Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial

The Lancet Oncology - Tập 19 Số 7 - Trang 940-952 - 2018
Andrew X. Zhu1,2, Richard S. Finn3, Julien Edeline4, Stéphane Cattan5, Sadahisa Ogasawara6, Daniel H. Palmer7, Chris Verslype8, Vittorina Zagonel9, Lætitia Fartoux10, Arndt Vogel11, Debashis Sarker12, Gontran Verset13, Stephen L. Chan14, Jennifer J. Knox15, Bruno Daniele16, Andrea L. Webber17, Scot Ebbinghaus17, Junshui Ma17, Abby B. Siegel17, Ann‐Lii Cheng18, Masatoshi Kudo19, Angela Alistar, Jamil Asselah, Jean–Frédéric Blanc, Ivan Borbath, Timothy Lewis Cannon, Ki Y. Chung, Allen Lee Cohn, David Cosgrove, Nevena Damjanov, Mukul Gupta, Yoshivasu Karino, Mark Karwal, Andreas Kaubisch, Robin Kate Kelley, Jena-Luc Van Laethem, Timothy Larson, James Lee, Daneng Li18, Atisha Manhas, Gulam A. Manji, Kazushi Numata, Benjamin M. Parsons, Andrew Scott Paulson, Carmine Pinto, Robert A. Ramirez, Suresh Ratnam, Magnus Rizell, Olivier Rosmorduc, Yvonne H. Sada6, Yutaka Sasaki, Per Stål, Simone I. Strasser, Jörg Trojan, Gina M. Vaccaro, Hans Van Vlierberghe, Alan Weiss, Karl-Heinz Weiss, Tatsuya Yamashita
1Department of Medicine, Harvard Medical School, Boston, MA USA
2Massachusetts General Hospital Cancer Center, Boston, MA, USA
3Department of Medicine, University of California Los Angeles, Los Angeles, CA, USA
4Department of Medical Oncology, Centre Eugène Marquis, Rennes, France
5Department of Medical Oncology and Gastroenterology, Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire de Lille, Lille, France
6Department of Gastroenterology, Graduate School of Medicine, Chiba University, Chiba, Japan
7Department of Medical Oncology, University of Liverpool, Liverpool, UK
8Department of Hepatology, University Hospital Gasthuisberg, Leuven, Leuven, Belgium
9Istituto Oncologico Veneto-Istituto di Ricovero e Cura a Carattere Scientifico (IOV-IRCCS), Padua, Italy
10Department of Gastroenterology and Hepatology, Hôpital Universitaire Pitié-Salpêtrière, Paris, France
11Department of Gastroenterology, Hepatology and Endocrinology, Medizinische Hochschule Hannover, Germany
12Department of Medical Oncology, King's College Hospital, London, UK
13Gastrointestinal Oncology Unit, Hôpital Erasme, Brussels, Belgium
14Department of Clinical Oncology, State Key Laboratory of Oncology in South China, The Chinese University of Hong Kong, Shatin, Hong Kong
15Department of Medical Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada
16Department of Oncology, Azienda Ospedaliera Gaetano Rummo, Benevento, Italy
17Department of Global Clinical Development, Merck & Co, Kenilworth, NJ, USA
18Department of Medical Oncology, National Taiwan University Hospital, Taipei, Taiwan
19Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osaka, Japan

Tóm tắt

Từ khóa


Tài liệu tham khảo

Llovet, 2015, Advances in targeted therapies for hepatocellular carcinoma in the genomic era, Nat Rev Clin Oncol, 12, 408, 10.1038/nrclinonc.2015.103

Ringelhan, 2018, The immunology of hepatocellular carcinoma, Nat Immunol, 19, 222, 10.1038/s41590-018-0044-z

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

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

Kudo, 2017, Systemic therapy for hepatocellular carcinoma: 2017 update, Oncology, 93, 135, 10.1159/000481244

