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Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial
Background This prospective study investigated the superiority of transarterial chemoembolization (TACE) with miriplatin over TACE with epirubicin regarding overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC). Methods Patients with unresectable HCC were randomized 1:1...
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| Published in: | Journal of gastroenterology 2018-02, Vol.53 (2), p.281-290 |
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| container_title | Journal of gastroenterology |
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| creator | Ikeda, Masafumi Kudo, Masatoshi Aikata, Hiroshi Nagamatsu, Hiroaki Ishii, Hiroshi Yokosuka, Osamu Torimura, Takuji Morimoto, Manabu Ikeda, Kenji Kumada, Hiromitsu Sato, Tosiya Kawai, Ikuko Yamashita, Toru Horio, Hiroshi Okusaka, Takuji |
| description | Background
This prospective study investigated the superiority of transarterial chemoembolization (TACE) with miriplatin over TACE with epirubicin regarding overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC).
Methods
Patients with unresectable HCC were randomized 1:1 to receive TACE with miriplatin or epirubicin in lipiodol. The primary endpoint was OS; secondary endpoints were percentages of patients who achieved treatment effect (TE) 4 (100% necrotizing effect or tumor reduction), duration of time to TACE failure, and adverse events (AEs). OS was compared using a stratified log-rank test adjusted for clinical stage, Child–Pugh class, and institution.
Results
Of 257 patients enrolled from August 2008 to August 2010, 247 were analyzed for efficacy and toxicity (miriplatin,
n
= 124; epirubicin,
n
= 123). Baseline characteristics were well balanced between the two groups. Median OS times were 1111 days for miriplatin and 1127 days for epirubicin (adjusted hazard ratio 1.01, 95% confidence interval 0.73–1.40,
P
= 0.946). TE4 rates were 44.4% for miriplatin and 37.4% for epirubicin. Median times to TACE failure were 365.5 days for miriplatin and 414.0 days for epirubicin. AEs of grade 3 or higher, including elevated aspartate aminotransferase (miriplatin, 39.5%; epirubicin, 57.7%) and elevated alanine aminotransferase (miriplatin, 31.5%; epirubicin, 53.7%), were less frequent in the miriplatin than the epirubicin group.
Conclusions
OS after TACE with miriplatin was not superior to that after TACE with epirubicin; however, hepatic AEs were less frequent with miriplatin.
Clinical Trial Registration: JapicCTI-080632. |
| doi_str_mv | 10.1007/s00535-017-1374-6 |
| format | article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5846877</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A714583399</galeid><sourcerecordid>A714583399</sourcerecordid><originalsourceid>FETCH-LOGICAL-c605t-1c3eb77ac20c0a0d53ac4f20ae4778fa8776466d07d7216de5b0dd345609a3d33</originalsourceid><addsrcrecordid>eNp1Uk1v1DAQtRCILgs_gAuyxDmLHX8lHJCqio-VKnEpZ2viTDaukjjYSRH9AfxuvNpSWgnkw8hv3nszIz1CXnO244yZd4kxJVTBuCm4MLLQT8iGy4youiyfkg2rpSw4N_KMvEjpmjEumKqek7OyMlozrjfk11WEKUFcMHoYqOtxDDg2YfC3sPgw0R9-6enoo5-HDEz0Ju0ozj6ujXf524VI1yliQrdAMyDtcYYlOByGdYBIHcRMCyO8p0DnHhLS_X5P89A2jP4WW7ocB78kzzoYEr66q1vy7dPHq4svxeXXz_uL88vCaaaWgjuBjTHgSuYYsFYJcLIrGaA0puqgMkZLrVtmWlNy3aJqWNsKqTSrQbRCbMmHk--8NiO2DqclwmDn6EeIP20Abx93Jt_bQ7ixqpI6u2eDt3cGMXxfMS32OqxxyjtbXtdC1Urq8i_rAANaP3Uhm7nRJ2fPDZeqEiKTt2T3D1Z-LY7ehQk7n_FHAn4SuBhSitjdL86ZPSbCnhJhcyLsMRFWZ82bhxffK_5EIBPKEyHl1nTA-OCi_7r-Bmd9w7E</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1993595462</pqid></control><display><type>article</type><title>Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial</title><source>Springer Nature</source><creator>Ikeda, Masafumi ; Kudo, Masatoshi ; Aikata, Hiroshi ; Nagamatsu, Hiroaki ; Ishii, Hiroshi ; Yokosuka, Osamu ; Torimura, Takuji ; Morimoto, Manabu ; Ikeda, Kenji ; Kumada, Hiromitsu ; Sato, Tosiya ; Kawai, Ikuko ; Yamashita, Toru ; Horio, Hiroshi ; Okusaka, Takuji</creator><creatorcontrib>Ikeda, Masafumi ; Kudo, Masatoshi ; Aikata, Hiroshi ; Nagamatsu, Hiroaki ; Ishii, Hiroshi ; Yokosuka, Osamu ; Torimura, Takuji ; Morimoto, Manabu ; Ikeda, Kenji ; Kumada, Hiromitsu ; Sato, Tosiya ; Kawai, Ikuko ; Yamashita, Toru ; Horio, Hiroshi ; Okusaka, Takuji ; Miriplatin TACE Study Group ; Miriplatin TACE Study Group</creatorcontrib><description>Background
This prospective study investigated the superiority of transarterial chemoembolization (TACE) with miriplatin over TACE with epirubicin regarding overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC).
