Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan
Summary Background Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HC...
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| Veröffentlicht in: | Investigational new drugs 2020-02, Vol.38 (1), p.172-180 |
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| creator | Ogasawara, Sadahisa Ooka, Yoshihiko Itokawa, Norio Inoue, Masanori Okabe, Shinichiro Seki, Atsuyoshi Haga, Yuki Obu, Masamichi Atsukawa, Masanori Itobayashi, Ei Mizumoto, Hideaki Sugiura, Nobuyuki Azemoto, Ryosaku Kanayama, Kengo Kanzaki, Hiroaki Maruta, Susumu Maeda, Takahiro Kusakabe, Yuko Yokoyama, Masayuki Kobayashi, Kazufumi Kiyono, Soichiro Nakamura, Masato Saito, Tomoko Suzuki, Eiichiro Nakamoto, Shingo Yasui, Shin Tawada, Akinobu Chiba, Tetsuhiro Arai, Makoto Kanda, Tatsuo Maruyama, Hitoshi Kato, Naoya |
| description | Summary
Background
Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HCC by analysis of outcomes in clinical practice with the aim to complement phase III findings.
Methods
The medical records of patients with advanced HCC receiving regorafenib were retrieved to collect data on sorafenib administration at seven Japanese institutions. Radiological responses and adverse events were evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Common Terminology Criteria for Adverse Events version 4.0, respectively.
Results
Before March 2018, 44 patients were administered regorafenib for advanced HCC. The median sorafenib treatment duration was 8.4 months. The most common adverse events were similar to those reported by the RESORCE trial. The median overall survival (OS) was 17.3 months (95% confidence interval [CI] 11.4–22.9), and 17 of 37 patients (45.9%) discontinued regorafenib and received sequential systemic therapy after regorafenib. These patients had significantly longer OS than those who were treated by the best supportive care or sub-optimal therapy (not reached versus 8.7 months [95% CI 5.8–11.7];
P
|
| doi_str_mv | 10.1007/s10637-019-00801-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2340037436</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2235965600</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-fad2de85effae3bb3064ec2e62143073f3154c05c6c3c5159a100887605f153b3</originalsourceid><addsrcrecordid>eNp9kUtv1TAQhS0EopcLf4AFssSGTcCP2E7YoYqnKrEA1tbEGfe6SpxgO0V3zR_H5ZYisWBljfzNmTlzCHnK2UvOmHmVOdPSNIz3DWMd4013j-y4MrJhutX3yY5xbRrd9-aMPMr5ijEme9M-JGeScyPaVuzIzy_4fcNYAky0HDDBeqQ_QjnQvCTwGMNAIY404eVd7ZdEYbyG6HCkB1yhLA6naZsgUQfJhbjM8JoCnbepBFfFMVWBkpa8oivhGmku23ikIdJPsEJ8TB54mDI-uX335Nu7t1_PPzQXn99_PH9z0ThpVGk8jGLETqH3gHIYZHWJTqAWvJXMSC-5ah1TTjvpFFc91Ct1ndFMea7kIPfkxUl3TUs1nYudQ75ZHSIuW7ZCtvVCppW6os__Qa-WLcW6nRVCql4rXdE9ESfKVW85obdrCjOko-XM3kRkTxHZGpH9HZHtatOzW-ltmHG8a_mTSQXkCcj1K15i-jv7P7K_AIxbnf0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2235965600</pqid></control><display><type>article</type><title>Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Ogasawara, Sadahisa ; Ooka, Yoshihiko ; Itokawa, Norio ; Inoue, Masanori ; Okabe, Shinichiro ; Seki, Atsuyoshi ; Haga, Yuki ; Obu, Masamichi ; Atsukawa, Masanori ; Itobayashi, Ei ; Mizumoto, Hideaki ; Sugiura, Nobuyuki ; Azemoto, Ryosaku ; Kanayama, Kengo ; Kanzaki, Hiroaki ; Maruta, Susumu ; Maeda, Takahiro ; Kusakabe, Yuko ; Yokoyama, Masayuki ; Kobayashi, Kazufumi ; Kiyono, Soichiro ; Nakamura, Masato ; Saito, Tomoko ; Suzuki, Eiichiro ; Nakamoto, Shingo ; Yasui, Shin ; Tawada, Akinobu ; Chiba, Tetsuhiro ; Arai, Makoto ; Kanda, Tatsuo ; Maruyama, Hitoshi ; Kato, Naoya</creator><creatorcontrib>Ogasawara, Sadahisa ; Ooka, Yoshihiko ; Itokawa, Norio ; Inoue, Masanori ; Okabe, Shinichiro ; Seki, Atsuyoshi ; Haga, Yuki ; Obu, Masamichi ; Atsukawa, Masanori ; Itobayashi, Ei ; Mizumoto, Hideaki ; Sugiura, Nobuyuki ; Azemoto, Ryosaku ; Kanayama, Kengo ; Kanzaki, Hiroaki ; Maruta, Susumu ; Maeda, Takahiro ; Kusakabe, Yuko ; Yokoyama, Masayuki ; Kobayashi, Kazufumi ; Kiyono, Soichiro ; Nakamura, Masato ; Saito, Tomoko ; Suzuki, Eiichiro ; Nakamoto, Shingo ; Yasui, Shin ; Tawada, Akinobu ; Chiba, Tetsuhiro ; Arai, Makoto ; Kanda, Tatsuo ; Maruyama, Hitoshi ; Kato, Naoya</creatorcontrib><description>Summary
Background
Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HCC by analysis of outcomes in clinical practice with the aim to complement phase III findings.