Bruix, 2017, Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial, Lancet, 389, 56, 10.1016/S0140-6736(16)32453-9

Abou-Alfa, 2018, Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: results from the randomized phase III CELESTIAL trial, Proc Am Soc Clin Oncol, 36, 207, 10.1200/JCO.2018.36.4_suppl.207

Prieto, 2015, Immunological landscape and immunotherapy of hepatocellular carcinoma, Nat Rev Gastroenterol Hepatol, 12, 681, 10.1038/nrgastro.2015.173

Hoshida, 2008, Gene expression in fixed tissues and outcome in hepatocellular carcinoma, N Engl J Med, 359, 1995, 10.1056/NEJMoa0804525

Gao, 2009, Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma, Clin Cancer Res, 15, 971, 10.1158/1078-0432.CCR-08-1608

Shi, 2011, PD-1 and PD-L1 upregulation promotes CD8(+) T-cell apoptosis and postoperative recurrence in hepatocellular carcinoma patients, Int J Cancer, 128, 887, 10.1002/ijc.25397

Zheng, 2017, Landscape of infiltrating T cells in liver cancer revealed by single-cell sequencing, Cell, 169, 1342, 10.1016/j.cell.2017.05.035

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

Sharma, 2015, The future of immune checkpoint therapy, Science, 348, 56, 10.1126/science.aaa8172

Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026

Nishino, 2013, Developing a common language for tumor response to immunotherapy: immune-related response criteria using unidimensional measurements, Clin Cancer Res, 19, 3936, 10.1158/1078-0432.CCR-13-0895

Dolled-Filhart, 2016, Development of a companion diagnostic for pembrolizumab in non-small cell lung cancer using immunohistochemistry for programmed death ligand-1, Arch Pathol Lab Med, 140, 1243, 10.5858/arpa.2015-0542-OA

Kulangara K, Zhang N, Corigliano E, et al. Clinical utility of the combined positive score for programmed death ligand 1 expression and the approval of pembrolizumab in gastric cancer. Arch Pathol Lab Med (in press).

Lencioni, 2010, Modified RECIST (mRECIST) assessment for hepatocellular carcinoma, Semin Liver Dis, 30, 52, 10.1055/s-0030-1247132

Clopper, 1934, The use of confidence or fiducial limits illustrated in the case of binomial, Biometrika, 26, 404, 10.1093/biomet/26.4.404

Sangro, 2013, A clinical trial of CTLA-4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C, J Hepatol, 59, 81, 10.1016/j.jhep.2013.02.022

Kelley, 2017, Phase I/II study of durvalumab and tremelimumab in patients with unresectable hepatocellular carcinoma (HCC): phase I safety and efficacy analyses, Proc Am Soc Clin Oncol, 35, 4073, 10.1200/JCO.2017.35.15_suppl.4073

Le, 2015, PD-1 blockade in tumors with mismatch-repair deficiency, N Engl J Med, 372, 2509, 10.1056/NEJMoa1500596

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

Wainberg, 2017, KEYNOTE-059 update: efficacy and safety of pembrolizumab alone or in combination with chemotherapy in patients with advanced gastric or gastroesophageal (G/GEJ) cancer, Ann Oncol, 28

Carbognin, 2015, Differential activity of nivolumab, pembrolizumab and MPDL3280A according to the tumor expression of programmed death-ligand-1 (PD-L1): sensitivity analysis of trials in melanoma, lung and genitourinary cancers, PLoS One, 10, e0130142, 10.1371/journal.pone.0130142

Garon, 2015, Pembrolizumab for the treatment of non-small-cell lung cancer, N Engl J Med, 372, 2018, 10.1056/NEJMoa1501824

Overman, 2017, Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study, Lancet Oncol, 18, 1182, 10.1016/S1470-2045(17)30422-9

Thông tin
Thông tin xuất bản

The Lancet Oncology

Tập 19 Số 7

940-952

Thông tin tác giả