Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2–3 study

The Lancet Oncology - Tập 22 Số 7 - Trang 977-990 - 2021
Zhenggang Ren1,2, Jianming Xu3, Yuxian Bai4, Aibing Xu5, Shundong Cang6, Chengyou Du7, Qiu Li8, Yinying Lu9, Yajin Chen10, Yabing Guo11, Zhendong Chen12, Baorui Liu13, Weidong Jia14, Jian Wu15, Junye Wang16, Guoliang Shao17, Bixiang Zhang18, Yunfeng Shan19, Zhiqiang Meng20, Jianbing Wu21, Shanzhi Gu22, Wei Yang23, Chao Liu24, Lei Zhao25, Zhenyuan Gao26, Tao Yin27, Jiuwei Cui28, Ming Huang29, Lijun Wang30, Yilei Mao31, Gao‐Jun Teng32, Yan‐Ru Qin33, Jinhai Wang34, Feng Xia35, Guowen Yin36, Yong Yang37, Mingxia Chen38, Yan Wang37, Hui Zhou37, Jia Fan39,2
1Department of Hepatic Oncology, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China
2Key Laboratory of Carcinogenesis and Cancer Invasion, Ministry of Education, Shanghai, China
3Digestive Oncology Department, The Fifth Medical Centre of PLA General Hospital, Beijing, China
4Department of Internal Medicine, Harbin Medical University Cancer Hospital, Harbin, China
5Department of Oncological Internal Medicine, Nantong Tumour Hospital, Nantong, China
6Department of Internal Medicine—Oncology, Henan Provincial People's Hospital, Zhengzhou, China
7Department of Hepatobiliary Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China
8Abdominal Tumour Department, West China Hospital, Sichuan University, Chengdu, China
9Treatment and Research Centre for Liver Cancer Department 2, The Fifth Medical Centre of PLA General Hospital, Beijing, China
10Department of Hepatobiliary Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
11Department of Tumours of Liver, Nan Fang Hospital, Guangzhou, China
12Oncology Department, The Second Hospital of Anhui Medical University, Hefei, China
13Department of Oncology, Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing, China
14General Surgery Department, Anhui Provincial Hospital, Hefei, China
15Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University, Hangzhou, China
16Department of Oncology, Affiliated Hospital of Jining Medical University, Jining, China
17Department of Interventional Therapy, Zhejiang Cancer Hospital, Hangzhou, China
18Department of Hepatobiliary Surgery, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China
19Department of Hepatobiliary Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
20Department of Traditional Chinese Medicine/Integrative Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China
21Oncology Department, The Second Affiliated Hospital of Nanchang University, Nanchang, China
22Radioactive Interventional Department, Hunan Cancer Hospital, Changsha, China
23Department of Hepatobiliary Surgery, The First Affiliated Hospital of Xi’an Jiao Tong University, Xi’an, China
24Department of Pancreaticobiliary Surgery, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
25Department of Hepatobiliary Surgery, Shandong Cancer Hospital, Jinan, China
26Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China
27Department of Hepatobiliary Surgery, Hubei Cancer Hospital, Wuhan, China
28Oncology Department, Bethune First Hospital of Jilin University, Changchun, China
29Department of Minimally Invasive Interventional Medicine, Yunnan Cancer Hospital, Kunming, China
30Hepatobiliary Pancreatic Surgery 1, Beijing Cancer Hospital, Beijing, China
31Live Surgery Ward, Peking Union Medical College Hospital, Beijing, China
32Radiology Department, Zhongda Hospital Southeast University, Nanjing, China
33Department of Internal Medicine Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
34Department of Gastroenterology, The Second Affiliated Hospital of Xi'an Jiao Tong University, Xi'an, China
35Department of Hepatobiliary Surgery, The First Hospital Affiliated to AMU (Southwest Hospital), Chongqing, China
36Intervention Department, Jiangsu Cancer Hospital, Nanjing, China
37Department of Medical Science and Strategy Oncology, Innovent Biologics, Suzhou, China
38Department of Biostatistics and Information, Innovent Biologics, Suzhou, China
39Department of Liver Surgery & Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China

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Tài liệu tham khảo

Bray, 2018, Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, CA Cancer J Clin, 68, 394, 10.3322/caac.21492

Chen, 2016, Cancer statistics in China, 2015, CA Cancer J Clin, 66, 115, 10.3322/caac.21338

Llovet, 2008, Sorafenib in advanced hepatocellular carcinoma, N Engl J Med, 359, 378, 10.1056/NEJMoa0708857

Kudo, 2018, Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial, Lancet, 391, 1163, 10.1016/S0140-6736(18)30207-1

Cheng, 2009, Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial, Lancet Oncol, 10, 25, 10.1016/S1470-2045(08)70285-7