Methods
The medical records of patients with advanced HCC receiving regorafenib were retrieved to collect data on sorafenib administration at seven Japanese institutions. Radiological responses and adverse events were evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Common Terminology Criteria for Adverse Events version 4.0, respectively.
Results
Before March 2018, 44 patients were administered regorafenib for advanced HCC. The median sorafenib treatment duration was 8.4 months. The most common adverse events were similar to those reported by the RESORCE trial. The median overall survival (OS) was 17.3 months (95% confidence interval [CI] 11.4–22.9), and 17 of 37 patients (45.9%) discontinued regorafenib and received sequential systemic therapy after regorafenib. These patients had significantly longer OS than those who were treated by the best supportive care or sub-optimal therapy (not reached versus 8.7 months [95% CI 5.8–11.7];
P
< 0.001).
Conclusion
The results based on Japanese clinical practices verified the tolerability of regorafenib in advanced HCC. Major regorafenib-associated adverse events were similar to those related to sorafenib. OS was significantly longer than expected, which might be associated with the sequential systemic therapies after regorafenib, mainly lenvatinib.</description><identifier>ISSN: 0167-6997</identifier><identifier>EISSN: 1573-0646</identifier><identifier>DOI: 10.1007/s10637-019-00801-8</identifier><identifier>PMID: 31172442</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Aged ; Aged, 80 and over ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - pathology ; Confidence intervals ; Female ; Follow-Up Studies ; Hepatocellular carcinoma ; Humans ; Inhibitor drugs ; Liver cancer ; Liver Neoplasms - drug therapy ; Liver Neoplasms - pathology ; Male ; Medical records ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Patients ; Pharmacology/Toxicology ; Phenylurea Compounds - administration & dosage ; Prognosis ; Pyridines - administration & dosage ; Response Evaluation Criteria in Solid Tumors ; Retrospective Studies ; Short Report ; Solid tumors ; Sorafenib - administration & dosage ; Studies ; Survival Rate ; Targeted cancer therapy ; Terminology ; Therapy ; Tumors</subject><ispartof>Investigational new drugs, 2020-02, Vol.38 (1), p.172-180</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2019</rights><rights>Investigational New Drugs is a copyright of Springer, (2019). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c375t-fad2de85effae3bb3064ec2e62143073f3154c05c6c3c5159a100887605f153b3</citedby><cites>FETCH-LOGICAL-c375t-fad2de85effae3bb3064ec2e62143073f3154c05c6c3c5159a100887605f153b3</cites><orcidid>0000-0002-6540-9064</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/s10637-019-00801-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10637-019-00801-8$$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/31172442$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ogasawara, Sadahisa</creatorcontrib><creatorcontrib>Ooka, Yoshihiko</creatorcontrib><creatorcontrib>Itokawa, Norio</creatorcontrib><creatorcontrib>Inoue, Masanori</creatorcontrib><creatorcontrib>Okabe, Shinichiro</creatorcontrib><creatorcontrib>Seki, Atsuyoshi</creatorcontrib><creatorcontrib>Haga, Yuki</creatorcontrib><creatorcontrib>Obu, Masamichi</creatorcontrib><creatorcontrib>Atsukawa, Masanori</creatorcontrib><creatorcontrib>Itobayashi, Ei</creatorcontrib><creatorcontrib>Mizumoto, Hideaki</creatorcontrib><creatorcontrib>Sugiura, Nobuyuki</creatorcontrib><creatorcontrib>Azemoto, Ryosaku</creatorcontrib><creatorcontrib>Kanayama, Kengo</creatorcontrib><creatorcontrib>Kanzaki, Hiroaki</creatorcontrib><creatorcontrib>Maruta, Susumu</creatorcontrib><creatorcontrib>Maeda, Takahiro</creatorcontrib><creatorcontrib>Kusakabe, Yuko</creatorcontrib><creatorcontrib>Yokoyama, Masayuki</creatorcontrib><creatorcontrib>Kobayashi, Kazufumi</creatorcontrib><creatorcontrib>Kiyono, Soichiro</creatorcontrib><creatorcontrib>Nakamura, Masato</creatorcontrib><creatorcontrib>Saito, Tomoko</creatorcontrib><creatorcontrib>Suzuki, Eiichiro</creatorcontrib><creatorcontrib>Nakamoto, Shingo</creatorcontrib><creatorcontrib>Yasui, Shin</creatorcontrib><creatorcontrib>Tawada, Akinobu</creatorcontrib><creatorcontrib>Chiba, Tetsuhiro</creatorcontrib><creatorcontrib>Arai, Makoto</creatorcontrib><creatorcontrib>Kanda, Tatsuo</creatorcontrib><creatorcontrib>Maruyama, Hitoshi</creatorcontrib><creatorcontrib>Kato, Naoya</creatorcontrib><title>Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan</title><title>Investigational new drugs</title><addtitle>Invest New Drugs</addtitle><addtitle>Invest New Drugs</addtitle><description>Summary
Background
Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HCC by analysis of outcomes in clinical practice with the aim to complement phase III findings.
Methods
The medical records of patients with advanced HCC receiving regorafenib were retrieved to collect data on sorafenib administration at seven Japanese institutions. Radiological responses and adverse events were evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Common Terminology Criteria for Adverse Events version 4.0, respectively.
Results
Before March 2018, 44 patients were administered regorafenib for advanced HCC. The median sorafenib treatment duration was 8.4 months. The most common adverse events were similar to those reported by the RESORCE trial. The median overall survival (OS) was 17.3 months (95% confidence interval [CI] 11.4–22.9), and 17 of 37 patients (45.9%) discontinued regorafenib and received sequential systemic therapy after regorafenib. These patients had significantly longer OS than those who were treated by the best supportive care or sub-optimal therapy (not reached versus 8.7 months [95% CI 5.8–11.7];
P
< 0.001).
Conclusion
The results based on Japanese clinical practices verified the tolerability of regorafenib in advanced HCC. Major regorafenib-associated adverse events were similar to those related to sorafenib. OS was significantly longer than expected, which might be associated with the sequential systemic therapies after regorafenib, mainly lenvatinib.</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>Carcinoma, Hepatocellular - pathology</subject><subject>Confidence intervals</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Hepatocellular carcinoma</subject><subject>Humans</subject><subject>Inhibitor drugs</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Liver Neoplasms - pathology</subject><subject>Male</subject><subject>Medical records</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Patients</subject><subject>Pharmacology/Toxicology</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Prognosis</subject><subject>Pyridines - administration & dosage</subject><subject>Response Evaluation Criteria in Solid Tumors</subject><subject>Retrospective Studies</subject><subject>Short Report</subject><subject>Solid tumors</subject><subject>Sorafenib - administration & dosage</subject><subject>Studies</subject><subject>Survival Rate</subject><subject>Targeted cancer therapy</subject><subject>Terminology</subject><subject>Therapy</subject><subject>Tumors</subject><issn>0167-6997</issn><issn>1573-0646</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp9kUtv1TAQhS0EopcLf4AFssSGTcCP2E7YoYqnKrEA1tbEGfe6SpxgO0V3zR_H5ZYisWBljfzNmTlzCHnK2UvOmHmVOdPSNIz3DWMd4013j-y4MrJhutX3yY5xbRrd9-aMPMr5ijEme9M-JGeScyPaVuzIzy_4fcNYAky0HDDBeqQ_QjnQvCTwGMNAIY404eVd7ZdEYbyG6HCkB1yhLA6naZsgUQfJhbjM8JoCnbepBFfFMVWBkpa8oivhGmku23ikIdJPsEJ8TB54mDI-uX335Nu7t1_PPzQXn99_PH9z0ThpVGk8jGLETqH3gHIYZHWJTqAWvJXMSC-5ah1TTjvpFFc91Ct1ndFMea7kIPfkxUl3TUs1nYudQ75ZHSIuW7ZCtvVCppW6os__Qa-WLcW6nRVCql4rXdE9ESfKVW85obdrCjOko-XM3kRkTxHZGpH9HZHtatOzW-ltmHG8a_mTSQXkCcj1K15i-jv7P7K_AIxbnf0</recordid><startdate>20200201</startdate><enddate>20200201</enddate><creator>Ogasawara, Sadahisa</creator><creator>Ooka, Yoshihiko</creator><creator>Itokawa, Norio</creator><creator>Inoue, Masanori</creator><creator>Okabe, Shinichiro</creator><creator>Seki, Atsuyoshi</creator><creator>Haga, Yuki</creator><creator>Obu, Masamichi</creator><creator>Atsukawa, Masanori</creator><creator>Itobayashi, Ei</creator><creator>Mizumoto, Hideaki</creator><creator>Sugiura, Nobuyuki</creator><creator>Azemoto, Ryosaku</creator><creator>Kanayama, Kengo</creator><creator>Kanzaki, Hiroaki</creator><creator>Maruta, Susumu</creator><creator>Maeda, Takahiro</creator><creator>Kusakabe, Yuko</creator><creator>Yokoyama, Masayuki</creator><creator>Kobayashi, Kazufumi</creator><creator>Kiyono, Soichiro</creator><creator>Nakamura, Masato</creator><creator>Saito, Tomoko</creator><creator>Suzuki, Eiichiro</creator><creator>Nakamoto, Shingo</creator><creator>Yasui, Shin</creator><creator>Tawada, Akinobu</creator><creator>Chiba, Tetsuhiro</creator><creator>Arai, Makoto</creator><creator>Kanda, Tatsuo</creator><creator>Maruyama, Hitoshi</creator><creator>Kato, Naoya</creator><general>Springer US</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>7QO</scope><scope>7RV</scope><scope>7WY</scope><scope>7WZ</scope><scope>7X7</scope><scope>7XB</scope><scope>87Z</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FL</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BEZIV</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FRNLG</scope><scope>FYUFA</scope><scope>F~G</scope><scope>GHDGH</scope><scope>K60</scope><scope>K6~</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>L.-</scope><scope>M0C</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQBIZ</scope><scope>PQBZA</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-6540-9064</orcidid></search><sort><creationdate>20200201</creationdate><title>Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan</title><author>Ogasawara, Sadahisa ; Ooka, Yoshihiko ; Itokawa, Norio ; Inoue, Masanori ; Okabe, Shinichiro ; Seki, Atsuyoshi ; Haga, Yuki ; Obu, Masamichi ; Atsukawa, Masanori ; Itobayashi, Ei ; Mizumoto, Hideaki ; Sugiura, Nobuyuki ; Azemoto, Ryosaku ; Kanayama, Kengo ; Kanzaki, Hiroaki ; Maruta, Susumu ; Maeda, Takahiro ; Kusakabe, Yuko ; Yokoyama, Masayuki ; Kobayashi, Kazufumi ; Kiyono, Soichiro ; Nakamura, Masato ; Saito, Tomoko ; Suzuki, Eiichiro ; Nakamoto, Shingo ; Yasui, Shin ; Tawada, Akinobu ; Chiba, Tetsuhiro ; Arai, Makoto ; Kanda, Tatsuo ; Maruyama, Hitoshi ; Kato, Naoya</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-fad2de85effae3bb3064ec2e62143073f3154c05c6c3c5159a100887605f153b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>Carcinoma, Hepatocellular - pathology</topic><topic>Confidence intervals</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Hepatocellular carcinoma</topic><topic>Humans</topic><topic>Inhibitor drugs</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - drug therapy</topic><topic>Liver Neoplasms - pathology</topic><topic>Male</topic><topic>Medical records</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle 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Akinobu</creatorcontrib><creatorcontrib>Chiba, Tetsuhiro</creatorcontrib><creatorcontrib>Arai, Makoto</creatorcontrib><creatorcontrib>Kanda, Tatsuo</creatorcontrib><creatorcontrib>Maruyama, Hitoshi</creatorcontrib><creatorcontrib>Kato, Naoya</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>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>ABI/INFORM Collection</collection><collection>ABI/INFORM Global (PDF only)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>ABI/INFORM Global (Alumni Edition)</collection><collection>Medical Database (Alumni 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Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Investigational new