Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma

Jaekyung Cheon; Changhoon Yoo; Jung Yong Hong; Han Sang Kim; Dae Won Lee; Myung Ah Lee; Jin Won Kim; Ilhwan Kim; Sang Bo Oh; Jun Eul Hwang; Hong Jae Chon; Ho Yeong Lim

doi:10.1111/liv.15102

Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma

Jaekyung Cheon, Changhoon Yoo, Jung Yong Hong, Han Sang Kim, Dae Won Lee, Myung Ah Lee, Jin Won Kim, Ilhwan Kim, Sang Bo Oh, Jun Eul Hwang, Hong Jae Chon, Ho Yeong Lim

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16 Citations (Scopus)

Abstract

Background & Aims: Atezolizumab plus bevacizumab (Ate/Bev) has demonstrated efficacy and safety in patients with advanced hepatocellular carcinoma (HCC) in the phase III trial. Further evaluation is necessary to investigate the safety and efficacy of Ate/Bev in real settings. Methods: This was a multicentre retrospective analysis. Between May 2020 and February 2021, 138 patients received Ate/Bev as first-line treatment for advanced HCC from 11 institutions. We excluded patients with Child-Pugh B or C and BCLC D stage, and the remaining 121 patients were included in this analysis. Results: According to RECIST 1.1, the objective response and disease control rates were 24.0% and 76.0%. The median follow-up duration was 5.9 months (95% confidence interval [CI], 5.4-6.4), the median progression-free survival (PFS) was 6.5 months (95% CI, 4.1-9.0), and median overall survival (OS) was not reached (95% CI, not available). The most frequent grade 3-4 adverse event was aspartate aminotransferase elevation (10.7%). In the multivariate analyses, AFP increase (P =.037), baseline neutrophil-to-lymphocyte ratio (NLR) ≥ 5 (P =.023), and best response to stable disease or progressive disease (P =.019) were significantly associated with worse PFS. Macrovascular invasion (P =.048) and baseline NLR ≥5 (P <.001) were significantly associated with worse OS. Conclusions: Ate/Bev showed real-life efficacy and safety in Korean patients with advanced HCC, in line with results from phase III trial. Considering unfavourable survival outcomes of Ate/Bev in patients with elevated NLR, careful assessment of treatment response needs to be performed in this group.

Original language	English
Pages (from-to)	674-681
Number of pages	8
Journal	Liver International
Volume	42
Issue number	3
DOIs	https://doi.org/10.1111/liv.15102
Publication status	Published - 2022 Mar

Bibliographical note

Funding Information:
JC received research grants from Bayer and honoraria from Eisai. CY received research grants from Bayer, ONO pharmaceuticals, AstraZeneca, and Ipsen; honoraria from Bayer, ONO pharmaceuticals, AstraZeneca, Roche, BMS, MSD, Eisai, Ipsen, and AstraZeneca. HJC has a consulting or advisory role at Roche, Bayer, Eisai, ONO, BMS, and MSD. HYL received honoraria from Bayer, BMS, Ipsen, and Eisai; fees for advisory board participation from Bayer, BMS, Ipsen, Eisai, MSD, and Roche. The other authors have no potential conflicts of interest related to this article or the research described therein.

Publisher Copyright:
© 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

All Science Journal Classification (ASJC) codes

Hepatology

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10.1111/liv.15102

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@article{95814c54d5774d5a9f2e751ce15e87c5,

title = "Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma",

abstract = "Background & Aims: Atezolizumab plus bevacizumab (Ate/Bev) has demonstrated efficacy and safety in patients with advanced hepatocellular carcinoma (HCC) in the phase III trial. Further evaluation is necessary to investigate the safety and efficacy of Ate/Bev in real settings. Methods: This was a multicentre retrospective analysis. Between May 2020 and February 2021, 138 patients received Ate/Bev as first-line treatment for advanced HCC from 11 institutions. We excluded patients with Child-Pugh B or C and BCLC D stage, and the remaining 121 patients were included in this analysis. Results: According to RECIST 1.1, the objective response and disease control rates were 24.0% and 76.0%. The median follow-up duration was 5.9 months (95% confidence interval [CI], 5.4-6.4), the median progression-free survival (PFS) was 6.5 months (95% CI, 4.1-9.0), and median overall survival (OS) was not reached (95% CI, not available). The most frequent grade 3-4 adverse event was aspartate aminotransferase elevation (10.7%). In the multivariate analyses, AFP increase (P =.037), baseline neutrophil-to-lymphocyte ratio (NLR) ≥ 5 (P =.023), and best response to stable disease or progressive disease (P =.019) were significantly associated with worse PFS. Macrovascular invasion (P =.048) and baseline NLR ≥5 (P <.001) were significantly associated with worse OS. Conclusions: Ate/Bev showed real-life efficacy and safety in Korean patients with advanced HCC, in line with results from phase III trial. Considering unfavourable survival outcomes of Ate/Bev in patients with elevated NLR, careful assessment of treatment response needs to be performed in this group.",

author = "Jaekyung Cheon and Changhoon Yoo and Hong, {Jung Yong} and Kim, {Han Sang} and Lee, {Dae Won} and Lee, {Myung Ah} and Kim, {Jin Won} and Ilhwan Kim and Oh, {Sang Bo} and Hwang, {Jun Eul} and Chon, {Hong Jae} and Lim, {Ho Yeong}",

