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

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          Abstract

          In a randomized phase II study of sorafenib plus hepatic arterial infusion chemotherapy with cisplatin in comparison with sorafenib alone in patients with advanced hepatocellular carcinoma, it yielded favorable overall survival when compared with sorafenib alone. This is the first report of its effectiveness in relation to the overall survival in comparison with that of sorafenib alone in patients with advanced hepatocellular carcinoma.

          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/m 2, 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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          Most cited references8

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          Treatment of Advanced Hepatocellular Carcinoma with Emphasis on Hepatic Arterial Infusion Chemotherapy and Molecular Targeted Therapy

          Advanced hepatocellular carcinoma is defined as liver cancer with vascular invasion or extrahepatic metastasis that is untreatable by local therapy. In Japan, hepatic arterial infusion chemotherapy (HAIC) with interferon plus 5-fluorouracil (5-FU) or a combination of low-dose 5-FU and cisplatin, referred to as low-dose FP, is administered for treating advanced liver cancer and yields favorable outcomes. Outside Japan, the molecular targeted agent, sorafenib, is used as a first-line treatment for advanced liver cancer. New drug development for advanced liver cancer and clinical trials on combination therapy with sorafenib and HAIC are currently underway. The prognosis of advanced liver cancer will significantly improve if these clinical trials yield positive results.
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            Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer.

            This trial evaluated the efficacy and safety of sorafenib plus gemcitabine/cisplatin in chemotherapy-naive patients with unresectable stage IIIB to IV nonsquamous non-small-cell lung cancer (NSCLC). Between February 2007 and March 2009, 904 patients were randomly assigned to daily sorafenib (400 mg twice a day) or matching placebo plus gemcitabine (1,250 mg/m(2) per day on days 1 and 8) and cisplatin (75 mg/m(2) on day 1) for up to six 21-day cycles. Because of safety findings from the Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC (ESCAPE) trial, patients with squamous cell histology were withdrawn from the trial in February 2008 and excluded from analysis. The primary end point was overall survival (OS), and secondary end points included progression-free survival (PFS) and time-to-progression (TTP). The primary analysis population consisted of 772 patients (sorafenib, 385; placebo, 387); the two groups had similar demographic and baseline characteristics. Median OS was similar in the sorafenib and placebo groups (12.4 v 12.5 months; hazard ratio [HR], 0.98; P = .401). By investigator assessment, sorafenib improved median PFS (6.0 v 5.5 months; HR, 0.83; P = .008) and TTP (6.1 v 5.5 months; HR, 0.73; P < .001). Grade 3 to 4 drug-related adverse events more than two-fold higher in the sorafenib group included hand-foot skin reaction (8.6% v 0.3%), fatigue (7.3% v 3.6%), rash (5.7% v 0.5%), and hypertension (4.2% v 1.8%). No unexpected toxicities were observed. This study did not meet its primary end point of improved OS when sorafenib was added to first-line gemcitabine/cisplatin in patients with advanced nonsquamous NSCLC. Identification of predictive biomarkers is warranted in future trials of sorafenib.
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              Phase II study of sorafenib in combination with cisplatin and 5-fluorouracil to treat recurrent or metastatic nasopharyngeal carcinoma.

              We aimed to investigate the efficacy and tolerability of sorafenib combined with cisplatin and 5-fluorouracil (5-FU) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).
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                Author and article information

                Journal
                Ann Oncol
                Ann. Oncol
                annonc
                annonc
                Annals of Oncology
                Oxford University Press
                0923-7534
                1569-8041
                November 2016
                29 August 2016
                29 August 2016
                : 27
                : 11
                : 2090-2096
                Affiliations
                [1 ]Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East , Kashiwa
                [2 ]Department of Biostatistics, Kyoto University School of Public Health , Kyoto
                [3 ]Department of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center , Yokohama
                [4 ]Department of Gastroenterology, National Center for Global Health and Medicine Center Hospital , Tokyo
                [5 ]Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital , Nagoya
                [6 ]Department of Hepatology, Osaka City University Hospital , Osaka
                [7 ]Department of Gastroenterology and Hepatology, Kinki University School of Medicine , Osaka
                [8 ]Department of Hepatobiliary and Pancreatic Surgery, Osaka National Hospital , Osaka
                [9 ]Department of Gastroenterology, Kanazawa University Hospital , Kanazawa
                [10 ]Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center , Fukuoka
                [11 ]Department of Gastroenterology, Saiseikai Utsunomiya Hospital , Tochigi
                [12 ]Department of Gastroenterology, Sapporo Kosei General Hospital , Sapporo
                [13 ]Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine , Kyoto
                [14 ]Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital , Kyoto
                [15 ]Clinical Research Center, Shikoku Cancer Center , Matsuyama
                [16 ]Department of Medical Oncology, Kyorin University , Tokyo
                [17 ]Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital , Tokyo, Japan
                Author notes
                [* ] Correspondence to: Dr Masafumi Ikeda, Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa 277–8577, Japan. Tel: +81-4-7133-1111; Fax: +81-4-7133-0335; E-mail: masikeda@ 123456east.ncc.go.jp
                Article
                mdw323
                10.1093/annonc/mdw323
                5091321
                27573564
                3c327359-f8e4-402e-955d-278413091c11
                © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 April 2016
                : 11 July 2016
                : 4 August 2016
                Categories
                Original Articles
                Gastrointestinal Tumors

                Oncology & Radiotherapy
                cisplatin,hepatic arterial infusion chemotherapy,hepatocellular carcinoma,sorafenib,randomized phase ii trial

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