2-16-1
Chiaki Okuse
Division of Gastroenterology and Hepatology, Kawasaki Municipal Tama Hospital; 1-30-37
Michihiro Suzuki
Division of Gastroenterology and Hepatology, Kawasaki Municipal Tama Hospital; 1-30-37
Masataka Taguri
Department of Data Science, Yokohama City University School of Data Science; 3-9
Takako Ishibashi
Yokohama City University Center for Novel and Exploratory Clinical trials; 1-1-1
Kazushi Numata
Gastroenterological Center, Yokohama City University Medical Center 4-57
Shin Maeda
Department of Gastroenterology, Yokohama City University Hospital; 3-9
Katsuaki Tanaka
Gastroenterological Center, Yokohama City University Medical Center 4-57
Abstract 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.
