Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial

The Lancet - Tập 383 Số 9911 - Trang 31-39 - 2014
Charles S. Fuchs1, Jiří Tomášek2, Jae Yong Cho3, Filip Dumitru4, Rodolfo Passalacqua5, Chanchal Goswami6, Howard Safran7, Lucas Vieira dos Santos8, Giuseppe Aprile9, David Ferry10, Bohuslav Melichar11, Mustapha Tehfé12, Э. Э. Топузов13, John Zalcberg14,15, Ian Chau16, William Campbell17, Choondal Devan Sivanandan18, Joanna Pikiel19, Minori Koshiji20, Yanzhi Hsu20, Astra M. Liepa21, Ling Gao20, Jonathan D. Schwartz20, Josep Tabernero22
1Department of Medical Oncology, Dana-Farber Cancer Institute/Harvard Medical School, Boston, MA, USA
2Department of Complex Oncology Care, Masaryk Memorial Cancer Institute, Brno, Czech Republic
3Department of Medical Oncology, Yonsei University College of Medicine, Gangnam Severance Hospital, Seoul, Korea
4Oncology Department, Emergency County Hospital “Dr Constantin Opris”, Baia Mare, Romania
5Medical Oncology Division, Istituti Ospitalieri di Cremona, Cremona, Italy
6Department of Medical Oncology, B P Poddar Hospital and Medical Research, Kolkata, West Bengal
7Department of Medicine, The Brown University Oncology Group, Brown University, Providence, RI, USA
8Medical Oncology Department, Gastrointestinal Oncology Division, Hospital de Câncer de Barretos and Hemomed Instituto de Oncologia e Hematologia, São Paulo, Brazil
9Department of Oncology, University and General Hospital, Udine, Italy
10Department of Medical Oncology, New Cross Hospital, West Midlands, UK.
11Department of Oncology, Palacky University Medical School and Teaching Hospital, Olomouc, CzechRepublic.
12Department of Medical Oncology, Hôpital Notre Dame de CHUM, Montreal, Quebec
13State Budgetary Educational Institution of Higher Professional Education (SBEIHPE), “Northwest State Medical University na II Mechnikov”, Ministry of Healthcare of the Russian Federation, Russia
14Departments of Medicine and Oncology, Faculty of Medicine, University of Melbourne, Australia
15Division of Cancer Medicine, Peter McCallum Cancer Centre, East Melbourne, VIC, Australia
16Department of Medicine, Royal Marsden Hospital, London and Surrey, England.
17Department of Oncology, Hospital Herrera Llerandi-Clinicas Médicas, Guatemala
18Division of Cancer Research, Regional Cancer Centre, Kerala, India
19Wojewódzkie Centrum Onkologii, Gdańsk, Poland
20ImClone Systems LLC, Bridgewater, NJ, USA
21Eli Lilly, Indianapolis, IN, USA
22Medical Oncology Department Vall d'Hebron University Hospital, UniversitatAutònoma de Barcelona, Barcelona, Spain

Tóm tắt

Từ khóa


Tài liệu tham khảo

Jemal, 2011, Global cancer statistics, CA Cancer J Clin, 61, 69, 10.3322/caac.20107

Wagner, 2010, Chemotherapy for advanced gastric cancer, Cochrane Database Syst Rev, 3, 10.1002/14651858.CD004064.pub3

Jung, 2002, Effects of combination anti-vascular endothelial growth factor receptor and anti-epidermal growth factor receptor therapies on the growth of gastric cancer in a nude mouse model, Eur J Cancer, 38, 1133, 10.1016/S0959-8049(02)00013-8

Kim, 2009, The clinicopathological significance of tissue levels of hypoxia-inducible factor-1alpha and vascular endothelial growth factor in gastric cancer, Gut Liver, 3, 88, 10.5009/gnl.2009.3.2.88

Lieto, 2008, