Regorafenib in patients with advanced Child‐Pugh B hepatocellular carcinoma: A multicentre retrospective study
Introduction Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child‐Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child‐Pugh B HCC patien...
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| Veröffentlicht in: | Liver international 2020-10, Vol.40 (10), p.2544-2552 |
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| creator | Kim, Hyung‐Don Bang, Yeonghak Lee, Myung Ah Kim, Jin Won Kim, Jee Hyun Chon, Hong Jae Kang, Beodeul Kang, Myoung Joo Kim, Ilhwan Cheon, Jaekyung Hwang, Jun‐Eul Kang, Jung Hun Byeon, Seonggyu Hong, Jung Yong Ryoo, Baek‐Yeol Lim, Ho Yeong Yoo, Changhoon |
| description | Introduction
Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child‐Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child‐Pugh B HCC patients.
Methods
This multicentre retrospective study included 59 patients with Child‐Pugh B HCC who received regorafenib. Comparative analyses were performed with an independent cohort of Child‐Pugh class A patients from the same registry (n = 440).
Results
The median age was 58 years (range, 19‐83). All patients had progression on prior sorafenib. Regorafenib was given as 2nd line, and 3rd‐4th line systemic therapy in 37 (62.7%) and 22 (37.3%) patients respectively. Compared to Child‐Pugh A cohort, grade 3‐4 AEs were more common in the Child‐Pugh B cohort (27.1% vs 14.1%, P = .017). The median progression‐free survival (PFS) and overall survival (OS) were 1.8 and 4.6 months, respectively, and these were significantly poorer than the Child‐Pugh A cohort (P = .008 and P |
| doi_str_mv | 10.1111/liv.14573 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2415288683</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2415288683</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3533-363f744483bd61c0c3aca6a80b4359d81ff82a0ab0e402a434a9e38f09fb42503</originalsourceid><addsrcrecordid>eNp10c9O3DAQBnALgYACB14AWeLSHhZsj5N1uMGqpUgrUVXANZo4E9Yo_7CTRXvrI_QZ-ySYLnBAwhf78NOn8XyMHUpxIuM5rd3yROpkChtsV-qpmYACufn-VrDDvoTwIITMskRusx1QSQpKwi7rf9N957Gi1hXctbzHwVE7BP7khgXHcomtpZLPFq4u__35-2u8X_ALvqDoOkt1PdbouUVvXds1eMbPeTPWg7MxwxP3NPgu9GQHtyQehrFc7bOtCutAB6_3Hrv98f1m9nMyv768mp3PJxYSgAmkUE211gaKMpVWWECLKRpRaEiy0siqMgoFFoK0UKhBY0ZgKpFVhVaJgD32dZ3b--5xpDDkjQsvE2NL3RhypWWijEkNRHr8gT50o2_jdFHpJK5NGBPVt7Wy8UvBU5X33jXoV7kU-UsNeawh_19DtEeviWPRUPku3_YewekaPLmaVp8n5fOru3XkM90rkro</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2445001088</pqid></control><display><type>article</type><title>Regorafenib in patients with advanced Child‐Pugh B hepatocellular carcinoma: A multicentre retrospective study</title><source>Wiley Online Library - AutoHoldings Journals</source><creator>Kim, Hyung‐Don ; Bang, Yeonghak ; Lee, Myung Ah ; Kim, Jin Won ; Kim, Jee Hyun ; Chon, Hong Jae ; Kang, Beodeul ; Kang, Myoung Joo ; Kim, Ilhwan ; Cheon, Jaekyung ; Hwang, Jun‐Eul ; Kang, Jung Hun ; Byeon, Seonggyu ; Hong, Jung Yong ; Ryoo, Baek‐Yeol ; Lim, Ho Yeong ; Yoo, Changhoon</creator><creatorcontrib>Kim, Hyung‐Don ; Bang, Yeonghak ; Lee, Myung Ah ; Kim, Jin Won ; Kim, Jee Hyun ; Chon, Hong Jae ; Kang, Beodeul ; Kang, Myoung Joo ; Kim, Ilhwan ; Cheon, Jaekyung ; Hwang, Jun‐Eul ; Kang, Jung Hun ; Byeon, Seonggyu ; Hong, Jung Yong ; Ryoo, Baek‐Yeol ; Lim, Ho Yeong ; Yoo, Changhoon</creatorcontrib><description>Introduction
Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child‐Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child‐Pugh B HCC patients.
Methods
This multicentre retrospective study included 59 patients with Child‐Pugh B HCC who received regorafenib. Comparative analyses were performed with an independent cohort of Child‐Pugh class A patients from the same registry (n = 440).
Results
The median age was 58 years (range, 19‐83). All patients had progression on prior sorafenib. Regorafenib was given as 2nd line, and 3rd‐4th line systemic therapy in 37 (62.7%) and 22 (37.3%) patients respectively. Compared to Child‐Pugh A cohort, grade 3‐4 AEs were more common in the Child‐Pugh B cohort (27.1% vs 14.1%, P = .017). The median progression‐free survival (PFS) and overall survival (OS) were 1.8 and 4.6 months, respectively, and these were significantly poorer than the Child‐Pugh A cohort (P = .008 and P < .001 respectively). Child‐Pugh B patients with albumin‐bilirubin (ALBI) grade 3 had a significantly higher frequency of increased bilirubin (P = .01 for any grade and P = .01 for grade 3‐4) and showed significantly poorer OS (P = .021), compared to those with ALBI grade 1 or 2.
Conclusion
Regorafenib's poor clinical outcomes and increased frequency of severe adverse events lead us to discourage its use in the Child‐Pugh B population. In particular, regorafenib should not be used in Child‐Pugh B patients with ALBI grade 3.</description><identifier>ISSN: 1478-3223</identifier><identifier>EISSN: 1478-3231</identifier><identifier>DOI: 10.1111/liv.14573</identifier><identifier>PMID: 32563213</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Albumins ; Bilirubin ; Children ; Child‐Pugh B ; Clinical outcomes ; Comparative analysis ; Hepatocellular carcinoma ; Liver cancer ; regorafenib ; Survival</subject><ispartof>Liver international, 2020-10, Vol.40 (10), p.2544-2552</ispartof><rights>2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd</rights><rights>2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</rights><rights>2020 John Wiley & Sons A/S</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3533-363f744483bd61c0c3aca6a80b4359d81ff82a0ab0e402a434a9e38f09fb42503</citedby><cites>FETCH-LOGICAL-c3533-363f744483bd61c0c3aca6a80b4359d81ff82a0ab0e402a434a9e38f09fb42503</cites><orcidid>0000-0002-1357-7015 ; 0000-0002-9052-833X ; 0000-0002-1451-8455 ; 0000-0001-9959-0642</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%2Fliv.14573$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fliv.14573$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32563213$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kim, Hyung‐Don</creatorcontrib><creatorcontrib>Bang, Yeonghak</creatorcontrib><creatorcontrib>Lee, Myung Ah</creatorcontrib><creatorcontrib>Kim, Jin Won</creatorcontrib><creatorcontrib>Kim, Jee Hyun</creatorcontrib><creatorcontrib>Chon, Hong Jae</creatorcontrib><creatorcontrib>Kang, Beodeul</creatorcontrib><creatorcontrib>Kang, Myoung Joo</creatorcontrib><creatorcontrib>Kim, Ilhwan</creatorcontrib><creatorcontrib>Cheon, Jaekyung</creatorcontrib><creatorcontrib>Hwang, Jun‐Eul</creatorcontrib><creatorcontrib>Kang, Jung Hun</creatorcontrib><creatorcontrib>Byeon, Seonggyu</creatorcontrib><creatorcontrib>Hong, Jung Yong</creatorcontrib><creatorcontrib>Ryoo, Baek‐Yeol</creatorcontrib><creatorcontrib>Lim, Ho Yeong</creatorcontrib><creatorcontrib>Yoo, Changhoon</creatorcontrib><title>Regorafenib in patients with advanced Child‐Pugh B hepatocellular carcinoma: A multicentre retrospective study</title><title>Liver international</title><addtitle>Liver Int</addtitle><description>Introduction
Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child‐Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child‐Pugh B HCC patients.
Methods
This multicentre retrospective study included 59 patients with Child‐Pugh B HCC who received regorafenib. Comparative analyses were performed with an independent cohort of Child‐Pugh class A patients from the same registry (n = 440).
Results
The median age was 58 years (range, 19‐83). All patients had progression on prior sorafenib. Regorafenib was given as 2nd line, and 3rd‐4th line systemic therapy in 37 (62.7%) and 22 (37.3%) patients respectively. Compared to Child‐Pugh A cohort, grade 3‐4 AEs were more common in the Child‐Pugh B cohort (27.1% vs 14.1%, P = .017). The median progression‐free survival (PFS) and overall survival (OS) were 1.8 and 4.6 months, respectively, and these were significantly poorer than the Child‐Pugh A cohort (P = .008 and P < .001 respectively). Child‐Pugh B patients with albumin‐bilirubin (ALBI) grade 3 had a significantly higher frequency of increased bilirubin (P = .01 for any grade and P = .01 for grade 3‐4) and showed significantly poorer OS (P = .021), compared to those with ALBI grade 1 or 2.
