title: Sorafenib plus hepatic arterial infusion chemotherapy with cisplatin versus sorafenib for advanced hepatocellular carcinoma: randomized phase II trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  SorCDDP yielded favorable overall survival when compared with Sor in patients with advanced HCC.
  
  
  
  UMIN-CTR (http://www.umin.ac.jp/ctr/index-j.htm), identification number: UMIN000005703.
authors: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa masikeda@east.ncc.go.jp.
authors: M
authors: M
authors: Ikeda
authors: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa.
authors: S
authors: S
authors: Shimizu
authors: Department of Biostatistics, Kyoto University School of Public Health, Kyoto.
authors: T
authors: T
authors: Sato
authors: Department of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama.
authors: M
authors: M
authors: Morimoto
authors: Department of Gastroenterology, National Center for Global Health and Medicine Center Hospital, Tokyo.
authors: Y
authors: Y
authors: Kojima
authors: Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya.
authors: Y
authors: Y
authors: Inaba
authors: Department of Hepatology, Osaka City University Hospital, Osaka.
authors: A
authors: A
authors: Hagihara
authors: Department of Gastroenterology and Hepatology, Kinki University School of Medicine, Osaka.
authors: M
authors: M
authors: Kudo
authors: Department of Hepatobiliary and Pancreatic Surgery, Osaka National Hospital, Osaka.
authors: S
authors: S
authors: Nakamori
authors: Department of Gastroenterology, Kanazawa University Hospital, Kanazawa.
authors: S
authors: S
authors: Kaneko
authors: Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center, Fukuoka.
authors: R
authors: R
authors: Sugimoto
authors: Department of Gastroenterology, Saiseikai Utsunomiya Hospital, Tochigi.
authors: T
authors: T
authors: Tahara
authors: Department of Gastroenterology, Sapporo Kosei General Hospital, Sapporo.
authors: T
authors: T
authors: Ohmura
authors: Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto.
authors: K
authors: K
authors: Yasui
authors: Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, Kyoto.
authors: K
authors: K
authors: Sato
authors: Clinical Research Center, Shikoku Cancer Center, Matsuyama.
authors: H
authors: H
authors: Ishii
authors: Department of Medical Oncology, Kyorin University, Tokyo.
authors: J
authors: J
authors: Furuse
authors: Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
authors: T
authors: T
authors: Okusaka
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage*; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib; D002945:Cisplatin
keywords: cisplatin; hepatic arterial infusion chemotherapy; hepatocellular carcinoma; randomized phase II trial; sorafenib