note = "Funding Information: JC received research grants from Bayer and honoraria from Eisai. CY received research grants from Bayer, ONO pharmaceuticals, AstraZeneca, and Ipsen; honoraria from Bayer, ONO pharmaceuticals, AstraZeneca, Roche, BMS, MSD, Eisai, Ipsen, and AstraZeneca. HJC has a consulting or advisory role at Roche, Bayer, Eisai, ONO, BMS, and MSD. HYL received honoraria from Bayer, BMS, Ipsen, and Eisai; fees for advisory board participation from Bayer, BMS, Ipsen, Eisai, MSD, and Roche. The other authors have no potential conflicts of interest related to this article or the research described therein. Publisher Copyright: {\textcopyright} 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.",

year = "2022",

month = mar,

doi = "10.1111/liv.15102",

language = "English",

volume = "42",

pages = "674--681",

journal = "Liver International",

issn = "1478-3223",

publisher = "Wiley-Blackwell",

number = "3",

}

TY - JOUR

T1 - Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma

AU - Cheon, Jaekyung

AU - Yoo, Changhoon

AU - Hong, Jung Yong

AU - Kim, Han Sang

AU - Lee, Dae Won

AU - Lee, Myung Ah

AU - Kim, Jin Won

AU - Kim, Ilhwan

AU - Oh, Sang Bo

AU - Hwang, Jun Eul

AU - Chon, Hong Jae

AU - Lim, Ho Yeong

N1 - Funding Information: JC received research grants from Bayer and honoraria from Eisai. CY received research grants from Bayer, ONO pharmaceuticals, AstraZeneca, and Ipsen; honoraria from Bayer, ONO pharmaceuticals, AstraZeneca, Roche, BMS, MSD, Eisai, Ipsen, and AstraZeneca. HJC has a consulting or advisory role at Roche, Bayer, Eisai, ONO, BMS, and MSD. HYL received honoraria from Bayer, BMS, Ipsen, and Eisai; fees for advisory board participation from Bayer, BMS, Ipsen, Eisai, MSD, and Roche. The other authors have no potential conflicts of interest related to this article or the research described therein. Publisher Copyright: © 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

PY - 2022/3

Y1 - 2022/3

N2 - Background & Aims: Atezolizumab plus bevacizumab (Ate/Bev) has demonstrated efficacy and safety in patients with advanced hepatocellular carcinoma (HCC) in the phase III trial. Further evaluation is necessary to investigate the safety and efficacy of Ate/Bev in real settings. Methods: This was a multicentre retrospective analysis. Between May 2020 and February 2021, 138 patients received Ate/Bev as first-line treatment for advanced HCC from 11 institutions. We excluded patients with Child-Pugh B or C and BCLC D stage, and the remaining 121 patients were included in this analysis. Results: According to RECIST 1.1, the objective response and disease control rates were 24.0% and 76.0%. The median follow-up duration was 5.9 months (95% confidence interval [CI], 5.4-6.4), the median progression-free survival (PFS) was 6.5 months (95% CI, 4.1-9.0), and median overall survival (OS) was not reached (95% CI, not available). The most frequent grade 3-4 adverse event was aspartate aminotransferase elevation (10.7%). In the multivariate analyses, AFP increase (P =.037), baseline neutrophil-to-lymphocyte ratio (NLR) ≥ 5 (P =.023), and best response to stable disease or progressive disease (P =.019) were significantly associated with worse PFS. Macrovascular invasion (P =.048) and baseline NLR ≥5 (P <.001) were significantly associated with worse OS. Conclusions: Ate/Bev showed real-life efficacy and safety in Korean patients with advanced HCC, in line with results from phase III trial. Considering unfavourable survival outcomes of Ate/Bev in patients with elevated NLR, careful assessment of treatment response needs to be performed in this group.

AB - Background & Aims: Atezolizumab plus bevacizumab (Ate/Bev) has demonstrated efficacy and safety in patients with advanced hepatocellular carcinoma (HCC) in the phase III trial. Further evaluation is necessary to investigate the safety and efficacy of Ate/Bev in real settings. Methods: This was a multicentre retrospective analysis. Between May 2020 and February 2021, 138 patients received Ate/Bev as first-line treatment for advanced HCC from 11 institutions. We excluded patients with Child-Pugh B or C and BCLC D stage, and the remaining 121 patients were included in this analysis. Results: According to RECIST 1.1, the objective response and disease control rates were 24.0% and 76.0%. The median follow-up duration was 5.9 months (95% confidence interval [CI], 5.4-6.4), the median progression-free survival (PFS) was 6.5 months (95% CI, 4.1-9.0), and median overall survival (OS) was not reached (95% CI, not available). The most frequent grade 3-4 adverse event was aspartate aminotransferase elevation (10.7%). In the multivariate analyses, AFP increase (P =.037), baseline neutrophil-to-lymphocyte ratio (NLR) ≥ 5 (P =.023), and best response to stable disease or progressive disease (P =.019) were significantly associated with worse PFS. Macrovascular invasion (P =.048) and baseline NLR ≥5 (P <.001) were significantly associated with worse OS. Conclusions: Ate/Bev showed real-life efficacy and safety in Korean patients with advanced HCC, in line with results from phase III trial. Considering unfavourable survival outcomes of Ate/Bev in patients with elevated NLR, careful assessment of treatment response needs to be performed in this group.

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U2 - 10.1111/liv.15102

DO - 10.1111/liv.15102

M3 - Article

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EP - 681

JO - Liver International

JF - Liver International

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ER -

Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma

Abstract

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