Conclusion
Regorafenib's poor clinical outcomes and increased frequency of severe adverse events lead us to discourage its use in the Child‐Pugh B population. In particular, regorafenib should not be used in Child‐Pugh B patients with ALBI grade 3.</description><subject>Albumins</subject><subject>Bilirubin</subject><subject>Children</subject><subject>Child‐Pugh B</subject><subject>Clinical outcomes</subject><subject>Comparative analysis</subject><subject>Hepatocellular carcinoma</subject><subject>Liver cancer</subject><subject>regorafenib</subject><subject>Survival</subject><issn>1478-3223</issn><issn>1478-3231</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp10c9O3DAQBnALgYACB14AWeLSHhZsj5N1uMGqpUgrUVXANZo4E9Yo_7CTRXvrI_QZ-ySYLnBAwhf78NOn8XyMHUpxIuM5rd3yROpkChtsV-qpmYACufn-VrDDvoTwIITMskRusx1QSQpKwi7rf9N957Gi1hXctbzHwVE7BP7khgXHcomtpZLPFq4u__35-2u8X_ALvqDoOkt1PdbouUVvXds1eMbPeTPWg7MxwxP3NPgu9GQHtyQehrFc7bOtCutAB6_3Hrv98f1m9nMyv768mp3PJxYSgAmkUE211gaKMpVWWECLKRpRaEiy0siqMgoFFoK0UKhBY0ZgKpFVhVaJgD32dZ3b--5xpDDkjQsvE2NL3RhypWWijEkNRHr8gT50o2_jdFHpJK5NGBPVt7Wy8UvBU5X33jXoV7kU-UsNeawh_19DtEeviWPRUPku3_YewekaPLmaVp8n5fOru3XkM90rkro</recordid><startdate>202010</startdate><enddate>202010</enddate><creator>Kim, Hyung‐Don</creator><creator>Bang, Yeonghak</creator><creator>Lee, Myung Ah</creator><creator>Kim, Jin Won</creator><creator>Kim, Jee Hyun</creator><creator>Chon, Hong Jae</creator><creator>Kang, Beodeul</creator><creator>Kang, Myoung Joo</creator><creator>Kim, Ilhwan</creator><creator>Cheon, Jaekyung</creator><creator>Hwang, Jun‐Eul</creator><creator>Kang, Jung Hun</creator><creator>Byeon, Seonggyu</creator><creator>Hong, Jung Yong</creator><creator>Ryoo, Baek‐Yeol</creator><creator>Lim, Ho Yeong</creator><creator>Yoo, Changhoon</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QO</scope><scope>7T5</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1357-7015</orcidid><orcidid>https://orcid.org/0000-0002-9052-833X</orcidid><orcidid>https://orcid.org/0000-0002-1451-8455</orcidid><orcidid>https://orcid.org/0000-0001-9959-0642</orcidid></search><sort><creationdate>202010</creationdate><title>Regorafenib in patients with advanced Child‐Pugh B hepatocellular carcinoma: A multicentre retrospective study</title><author>Kim, Hyung‐Don ; Bang, Yeonghak ; Lee, Myung Ah ; Kim, Jin Won ; Kim, Jee Hyun ; Chon, Hong Jae ; Kang, Beodeul ; Kang, Myoung Joo ; Kim, Ilhwan ; Cheon, Jaekyung ; Hwang, Jun‐Eul ; Kang, Jung Hun ; Byeon, Seonggyu ; Hong, Jung Yong ; Ryoo, Baek‐Yeol ; Lim, Ho Yeong ; Yoo, Changhoon</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3533-363f744483bd61c0c3aca6a80b4359d81ff82a0ab0e402a434a9e38f09fb42503</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Albumins</topic><topic>Bilirubin</topic><topic>Children</topic><topic>Child‐Pugh B</topic><topic>Clinical outcomes</topic><topic>Comparative analysis</topic><topic>Hepatocellular carcinoma</topic><topic>Liver cancer</topic><topic>regorafenib</topic><topic>Survival</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kim, Hyung‐Don</creatorcontrib><creatorcontrib>Bang, Yeonghak</creatorcontrib><creatorcontrib>Lee, Myung Ah</creatorcontrib><creatorcontrib>Kim, Jin Won</creatorcontrib><creatorcontrib>Kim, Jee Hyun</creatorcontrib><creatorcontrib>Chon, Hong Jae</creatorcontrib><creatorcontrib>Kang, Beodeul</creatorcontrib><creatorcontrib>Kang, Myoung Joo</creatorcontrib><creatorcontrib>Kim, Ilhwan</creatorcontrib><creatorcontrib>Cheon, Jaekyung</creatorcontrib><creatorcontrib>Hwang, Jun‐Eul</creatorcontrib><creatorcontrib>Kang, Jung