drugs</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ogasawara, Sadahisa</au><au>Ooka, Yoshihiko</au><au>Itokawa, Norio</au><au>Inoue, Masanori</au><au>Okabe, Shinichiro</au><au>Seki, Atsuyoshi</au><au>Haga, Yuki</au><au>Obu, Masamichi</au><au>Atsukawa, Masanori</au><au>Itobayashi, Ei</au><au>Mizumoto, Hideaki</au><au>Sugiura, Nobuyuki</au><au>Azemoto, Ryosaku</au><au>Kanayama, Kengo</au><au>Kanzaki, Hiroaki</au><au>Maruta, Susumu</au><au>Maeda, Takahiro</au><au>Kusakabe, Yuko</au><au>Yokoyama, Masayuki</au><au>Kobayashi, Kazufumi</au><au>Kiyono, Soichiro</au><au>Nakamura, Masato</au><au>Saito, Tomoko</au><au>Suzuki, Eiichiro</au><au>Nakamoto, Shingo</au><au>Yasui, Shin</au><au>Tawada, Akinobu</au><au>Chiba, Tetsuhiro</au><au>Arai, Makoto</au><au>Kanda, Tatsuo</au><au>Maruyama, Hitoshi</au><au>Kato, Naoya</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan</atitle><jtitle>Investigational new drugs</jtitle><stitle>Invest New Drugs</stitle><addtitle>Invest New Drugs</addtitle><date>2020-02-01</date><risdate>2020</risdate><volume>38</volume><issue>1</issue><spage>172</spage><epage>180</epage><pages>172-180</pages><issn>0167-6997</issn><eissn>1573-0646</eissn><abstract>Summary
Background
Conversion from sorafenib to regorafenib is primarily an evidence-based treatment strategy in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess the safety and efficacy of sequential therapy with sorafenib and regorafenib in patients with advanced HCC by analysis of outcomes in clinical practice with the aim to complement phase III findings.
Methods
The medical records of patients with advanced HCC receiving regorafenib were retrieved to collect data on sorafenib administration at seven Japanese institutions. Radiological responses and adverse events were evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1 and the Common Terminology Criteria for Adverse Events version 4.0, respectively.
Results
Before March 2018, 44 patients were administered regorafenib for advanced HCC. The median sorafenib treatment duration was 8.4 months. The most common adverse events were similar to those reported by the RESORCE trial. The median overall survival (OS) was 17.3 months (95% confidence interval [CI] 11.4–22.9), and 17 of 37 patients (45.9%) discontinued regorafenib and received sequential systemic therapy after regorafenib. These patients had significantly longer OS than those who were treated by the best supportive care or sub-optimal therapy (not reached versus 8.7 months [95% CI 5.8–11.7];
P
< 0.001).
Conclusion
The results based on Japanese clinical practices verified the tolerability of regorafenib in advanced HCC. Major regorafenib-associated adverse events were similar to those related to sorafenib. OS was significantly longer than expected, which might be associated with the sequential systemic therapies after regorafenib, mainly lenvatinib.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>31172442</pmid><doi>10.1007/s10637-019-00801-8</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-6540-9064</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-6997 |
| ispartof | Investigational new drugs, 2020-02, Vol.38 (1), p.172-180 |
| issn | 0167-6997 1573-0646 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2340037436 |
| source | MEDLINE; SpringerLink Journals - AutoHoldings |
| subjects | Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - pathology Confidence intervals Female Follow-Up Studies Hepatocellular carcinoma Humans Inhibitor drugs Liver cancer Liver Neoplasms - drug therapy Liver Neoplasms - pathology Male Medical records Medicine Medicine & Public Health Middle Aged Oncology Patients Pharmacology/Toxicology Phenylurea Compounds - administration & dosage Prognosis Pyridines - administration & dosage Response Evaluation Criteria in Solid Tumors Retrospective Studies Short Report Solid tumors Sorafenib - administration & dosage Studies Survival Rate Targeted cancer therapy Terminology Therapy Tumors |
| title | Sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Japan |
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