Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study

Background Adjuvant therapy may improve survival of patients with hepatocellular carcinoma (HCC) after curative resection. This study compared safety and efficacy outcomes between patients at high risk of recurrence who received different types of adjuvant therapy or no such therapy after hepatic re...

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Veröffentlicht in:Journal of gastroenterology 2023-10, Vol.58 (10), p.1043-1054
Hauptverfasser: Li, Le, Wu, Pei-Sheng, Liang, Xiu-Mei, Chen, Kang, Zhang, Guan-Lan, Su, Qi-Bin, Huo, Rong-Rui, Xie, Rong-Wei, Huang, Shan, Ma, Liang, Zhong, Jian-Hong
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container_end_page 1054
container_issue 10
container_start_page 1043
container_title Journal of gastroenterology
container_volume 58
creator Li, Le
Wu, Pei-Sheng
Liang, Xiu-Mei
Chen, Kang
Zhang, Guan-Lan
Su, Qi-Bin
Huo, Rong-Rui
Xie, Rong-Wei
Huang, Shan
Ma, Liang
Zhong, Jian-Hong
description Background Adjuvant therapy may improve survival of patients with hepatocellular carcinoma (HCC) after curative resection. This study compared safety and efficacy outcomes between patients at high risk of recurrence who received different types of adjuvant therapy or no such therapy after hepatic resection for HCC. Methods Recurrence-free survival (RFS), overall survival, and adverse events were compared among patients who received adjuvant immune checkpoint inhibitors (ICIs) alone, ICIs with tyrosine kinase inhibitors (TKIs), or no adjuvant therapy between 13 March 2019 and 19 March 2022. This study was registered on ClinicalTrials.gov (NCT05221398). Results Of the 517 patients in final analysis, 432 (83.6%) received no adjuvant therapy, 53 (10.2%) received ICIs alone, and 32 (6.2%) received adjuvant ICIs and TKIs. During median follow-up of 34.0 months (IQR 27.8 to 41.6 months), RFS was significantly longer among patients who received either type of adjuvant therapy (25.2 months, 95%CI 16.4–34.0) than among those who received none (16.1 months, 95%CI 12.9–19.4), and this difference remained significant after propensity score matching (HR 0.52, 95%CI 0.35–0.76, P  = 0.004). Overall survival was unaffected by either type of adjuvant therapy, while significant difference was observed between patients who received adjuvant therapy or not after propensity score matching (HR 0.31, 95%CI 0.17–0.59, P  = 0.005). The rate of grade 3 or 4 adverse events was similar between the two types of adjuvant therapy. Conclusions ICIs alone or with TKIs may improve RFS of patients at high risk of HCC recurrence after curative resection.
doi_str_mv 10.1007/s00535-023-02018-2
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This study compared safety and efficacy outcomes between patients at high risk of recurrence who received different types of adjuvant therapy or no such therapy after hepatic resection for HCC. Methods Recurrence-free survival (RFS), overall survival, and adverse events were compared among patients who received adjuvant immune checkpoint inhibitors (ICIs) alone, ICIs with tyrosine kinase inhibitors (TKIs), or no adjuvant therapy between 13 March 2019 and 19 March 2022. This study was registered on ClinicalTrials.gov (NCT05221398). Results Of the 517 patients in final analysis, 432 (83.6%) received no adjuvant therapy, 53 (10.2%) received ICIs alone, and 32 (6.2%) received adjuvant ICIs and TKIs. During median follow-up of 34.0 months (IQR 27.8 to 41.6 months), RFS was significantly longer among patients who received either type of adjuvant therapy (25.2 months, 95%CI 16.4–34.0) than among those who received none (16.1 months, 95%CI 12.9–19.4), and this difference remained significant after propensity score matching (HR 0.52, 95%CI 0.35–0.76, P  = 0.004). Overall survival was unaffected by either type of adjuvant therapy, while significant difference was observed between patients who received adjuvant therapy or not after propensity score matching (HR 0.31, 95%CI 0.17–0.59, P  = 0.005). The rate of grade 3 or 4 adverse events was similar between the two types of adjuvant therapy. Conclusions ICIs alone or with TKIs may improve RFS of patients at high risk of HCC recurrence after curative resection.</description><identifier>ISSN: 0944-1174</identifier><identifier>EISSN: 1435-5922</identifier><identifier>DOI: 10.1007/s00535-023-02018-2</identifier><identifier>PMID: 37452107</identifier><language>eng</language><publisher>Singapore: Springer Nature Singapore</publisher><subject>Abdominal Surgery ; Adverse events ; Biliary Tract ; Care and treatment ; Colorectal Surgery ; Comparative analysis ; Gastroenterology ; Hepatocellular carcinoma ; Hepatology ; Hepatoma ; Immune checkpoint inhibitors ; Liver cancer ; Medicine ; Medicine &amp; Public Health ; Original Article―Liver ; Pancreas ; Patient outcomes ; Prevention ; Protein-tyrosine kinase ; Surgical Oncology ; Survival ; Tyrosine</subject><ispartof>Journal of gastroenterology, 2023-10, Vol.58 (10), p.1043-1054</ispartof><rights>Japanese Society of Gastroenterology 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. Japanese Society of Gastroenterology.