Methods
Patients with unresectable HCC were randomized 1:1 to receive TACE with miriplatin or epirubicin in lipiodol. The primary endpoint was OS; secondary endpoints were percentages of patients who achieved treatment effect (TE) 4 (100% necrotizing effect or tumor reduction), duration of time to TACE failure, and adverse events (AEs). OS was compared using a stratified log-rank test adjusted for clinical stage, Child–Pugh class, and institution.
Results
Of 257 patients enrolled from August 2008 to August 2010, 247 were analyzed for efficacy and toxicity (miriplatin,
n
= 124; epirubicin,
n
= 123). Baseline characteristics were well balanced between the two groups. Median OS times were 1111 days for miriplatin and 1127 days for epirubicin (adjusted hazard ratio 1.01, 95% confidence interval 0.73–1.40,
P
= 0.946). TE4 rates were 44.4% for miriplatin and 37.4% for epirubicin. Median times to TACE failure were 365.5 days for miriplatin and 414.0 days for epirubicin. AEs of grade 3 or higher, including elevated aspartate aminotransferase (miriplatin, 39.5%; epirubicin, 57.7%) and elevated alanine aminotransferase (miriplatin, 31.5%; epirubicin, 53.7%), were less frequent in the miriplatin than the epirubicin group.
Conclusions
OS after TACE with miriplatin was not superior to that after TACE with epirubicin; however, hepatic AEs were less frequent with miriplatin.
Clinical Trial Registration: JapicCTI-080632.</description><identifier>ISSN: 0944-1174</identifier><identifier>EISSN: 1435-5922</identifier><identifier>DOI: 10.1007/s00535-017-1374-6</identifier><identifier>PMID: 28766016</identifier><language>eng</language><publisher>Tokyo: Springer Japan</publisher><subject>Abdominal Surgery ; Adult ; Aged ; Aged, 80 and over ; Alanine ; Alanine transaminase ; Antibiotics, Antineoplastic - administration & dosage ; Antibiotics, Antineoplastic - adverse effects ; Antimitotic agents ; Antineoplastic agents ; Antineoplastic Agents - administration & dosage ; Antineoplastic Agents - adverse effects ; Aspartate ; Aspartate aminotransferase ; Biliary Tract ; Carcinoma, Hepatocellular - pathology ; Carcinoma, Hepatocellular - therapy ; Care and treatment ; Chemoembolization ; Chemoembolization, Therapeutic - adverse effects ; Chemoembolization, Therapeutic - methods ; Colorectal Surgery ; Comparative analysis ; Epirubicin ; Epirubicin - administration & dosage ; Epirubicin - adverse effects ; Female ; Gastroenterology ; Hepatocellular carcinoma ; Hepatology ; Hepatoma ; Humans ; JapicCTI ; JapicCTI-080632 ; Liver cancer ; Liver Neoplasms - pathology ; Liver Neoplasms - therapy ; Male ; Medical colleges ; Medicine ; Medicine & Public Health ; Middle Aged ; Neoplasm Staging ; Organoplatinum Compounds - administration & dosage ; Organoplatinum Compounds - adverse effects ; Original Article—Liver ; Original —Liver, Pancreas, and Biliary Tract ; Pancreas ; Product development ; Rankings ; Surgical Oncology ; Survival Analysis ; Toxicity ; Treatment Outcome</subject><ispartof>Journal of gastroenterology, 2018-02, Vol.53 (2), p.281-290</ispartof><rights>The Author(s) 2017</rights><rights>COPYRIGHT 2018 Springer</rights><rights>Journal of Gastroenterology is a copyright of Springer, (2017). