Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group
Aim Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for...
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| Veröffentlicht in: | Hepatology research 2024-07, Vol.54 (7), p.667-677 |
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| creator | Kobayashi, Shogo Tomokuni, Akira Takeda, Yutaka Wada, Hiroshi Katsura, Yoshiteru Hashimoto, Kazuhiko Tomimaru, Yoshito Asaoka, Tadafumi Yamada, Terumasa Tsujie, Masanori Noda, Takehiro Morita, Satoshi Nagano, Hiroaki Mori, Masaki Doki, Yuichiro Eguchi, Hidetoshi |
| description | Aim
Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for hepatocellular carcinoma >5 cm.
Methods
In this exploratory, multicenter, randomized phase I study, the primary measure was 2‐year disease‐free survival (DFS). Secondary measures were resection rate, necrosis rate by TACE, 2‐year overall survival, and site of recurrence. A total of 30 patients were randomly allocated to each arm.
Results
The two arms did not differ in patient characteristics. The median time to surgery from randomization was 48 days for TACE + surgery and 29 for surgery only (p 5 cm in this exploratory, multicenter, randomized phase II study. Neoadjuvant transcatheter arterial chemoembolization allowed delay of surgical treatment without increased morbidity and cancer progress. |
| doi_str_mv | 10.1111/hepr.14013 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2929067395</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3074763834</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3523-5d11f8490d85d86333835fb99aa713b17ed584e6082c5a7b598a525ac783130e3</originalsourceid><addsrcrecordid>eNp9ks1uEzEQxxcEoqVw6QMgS70U1BR7vZ_caBSSSJUSUSpxW028s8TBu17s3UB64hF4hD5LH4UnYZIUhDjgg7_0m__8x54gOBb8XNB4vcTWnYuIC_kwOBRZGg64jD4-or3MkkEio-QgeOr9inOR8jB6EhzILEzzJJeHD45H31pjHXTWbVjrrG9RdXqNZ8xBU9pa32DJ2iV4vLudTpnv-nLDbMUatFCu-jU0HesI9Qq6JXboGDiaNRimllhbrBfW6BvotG1Ya3rPfO8-ISVbo_N_HcHYBlllHTNAN4yKIlMKjenpgilwSje2BnY6vBrPfn7_MbmY08x5_PINGxrdaEU5r3b-xs727dblzMNnYNeN3ibT3eaMTXayFHihjQa3od0cGuWQHKp94LPgcQXG4_P79Si4fjf6MJwMLmfj6fDt5UDJOJSDuBSiyqKcl1lcZomUMpNxtchzgFTIhUixjLMIE56FKoZ0EecZxGEMKs2kkBzlUXC616Vn_9Kj74pa-23BQI_b-yLMw5wnqcxjQk_-QVe2dw25KyRPozSh3BFRr_aUon_0DquidbqmIgvBi22nFNtOKXadQvCLe8l-UWP5B_3dGgSIPfBVG9z8R6qYjObv96K_ANBC0vI</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3074763834</pqid></control><display><type>article</type><title>Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</title><source>Wiley Online Library Journals Frontfile Complete</source><creator>Kobayashi, Shogo ; Tomokuni, Akira ; Takeda, Yutaka ; Wada, Hiroshi ; Katsura, Yoshiteru ; Hashimoto, Kazuhiko ; Tomimaru, Yoshito ; Asaoka, Tadafumi ; Yamada, Terumasa ; Tsujie, Masanori ; Noda, Takehiro ; Morita, Satoshi ; Nagano, Hiroaki ; Mori, Masaki ; Doki, Yuichiro ; Eguchi, Hidetoshi</creator><creatorcontrib>Kobayashi, Shogo ; Tomokuni, Akira ; Takeda, Yutaka ; Wada, Hiroshi ; Katsura, Yoshiteru ; Hashimoto, Kazuhiko ; Tomimaru, Yoshito ; Asaoka, Tadafumi ; Yamada, Terumasa ; Tsujie, Masanori ; Noda, Takehiro ; Morita, Satoshi ; Nagano, Hiroaki ; Mori, Masaki ; Doki, Yuichiro ; Eguchi, Hidetoshi ; Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group ; the Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</creatorcontrib><description>Aim
Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for hepatocellular carcinoma >5 cm.
Methods
In this exploratory, multicenter, randomized phase I study, the primary measure was 2‐year disease‐free survival (DFS). Secondary measures were resection rate, necrosis rate by TACE, 2‐year overall survival, and site of recurrence. A total of 30 patients were randomly allocated to each arm.
