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Abstract Details |
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Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial |
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Lancet. 2023 Nov 18;402(10415):1835-1847.doi: 10.1016/S0140-6736(23)01796-8. Epub 2023 Oct 20.
Shukui Qin 1, Minshan Chen 2, Ann-Lii Cheng 3, Ahmed O Kaseb 4, Masatoshi Kudo 5, Han Chu Lee 6, Adam C Yopp 7, Jian Zhou 8, Lu Wang 9, Xiaoyu Wen 10, Jeong Heo 11, Won Young Tak 12, Shinichiro Nakamura 13, Kazushi Numata 14, Thomas Uguen 15, David Hsiehchen 16, Edward Cha 17, Stephen P Hack 17, Qinshu Lian 17, Ning Ma 17, Jessica H Spahn 17, Yulei Wang 18, Chun Wu 19, Pierce K H Chow 20; IMbrave050 investigators
IMbrave050 investigators:
Alexander Thompson, Mark Danta, Pirooz Poursoltan, Andrew Kiberu, Renuka Chittajallu, Siddarth Sood, Rudolf Stauber, Matthias Pinter, Markus Peck-Radosavljevic, Jochen Decaestecker, Pieter-Jan Cuyle, Gontran Verset, Hans Van Vlierberghe, Sergio De Azevedo, Livia Andrade, Ademar Cunha Júnior, Luiza Faria, Cheng Tzu Yen, Leandro Colli, Jamil Asselah, Petr Kavan, Vladimir Marquez, Mayur Brahmania, Qiang Li, Baocai Xing, Yabing Guo, Zhendong Chen, Haitao Zhao, Tao Peng, Liming Wang, Lu Wang, Hongming Liu, Feixiang Wu, Lunxiu Qin, Qichang Zheng, Jieer Ying, Haitao Li, Tianfu Wen, Shukui Qin, Xiaoyu Wen, Yunpeng Liu, Minshan Chen, Boqing Wang, Yuxian Bai, Yifu He, Hong Zhao, Dong Zhou, Chaoliu Dai, Gaojun Teng, Shuzhong Cui, Yi Gao, Xizhi Zhang, Zheng Lu, Tao Yin, Youming Ding, Weidong Jia, Yongxiang Xia, Beicheng Sun, Qiang Xia, Yufeng Yuan, Huichuan Sun, Xuetao Shi, Adrián Guzmán, Luis Corrales, Zdenek Kral, Peter Priester, Eugen Kubala, Jean Frederic Blanc, Marc Bourliere, Jean Marie Peron, Christophe Borg, Jean-Pierre Bronowicki, Nathalie Ganne, Thomas Decaens, Thomas Uguen, Alexandra Heurgue, Joerg Trojan, Maria Angeles Gonzalez-Carmona, Christoph Roderburg, Thomas Ettrich, Clemens Schotten, Arne Kandulski, Thomas Yau, Lam Chan, Mario Scartozzi, Gianluca Masi, Silvia Fanello, Pier Maria Battezzati, Francesco Leonardi, Michele Ghidini, Kazushi Numata, Manabu Morimoto, Hisashi Hidaka, Kaoru Tsuchiya, Tatsuya Yamashita, Naoya Kato, Masatoshi Kudo, Atsushi Hagihara, Hironori Koga, Tomohiro Arakawa, Ikuo Nakamura, Yusuke Kawamura, Tomokazu Kawaoka, Mitsuo Shimada, Kiyoshi Hasegawa, Hiroyuki Marusawa, Shinchiro Nakamura, Atsushi Hiraoka, Hiromitsu Hayashi, Shin Takeda, Han Chu Lee, Seung Woon Paik, Do Young Kim, Jung Il Lee, Sook-Hyang Jeong, Won Kim, Won Young Tak, Jeong Heo, Hyeyeong Kim, Hong Jae Chon, Jaeyoun Cheong, Seung Kew Yoon, Jung-Hwan Yoon, Ricardo Villalobos, Jorge Luis Martinez Rodriguez, Victor Oyervides Juarez, Carlos Alberto Hernández, Heinz-Josef Klumpen, Judith de Vos-Geelen, Edward Gane, < |
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Author information
1Jinling Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
2Sun Yat-sen University Cancer Center, Guangzhou, China.