Hun</creatorcontrib><creatorcontrib>Byeon, Seonggyu</creatorcontrib><creatorcontrib>Hong, Jung Yong</creatorcontrib><creatorcontrib>Ryoo, Baek‐Yeol</creatorcontrib><creatorcontrib>Lim, Ho Yeong</creatorcontrib><creatorcontrib>Yoo, Changhoon</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Liver international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kim, Hyung‐Don</au><au>Bang, Yeonghak</au><au>Lee, Myung Ah</au><au>Kim, Jin Won</au><au>Kim, Jee Hyun</au><au>Chon, Hong Jae</au><au>Kang, Beodeul</au><au>Kang, Myoung Joo</au><au>Kim, Ilhwan</au><au>Cheon, Jaekyung</au><au>Hwang, Jun‐Eul</au><au>Kang, Jung Hun</au><au>Byeon, Seonggyu</au><au>Hong, Jung Yong</au><au>Ryoo, Baek‐Yeol</au><au>Lim, Ho Yeong</au><au>Yoo, Changhoon</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Regorafenib in patients with advanced Child‐Pugh B hepatocellular carcinoma: A multicentre retrospective study</atitle><jtitle>Liver international</jtitle><addtitle>Liver Int</addtitle><date>2020-10</date><risdate>2020</risdate><volume>40</volume><issue>10</issue><spage>2544</spage><epage>2552</epage><pages>2544-2552</pages><issn>1478-3223</issn><eissn>1478-3231</eissn><abstract>Introduction
Regorafenib is an approved agent in patients with advanced hepatocellular carcinoma (HCC) who progressed on sorafenib, but little is known about its clinical outcomes in Child‐Pugh B patients. We aimed to investigate the safety and effectiveness of regorafenib in Child‐Pugh B HCC patients.
Methods
This multicentre retrospective study included 59 patients with Child‐Pugh B HCC who received regorafenib. Comparative analyses were performed with an independent cohort of Child‐Pugh class A patients from the same registry (n = 440).
Results
The median age was 58 years (range, 19‐83). All patients had progression on prior sorafenib. Regorafenib was given as 2nd line, and 3rd‐4th line systemic therapy in 37 (62.7%) and 22 (37.3%) patients respectively. Compared to Child‐Pugh A cohort, grade 3‐4 AEs were more common in the Child‐Pugh B cohort (27.1% vs 14.1%, P = .017). The median progression‐free survival (PFS) and overall survival (OS) were 1.8 and 4.6 months, respectively, and these were significantly poorer than the Child‐Pugh A cohort (P = .008 and P < .001 respectively). Child‐Pugh B patients with albumin‐bilirubin (ALBI) grade 3 had a significantly higher frequency of increased bilirubin (P = .01 for any grade and P = .01 for grade 3‐4) and showed significantly poorer OS (P = .021), compared to those with ALBI grade 1 or 2.
Conclusion
Regorafenib's poor clinical outcomes and increased frequency of severe adverse events lead us to discourage its use in the Child‐Pugh B population. In particular, regorafenib should not be used in Child‐Pugh B patients with ALBI grade 3.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32563213</pmid><doi>10.1111/liv.14573</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-1357-7015</orcidid><orcidid>https://orcid.org/0000-0002-9052-833X</orcidid><orcidid>https://orcid.org/0000-0002-1451-8455</orcidid><orcidid>https://orcid.org/0000-0001-9959-0642</orcidid></addata></record> |
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| source | Wiley Online Library - AutoHoldings Journals |
| subjects | Albumins Bilirubin Children Child‐Pugh B Clinical outcomes Comparative analysis Hepatocellular carcinoma Liver cancer regorafenib Survival |
| title | Regorafenib in patients with advanced Child‐Pugh B hepatocellular carcinoma: A multicentre retrospective study |
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