Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial
In the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as t...
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| creator | Kelley, RobinKate Ryoo, Baek-Yeol Merle, Philippe Park, Joong-Won Bolondi, Luigi Chan, Stephen L. Lim, HoYeong Baron, Ari D. Parnis, Francis Knox, Jennifer Cattan, Stéphane Yau, Thomas Lougheed, Julie C. Milwee, Steven El-Khoueiry, Anthony B. Cheng, Ann-Lii Meyer, Tim Abou-Alfa, Ghassan K. |
| description | In the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as the only prior systemic therapy.
CELESTIAL randomised (2:1) patients with advanced HCC and Child–Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib ( |
| doi_str_mv | 10.1136/esmoopen-2020-000714 |
| format | Article |
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CELESTIAL randomised (2:1) patients with advanced HCC and Child–Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib (<3 months, 3 to <6 months and ≥6 months).
Of patients who had received only prior sorafenib, 331 were randomised to cabozantinib and 164 to placebo; 136 patients had received sorafenib for <3 months, 141 for 3 to <6 months and 217 for ≥6 months. Cabozantinib improved OS relative to placebo in the overall second-line population who had received only prior sorafenib (median 11.3 vs 7.2 months; HR=0.70, 95% CI 0.55 to 0.88). This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS—median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months. Cabozantinib also improved PFS in all duration subgroups. Safety data were consistent with the overall study population.
Cabozantinib improved efficacy outcomes versus placebo in the second-line population who had received only prior sorafenib irrespective of duration of prior sorafenib treatment, further supporting the utility of cabozantinib in the evolving treatment landscape of HCC.
NCT01908426.]]></description><identifier>ISSN: 2059-7029</identifier><identifier>EISSN: 2059-7029</identifier><identifier>DOI: 10.1136/esmoopen-2020-000714</identifier><identifier>PMID: 32847838</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Anilides ; Antineoplastic Agents - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; cabozantinib ; Cancer ; Carcinoma, Hepatocellular - drug therapy ; hepatocellular carcinoma ; Humans ; Life Sciences ; Liver Neoplasms - drug therapy ; Male ; Middle Aged ; Original Research ; Pyridines ; sorafenib ; Sorafenib - therapeutic use ; tyrosine kinase inhibitor ; Young Adult</subject><ispartof>ESMO open, 2020-01, Vol.5 (4), p.e000714, Article e000714</ispartof><rights>2020 © 2020 THE AUTHORS. Published by Elsevier Limited on behalf of European Society for Medical Oncology.</rights><rights>Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c563t-aff768f9d6c276e2bdc7821b16a5a049da3c4d30121107ab8822a225baf0e5ac3</citedby><cites>FETCH-LOGICAL-c563t-aff768f9d6c276e2bdc7821b16a5a049da3c4d30121107ab8822a225baf0e5ac3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7451459/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7451459/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32847838$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04160520$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Kelley, RobinKate</creatorcontrib><creatorcontrib>Ryoo, Baek-Yeol</creatorcontrib><creatorcontrib>Merle, Philippe</creatorcontrib><creatorcontrib>Park, Joong-Won</creatorcontrib><creatorcontrib>Bolondi, Luigi</creatorcontrib><creatorcontrib>Chan, Stephen L.</creatorcontrib><creatorcontrib>Lim, HoYeong</creatorcontrib><creatorcontrib>Baron, Ari D.</creatorcontrib><creatorcontrib>Parnis, Francis</creatorcontrib><creatorcontrib>Knox, Jennifer</creatorcontrib><creatorcontrib>Cattan, Stéphane</creatorcontrib><creatorcontrib>Yau, Thomas</creatorcontrib><creatorcontrib>Lougheed, Julie C.</creatorcontrib><creatorcontrib>Milwee, Steven</creatorcontrib><creatorcontrib>El-Khoueiry, Anthony B.</creatorcontrib><creatorcontrib>Cheng, Ann-Lii</creatorcontrib><creatorcontrib>Meyer, Tim</creatorcontrib><creatorcontrib>Abou-Alfa, Ghassan K.</creatorcontrib><title>Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial</title><title>ESMO open</title><addtitle>ESMO Open</addtitle><description><![CDATA[In the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as the only prior systemic therapy.
CELESTIAL randomised (2:1) patients with advanced HCC and Child–Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib (<3 months, 3 to <6 months and ≥6 months).