Kato, 2019, Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial, Lancet Oncol, 20, 1506, 10.1016/S1470-2045(19)30626-6

Reck, 2016, Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer, N Engl J Med, 375, 1823, 10.1056/NEJMoa1606774

El-Khoueiry, 2017, Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial, Lancet, 389, 2492, 10.1016/S0140-6736(17)31046-2

Zhu, 2018, Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial, Lancet Oncol, 19, 940, 10.1016/S1470-2045(18)30351-6

Yau, 2020, Efficacy and safety of nivolumab plus ipilimumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib: the CheckMate 040 randomized clinical trial, JAMA Oncol, 6, 10.1001/jamaoncol.2020.4564

Yau, 2019, LBA38_PR-CheckMate 459: a randomized, multi-center phase III study of nivolumab (NIVO) vs sorafenib (SOR) as first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC), Ann Oncol, 30, 874, 10.1093/annonc/mdz394.029

Finn, 2020, Pembrolizumab as second-line therapy in patients with advanced hepatocellular carcinoma in KEYNOTE-240: a randomized, double-blind, phase III trial, J Clin Oncol, 38, 193, 10.1200/JCO.19.01307

Voron, 2015, VEGF-A modulates expression of inhibitory checkpoints on CD8+ T cells in tumors, J Exp Med, 212, 139, 10.1084/jem.20140559

Hegde, 2018, Predictive markers of anti-VEGF and emerging role of angiogenesis inhibitors as immunotherapeutics, Semin Cancer Biol, 52, 117, 10.1016/j.semcancer.2017.12.002

Finn, 2020, Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma, N Engl J Med, 382, 1894, 10.1056/NEJMoa1915745

Duan, 2020, Use of immunotherapy with programmed cell death 1 vs programmed cell death ligand 1 inhibitors in patients with cancer: a systematic review and meta-analysis, JAMA Oncol, 6, 375, 10.1001/jamaoncol.2019.5367

Gao, 2020, Neoadjuvant PD-1 inhibitor (sintilimab) in NSCLC, J Thorac Oncol, 15, 816, 10.1016/j.jtho.2020.01.017

Yang, 2020, Efficacy and safety of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous NSCLC: a randomized, double-blind, phase 3 study (Oncology pRogram by InnovENT anti-PD-1-11), J Thorac Oncol, 15, 1636, 10.1016/j.jtho.2020.07.014

Zhang, 2020, Preliminary results of sintilimab plus different dose of IBI305 (anti-VEGF monoclonal antibody) in patients with advanced hepatocellular carcinoma: a phase Ib study, Proc Am Soc Clin Oncol, 38

Shi, 2019, Safety and activity of sintilimab in patients with relapsed or refractory classical Hodgkin lymphoma (ORIENT-1): a multicentre, single-arm, phase 2 trial, Lancet Haematol, 6, e12, 10.1016/S2352-3026(18)30192-3

Yang, 2019, Biosimilar candidate IBI305 plus paclitaxel/carboplatin for the treatment of non-squamous non-small cell lung cancer, Transl Lung Cancer Res, 8, 989, 10.21037/tlcr.2019.12.23

Pishvaian, 2018, Updated safety and clinical activity results from a phase Ib study of atezolizumab + bevacizumab in hepatocellular carcinoma (HCC), Ann Oncol, 29, 10.1093/annonc/mdy424.028

Finn, 2021, IMbrave150: updated overall survival (OS) data from a global, randomized, open-label phase III study of atezolizumab (atezo)+ bevacizumab (bev) versus sorafenib (sor) in patients (pts) with unresectable hepatocellular carcinoma (HCC), Proc Am Soc Clin Oncol, 39, 267, 10.1200/JCO.2021.39.3_suppl.267

Kudo, 2019, Checkmate-040: nivolumab (NIVO) in patients (pts) with advanced hepatocellular carcinoma (aHCC) and Child-Pugh B (CPB) status, Proc Am Soc Clin Oncol, 37, 327, 10.1200/JCO.2019.37.4_suppl.327

Siegel, 2008, Phase II trial evaluating the clinical and biologic effects of bevacizumab in unresectable hepatocellular carcinoma, J Clin Oncol, 26, 2992, 10.1200/JCO.2007.15.9947

Mok, 2019, Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial, Lancet, 393, 1819, 10.1016/S0140-6736(18)32409-7

Rini, 2019, Atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (IMmotion151): a multicentre, open-label, phase 3, randomised controlled trial, Lancet, 393, 2404, 10.1016/S0140-6736(19)30723-8

Feun, 2019, Phase 2 study of pembrolizumab and circulating biomarkers to predict anticancer response in advanced, unresectable hepatocellular carcinoma, Cancer, 125, 3603, 10.1002/cncr.32339

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The Lancet Oncology

Tập 22 Số 7

977-990

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