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c605t-1c3eb77ac20c0a0d53ac4f20ae4778fa8776466d07d7216de5b0dd345609a3d33</citedby><cites>FETCH-LOGICAL-c605t-1c3eb77ac20c0a0d53ac4f20ae4778fa8776466d07d7216de5b0dd345609a3d33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28766016$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ikeda, Masafumi</creatorcontrib><creatorcontrib>Kudo, Masatoshi</creatorcontrib><creatorcontrib>Aikata, Hiroshi</creatorcontrib><creatorcontrib>Nagamatsu, Hiroaki</creatorcontrib><creatorcontrib>Ishii, Hiroshi</creatorcontrib><creatorcontrib>Yokosuka, Osamu</creatorcontrib><creatorcontrib>Torimura, Takuji</creatorcontrib><creatorcontrib>Morimoto, Manabu</creatorcontrib><creatorcontrib>Ikeda, Kenji</creatorcontrib><creatorcontrib>Kumada, Hiromitsu</creatorcontrib><creatorcontrib>Sato, Tosiya</creatorcontrib><creatorcontrib>Kawai, Ikuko</creatorcontrib><creatorcontrib>Yamashita, Toru</creatorcontrib><creatorcontrib>Horio, Hiroshi</creatorcontrib><creatorcontrib>Okusaka, Takuji</creatorcontrib><creatorcontrib>Miriplatin TACE Study Group</creatorcontrib><creatorcontrib>Miriplatin TACE Study Group</creatorcontrib><title>Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial</title><title>Journal of gastroenterology</title><addtitle>J Gastroenterol</addtitle><addtitle>J Gastroenterol</addtitle><description>Background
This prospective study investigated the superiority of transarterial chemoembolization (TACE) with miriplatin over TACE with epirubicin regarding overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC).
Methods
Patients with unresectable HCC were randomized 1:1 to receive TACE with miriplatin or epirubicin in lipiodol. The primary endpoint was OS; secondary endpoints were percentages of patients who achieved treatment effect (TE) 4 (100% necrotizing effect or tumor reduction), duration of time to TACE failure, and adverse events (AEs). OS was compared using a stratified log-rank test adjusted for clinical stage, Child–Pugh class, and institution.
Results
Of 257 patients enrolled from August 2008 to August 2010, 247 were analyzed for efficacy and toxicity (miriplatin,
n
= 124; epirubicin,
n
= 123). Baseline characteristics were well balanced between the two groups. Median OS times were 1111 days for miriplatin and 1127 days for epirubicin (adjusted hazard ratio 1.01, 95% confidence interval 0.73–1.40,
P
= 0.946). TE4 rates were 44.4% for miriplatin and 37.4% for epirubicin. Median times to TACE failure were 365.5 days for miriplatin and 414.0 days for epirubicin. AEs of grade 3 or higher, including elevated aspartate aminotransferase (miriplatin, 39.5%; epirubicin, 57.7%) and elevated alanine aminotransferase (miriplatin, 31.5%; epirubicin, 53.7%), were less frequent in the miriplatin than the epirubicin group.
Conclusions
OS after TACE with miriplatin was not superior to that after TACE with epirubicin; however, hepatic AEs were less frequent with miriplatin.
