Survival Trends in Sorafenib for Advanced Hepatocellular Carcinoma: A Reconstructed Individual Patient Data Meta-Analysis of Randomized Trials
Background: Emerging data suggest that outcomes for advanced hepatocellular carcinoma (HCC) treated with sorafenib may have improved over time. We aimed to provide robust, time-to-event estimates of survival outcomes for sorafenib in advanced HCC. Summary: In this systematic review and individual pa...
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| Veröffentlicht in: | Liver cancer (Basel ) 2023-10, Vol.12 (5), p.445-456 |
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| creator | Tan, Darren Jun Hao Tang, Ansel Shao Pin Lim, Wen Hui Ng, Cheng Han Nah, Benjamin Fu, Clarissa Xiao, Jieling Koh, Benjamin Tay, Phoebe Wen Lin Tan, Eunice X Teng, Margaret Syn, Nicholas Muthiah, Mark D Tamaki, Nobuharu Lee, Sung Won Kim, Beom Kyung Yau, Thomas Vogel, Arndt Loomba, Rohit Huang, Daniel Q. |
| description | Background: Emerging data suggest that outcomes for advanced hepatocellular carcinoma (HCC) treated with sorafenib may have improved over time. We aimed to provide robust, time-to-event estimates of survival outcomes for sorafenib in advanced HCC. Summary: In this systematic review and individual patient data meta-analysis of randomized-controlled trials (RCTs), we searched MEDLINE and Embase from inception till September 2022 for RCTs that provided data for overall survival (OS) and progression-free survival (PFS) for sorafenib monotherapy as first-line systemic therapy for advanced HCC. We performed a pooled analysis using reconstructed individual participant data from published Kaplan-Meier curves to obtain robust estimates for OS and PFS. Of 1,599 articles identified, 29 studies (5,525 patients) met the inclusion criteria. Overall, the median OS was 10.4 (95% CI: 9.6–11.4) months. Median OS increased over time, from 9.8 (95% CI: 8.8–10.7) months in studies before 2015 to 13.4 (95% CI: 11.03–15.24) months in studies from 2015 onwards (p < 0.001). OS did not differ by trial phase, geographical region, or study design. The overall median PFS was 4.4 (95% CI: 3.9–4.8) months, but PFS did not improve over time. Sensitivity analysis of studies from 2015 and onwards to account for the introduction of direct-acting antivirals determined that hepatitis C virus was associated with reduced mortality (p < 0.001). There was minimal heterogeneity in the estimates for OS (all I 2 ≤ 33). Key Messages: Survival outcomes for sorafenib in advanced HCC have improved over time. These data have important implications for clinical trial design. |
| doi_str_mv | 10.1159/000529824 |
| format | Article |
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We aimed to provide robust, time-to-event estimates of survival outcomes for sorafenib in advanced HCC. Summary: In this systematic review and individual patient data meta-analysis of randomized-controlled trials (RCTs), we searched MEDLINE and Embase from inception till September 2022 for RCTs that provided data for overall survival (OS) and progression-free survival (PFS) for sorafenib monotherapy as first-line systemic therapy for advanced HCC. We performed a pooled analysis using reconstructed individual participant data from published Kaplan-Meier curves to obtain robust estimates for OS and PFS. Of 1,599 articles identified, 29 studies (5,525 patients) met the inclusion criteria. Overall, the median OS was 10.4 (95% CI: 9.6–11.4) months. Median OS increased over time, from 9.8 (95% CI: 8.8–10.7) months in studies before 2015 to 13.4 (95% CI: 11.03–15.24) months in studies from 2015 onwards (p < 0.001). OS did not differ by trial phase, geographical region, or study design. The overall median PFS was 4.4 (95% CI: 3.9–4.8) months, but PFS did not improve over time. Sensitivity analysis of studies from 2015 and onwards to account for the introduction of direct-acting antivirals determined that hepatitis C virus was associated with reduced mortality (p < 0.001). There was minimal heterogeneity in the estimates for OS (all I 2 ≤ 33). Key Messages: Survival outcomes for sorafenib in advanced HCC have improved over time. These data have important implications for clinical trial design.