</rights><rights>COPYRIGHT 2023 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c466t-fee9f42ab263078ddca69ecaf4cef2c911e290cf448de97ffc747af73bf14bcb3</citedby><cites>FETCH-LOGICAL-c466t-fee9f42ab263078ddca69ecaf4cef2c911e290cf448de97ffc747af73bf14bcb3</cites><orcidid>0000-0002-1494-6396</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00535-023-02018-2$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00535-023-02018-2$$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/37452107$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Li, Le</creatorcontrib><creatorcontrib>Wu, Pei-Sheng</creatorcontrib><creatorcontrib>Liang, Xiu-Mei</creatorcontrib><creatorcontrib>Chen, Kang</creatorcontrib><creatorcontrib>Zhang, Guan-Lan</creatorcontrib><creatorcontrib>Su, Qi-Bin</creatorcontrib><creatorcontrib>Huo, Rong-Rui</creatorcontrib><creatorcontrib>Xie, Rong-Wei</creatorcontrib><creatorcontrib>Huang, Shan</creatorcontrib><creatorcontrib>Ma, Liang</creatorcontrib><creatorcontrib>Zhong, Jian-Hong</creatorcontrib><title>Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study</title><title>Journal of gastroenterology</title><addtitle>J Gastroenterol</addtitle><addtitle>J Gastroenterol</addtitle><description>Background Adjuvant therapy may improve survival of patients with hepatocellular carcinoma (HCC) after curative resection. This study compared safety and efficacy outcomes between patients at high risk of recurrence who received different types of adjuvant therapy or no such therapy after hepatic resection for HCC. Methods Recurrence-free survival (RFS), overall survival, and adverse events were compared among patients who received adjuvant immune checkpoint inhibitors (ICIs) alone, ICIs with tyrosine kinase inhibitors (TKIs), or no adjuvant therapy between 13 March 2019 and 19 March 2022. This study was registered on ClinicalTrials.gov (NCT05221398). Results Of the 517 patients in final analysis, 432 (83.6%) received no adjuvant therapy, 53 (10.2%) received ICIs alone, and 32 (6.2%) received adjuvant ICIs and TKIs. During median follow-up of 34.0 months (IQR 27.8 to 41.6 months), RFS was significantly longer among patients who received either type of adjuvant therapy (25.2 months, 95%CI 16.4–34.0) than among those who received none (16.1 months, 95%CI 12.9–19.4), and this difference remained significant after propensity score matching (HR 0.52, 95%CI 0.35–0.76, P  = 0.004). Overall survival was unaffected by either type of adjuvant therapy, while significant difference was observed between patients who received adjuvant therapy or not after propensity score matching (HR 0.31, 95%CI 0.17–0.59, P  = 0.005). The rate of grade 3 or 4 adverse events was similar between the two types of adjuvant therapy. 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Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>Consumer Health Database</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing &amp; 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>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Li, Le</au><au>Wu, Pei-Sheng</au><au>Liang, Xiu-Mei</au><au>Chen, Kang</au><au>Zhang, Guan-Lan</au><au>Su, Qi-Bin</au><au>Huo, Rong-Rui</au><au>Xie, Rong-Wei</au><au>Huang, Shan</au><au>Ma, Liang</au><au>Zhong, Jian-Hong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study</atitle><jtitle>Journal of gastroenterology</jtitle><stitle>J Gastroenterol</stitle><addtitle>J Gastroenterol</addtitle><date>2023-10-01</date><risdate>2023</risdate><volume>58</volume><issue>10</issue><spage>1043</spage><epage>1054</epage><pages>1043-1054</pages><issn>0944-1174</issn><eissn>1435-5922</eissn><abstract>Background Adjuvant therapy may improve survival of patients with hepatocellular carcinoma (HCC) after curative resection. This study compared safety and efficacy outcomes between patients at high risk of recurrence who received different types of adjuvant therapy or no such therapy after hepatic resection for HCC. Methods Recurrence-free survival (RFS), overall survival, and adverse events were compared among patients who received adjuvant immune checkpoint inhibitors (ICIs) alone, ICIs with tyrosine kinase inhibitors (TKIs), or no adjuvant therapy between 13 March 2019 and 19 March 2022. This study was registered on ClinicalTrials.gov (NCT05221398). Results Of the 517 patients in final analysis, 432 (83.6%) received no adjuvant therapy, 53 (10.2%) received ICIs alone, and 32 (6.2%) received adjuvant ICIs and TKIs. During median follow-up of 34.0 months (IQR 27.8 to 41.6 months), RFS was significantly longer among patients who received either type of adjuvant therapy (25.2 months, 95%CI 16.4–34.0) than among those who received none (16.1 months, 95%CI 12.9–19.4), and this difference remained significant after propensity score matching (HR 0.52, 95%CI 0.35–0.76, P  = 0.004). Overall survival was unaffected by either type of adjuvant therapy, while significant difference was observed between patients who received adjuvant therapy or not after propensity score matching (HR 0.31, 95%CI 0.17–0.59, P  = 0.005). The rate of grade 3 or 4 adverse events was similar between the two types of adjuvant therapy. Conclusions ICIs alone or with TKIs may improve RFS of patients at high risk of HCC recurrence after curative resection.</abstract><cop>Singapore</cop><pub>Springer Nature Singapore</pub><pmid>37452107</pmid><doi>10.1007/s00535-023-02018-2</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0002-1494-6396</orcidid></addata></record>
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subjects Abdominal Surgery
Adverse events
Biliary Tract
Care and treatment
Colorectal Surgery
Comparative analysis
Gastroenterology
Hepatocellular carcinoma
Hepatology
Hepatoma
Immune checkpoint inhibitors
Liver cancer
Medicine
Medicine & Public Health
Original Article―Liver
Pancreas
Patient outcomes
Prevention
Protein-tyrosine kinase
Surgical Oncology
Survival
Tyrosine
title Adjuvant immune checkpoint inhibitors associated with higher recurrence-free survival in postoperative hepatocellular carcinoma (PREVENT): a prospective, multicentric cohort study
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