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 |
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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 |
format | Article |
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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.</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 & 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</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 %).
Conclusion
This HAIC provides promising therapeutic effects with acceptable safety to patients with intermediate-stage and advanced-stage HCCs.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Cancer Research</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>Carcinoma, Hepatocellular - pathology</subject><subject>Chemotherapy</subject><subject>Cisplatin - administration & dosage</subject><subject>Female</subject><subject>Hepatic Artery</subject><subject>Humans</subject><subject>Infusions, Intra-Arterial</subject><subject>Iodized Oil - administration & dosage</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Liver Neoplasms - pathology</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Powders</subject><subject>Prospective Studies</subject><subject>Surgical Oncology</subject><subject>Treatment Outcome</subject><issn>1341-9625</issn><issn>1437-7772</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp1ksFu1DAQhgMqoqXwAFyQJS7lYLATx-5yoyugK63EBc7RrD3pukrsYCetlqdnsmkRQuJij-z__2ZGM0XxWor3UgjzIUshleF0cGFMxdXT4kyqynBjTHlCcaUkX-myPi1e5HwrhDS6Lp8Xp2WtqlJrcfbk5BoHGL1lkEZMHjrmQztlHwOze-zjuMcEw4Hd-3HPWh-QD_HeYWLW56EjZ2AQHPPR-V_oePQdy1MeMBwR9DvTMYx5IfhAWXp0HkbkeYQbPNrB3UGw5F-eLq4gWexiALbufKDqtv6Ocq5nUWJHEb9i8TFcv2P7uY1Ipm7qgKojgA-xh4-snzrqD-fEbNhDRr7ZMHvEUrd5nNzhZfGshS7jq4f7vPjx5fP39TXffvu6WX_acqu0Hrm-hNbWsMJd6xzYunWVMCWAaZ0WtdagpazdylzuKmw1tE6CEmKFyio0Oymr8-Ji4Q4p_pwwj03v81wzBIxTbqQRJQ3IKEHSt_9Ib-OUAlV3VIm6qlczUC4qm2LOCdtmSL6HdGikaOYVaZYVaeho5hVpFHnePJCnHU3ij-NxJ0hQLoJMX-EG01-p_0v9DQaWzQU</recordid><startdate>20150801</startdate><enddate>20150801</enddate><creator>Takaki, Haruyuki</creator><creator>Yamakado, Koichiro</creator><creator>Tsurusaki, Masakatsu</creator><creator>Yasumoto, Taku</creator><creator>Baba, Yasutaka</creator><creator>Narimatsu, Yoshiaki</creator><creator>Shimohira, Masashi</creator><creator>Yamaguchi, Masato</creator><creator>Matsuo, Kunihiro</creator><creator>Inaba, Yoshitaka</creator><creator>Mikami, Koji</creator><creator>Watanabe, Ryohei</creator><creator>Nishida, Norifumi</creator><creator>Anai, Hiroshi</creator><creator>Kakizawa, Hideaki</creator><creator>Hirota, Shozo</creator><general>Springer Japan</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20150801</creationdate><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><author>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</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 & dosage</topic><topic>Female</topic><topic>Hepatic Artery</topic><topic>Humans</topic><topic>Infusions, Intra-Arterial</topic><topic>Iodized Oil - administration & 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 & 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 & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Takaki, Haruyuki</au><au>Yamakado, Koichiro</au><au>Tsurusaki, Masakatsu</au><au>Yasumoto, Taku</au><au>Baba, Yasutaka</au><au>Narimatsu, Yoshiaki</au><au>Shimohira, Masashi</au><au>Yamaguchi, Masato</au><au>Matsuo, Kunihiro</au><au>Inaba, Yoshitaka</au><au>Mikami, Koji</au><au>Watanabe, Ryohei</au><au>Nishida, Norifumi</au><au>Anai, Hiroshi</au><au>Kakizawa, Hideaki</au><au>Hirota, Shozo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>International journal of clinical oncology</jtitle><stitle>Int J Clin Oncol</stitle><addtitle>Int J Clin Oncol</addtitle><date>2015-08-01</date><risdate>2015</risdate><volume>20</volume><issue>4</issue><spage>745</spage><epage>754</epage><pages>745-754</pages><issn>1341-9625</issn><eissn>1437-7772</eissn><abstract>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.</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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source | MEDLINE; SpringerLink Journals - AutoHoldings |
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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