Supplementary Material for: Albumin-Bilirubin Grade Analyses of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study
Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) vs sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of baseline albumin-bilirubin (ALBI) score. Methods: Patients with tr...
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creator | M., Kudo R.S., Finn A.-L., Cheng A.X., Zhu M., Ducreux P.R., Galle N., Sakamoto N., Kato M., Nakano J., Jia A., Vogel |
description | Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) vs sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of baseline albumin-bilirubin (ALBI) score. Methods: Patients with treatment-naïve unresectable HCC, ≥1 measurable untreated lesion and Child-Pugh Class A liver function were randomized 2:1 to receive atezolizumab 1200 mg + bevacizumab 15 mg/kg every 3 weeks or sorafenib 400 mg twice daily. Overall survival (OS) and progression-free survival (PFS) were assessed in the intention-to-treat population by ALBI/modified (m)ALBI grade. Time to deterioration (TTD; defined as time to 0.5-point increase from baseline ALBI score over 2 visits or death) of liver function and safety were investigated. Results: Of 501 enrolled patients, 336 were randomized to receive atezolizumab + bevacizumab (ALBI Grade (G) 1: n=191; G2: n=144 (mALBI G2a: n=72, G2b: n=72); missing ALBI Grade: n=1) and 165 to sorafenib (ALBI G1: n=87; G2: n=78 (mALBI G2a: n=37; G2b: n=41)). Median follow-up was 15.6 months. OS and PFS improved with atezolizumab + bevacizumab vs sorafenib in patients with ALBI G1 (OS HR, 0.50 (95% CI: 0.35, 0.72); PFS HR, 0.61 (95% CI: 0.45, 0.82)). In patients with ALBI G2 or mALBI G2a or G2b, PFS was numerically longer with atezolizumab + bevacizumab vs sorafenib but no OS benefit was seen. Median TTD in the intention-to-treat population was 10.2 months (95% CI: 8.0, 11.0) with atezolizumab + bevacizumab vs 8.6 months (95% CI: 6.2, 11.8) with sorafenib (HR, 0.82 (95% CI: 0.65, 1.03)). Safety profiles of atezolizumab and bevacizumab were consistent with previous analyses, regardless of ALBI grade. Discussion/Conclusion: ALBI grade appeared to be prognostic for outcomes with both atezolizumab + bevacizumab and sorafenib treatment in patients with HCC. Atezolizumab + bevacizumab preserved liver function for a numerically longer duration than sorafenib. |
doi_str_mv | 10.6084/m9.figshare.22214530 |
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fullrecord | <record><control><sourceid>datacite_PQ8</sourceid><recordid>TN_cdi_datacite_primary_10_6084_m9_figshare_22214530</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>10_6084_m9_figshare_22214530</sourcerecordid><originalsourceid>FETCH-datacite_primary_10_6084_m9_figshare_222145303</originalsourceid><addsrcrecordid>eNqdkEtOhFAQRZk4MOoOHNQGGoGmje2M7qgw6IQEjUNSQCGVvA95HxJ6pS5HNPQGHFVyk5tz6wTBfRyFj9FT-iD3Yc9fdkBDYZIkcbrbRtfBd-XHUZAk5dDMcEJHhlFAr80zZKLxktXmwIKNb1jBm8GOIFMoZksWdA-Zo7MWfPYSGyiFt3CgCds1mCxU2mBPihtY-iU6XlAWPtkN8KEMWWodNoIgpxGdbkkIL9DAEU3LSktcZkCprYNctyuZ_8huICgHtARFUUBxagxOFO8iqJzv5tvgqkdh6W69N0H6-vJ-zDcdumWeo3o0LJef6ziqfwXVcl9fBNUXQdt_1n4AlGp9Rw</addsrcrecordid><sourcetype>Publisher</sourcetype><iscdi>true</iscdi><recordtype>dataset</recordtype></control><display><type>dataset</type><title>Supplementary Material for: Albumin-Bilirubin Grade Analyses of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study</title><source>DataCite</source><creator>M., Kudo ; R.S., Finn ; A.