Hepatic arterial infusion chemotherapy with fine-powder cisplatin and iodized-oil suspension in patients with intermediate-stage and advanced-stage (Barcelona Clinic Liver Cancer stage-B or stage-C) hepatocellular carcinoma: multicenter phase-II clinical study

Purpose This single-arm, multicenter, phase-II trial evaluated the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using fine-powder cisplatin and iodized-oil suspension in patients with intermediate- and advanced-stage [Barcelona Clinic Liver Cancer (BCLC) stage-B and stage-C]...

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Veröffentlicht in:International journal of clinical oncology 2015-08, Vol.20 (4), p.745-754
Hauptverfasser: Takaki, Haruyuki, Yamakado, Koichiro, Tsurusaki, Masakatsu, Yasumoto, Taku, Baba, Yasutaka, Narimatsu, Yoshiaki, Shimohira, Masashi, Yamaguchi, Masato, Matsuo, Kunihiro, Inaba, Yoshitaka, Mikami, Koji, Watanabe, Ryohei, Nishida, Norifumi, Anai, Hiroshi, Kakizawa, Hideaki, Hirota, Shozo
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container_issue 4
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container_title International journal of clinical oncology
container_volume 20
creator Takaki, Haruyuki
Yamakado, Koichiro
Tsurusaki, Masakatsu
Yasumoto, Taku
Baba, Yasutaka
Narimatsu, Yoshiaki
Shimohira, Masashi
Yamaguchi, Masato
Matsuo, Kunihiro
Inaba, Yoshitaka
Mikami, Koji
Watanabe, Ryohei
Nishida, Norifumi
Anai, Hiroshi
Kakizawa, Hideaki
Hirota, Shozo
description Purpose This single-arm, multicenter, phase-II trial evaluated the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using fine-powder cisplatin and iodized-oil suspension in patients with intermediate- and advanced-stage [Barcelona Clinic Liver Cancer (BCLC) stage-B and stage-C] hepatocellular carcinomas (HCCs). Methods The Institutional Review Board approved this study and patients provided written informed consent. Thirty-five patients (24 men and 11 women, mean 74 ± 6 years [range 60–87 years]) with BCLC stage-B (57 %, 20/35) or stage-C (43 %, 15/35) HCCs who were not candidates for other locoregional treatments were enrolled. HAIC was performed using a suspension of fine-powder cisplatin with a maximum dose of 65 mg/m 2 and iodized oil on demand. The primary endpoint was the response rate evaluated based on Response Evaluation Criteria in Solid Tumor (RECIST) and modified RECIST (mRECIST). Secondary endpoints were overall survival, progression-free survival, and safety. Results The initial and best overall response rates at 4 weeks and 3 months, respectively, were 14 and 17 % based on RECIST, and 57 and 23 % based on mRECIST. The median overall and progression-free survival times were 18 and 4 months, respectively. The most frequent grade-3 or grade-4 adverse events were elevation of serum alanine (23 %) and aspartate aminotransferase (20 %), and thrombocytopenia (17 %). Conclusion This HAIC provides promising therapeutic effects with acceptable safety to patients with intermediate-stage and advanced-stage HCCs.