3National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan.
4The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
5Kindai University, Osaka, Japan.
6Department of Gastroenterology, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
7Department of Surgery, Division of Surgical Oncology, The University of Texas Southwestern Medical Center, Dallas, TX, USA.
8Zhongshan Hospital, Fudan University, Shanghai, China.
9Fudan University Shanghai Cancer Center, Shanghai, China.
101st Hospital of Jilin University, Jilin, China.
11College of Medicine, Pusan National University and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
12Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
13Himeji Red Cross Hospital, Hyogo, Japan.
14Yokohama City University Medical Center, Yokohama, Japan.
15Hôpital de Pontchaillou, Rennes, France.
16Department of Internal Medicine, Division of Hematology and Oncology, The University of Texas Southwestern Medical Center, Dallas, TX, USA.
17Genentech, South San Francisco, CA, USA.
18Fudan University Shanghai Cancer Center, Shanghai, China; Genentech, South San Francisco, CA, USA.
19Roche (China) Holding, Shanghai, China.
20National Cancer Centre Singapore, Singapore; Duke-NUS Medical School, Singapore. Electronic address: pierce.chow@duke-nus.edu.sg.
Abstract
Background: No adjuvant treatment has been established for patients who remain at high risk for hepatocellular carcinoma recurrence after curative-intent resection or ablation. We aimed to assess the efficacy of adjuvant atezolizumab plus bevacizumab versus active surveillance in patients with high-risk hepatocellular carcinoma.
Methods: In the global, open-label, phase 3 IMbrave050 study, adult patients with high-risk surgically resected or ablated hepatocellular carcinoma were recruited from 134 hospitals and medical centres in 26 countries in four WHO regions (European region, region of the Americas, South-East Asia region, and Western Pacific region). Patients were randomly assigned in a 1:1 ratio via an interactive voice-web response system using permuted blocks, using a block size of 4, to receive intravenous 1200 mg atezolizumab plus 15 mg/kg bevacizumab every 3 weeks for 17 cycles (12 months) or to active surveillance. The primary endpoint was recurrence-free survival by independent review facility assessment in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT04102098.
Findings: The intention-to-treat population included 668 patients randomly assigned between Dec 31, 2019, and Nov 25, 2021, to either atezolizumab plus bevacizumab (n=334) or to active surveillance (n=334). At the prespecified interim analysis (Oct 21, 2022), median duration of follow-up was 17·4 months (IQR 13·9-22·1). Adjuvant atezolizumab plus bevacizumab was associated with significantly improved recurrence-free survival (median, not evaluable [NE]; [95% CI 22·1-NE]) compared with active surveillance (median, NE [21·4-NE]; hazard ratio, 0·72 [adjusted 95% CI 0·53-0·98]; p=0·012). Grade 3 or 4 adverse events occurred in 136 (41%) of 332 patients who received atezolizumab plus bevacizumab and 44 (13%) of 330 patients in the active surveillance group. Grade 5 adverse events occurred in six patients (2%, two of which were treatment related) in the atezolizumab plus bevacizumab group, and one patient (<1%) in the active surveillance group. Both atezolizumab and bevacizumab were discontinued because of adverse events in 29 patients (9%) who received atezolizumab plus bevacizumab.
Interpretation: Among patients at high risk of hepatocellular carcinoma recurrence following curative-intent resection or ablation, recurrence-free survival was improved in those who received atezolizumab plus bevacizumab versus active surveillance. To our knowledge, IMbrave050 is the first phase 3 study of adjuvant treatment for hepatocellular carcinoma to report positive results. However, longer follow-up for both recurrence-free and overall survival is needed to assess the benefit-risk profile more fully.
Funding: F Hoffmann-La Roche/Genentech.
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