Clinical Trial Registration: JapicCTI-080632.</description><subject>Abdominal Surgery</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alanine</subject><subject>Alanine transaminase</subject><subject>Antibiotics, Antineoplastic - administration & dosage</subject><subject>Antibiotics, Antineoplastic - adverse effects</subject><subject>Antimitotic agents</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Aspartate</subject><subject>Aspartate aminotransferase</subject><subject>Biliary Tract</subject><subject>Carcinoma, Hepatocellular - pathology</subject><subject>Carcinoma, Hepatocellular - therapy</subject><subject>Care and treatment</subject><subject>Chemoembolization</subject><subject>Chemoembolization, Therapeutic - adverse effects</subject><subject>Chemoembolization, Therapeutic - methods</subject><subject>Colorectal Surgery</subject><subject>Comparative analysis</subject><subject>Epirubicin</subject><subject>Epirubicin - administration & dosage</subject><subject>Epirubicin - adverse effects</subject><subject>Female</subject><subject>Gastroenterology</subject><subject>Hepatocellular carcinoma</subject><subject>Hepatology</subject><subject>Hepatoma</subject><subject>Humans</subject><subject>JapicCTI</subject><subject>JapicCTI-080632</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - pathology</subject><subject>Liver Neoplasms - therapy</subject><subject>Male</subject><subject>Medical colleges</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Organoplatinum Compounds - administration & dosage</subject><subject>Organoplatinum Compounds - adverse effects</subject><subject>Original Article—Liver</subject><subject>Original —Liver, Pancreas, and Biliary Tract</subject><subject>Pancreas</subject><subject>Product development</subject><subject>Rankings</subject><subject>Surgical Oncology</subject><subject>Survival Analysis</subject><subject>Toxicity</subject><subject>Treatment Outcome</subject><issn>0944-1174</issn><issn>1435-5922</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><recordid>eNp1Uk1v1DAQtRCILgs_gAuyxDmLHX8lHJCqio-VKnEpZ2viTDaukjjYSRH9AfxuvNpSWgnkw8hv3nszIz1CXnO244yZd4kxJVTBuCm4MLLQT8iGy4youiyfkg2rpSw4N_KMvEjpmjEumKqek7OyMlozrjfk11WEKUFcMHoYqOtxDDg2YfC3sPgw0R9-6enoo5-HDEz0Ju0ozj6ujXf524VI1yliQrdAMyDtcYYlOByGdYBIHcRMCyO8p0DnHhLS_X5P89A2jP4WW7ocB78kzzoYEr66q1vy7dPHq4svxeXXz_uL88vCaaaWgjuBjTHgSuYYsFYJcLIrGaA0puqgMkZLrVtmWlNy3aJqWNsKqTSrQbRCbMmHk--8NiO2DqclwmDn6EeIP20Abx93Jt_bQ7ixqpI6u2eDt3cGMXxfMS32OqxxyjtbXtdC1Urq8i_rAANaP3Uhm7nRJ2fPDZeqEiKTt2T3D1Z-LY7ehQk7n_FHAn4SuBhSitjdL86ZPSbCnhJhcyLsMRFWZ82bhxffK_5EIBPKEyHl1nTA-OCi_7r-Bmd9w7E</recordid><startdate>20180201</startdate><enddate>20180201</enddate><creator>Ikeda, Masafumi</creator><creator>Kudo, Masatoshi</creator><creator>Aikata, Hiroshi</creator><creator>Nagamatsu, Hiroaki</creator><creator>Ishii, Hiroshi</creator><creator>Yokosuka, Osamu</creator><creator>Torimura, Takuji</creator><creator>Morimoto, Manabu</creator><creator>Ikeda, Kenji</creator><creator>Kumada, Hiromitsu</creator><creator>Sato, Tosiya</creator><creator>Kawai, Ikuko</creator><creator>Yamashita, Toru</creator><creator>Horio, Hiroshi</creator><creator>Okusaka, Takuji</creator><general>Springer Japan</general><general>Springer</general><general>Springer Nature B.V</general><scope>C6C</scope><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>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20180201</creationdate><title>Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial</title><author>Ikeda, Masafumi ; Kudo, Masatoshi ; Aikata, Hiroshi ; Nagamatsu, Hiroaki ; Ishii, Hiroshi ; Yokosuka, Osamu ; Torimura, Takuji ; Morimoto, Manabu ; Ikeda, Kenji ; Kumada, Hiromitsu ; Sato, Tosiya ; Kawai, Ikuko ; Yamashita, Toru ; Horio, Hiroshi ; Okusaka, Takuji</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c605t-1c3eb77ac20c0a0d53ac4f20ae4778fa8776466d07d7216de5b0dd345609a3d33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Abdominal Surgery</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Alanine</topic><topic>Alanine