Results
The two arms did not differ in patient characteristics. The median time to surgery from randomization was 48 days for TACE + surgery and 29 for surgery only (p < 0.001). Postoperative morbidities did not differ between arms. The 2‐year DFS, overall survival, and resection rates were 56.7%, 80.0%, and 93.3%, respectively, in the TACE + surgery arm, and 56.1%, 89.9%, and 90.0% in the upfront surgery arm. Minimally invasive surgery was carried out in 35.7% in the TACE + surgery arm and in 29.6% in the upfront surgery arm. The median necrosis rate by TACE was 90.0%. In resected specimens, invasion to the hepatic vein was less with TACE + surgery (3.6% vs. 22.2%, p = 0.0380). In cases of 100% necrosis with TACE, 2‐year DFS was 100%. Site of recurrence did not differ between groups.
Conclusion
Neoadjuvant TACE did not improve 2‐year DFS, and neoadjuvant TACE allowed delay of surgical treatment without increased morbidity and cancer progress.
Clinical trial registration
UMIN: 000005241.
Neoadjuvant transcatheter arterial chemoembolization plus surgery was compared with surgery alone for hepatocellular carcinoma >5 cm in this exploratory, multicenter, randomized phase II study. Neoadjuvant transcatheter arterial chemoembolization allowed delay of surgical treatment without increased morbidity and cancer progress.</description><identifier>ISSN: 1386-6346</identifier><identifier>EISSN: 1872-034X</identifier><identifier>DOI: 10.1111/hepr.14013</identifier><identifier>PMID: 38279693</identifier><language>eng</language><publisher>Netherlands: Wiley Subscription Services, Inc</publisher><subject>Chemoembolization ; Hepatic vein ; Hepatocellular carcinoma ; Laparoscopy ; Liver cancer ; Morbidity ; Necrosis ; neoadjuvant ; Patients ; Surgery ; Survival ; transcatheter arterial chemoembolization</subject><ispartof>Hepatology research, 2024-07, Vol.54 (7), p.667-677</ispartof><rights>2024 Japan Society of Hepatology.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3523-5d11f8490d85d86333835fb99aa713b17ed584e6082c5a7b598a525ac783130e3</cites><orcidid>0000-0002-4432-060X ; 0000-0002-2828-0951 ; 0000-0002-8828-1067 ; 0000-0002-6768-5783</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhepr.14013$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhepr.14013$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38279693$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kobayashi, Shogo</creatorcontrib><creatorcontrib>Tomokuni, Akira</creatorcontrib><creatorcontrib>Takeda, Yutaka</creatorcontrib><creatorcontrib>Wada, Hiroshi</creatorcontrib><creatorcontrib>Katsura, Yoshiteru</creatorcontrib><creatorcontrib>Hashimoto, Kazuhiko</creatorcontrib><creatorcontrib>Tomimaru, Yoshito</creatorcontrib><creatorcontrib>Asaoka, Tadafumi</creatorcontrib><creatorcontrib>Yamada, Terumasa</creatorcontrib><creatorcontrib>Tsujie, Masanori</creatorcontrib><creatorcontrib>Noda, Takehiro</creatorcontrib><creatorcontrib>Morita, Satoshi</creatorcontrib><creatorcontrib>Nagano, Hiroaki</creatorcontrib><creatorcontrib>Mori, Masaki</creatorcontrib><creatorcontrib>Doki, Yuichiro</creatorcontrib><creatorcontrib>Eguchi, Hidetoshi</creatorcontrib><creatorcontrib>Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</creatorcontrib><creatorcontrib>the Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</creatorcontrib><title>Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</title><title>Hepatology research</title><addtitle>Hepatol Res</addtitle><description>Aim
Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for hepatocellular carcinoma >5 cm.
Methods
In this exploratory, multicenter, randomized phase I study, the primary measure was 2‐year disease‐free survival (DFS). Secondary measures were resection rate, necrosis rate by TACE, 2‐year overall survival, and site of recurrence. A total of 30 patients were randomly allocated to each arm.
Results
The two arms did not differ in patient characteristics. The median time to surgery from randomization was 48 days for TACE + surgery and 29 for surgery only (p < 0.001). Postoperative morbidities did not differ between arms. The 2‐year DFS, overall survival, and resection rates were 56.7%, 80.0%, and 93.3%, respectively, in the TACE + surgery arm, and 56.1%, 89.9%, and 90.0% in the upfront surgery arm. Minimally invasive surgery was carried out in 35.7% in the TACE + surgery arm and in 29.6% in the upfront surgery arm. The median necrosis rate by TACE was 90.0%. In resected specimens, invasion to the hepatic vein was less with TACE + surgery (3.6% vs. 22.2%, p = 0.0380). In cases of 100% necrosis with TACE, 2‐year DFS was 100%. Site of recurrence did not differ between groups.
Conclusion
Neoadjuvant TACE did not improve 2‐year DFS, and neoadjuvant TACE allowed delay of surgical treatment without increased morbidity and cancer progress.
Clinical trial registration
UMIN: 000005241.