doi_str_mv 10.1007/s10147-014-0773-4
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Methods The Institutional Review Board approved this study and patients provided written informed consent. Thirty-five patients (24 men and 11 women, mean 74 ± 6 years [range 60–87 years]) with BCLC stage-B (57 %, 20/35) or stage-C (43 %, 15/35) HCCs who were not candidates for other locoregional treatments were enrolled. HAIC was performed using a suspension of fine-powder cisplatin with a maximum dose of 65 mg/m 2 and iodized oil on demand. The primary endpoint was the response rate evaluated based on Response Evaluation Criteria in Solid Tumor (RECIST) and modified RECIST (mRECIST). Secondary endpoints were overall survival, progression-free survival, and safety. Results The initial and best overall response rates at 4 weeks and 3 months, respectively, were 14 and 17 % based on RECIST, and 57 and 23 % based on mRECIST. The median overall and progression-free survival times were 18 and 4 months, respectively. The most frequent grade-3 or grade-4 adverse events were elevation of serum alanine (23 %) and aspartate aminotransferase (20 %), and thrombocytopenia (17 %). Conclusion This HAIC provides promising therapeutic effects with acceptable safety to patients with intermediate-stage and advanced-stage HCCs.</description><identifier>ISSN: 1341-9625</identifier><identifier>EISSN: 1437-7772</identifier><identifier>DOI: 10.1007/s10147-014-0773-4</identifier><identifier>PMID: 25432660</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Aged ; Aged, 80 and over ; Cancer Research ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - pathology ; Chemotherapy ; Cisplatin - administration &amp; dosage ; Female ; Hepatic Artery ; Humans ; Infusions, Intra-Arterial ; Iodized Oil - administration &amp; dosage ; Liver cancer ; Liver Neoplasms - drug therapy ; Liver Neoplasms - pathology ; Male ; Medicine ; Medicine &amp; Public Health ; Middle Aged ; Neoplasm Staging ; Oncology ; Original Article ; Powders ; Prospective Studies ; Surgical Oncology ; Treatment Outcome</subject><ispartof>International journal of clinical oncology, 2015-08, Vol.20 (4), p.745-754</ispartof><rights>Japan Society of Clinical Oncology 2014</rights><rights>Japan Society of Clinical Oncology 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-68afc5a9ebfddac5fd3072aa7fd60566a6115d978b3ef6afd1a4009e4c4e7b113</citedby><cites>FETCH-LOGICAL-c466t-68afc5a9ebfddac5fd3072aa7fd60566a6115d978b3ef6afd1a4009e4c4e7b113</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/s10147-014-0773-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10147-014-0773-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25432660$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Takaki, Haruyuki</creatorcontrib><creatorcontrib>Yamakado, Koichiro</creatorcontrib><creatorcontrib>Tsurusaki, Masakatsu</creatorcontrib><creatorcontrib>Yasumoto, Taku</creatorcontrib><creatorcontrib>Baba, Yasutaka</creatorcontrib><creatorcontrib>Narimatsu, Yoshiaki</creatorcontrib><creatorcontrib>Shimohira, Masashi</creatorcontrib><creatorcontrib>Yamaguchi, Masato</creatorcontrib><creatorcontrib>Matsuo, Kunihiro</creatorcontrib><creatorcontrib>Inaba, Yoshitaka</creatorcontrib><creatorcontrib>Mikami, Koji</creatorcontrib><creatorcontrib>Watanabe, Ryohei</creatorcontrib><creatorcontrib>Nishida, Norifumi</creatorcontrib><creatorcontrib>Anai, Hiroshi</creatorcontrib><creatorcontrib>Kakizawa, Hideaki</creatorcontrib><creatorcontrib>Hirota, Shozo</creatorcontrib><title>Hepatic arterial infusion chemotherapy with fine-powder cisplatin and iodized-oil suspension in patients with intermediate-stage and advanced-stage (Barcelona Clinic Liver Cancer stage-B or stage-C) hepatocellular carcinoma: multicenter phase-II clinical study</title><title>International journal of clinical oncology</title><addtitle>Int J Clin Oncol</addtitle><addtitle>Int J Clin Oncol</addtitle><description>Purpose This single-arm, multicenter, phase-II trial evaluated the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using fine-powder cisplatin and iodized-oil suspension in patients with intermediate- and advanced-stage [Barcelona Clinic Liver Cancer (BCLC) stage-B and stage-C] hepatocellular carcinomas (HCCs). Methods The Institutional Review Board approved this study and patients provided written informed consent. Thirty-five patients (24 men and 11 women, mean 74 ± 6 years [range 60–87 years]) with BCLC stage-B (57 %, 20/35) or stage-C (43 %, 15/35) HCCs who were not candidates for other locoregional treatments were enrolled. HAIC was performed using a suspension of fine-powder cisplatin with a maximum dose of 65 mg/m 2 and iodized oil on demand. The primary endpoint was the response rate evaluated based on Response Evaluation Criteria in Solid Tumor (RECIST) and modified RECIST (mRECIST). Secondary endpoints were overall survival, progression-free survival, and safety. Results The initial and best overall response rates at 4 weeks and 3 months, respectively, were 14 and 17 % based on RECIST, and 57 and 23 % based on mRECIST. The median overall and progression-free survival times were 18 and 4 months, respectively. The most frequent grade-3 or grade-4 adverse events were elevation of serum alanine (23 %) and aspartate aminotransferase (20 %), and thrombocytopenia (17 %). 