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Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma: Phase 3 Randomized, Open-Label IMbrave150 Study.

作者信息

Qin Shukui, Ren Zhenggang, Feng Yin-Hsun, Yau Thomas, Wang Baocheng, Zhao Haitao, Bai Yuxian, Gu Shanzhi, Li Lindong, Hernandez Sairy, Xu Derek-Zhen, Mulla Sohail, Wang Yifan, Shao Hui, Cheng Ann Lii

机构信息

People's Liberation Army Cancer Center, Jinling Hospital, Nanjing, China.

Liver Cancer Institute and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.

出版信息

Liver Cancer. 2021 Jul;10(4):296-308. doi: 10.1159/000513486. Epub 2021 Apr 23.


DOI:10.1159/000513486
PMID:34414118
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8339481/
Abstract

INTRODUCTION: Atezolizumab plus bevacizumab significantly improved overall survival (OS) and progression-free survival (PFS) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in IMbrave150. Efficacy and safety data from the Chinese subpopulation are reported. METHODS: IMbrave150, a global, randomized, open-label, phase 3 study in patients with systemic treatment-naive unresectable HCC, included an extension phase that enrolled additional patients from mainland China. Patients were randomized (2:1) to receive intravenous atezolizumab 1,200 mg plus bevacizumab 15 mg/kg once every 3 weeks or sorafenib 400 mg twice a day until unacceptable toxicity or loss of clinical benefit. Co-primary endpoints were OS and independent review facility-assessed PFS per Response Evaluation Criteria in Solid Tumors version 1.1 in the intention-to-treat population. RESULTS: Of 194 Chinese patients enrolled from April 16, 2018, to April 8, 2019 (137 in the global study and 57 in the China extension phase), 133 received atezolizumab plus bevacizumab and 61 received sorafenib. At the data cutoff (August 29, 2019), the stratified hazard ratio for OS was 0.44 (95% CI, 0.25-0.76) and for PFS was 0.60 (95% CI, 0.40-0.90). The respective median OS and PFS with atezolizumab plus bevacizumab were not reached (NR; 95% CI, 13.5 months to NR) and 5.7 months (95% CI, 4.2-8.3) versus 11.4 months (95% CI, 6.7 to NR) and 3.2 months (95% CI, 2.6-4.8) with sorafenib. Grade 3-4 adverse events (AEs) occurred in 78 of 132 (59.1%) atezolizumab plus bevacizumab-treated and 27 of 58 (46.6%) sorafenib-treated patients. The most common grade 3-4 AE with atezolizumab plus bevacizumab was hypertension, occurring in 15.2% of patients; however, other high-grade AEs were infrequent. CONCLUSION: Clinically meaningful improvements in OS and PFS observed with atezolizumab plus bevacizumab versus sorafenib suggest that atezolizumab plus bevacizumab may become a practice-changing treatment for Chinese patients with unresectable HCC.

摘要

相似文献

[1]
Atezolizumab plus Bevacizumab versus Sorafenib in the Chinese Subpopulation with Unresectable Hepatocellular Carcinoma: Phase 3 Randomized, Open-Label IMbrave150 Study.

Liver Cancer. 2021-7

[2]
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J Hepatol. 2022-4

[3]
Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial.

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[4]
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[5]
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[6]
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[8]
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本文引用的文献

[1]
Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.

Lancet Oncol. 2020-6

[2]
Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma.

N Engl J Med. 2020-5-14

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Comparison of clinical features and outcomes between HBV-related and non-B non-C hepatocellular carcinoma.

Infect Agent Cancer. 2020-2-14

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Comparison of the current international guidelines on the management of HCC.

JHEP Rep. 2019-5-28

[5]
Pembrolizumab As Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240: A Randomized, Double-Blind, Phase III Trial.

J Clin Oncol. 2019-12-2

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J Hematol Oncol. 2019-9-5

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Nat Rev Gastroenterol Hepatol. 2019-8-22

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N Engl J Med. 2019-4-11

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Liver cancer incidence and mortality in China: Temporal trends and projections to 2030.

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