-L., Cheng ; A.X., Zhu ; M., Ducreux ; P.R., Galle ; N., Sakamoto ; N., Kato ; M., Nakano ; J., Jia ; A., Vogel</creator><creatorcontrib>M., Kudo ; R.S., Finn ; A.-L., Cheng ; A.X., Zhu ; M., Ducreux ; P.R., Galle ; N., Sakamoto ; N., Kato ; M., Nakano ; J., Jia ; A., Vogel</creatorcontrib><description>Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) vs sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of baseline albumin-bilirubin (ALBI) score. Methods: Patients with treatment-naïve unresectable HCC, ≥1 measurable untreated lesion and Child-Pugh Class A liver function were randomized 2:1 to receive atezolizumab 1200 mg + bevacizumab 15 mg/kg every 3 weeks or sorafenib 400 mg twice daily. Overall survival (OS) and progression-free survival (PFS) were assessed in the intention-to-treat population by ALBI/modified (m)ALBI grade. Time to deterioration (TTD; defined as time to 0.5-point increase from baseline ALBI score over 2 visits or death) of liver function and safety were investigated. Results: Of 501 enrolled patients, 336 were randomized to receive atezolizumab + bevacizumab (ALBI Grade (G) 1: n=191; G2: n=144 (mALBI G2a: n=72, G2b: n=72); missing ALBI Grade: n=1) and 165 to sorafenib (ALBI G1: n=87; G2: n=78 (mALBI G2a: n=37; G2b: n=41)). Median follow-up was 15.6 months. OS and PFS improved with atezolizumab + bevacizumab vs sorafenib in patients with ALBI G1 (OS HR, 0.50 (95% CI: 0.35, 0.72); PFS HR, 0.61 (95% CI: 0.45, 0.82)). In patients with ALBI G2 or mALBI G2a or G2b, PFS was numerically longer with atezolizumab + bevacizumab vs sorafenib but no OS benefit was seen. Median TTD in the intention-to-treat population was 10.2 months (95% CI: 8.0, 11.0) with atezolizumab + bevacizumab vs 8.6 months (95% CI: 6.2, 11.8) with sorafenib (HR, 0.82 (95% CI: 0.65, 1.03)). Safety profiles of atezolizumab and bevacizumab were consistent with previous analyses, regardless of ALBI grade. Discussion/Conclusion: ALBI grade appeared to be prognostic for outcomes with both atezolizumab + bevacizumab and sorafenib treatment in patients with HCC. Atezolizumab + bevacizumab preserved liver function for a numerically longer duration than sorafenib.</description><identifier>DOI: 10.6084/m9.figshare.22214530</identifier><language>eng</language><publisher>Karger Publishers</publisher><subject>Medicine</subject><creationdate>2023</creationdate><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>776,1887</link.rule.ids><linktorsrc>$$Uhttps://commons.datacite.org/doi.org/10.6084/m9.figshare.22214530$$EView_record_in_DataCite.org$$FView_record_in_$$GDataCite.org$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>M., Kudo</creatorcontrib><creatorcontrib>R.S., Finn</creatorcontrib><creatorcontrib>A.-L., Cheng</creatorcontrib><creatorcontrib>A.X., Zhu</creatorcontrib><creatorcontrib>M., Ducreux</creatorcontrib><creatorcontrib>P.R., Galle</creatorcontrib><creatorcontrib>N., Sakamoto</creatorcontrib><creatorcontrib>N., Kato</creatorcontrib><creatorcontrib>M., Nakano</creatorcontrib><creatorcontrib>J., Jia</creatorcontrib><creatorcontrib>A., Vogel</creatorcontrib><title>Supplementary Material for: Albumin-Bilirubin Grade Analyses of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study</title><description>Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) vs sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of baseline albumin-bilirubin (ALBI) score. Methods: Patients with treatment-naïve unresectable HCC, ≥1 measurable untreated lesion and Child-Pugh Class A liver function were randomized 2:1 to receive atezolizumab 1200 mg + bevacizumab 15 mg/kg every 3 weeks or sorafenib 400 mg twice daily. Overall survival (OS) and progression-free survival (PFS) were assessed in the intention-to-treat population by ALBI/modified (m)ALBI grade. Time to deterioration (TTD; defined as time to 0.5-point increase from baseline ALBI score over 2 visits or death) of liver function and safety were investigated. Results: Of 501 enrolled patients, 336 were randomized to receive atezolizumab + bevacizumab (ALBI Grade (G) 1: n=191; G2: n=144 (mALBI G2a: n=72, G2b: n=72); missing ALBI Grade: n=1) and 165 to sorafenib (ALBI G1: n=87; G2: n=78 (mALBI G2a: n=37; G2b: n=41)). Median follow-up was 15.6 months. OS and PFS improved with atezolizumab + bevacizumab vs sorafenib in patients with ALBI G1 (OS HR, 0.50 (95% CI: 0.35, 0.72); PFS HR, 0.61 (95% CI: 0.45, 0.82)). In patients with ALBI G2 or mALBI G2a or G2b, PFS was numerically longer with atezolizumab + bevacizumab vs sorafenib but no OS benefit was seen. Median TTD in the intention-to-treat population was 10.2 months (95% CI: 8.0, 11.0) with atezolizumab + bevacizumab vs 8.6 months (95% CI: 6.2, 11.8) with sorafenib (HR, 0.82 (95% CI: 0.65, 1.03)). Safety profiles of atezolizumab and bevacizumab were consistent with previous analyses, regardless of ALBI grade. Discussion/Conclusion: ALBI grade appeared to be prognostic for outcomes with both atezolizumab + bevacizumab and sorafenib treatment in patients with HCC. Atezolizumab + bevacizumab preserved liver function for a numerically longer duration than sorafenib.</description><subject>Medicine</subject><fulltext>true</fulltext><rsrctype>dataset</rsrctype><creationdate>2023</creationdate><recordtype>dataset</recordtype><sourceid>PQ8</sourceid><recordid>eNqdkEtOhFAQRZk4MOoOHNQGGoGmje2M7qgw6IQEjUNSQCGVvA95HxJ6pS5HNPQGHFVyk5tz6wTBfRyFj9FT-iD3Yc9fdkBDYZIkcbrbRtfBd-XHUZAk5dDMcEJHhlFAr80zZKLxktXmwIKNb1jBm8GOIFMoZksWdA-Zo7MWfPYSGyiFt3CgCds1mCxU2mBPihtY-iU6XlAWPtkN8KEMWWodNoIgpxGdbkkIL9DAEU3LSktcZkCprYNctyuZ_8huICgHtARFUUBxagxOFO8iqJzv5tvgqkdh6W69N0H6-vJ-zDcdumWeo3o0LJef6ziqfwXVcl9fBNUXQdt_1n4AlGp9Rw</recordid><startdate>20230304</startdate><enddate>20230304</enddate><creator>M., Kudo</creator><creator>R.S., Finn</creator><creator>A.-L., Cheng</creator><creator>A.X., Zhu</creator><creator>M., Ducreux</creator><creator>P.R., Galle</creator><creator>N., Sakamoto</creator><creator>N., Kato</creator><creator>M., Nakano</creator><creator>J., Jia</creator><creator>A., Vogel</creator><general>Karger Publishers</general><scope>DYCCY</scope><scope>PQ8</scope></search><sort><creationdate>20230304</creationdate><title>Supplementary Material for: Albumin-Bilirubin Grade Analyses of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study</title><author>M., Kudo ; R.S., Finn ; A.-L., Cheng ; A.X., Zhu ; M., Ducreux ; P.R., Galle ; N., Sakamoto ; N., Kato ; M., Nakano ; J., Jia ; A., Vogel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-datacite_primary_10_6084_m9_figshare_222145303</frbrgroupid><rsrctype>datasets</rsrctype><prefilter>datasets</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Medicine</topic><toplevel>online_resources</toplevel><creatorcontrib>M., Kudo</creatorcontrib><creatorcontrib>R.S., Finn</creatorcontrib><creatorcontrib>A.