transaminase</topic><topic>Antibiotics, Antineoplastic - administration & dosage</topic><topic>Antibiotics, Antineoplastic - adverse effects</topic><topic>Antimitotic agents</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Aspartate</topic><topic>Aspartate aminotransferase</topic><topic>Biliary Tract</topic><topic>Carcinoma, Hepatocellular - pathology</topic><topic>Carcinoma, Hepatocellular - therapy</topic><topic>Care and treatment</topic><topic>Chemoembolization</topic><topic>Chemoembolization, Therapeutic - adverse effects</topic><topic>Chemoembolization, Therapeutic - methods</topic><topic>Colorectal Surgery</topic><topic>Comparative analysis</topic><topic>Epirubicin</topic><topic>Epirubicin - administration & dosage</topic><topic>Epirubicin - adverse effects</topic><topic>Female</topic><topic>Gastroenterology</topic><topic>Hepatocellular carcinoma</topic><topic>Hepatology</topic><topic>Hepatoma</topic><topic>Humans</topic><topic>JapicCTI</topic><topic>JapicCTI-080632</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - pathology</topic><topic>Liver Neoplasms - therapy</topic><topic>Male</topic><topic>Medical colleges</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Organoplatinum Compounds - administration & dosage</topic><topic>Organoplatinum Compounds - adverse effects</topic><topic>Original Article—Liver</topic><topic>Original —Liver, Pancreas, and Biliary Tract</topic><topic>Pancreas</topic><topic>Product development</topic><topic>Rankings</topic><topic>Surgical Oncology</topic><topic>Survival Analysis</topic><topic>Toxicity</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ikeda, Masafumi</creatorcontrib><creatorcontrib>Kudo, Masatoshi</creatorcontrib><creatorcontrib>Aikata, Hiroshi</creatorcontrib><creatorcontrib>Nagamatsu, Hiroaki</creatorcontrib><creatorcontrib>Ishii, Hiroshi</creatorcontrib><creatorcontrib>Yokosuka, Osamu</creatorcontrib><creatorcontrib>Torimura, Takuji</creatorcontrib><creatorcontrib>Morimoto, Manabu</creatorcontrib><creatorcontrib>Ikeda, Kenji</creatorcontrib><creatorcontrib>Kumada, Hiromitsu</creatorcontrib><creatorcontrib>Sato, Tosiya</creatorcontrib><creatorcontrib>Kawai, Ikuko</creatorcontrib><creatorcontrib>Yamashita, Toru</creatorcontrib><creatorcontrib>Horio, Hiroshi</creatorcontrib><creatorcontrib>Okusaka, Takuji</creatorcontrib><creatorcontrib>Miriplatin TACE Study Group</creatorcontrib><creatorcontrib>Miriplatin TACE Study Group</creatorcontrib><collection>SpringerOpen</collection><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>Proquest Nursing & Allied Health Source</collection><collection>Immunology Abstracts</collection><collection>ProQuest_Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>Nursing & Allied Health Premium</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>PubMed Central (Full Participant titles)</collection><jtitle>Journal of gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ikeda, Masafumi</au><au>Kudo, Masatoshi</au><au>Aikata, Hiroshi</au><au>Nagamatsu, Hiroaki</au><au>Ishii, Hiroshi</au><au>Yokosuka, Osamu</au><au>Torimura, Takuji</au><au>Morimoto, Manabu</au><au>Ikeda, Kenji</au><au>Kumada, Hiromitsu</au><au>Sato, Tosiya</au><au>Kawai, Ikuko</au><au>Yamashita, Toru</au><au>Horio, Hiroshi</au><au>Okusaka, Takuji</au><aucorp>Miriplatin TACE Study Group</aucorp><aucorp>Miriplatin TACE Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial</atitle><jtitle>Journal of gastroenterology</jtitle><stitle>J Gastroenterol</stitle><addtitle>J Gastroenterol</addtitle><date>2018-02-01</date><risdate>2018</risdate><volume>53</volume><issue>2</issue><spage>281</spage><epage>290</epage><pages>281-290</pages><issn>0944-1174</issn><eissn>1435-5922</eissn><abstract>Background
This prospective study investigated the superiority of transarterial chemoembolization (TACE) with miriplatin over TACE with epirubicin regarding overall survival (OS) in patients with unresectable hepatocellular carcinoma (HCC).