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Yamakado, Koichiro ; Tsurusaki, Masakatsu ; Yasumoto, Taku ; Baba, Yasutaka ; Narimatsu, Yoshiaki ; Shimohira, Masashi ; Yamaguchi, Masato ; Matsuo, Kunihiro ; Inaba, Yoshitaka ; Mikami, Koji ; Watanabe, Ryohei ; Nishida, Norifumi ; Anai, Hiroshi ; Kakizawa, Hideaki ; Hirota, Shozo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c466t-68afc5a9ebfddac5fd3072aa7fd60566a6115d978b3ef6afd1a4009e4c4e7b113</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Cancer Research</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>Carcinoma, Hepatocellular - pathology</topic><topic>Chemotherapy</topic><topic>Cisplatin - administration &amp; dosage</topic><topic>Female</topic><topic>Hepatic Artery</topic><topic>Humans</topic><topic>Infusions, Intra-Arterial</topic><topic>Iodized Oil - administration &amp; dosage</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - drug therapy</topic><topic>Liver Neoplasms - pathology</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine &amp; Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Powders</topic><topic>Prospective Studies</topic><topic>Surgical Oncology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Takaki, Haruyuki</creatorcontrib><creatorcontrib>Yamakado, Koichiro</creatorcontrib><creatorcontrib>Tsurusaki, Masakatsu</creatorcontrib><creatorcontrib>Yasumoto, Taku</creatorcontrib><creatorcontrib>Baba, Yasutaka</creatorcontrib><creatorcontrib>Narimatsu, Yoshiaki</creatorcontrib><creatorcontrib>Shimohira, Masashi</creatorcontrib><creatorcontrib>Yamaguchi, Masato</creatorcontrib><creatorcontrib>Matsuo, Kunihiro</creatorcontrib><creatorcontrib>Inaba, Yoshitaka</creatorcontrib><creatorcontrib>Mikami, Koji</creatorcontrib><creatorcontrib>Watanabe, Ryohei</creatorcontrib><creatorcontrib>Nishida, Norifumi</creatorcontrib><creatorcontrib>Anai, Hiroshi</creatorcontrib><creatorcontrib>Kakizawa, Hideaki</creatorcontrib><creatorcontrib>Hirota, Shozo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health &amp; 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Methods The Institutional Review Board approved this study and patients provided written informed consent. Thirty-five patients (24 men and 11 women, mean 74 ± 6 years [range 60–87 years]) with BCLC stage-B (57 %, 20/35) or stage-C (43 %, 15/35) HCCs who were not candidates for other locoregional treatments were enrolled. HAIC was performed using a suspension of fine-powder cisplatin with a maximum dose of 65 mg/m 2 and iodized oil on demand. The primary endpoint was the response rate evaluated based on Response Evaluation Criteria in Solid Tumor (RECIST) and modified RECIST (mRECIST). Secondary endpoints were overall survival, progression-free survival, and safety. Results The initial and best overall response rates at 4 weeks and 3 months, respectively, were 14 and 17 % based on RECIST, and 57 and 23 % based on mRECIST. The median overall and progression-free survival times were 18 and 4 months, respectively. The most frequent grade-3 or grade-4 adverse events were elevation of serum alanine (23 %) and aspartate aminotransferase (20 %), and thrombocytopenia (17 %). Conclusion This HAIC provides promising therapeutic effects with acceptable safety to patients with intermediate-stage and advanced-stage HCCs.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>25432660</pmid><doi>10.1007/s10147-014-0773-4</doi><tpages>10</tpages></addata></record>
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subjects Aged
Aged, 80 and over
Cancer Research
Carcinoma, Hepatocellular - drug therapy
Carcinoma, Hepatocellular - pathology
Chemotherapy
Cisplatin - administration & dosage
Female
Hepatic Artery
Humans
Infusions, Intra-Arterial
Iodized Oil - administration & dosage
Liver cancer
Liver Neoplasms - drug therapy
Liver Neoplasms - pathology
Male
Medicine
Medicine & Public Health
Middle Aged
Neoplasm Staging
Oncology
Original Article
Powders
Prospective Studies
Surgical Oncology
Treatment Outcome
title Hepatic arterial infusion chemotherapy with fine-powder cisplatin and iodized-oil suspension in patients with intermediate-stage and advanced-stage (Barcelona Clinic Liver Cancer stage-B or stage-C) hepatocellular carcinoma: multicenter phase-II clinical study
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