Neoadjuvant transcatheter arterial chemoembolization plus surgery was compared with surgery alone for hepatocellular carcinoma >5 cm in this exploratory, multicenter, randomized phase II study. Neoadjuvant transcatheter arterial chemoembolization allowed delay of surgical treatment without increased morbidity and cancer progress.</description><subject>Chemoembolization</subject><subject>Hepatic vein</subject><subject>Hepatocellular carcinoma</subject><subject>Laparoscopy</subject><subject>Liver cancer</subject><subject>Morbidity</subject><subject>Necrosis</subject><subject>neoadjuvant</subject><subject>Patients</subject><subject>Surgery</subject><subject>Survival</subject><subject>transcatheter arterial chemoembolization</subject><issn>1386-6346</issn><issn>1872-034X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9ks1uEzEQxxcEoqVw6QMgS70U1BR7vZ_caBSSSJUSUSpxW028s8TBu17s3UB64hF4hD5LH4UnYZIUhDjgg7_0m__8x54gOBb8XNB4vcTWnYuIC_kwOBRZGg64jD4-or3MkkEio-QgeOr9inOR8jB6EhzILEzzJJeHD45H31pjHXTWbVjrrG9RdXqNZ8xBU9pa32DJ2iV4vLudTpnv-nLDbMUatFCu-jU0HesI9Qq6JXboGDiaNRimllhbrBfW6BvotG1Ya3rPfO8-ISVbo_N_HcHYBlllHTNAN4yKIlMKjenpgilwSje2BnY6vBrPfn7_MbmY08x5_PINGxrdaEU5r3b-xs727dblzMNnYNeN3ibT3eaMTXayFHihjQa3od0cGuWQHKp94LPgcQXG4_P79Si4fjf6MJwMLmfj6fDt5UDJOJSDuBSiyqKcl1lcZomUMpNxtchzgFTIhUixjLMIE56FKoZ0EecZxGEMKs2kkBzlUXC616Vn_9Kj74pa-23BQI_b-yLMw5wnqcxjQk_-QVe2dw25KyRPozSh3BFRr_aUon_0DquidbqmIgvBi22nFNtOKXadQvCLe8l-UWP5B_3dGgSIPfBVG9z8R6qYjObv96K_ANBC0vI</recordid><startdate>202407</startdate><enddate>202407</enddate><creator>Kobayashi, Shogo</creator><creator>Tomokuni, Akira</creator><creator>Takeda, Yutaka</creator><creator>Wada, Hiroshi</creator><creator>Katsura, Yoshiteru</creator><creator>Hashimoto, Kazuhiko</creator><creator>Tomimaru, Yoshito</creator><creator>Asaoka, Tadafumi</creator><creator>Yamada, Terumasa</creator><creator>Tsujie, Masanori</creator><creator>Noda, Takehiro</creator><creator>Morita, Satoshi</creator><creator>Nagano, Hiroaki</creator><creator>Mori, Masaki</creator><creator>Doki, Yuichiro</creator><creator>Eguchi, Hidetoshi</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TM</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4432-060X</orcidid><orcidid>https://orcid.org/0000-0002-2828-0951</orcidid><orcidid>https://orcid.org/0000-0002-8828-1067</orcidid><orcidid>https://orcid.org/0000-0002-6768-5783</orcidid></search><sort><creationdate>202407</creationdate><title>Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</title><author>Kobayashi, Shogo ; Tomokuni, Akira ; Takeda, Yutaka ; Wada, Hiroshi ; Katsura, Yoshiteru ; Hashimoto, Kazuhiko ; Tomimaru, Yoshito ; Asaoka, Tadafumi ; Yamada, Terumasa ; Tsujie, Masanori ; Noda, Takehiro ; Morita, Satoshi ; Nagano, Hiroaki ; Mori, Masaki ; Doki, Yuichiro ; Eguchi, Hidetoshi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3523-5d11f8490d85d86333835fb99aa713b17ed584e6082c5a7b598a525ac783130e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Chemoembolization</topic><topic>Hepatic vein</topic><topic>Hepatocellular carcinoma</topic><topic>Laparoscopy</topic><topic>Liver cancer</topic><topic>Morbidity</topic><topic>Necrosis</topic><topic>neoadjuvant</topic><topic>Patients</topic><topic>Surgery</topic><topic>Survival</topic><topic>transcatheter arterial chemoembolization</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kobayashi, Shogo</creatorcontrib><creatorcontrib>Tomokuni, Akira</creatorcontrib><creatorcontrib>Takeda, Yutaka</creatorcontrib><creatorcontrib>Wada, Hiroshi</creatorcontrib><creatorcontrib>Katsura, Yoshiteru</creatorcontrib><creatorcontrib>Hashimoto, Kazuhiko</creatorcontrib><creatorcontrib>Tomimaru, Yoshito</creatorcontrib><creatorcontrib>Asaoka, Tadafumi</creatorcontrib><creatorcontrib>Yamada, Terumasa</creatorcontrib><creatorcontrib>Tsujie, Masanori</creatorcontrib><creatorcontrib>Noda, Takehiro</creatorcontrib><creatorcontrib>Morita, Satoshi</creatorcontrib><creatorcontrib>Nagano, Hiroaki</creatorcontrib><creatorcontrib>Mori, Masaki</creatorcontrib><creatorcontrib>Doki, Yuichiro</creatorcontrib><creatorcontrib>Eguchi, Hidetoshi</creatorcontrib><creatorcontrib>Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</creatorcontrib><creatorcontrib>the Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Hepatology