-L., Cheng</creatorcontrib><creatorcontrib>A.X., Zhu</creatorcontrib><creatorcontrib>M., Ducreux</creatorcontrib><creatorcontrib>P.R., Galle</creatorcontrib><creatorcontrib>N., Sakamoto</creatorcontrib><creatorcontrib>N., Kato</creatorcontrib><creatorcontrib>M., Nakano</creatorcontrib><creatorcontrib>J., Jia</creatorcontrib><creatorcontrib>A., Vogel</creatorcontrib><collection>DataCite (Open Access)</collection><collection>DataCite</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>M., Kudo</au><au>R.S., Finn</au><au>A.-L., Cheng</au><au>A.X., Zhu</au><au>M., Ducreux</au><au>P.R., Galle</au><au>N., Sakamoto</au><au>N., Kato</au><au>M., Nakano</au><au>J., Jia</au><au>A., Vogel</au><format>book</format><genre>unknown</genre><ristype>DATA</ristype><title>Supplementary Material for: Albumin-Bilirubin Grade Analyses of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study</title><date>2023-03-04</date><risdate>2023</risdate><abstract>Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) vs sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of baseline albumin-bilirubin (ALBI) score. Methods: Patients with treatment-naïve unresectable HCC, ≥1 measurable untreated lesion and Child-Pugh Class A liver function were randomized 2:1 to receive atezolizumab 1200 mg + bevacizumab 15 mg/kg every 3 weeks or sorafenib 400 mg twice daily. Overall survival (OS) and progression-free survival (PFS) were assessed in the intention-to-treat population by ALBI/modified (m)ALBI grade. Time to deterioration (TTD; defined as time to 0.5-point increase from baseline ALBI score over 2 visits or death) of liver function and safety were investigated. Results: Of 501 enrolled patients, 336 were randomized to receive atezolizumab + bevacizumab (ALBI Grade (G) 1: n=191; G2: n=144 (mALBI G2a: n=72, G2b: n=72); missing ALBI Grade: n=1) and 165 to sorafenib (ALBI G1: n=87; G2: n=78 (mALBI G2a: n=37; G2b: n=41)). Median follow-up was 15.6 months. OS and PFS improved with atezolizumab + bevacizumab vs sorafenib in patients with ALBI G1 (OS HR, 0.50 (95% CI: 0.35, 0.72); PFS HR, 0.61 (95% CI: 0.45, 0.82)). In patients with ALBI G2 or mALBI G2a or G2b, PFS was numerically longer with atezolizumab + bevacizumab vs sorafenib but no OS benefit was seen. Median TTD in the intention-to-treat population was 10.2 months (95% CI: 8.0, 11.0) with atezolizumab + bevacizumab vs 8.6 months (95% CI: 6.2, 11.8) with sorafenib (HR, 0.82 (95% CI: 0.65, 1.03)). Safety profiles of atezolizumab and bevacizumab were consistent with previous analyses, regardless of ALBI grade. Discussion/Conclusion: ALBI grade appeared to be prognostic for outcomes with both atezolizumab + bevacizumab and sorafenib treatment in patients with HCC. Atezolizumab + bevacizumab preserved liver function for a numerically longer duration than sorafenib.</abstract><pub>Karger Publishers</pub><doi>10.6084/m9.figshare.22214530</doi><oa>free_for_read</oa></addata></record> |
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title | Supplementary Material for: Albumin-Bilirubin Grade Analyses of Atezolizumab Plus Bevacizumab vs Sorafenib in Patients With Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study |
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