A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma

Purpose This prospective study aims to explore the benefit of cytokine-induced killer cell (CIK) treatment in hepatocellular carcinoma patients, which has not yet been thoroughly studied before. Methods From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carc...

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Veröffentlicht in:Journal of clinical immunology 2014-02, Vol.34 (2), p.194-203
Hauptverfasser: Yu, Xiaozhou, Zhao, Hua, Liu, Liang, Cao, Shui, Ren, Baozhu, Zhang, Naining, An, Xiumei, Yu, Jinpu, Li, Hui, Ren, Xiubao
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container_end_page 203
container_issue 2
container_start_page 194
container_title Journal of clinical immunology
container_volume 34
creator Yu, Xiaozhou
Zhao, Hua
Liu, Liang
Cao, Shui
Ren, Baozhu
Zhang, Naining
An, Xiumei
Yu, Jinpu
Li, Hui
Ren, Xiubao
description Purpose This prospective study aims to explore the benefit of cytokine-induced killer cell (CIK) treatment in hepatocellular carcinoma patients, which has not yet been thoroughly studied before. Methods From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer (BCLC) stage A, B or C, Child–Pugh scores of A or B and without prior treatment were enrolled in the study. Patients were randomly assigned to either arm 1 ( n  = 66) to receive CIK treatment plus standard treatment, or arm 2 ( n  = 66) to receive standard treatment only. The primary end point was overall survival (OS) and the secondary endpoint was progression-free survival as evaluated by Kaplan–Meier analyses and treatment hazard ratios with the Cox proportional hazards model. Results The 1-year (OS: 74.2 % vs. 50.0 %, 95 % CI: 63.6–84.8 % vs. 37.8–62.2, p  = 0.002), 2-year (OS: 53.0 % vs. 30.3 %, 95 % CI: 40.8–65.2 % vs. 19.1–41.5 %, p  = 0.002), 3-year (OS: 42.4 % vs. 24.2 %, 95 % CI: 30.4–54.4 % vs. 13.8–34.6 %, p  = 0.005) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2. Therefore, in patients who are not suitable for surgery, significant benefit is obtained from CIK treatment. The main adverse effects of CIK included fever, allergy and headache pain. Conclusions Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment.
doi_str_mv 10.1007/s10875-013-9976-0
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Methods From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer (BCLC) stage A, B or C, Child–Pugh scores of A or B and without prior treatment were enrolled in the study. Patients were randomly assigned to either arm 1 ( n  = 66) to receive CIK treatment plus standard treatment, or arm 2 ( n  = 66) to receive standard treatment only. The primary end point was overall survival (OS) and the secondary endpoint was progression-free survival as evaluated by Kaplan–Meier analyses and treatment hazard ratios with the Cox proportional hazards model. Results The 1-year (OS: 74.2 % vs. 50.0 %, 95 % CI: 63.6–84.8 % vs. 37.8–62.2, p  = 0.002), 2-year (OS: 53.0 % vs. 30.3 %, 95 % CI: 40.8–65.2 % vs. 19.1–41.5 %, p  = 0.002), 3-year (OS: 42.4 % vs. 24.2 %, 95 % CI: 30.4–54.4 % vs. 13.8–34.6 %, p  = 0.005) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2. Therefore, in patients who are not suitable for surgery, significant benefit is obtained from CIK treatment. The main adverse effects of CIK included fever, allergy and headache pain. Conclusions Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment.</description><identifier>ISSN: 0271-9142</identifier><identifier>EISSN: 1573-2592</identifier><identifier>DOI: 10.1007/s10875-013-9976-0</identifier><identifier>CODEN: JCIMDO</identifier><language>eng</language><publisher>Boston: Springer US</publisher><subject>Biomedical and Life Sciences ; Biomedicine ; Immunology ; Infectious Diseases ; Internal Medicine ; Medical Microbiology ; Original Research</subject><ispartof>Journal of clinical immunology, 2014-02, Vol.34 (2), p.194-203</ispartof><rights>Springer Science+Business Media New York 2013</rights><rights>Springer Science+Business Media New York 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-111a55f12003ca425d83c6fa827bab89445a02baaca62fe5f7aa61acc8d8a81d3</citedby><cites>FETCH-LOGICAL-c415t-111a55f12003ca425d83c6fa827bab89445a02baaca62fe5f7aa61acc8d8a81d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10875-013-9976-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10875-013-9976-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids></links><search><creatorcontrib>Yu, Xiaozhou</creatorcontrib><creatorcontrib>Zhao, Hua</creatorcontrib><creatorcontrib>Liu, Liang</creatorcontrib><creatorcontrib>Cao, Shui</creatorcontrib><creatorcontrib>Ren, Baozhu</creatorcontrib><creatorcontrib>Zhang, Naining</creatorcontrib><creatorcontrib>An, Xiumei</creatorcontrib><creatorcontrib>Yu, Jinpu</creatorcontrib><creatorcontrib>Li, Hui</creatorcontrib><creatorcontrib>Ren, Xiubao</creatorcontrib><title>A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma</title><title>Journal of clinical immunology</title><addtitle>J Clin Immunol</addtitle><description>Purpose This prospective study aims to explore the benefit of cytokine-induced killer cell (CIK) treatment in hepatocellular carcinoma patients, which has not yet been thoroughly studied before. Methods From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer (BCLC) stage A, B or C, Child–Pugh scores of A or B and without prior treatment were enrolled in the study. Patients were randomly assigned to either arm 1 ( n  = 66) to receive CIK treatment plus standard treatment, or arm 2 ( n  = 66) to receive standard treatment only. The primary end point was overall survival (OS) and the secondary endpoint was progression-free survival as evaluated by Kaplan–Meier analyses and treatment hazard ratios with the Cox proportional hazards model. Results The 1-year (OS: 74.2 % vs. 50.0 %, 95 % CI: 63.6–84.8 % vs. 37.8–62.2, p  = 0.002), 2-year (OS: 53.0 % vs. 30.3 %, 95 % CI: 40.8–65.2 % vs. 19.1–41.5 %, p  = 0.002), 3-year (OS: 42.4 % vs. 24.2 %, 95 % CI: 30.4–54.4 % vs. 13.8–34.6 %, p  = 0.005) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2. Therefore, in patients who are not suitable for surgery, significant benefit is obtained from CIK treatment. The main adverse effects of CIK included fever, allergy and headache pain. 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Methods From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer (BCLC) stage A, B or C, Child–Pugh scores of A or B and without prior treatment were enrolled in the study. Patients were randomly assigned to either arm 1 ( n  = 66) to receive CIK treatment plus standard treatment, or arm 2 ( n  = 66) to receive standard treatment only. The primary end point was overall survival (OS) and the secondary endpoint was progression-free survival as evaluated by Kaplan–Meier analyses and treatment hazard ratios with the Cox proportional hazards model. Results The 1-year (OS: 74.2 % vs. 50.0 %, 95 % CI: 63.6–84.8 % vs. 37.8–62.2, p  = 0.002), 2-year (OS: 53.0 % vs. 30.3 %, 95 % CI: 40.8–65.2 % vs. 19.1–41.5 %, p  = 0.002), 3-year (OS: 42.4 % vs. 24.2 %, 95 % CI: 30.4–54.4 % vs. 13.8–34.6 %, p  = 0.005) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2. Therefore, in patients who are not suitable for surgery, significant benefit is obtained from CIK treatment. The main adverse effects of CIK included fever, allergy and headache pain. Conclusions Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment.</abstract><cop>Boston</cop><pub>Springer US</pub><doi>10.1007/s10875-013-9976-0</doi><tpages>10</tpages></addata></record>
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subjects Biomedical and Life Sciences
Biomedicine
Immunology
Infectious Diseases
Internal Medicine
Medical Microbiology
Original Research
title A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma
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