Of patients who had received only prior sorafenib, 331 were randomised to cabozantinib and 164 to placebo; 136 patients had received sorafenib for <3 months, 141 for 3 to <6 months and 217 for ≥6 months. Cabozantinib improved OS relative to placebo in the overall second-line population who had received only prior sorafenib (median 11.3 vs 7.2 months; HR=0.70, 95% CI 0.55 to 0.88). This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS—median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months. Cabozantinib also improved PFS in all duration subgroups. Safety data were consistent with the overall study population.
Cabozantinib improved efficacy outcomes versus placebo in the second-line population who had received only prior sorafenib irrespective of duration of prior sorafenib treatment, further supporting the utility of cabozantinib in the evolving treatment landscape of HCC.
NCT01908426.]]></description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anilides</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>cabozantinib</subject><subject>Cancer</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>hepatocellular carcinoma</subject><subject>Humans</subject><subject>Life Sciences</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original Research</subject><subject>Pyridines</subject><subject>sorafenib</subject><subject>Sorafenib - therapeutic use</subject><subject>tyrosine kinase inhibitor</subject><subject>Young Adult</subject><issn>2059-7029</issn><issn>2059-7029</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc9u1DAQxiMEolXpGyDkIxxS_C9xwgFptVraSitxaDlbE2fSGCV2sJOVyjPw0DjathQOnGyPv_mNvvmy7C2jF4yJ8iPG0fsJXc4ppzmlVDH5IjvltKhzRXn98tn9JDuP8XvSMCVTsXydnQheSVWJ6jT7dYPGuzYfrENioPE_wc3W2YZAN2Mg0QfocH3PAWEe0c2k84FAewBnsCU9TjB7g8OwDBASIhjr_AifCJC4NHfBLxMBB8N9tJH4jsw9kqmHiESQ7W6_u7m93uwT3cLwJnvVwRDx_OE8y7592d1ur_L918vr7Wafm6IUcw5dp8qqq9vScFUib1qjKs4aVkIBVNYtCCNbQRlnjCpoqopz4LxooKNYgBFn2ecjd1qaEVuTTAUY9BTsCOFee7D67x9ne33nD1rJgsmiToAPR0D_T9vVZq_XGpWspAWnB5a07x-GBf9jwTjr0cZ1X-DQL1FzKVQlWV2IJJVHqQk-xoDdE5tRveauH3PXa-76mHtqe_fczlPTY8p__GJa6sFi0NFYXOOzAc2sW2__P-E3vGnC3g</recordid><startdate>20200101</startdate><enddate>20200101</enddate><creator>Kelley, RobinKate</creator><creator>Ryoo, Baek-Yeol</creator><creator>Merle, Philippe</creator><creator>Park, Joong-Won</creator><creator>Bolondi, Luigi</creator><creator>Chan, Stephen L.</creator><creator>Lim, HoYeong</creator><creator>Baron, Ari D.</creator><creator>Parnis, Francis</creator><creator>Knox, Jennifer</creator><creator>Cattan, Stéphane</creator><creator>Yau, Thomas</creator><creator>Lougheed, Julie C.</creator><creator>Milwee, Steven</creator><creator>El-Khoueiry, Anthony B.</creator><creator>Cheng, Ann-Lii</creator><creator>Meyer, Tim</creator><creator>Abou-Alfa, Ghassan K.</creator><general>Elsevier Ltd</general><general>European Society for Medical Oncology</general><general>BMJ Publishing Group</general><scope>6I.</scope><scope>AAFTH</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>7X8</scope><scope>1XC</scope><scope>VOOES</scope><scope>5PM</scope></search><sort><creationdate>20200101</creationdate><title>Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial</title><author>Kelley, RobinKate ; Ryoo, Baek-Yeol ; Merle, Philippe ; Park, Joong-Won ; Bolondi, Luigi ; Chan, Stephen L. ; Lim, HoYeong ; Baron, Ari D. ; Parnis, Francis ; Knox, Jennifer ; Cattan, Stéphane ; Yau, Thomas ; Lougheed, Julie C. ; Milwee, Steven ; El-Khoueiry, Anthony B. ; Cheng, Ann-Lii ; Meyer, Tim ; Abou-Alfa, Ghassan K.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c563t-aff768f9d6c276e2bdc7821b16a5a049da3c4d30121107ab8822a225baf0e5ac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anilides</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>cabozantinib</topic><topic>Cancer</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>hepatocellular carcinoma</topic><topic>Humans</topic><topic>Life Sciences</topic><topic>Liver Neoplasms - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original Research</topic><topic>Pyridines</topic><topic>sorafenib</topic><topic>Sorafenib - therapeutic use</topic><topic>tyrosine kinase inhibitor</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kelley, RobinKate</creatorcontrib><creatorcontrib>Ryoo, Baek-Yeol</creatorcontrib><creatorcontrib>Merle, Philippe</creatorcontrib><creatorcontrib>Park, Joong-Won</creatorcontrib><creatorcontrib>Bolondi, Luigi</creatorcontrib><creatorcontrib>Chan, Stephen L.</creatorcontrib><creatorcontrib>Lim, HoYeong</creatorcontrib><creatorcontrib>Baron, Ari D.</creatorcontrib><creatorcontrib>Parnis, Francis</creatorcontrib><creatorcontrib>Knox, Jennifer</creatorcontrib><creatorcontrib>Cattan, Stéphane</creatorcontrib><creatorcontrib>Yau, Thomas</creatorcontrib><creatorcontrib>Lougheed, Julie C.</creatorcontrib><creatorcontrib>Milwee, Steven</creatorcontrib><creatorcontrib>El-Khoueiry, Anthony B.</creatorcontrib><creatorcontrib>Cheng, Ann-Lii</creatorcontrib><creatorcontrib>Meyer, Tim</creatorcontrib><creatorcontrib>Abou-Alfa, Ghassan K.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>ESMO open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kelley, RobinKate</au><au>Ryoo, Baek-Yeol</au><au>Merle, Philippe</au><au>Park, Joong-Won</au><au>Bolondi, Luigi</au><au>Chan, Stephen L.</au><au>Lim, HoYeong</au><au>Baron, Ari D.</au><au>Parnis, Francis</au><au>Knox, Jennifer</au><au>Cattan, Stéphane</au><au>Yau, Thomas</au><au>Lougheed, Julie C.</au><au>Milwee, Steven</au><au>El-Khoueiry, Anthony B.</au><au>Cheng, Ann-Lii</au><au>Meyer, Tim</au><au>Abou-Alfa, Ghassan K.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial</atitle><jtitle>ESMO open</jtitle><addtitle>ESMO Open</addtitle><date>2020-01-01</date><risdate>2020</risdate><volume>5</volume><issue>4</issue><spage>e000714</spage><pages>e000714-</pages><artnum>e000714</artnum><issn>2059-7029</issn><eissn>2059-7029</eissn><abstract><![CDATA[In the phase 3 CELESTIAL trial, cabozantinib improved overall survival (OS) and progression-free survival (PFS) compared with placebo in patients with previously treated advanced hepatocellular carcinoma (HCC). This subgroup analysis evaluated cabozantinib in patients who had received sorafenib as the only prior systemic therapy.
CELESTIAL randomised (2:1) patients with advanced HCC and Child–Pugh class A liver function to treatment with cabozantinib (60 mg daily) or placebo. Eligibility required prior treatment with sorafenib, and patients could have received ≤2 prior systemic regimens. The primary endpoint was OS. Outcomes in patients who had received sorafenib as the only prior therapy were analysed by duration of prior sorafenib (<3 months, 3 to <6 months and ≥6 months).
Of patients who had received only prior sorafenib, 331 were randomised to cabozantinib and 164 to placebo; 136 patients had received sorafenib for <3 months, 141 for 3 to <6 months and 217 for ≥6 months. Cabozantinib improved OS relative to placebo in the overall second-line population who had received only prior sorafenib (median 11.3 vs 7.2 months; HR=0.70, 95% CI 0.55 to 0.88). This improvement was maintained in analyses by prior sorafenib duration with longer duration generally corresponding to longer median OS—median OS 8.9 vs 6.9 months (HR=0.72, 95% CI 0.47 to 1.10) for prior sorafenib <3 months, 11.5 vs 6.5 months (HR=0.65, 95% CI 0.43 to 1.00) for 3 to <6 months and 12.3 vs 9.2 months (HR=0.82, 95% CI 0.58 to 1.16) for ≥6 months. Cabozantinib also improved PFS in all duration subgroups. Safety data were consistent with the overall study population.
Cabozantinib improved efficacy outcomes versus placebo in the second-line population who had received only prior sorafenib irrespective of duration of prior sorafenib treatment, further supporting the utility of cabozantinib in the evolving treatment landscape of HCC.
NCT01908426.]]></abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>32847838</pmid><doi>10.1136/esmoopen-2020-000714</doi><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 2059-7029 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Adult Aged Aged, 80 and over Anilides Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use cabozantinib Cancer Carcinoma, Hepatocellular - drug therapy hepatocellular carcinoma Humans Life Sciences Liver Neoplasms - drug therapy Male Middle Aged Original Research Pyridines sorafenib Sorafenib - therapeutic use tyrosine kinase inhibitor Young Adult |
| title | Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial |
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