Methods
Patients with unresectable HCC were randomized 1:1 to receive TACE with miriplatin or epirubicin in lipiodol. The primary endpoint was OS; secondary endpoints were percentages of patients who achieved treatment effect (TE) 4 (100% necrotizing effect or tumor reduction), duration of time to TACE failure, and adverse events (AEs). OS was compared using a stratified log-rank test adjusted for clinical stage, Child–Pugh class, and institution.
Results
Of 257 patients enrolled from August 2008 to August 2010, 247 were analyzed for efficacy and toxicity (miriplatin,
n
= 124; epirubicin,
n
= 123). Baseline characteristics were well balanced between the two groups. Median OS times were 1111 days for miriplatin and 1127 days for epirubicin (adjusted hazard ratio 1.01, 95% confidence interval 0.73–1.40,
P
= 0.946). TE4 rates were 44.4% for miriplatin and 37.4% for epirubicin. Median times to TACE failure were 365.5 days for miriplatin and 414.0 days for epirubicin. AEs of grade 3 or higher, including elevated aspartate aminotransferase (miriplatin, 39.5%; epirubicin, 57.7%) and elevated alanine aminotransferase (miriplatin, 31.5%; epirubicin, 53.7%), were less frequent in the miriplatin than the epirubicin group.
Conclusions
OS after TACE with miriplatin was not superior to that after TACE with epirubicin; however, hepatic AEs were less frequent with miriplatin.
Clinical Trial Registration: JapicCTI-080632.</abstract><cop>Tokyo</cop><pub>Springer Japan</pub><pmid>28766016</pmid><doi>10.1007/s00535-017-1374-6</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0944-1174 |
| ispartof | Journal of gastroenterology, 2018-02, Vol.53 (2), p.281-290 |
| issn | 0944-1174 1435-5922 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_5846877 |
| source | Springer Nature |
| subjects | Abdominal Surgery Adult Aged Aged, 80 and over Alanine Alanine transaminase Antibiotics, Antineoplastic - administration & dosage Antibiotics, Antineoplastic - adverse effects Antimitotic agents Antineoplastic agents Antineoplastic Agents - administration & dosage Antineoplastic Agents - adverse effects Aspartate Aspartate aminotransferase Biliary Tract Carcinoma, Hepatocellular - pathology Carcinoma, Hepatocellular - therapy Care and treatment Chemoembolization Chemoembolization, Therapeutic - adverse effects Chemoembolization, Therapeutic - methods Colorectal Surgery Comparative analysis Epirubicin Epirubicin - administration & dosage Epirubicin - adverse effects Female Gastroenterology Hepatocellular carcinoma Hepatology Hepatoma Humans JapicCTI JapicCTI-080632 Liver cancer Liver Neoplasms - pathology Liver Neoplasms - therapy Male Medical colleges Medicine Medicine & Public Health Middle Aged Neoplasm Staging Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - adverse effects Original Article—Liver Original —Liver, Pancreas, and Biliary Tract Pancreas Product development Rankings Surgical Oncology Survival Analysis Toxicity Treatment Outcome |
| title | Transarterial chemoembolization with miriplatin vs. epirubicin for unresectable hepatocellular carcinoma: a phase III randomized trial |
| url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-07T15%3A08%3A10IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Transarterial%20chemoembolization%20with%20miriplatin%20vs.%20epirubicin%20for%20unresectable%20hepatocellular%20carcinoma:%20a%20phase%20III%20randomized%20trial&rft.jtitle=Journal%20of%20gastroenterology&rft.au=Ikeda,%20Masafumi&rft.aucorp=Miriplatin%20TACE%20Study%20Group&rft.date=2018-02-01&rft.volume=53&rft.issue=2&rft.spage=281&rft.epage=290&rft.pages=281-290&rft.issn=0944-1174&rft.eissn=1435-5922&rft_id=info:doi/10.1007/s00535-017-1374-6&rft_dat=%3Cgale_pubme%3EA714583399%3C/gale_pubme%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c605t-1c3eb77ac20c0a0d53ac4f20ae4778fa8776466d07d7216de5b0dd345609a3d33%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=1993595462&rft_id=info:pmid/28766016&rft_galeid=A714583399&rfr_iscdi=true |