research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kobayashi, Shogo</au><au>Tomokuni, Akira</au><au>Takeda, Yutaka</au><au>Wada, Hiroshi</au><au>Katsura, Yoshiteru</au><au>Hashimoto, Kazuhiko</au><au>Tomimaru, Yoshito</au><au>Asaoka, Tadafumi</au><au>Yamada, Terumasa</au><au>Tsujie, Masanori</au><au>Noda, Takehiro</au><au>Morita, Satoshi</au><au>Nagano, Hiroaki</au><au>Mori, Masaki</au><au>Doki, Yuichiro</au><au>Eguchi, Hidetoshi</au><aucorp>Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</aucorp><aucorp>the Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group</atitle><jtitle>Hepatology research</jtitle><addtitle>Hepatol Res</addtitle><date>2024-07</date><risdate>2024</risdate><volume>54</volume><issue>7</issue><spage>667</spage><epage>677</epage><pages>667-677</pages><issn>1386-6346</issn><eissn>1872-034X</eissn><abstract>Aim
Neoadjuvant transcatheter arterial chemoembolization (TACE) for large tumors is controversial, especially in the minimally invasive surgery era. The aim of this study was to compare features between groups treated with neoadjuvant TACE followed by surgery (TACE + surgery) or upfront surgery for hepatocellular carcinoma >5 cm.
Methods
In this exploratory, multicenter, randomized phase I study, the primary measure was 2‐year disease‐free survival (DFS). Secondary measures were resection rate, necrosis rate by TACE, 2‐year overall survival, and site of recurrence. A total of 30 patients were randomly allocated to each arm.
Results
The two arms did not differ in patient characteristics. The median time to surgery from randomization was 48 days for TACE + surgery and 29 for surgery only (p < 0.001). Postoperative morbidities did not differ between arms. The 2‐year DFS, overall survival, and resection rates were 56.7%, 80.0%, and 93.3%, respectively, in the TACE + surgery arm, and 56.1%, 89.9%, and 90.0% in the upfront surgery arm. Minimally invasive surgery was carried out in 35.7% in the TACE + surgery arm and in 29.6% in the upfront surgery arm. The median necrosis rate by TACE was 90.0%. In resected specimens, invasion to the hepatic vein was less with TACE + surgery (3.6% vs. 22.2%, p = 0.0380). In cases of 100% necrosis with TACE, 2‐year DFS was 100%. Site of recurrence did not differ between groups.
Conclusion
Neoadjuvant TACE did not improve 2‐year DFS, and neoadjuvant TACE allowed delay of surgical treatment without increased morbidity and cancer progress.
Clinical trial registration
UMIN: 000005241.
Neoadjuvant transcatheter arterial chemoembolization plus surgery was compared with surgery alone for hepatocellular carcinoma >5 cm in this exploratory, multicenter, randomized phase II study. Neoadjuvant transcatheter arterial chemoembolization allowed delay of surgical treatment without increased morbidity and cancer progress.</abstract><cop>Netherlands</cop><pub>Wiley Subscription Services, Inc</pub><pmid>38279693</pmid><doi>10.1111/hepr.14013</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-4432-060X</orcidid><orcidid>https://orcid.org/0000-0002-2828-0951</orcidid><orcidid>https://orcid.org/0000-0002-8828-1067</orcidid><orcidid>https://orcid.org/0000-0002-6768-5783</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Hepatology research, 2024-07, Vol.54 (7), p.667-677 |
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| source | Wiley Online Library Journals Frontfile Complete |
| subjects | Chemoembolization Hepatic vein Hepatocellular carcinoma Laparoscopy Liver cancer Morbidity Necrosis neoadjuvant Patients Surgery Survival transcatheter arterial chemoembolization |
| title | Exploratory prospective, randomized phase II study of neoadjuvant transcatheter arterial chemoembolization plus surgery versus surgery alone for large hepatocellular carcinoma (CSGO‐HBP‐005): Clinical Study Group of Osaka University, Hepato‐Biliary‐Pancreatic Group |
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