</description><identifier>ISSN: 2235-1795</identifier><identifier>EISSN: 1664-5553</identifier><identifier>DOI: 10.1159/000529824</identifier><identifier>PMID: 37901764</identifier><language>eng</language><publisher>Basel, Switzerland: S. Karger AG</publisher><subject>Bias ; Cancer therapies ; Clinical trials ; Demographics ; Generalized linear models ; Hepatitis ; Inhibitor drugs ; Liver cancer ; Liver diseases ; Meta-Analysis ; Patients ; Survival analysis ; Targeted cancer therapy ; Trends</subject><ispartof>Liver cancer (Basel ), 2023-10, Vol.12 (5), p.445-456</ispartof><rights>2023 The Author(s). Published by S. Karger AG, Basel</rights><rights>2023 The Author(s). Published by S. Karger AG, Basel.</rights><rights>2023 The Author(s). Published by S. Karger AG, Basel. This work is licensed under the Creative Commons Attribution – Non-Commercial License http://creativecommons.org/licenses/by-nc/3.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2023 The Author(s). Published by S. Karger AG, Basel 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c519t-569ab2c28fe0962339765738f26e57e3b33a9bfdaeb1f2176794b490bb04c433</citedby><cites>FETCH-LOGICAL-c519t-569ab2c28fe0962339765738f26e57e3b33a9bfdaeb1f2176794b490bb04c433</cites><orcidid>0000-0003-4634-6616 ; 0000-0002-5194-5130 ; 0000-0002-6343-176X ; 0000-0002-9724-4743 ; 0000-0003-0560-5538 ; 0000-0002-5165-5061 ; 0000-0001-7472-9214</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601853/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601853/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,27614,27903,27904,53769,53771</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37901764$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tan, Darren Jun Hao</creatorcontrib><creatorcontrib>Tang, Ansel Shao Pin</creatorcontrib><creatorcontrib>Lim, Wen Hui</creatorcontrib><creatorcontrib>Ng, Cheng Han</creatorcontrib><creatorcontrib>Nah, Benjamin</creatorcontrib><creatorcontrib>Fu, Clarissa</creatorcontrib><creatorcontrib>Xiao, Jieling</creatorcontrib><creatorcontrib>Koh, Benjamin</creatorcontrib><creatorcontrib>Tay, Phoebe Wen Lin</creatorcontrib><creatorcontrib>Tan, Eunice X</creatorcontrib><creatorcontrib>Teng, Margaret</creatorcontrib><creatorcontrib>Syn, Nicholas</creatorcontrib><creatorcontrib>Muthiah, Mark D</creatorcontrib><creatorcontrib>Tamaki, Nobuharu</creatorcontrib><creatorcontrib>Lee, Sung Won</creatorcontrib><creatorcontrib>Kim, Beom Kyung</creatorcontrib><creatorcontrib>Yau, Thomas</creatorcontrib><creatorcontrib>Vogel, Arndt</creatorcontrib><creatorcontrib>Loomba, Rohit</creatorcontrib><creatorcontrib>Huang, Daniel Q.</creatorcontrib><title>Survival Trends in Sorafenib for Advanced Hepatocellular Carcinoma: A Reconstructed Individual Patient Data Meta-Analysis of Randomized Trials</title><title>Liver cancer (Basel )</title><addtitle>Liver Cancer</addtitle><description>Background: Emerging data suggest that outcomes for advanced hepatocellular carcinoma (HCC) treated with sorafenib may have improved over time. We aimed to provide robust, time-to-event estimates of survival outcomes for sorafenib in advanced HCC. Summary: In this systematic review and individual patient data meta-analysis of randomized-controlled trials (RCTs), we searched MEDLINE and Embase from inception till September 2022 for RCTs that provided data for