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Sorafenib plus hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma: randomized phase II trial.

Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa masikeda@east.ncc.go.jp. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa. Department of Biostatistics, Kyoto University School of Public Health, Kyoto. Department of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama. Department of Gastroenterology, National Center for Global Health and Medicine Center Hospital, Tokyo. Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya. Department of Hepatology, Osaka City University Hospital, Osaka. Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka. Department of Hepatobiliary and Pancreatic Surgery, Osaka National Hospital, Osaka. Department of Gastroenterology, Kanazawa University Hospital, Kanazawa. Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center, Fukuoka. Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Tochigi. Department of Gastroenterology, Sapporo Kosei General Hospital, Sapporo. Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto. Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto. Clinical Research Center, Shikoku Cancer Center, Matsuyama. Department of Medical Oncology, Kyorin University, Tokyo. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Annals of oncology : official journal of the European Society for Medical Oncology. 2016;(11):2090-2096
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Abstract

BACKGROUND Sorafenib (Sor) is acknowledged as a standard therapy for advanced hepatocellular carcinoma (HCC). This trial was conducted to evaluate the effect of addition of hepatic arterial infusion chemotherapy with cisplatin (SorCDDP) to Sor for the treatment of advanced HCC. PATIENTS AND METHODS We conducted a multicenter open-labeled randomized phase II trial in chemo-naïve patients with advanced HCC with Child-Pugh scores of 5-7. Eligible patients were randomly assigned 2:1 to receive SorCDDP (sorafenib: 400 mg bid; cisplatin: 65 mg/m2, day 1, every 4-6 weeks) or Sor (400 mg bid). The primary end point was overall survival. RESULTS A total of 108 patients were randomized (Sor, n = 42; SorCDDP, n = 66). The median survival in the Sor and SorCDDP arms were 8.7 and 10.6 months, respectively [stratified hazard ratio (95% confidence interval), 0.60 (0.38-0.96), P = 0.031]. The median time to progression and the response rate were, respectively, 2.8 months and 7.3% in the Sor arm and 3.1 months and 21.7% in the SorCDDP arm. The adverse events were more frequent in the SorCDDP arm than in the Sor arm, but well-tolerated. CONCLUSION SorCDDP yielded favorable overall survival when compared with Sor in patients with advanced HCC. CLINICAL TRIAL REGISTRATION UMIN-CTR (http://www.umin.ac.jp/ctr/index-j.htm), identification number: UMIN000005703.

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