overall survival (OS) and progression-free survival (PFS) for sorafenib monotherapy as first-line systemic therapy for advanced HCC. We performed a pooled analysis using reconstructed individual participant data from published Kaplan-Meier curves to obtain robust estimates for OS and PFS. Of 1,599 articles identified, 29 studies (5,525 patients) met the inclusion criteria. Overall, the median OS was 10.4 (95% CI: 9.6–11.4) months. Median OS increased over time, from 9.8 (95% CI: 8.8–10.7) months in studies before 2015 to 13.4 (95% CI: 11.03–15.24) months in studies from 2015 onwards (p < 0.001). OS did not differ by trial phase, geographical region, or study design. The overall median PFS was 4.4 (95% CI: 3.9–4.8) months, but PFS did not improve over time. Sensitivity analysis of studies from 2015 and onwards to account for the introduction of direct-acting antivirals determined that hepatitis C virus was associated with reduced mortality (p < 0.001). There was minimal heterogeneity in the estimates for OS (all I 2 ≤ 33). Key Messages: Survival outcomes for sorafenib in advanced HCC have improved over time. These data have important implications for clinical trial design.</description><subject>Bias</subject><subject>Cancer therapies</subject><subject>Clinical trials</subject><subject>Demographics</subject><subject>Generalized linear models</subject><subject>Hepatitis</subject><subject>Inhibitor drugs</subject><subject>Liver cancer</subject><subject>Liver diseases</subject><subject>Meta-Analysis</subject><subject>Patients</subject><subject>Survival analysis</subject><subject>Targeted cancer therapy</subject><subject>Trends</subject><issn>2235-1795</issn><issn>1664-5553</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>M--</sourceid><sourceid>BENPR</sourceid><sourceid>DOA</sourceid><recordid>eNptkstuEzEUQEcIRKvSBXuELLGBRcCvGY_ZoCg8GikI1GZvXT8mOEzsYM9EKh_BN-OQEChidSX7-NyHb1U9JvglIbV8hTGuqWwpv1edk6bhk7qu2f3qnFJWT4iQ9Vl1mfO6YLjFWEjxsDpjQmIiGn5e_bgZ087voEfL5ILNyAd0ExN0LniNupjQ1O4gGGfRldvCEI3r-7GHhGaQjA9xA6_RFF07E0Me0miGQs6D9Ttvx2L9DIN3YUBvYQD00Q0wmQbob7PPKHboGoKNG_-9vFkmD31-VD3oSnCXx3hRLd-_W86uJotPH-az6WJiaiKHSd1I0NTQtnNYNpQxKZpasLajjauFY5oxkLqz4DTpaOlUSK65xFpjbjhjF9X8oLUR1mqb_AbSrYrg1a-DmFYK0uBN75RpuJWNFq3BmAvc6U5opjk1YDkjtCuuNwfXdtQbZ03pNkF_R3r3JvgvahV3iuAGk7beV_P8aEjx2-jyoDY-7-cMwcUxK9q2nLTlO3FBn_2DruOYykQLJTFmRAjBC_XiQJkUc06uO1VDsNovjTotTWGf_l3-ify9In9SfoW0cukELOazg0Jt7X4KT_5LHbP8BHit0gI</recordid><startdate>20231001</startdate><enddate>20231001</enddate><creator>Tan, Darren Jun Hao</creator><creator>Tang, Ansel Shao Pin</creator><creator>Lim, Wen Hui</creator><creator>Ng, Cheng Han</creator><creator>Nah, Benjamin</creator><creator>Fu, Clarissa</creator><creator>Xiao, Jieling</creator><creator>Koh, Benjamin</creator><creator>Tay, Phoebe Wen Lin</creator><creator>Tan, Eunice X</creator><creator>Teng, Margaret</creator><creator>Syn, Nicholas</creator><creator>Muthiah, Mark D</creator><creator>Tamaki, Nobuharu</creator><creator>Lee, Sung Won</creator><creator>Kim, Beom Kyung</creator><creator>Yau, Thomas</creator><creator>Vogel, Arndt</creator><creator>Loomba, Rohit</creator><creator>Huang, Daniel Q.</creator><general>S. 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| ispartof | Liver cancer (Basel ), 2023-10, Vol.12 (5), p.445-456 |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; Karger Open Access |
| subjects | Bias Cancer therapies Clinical trials Demographics Generalized linear models Hepatitis Inhibitor drugs Liver cancer Liver diseases Meta-Analysis Patients Survival analysis Targeted cancer therapy Trends |
| title | Survival Trends in Sorafenib for Advanced Hepatocellular Carcinoma: A Reconstructed Individual Patient Data Meta-Analysis of Randomized Trials |
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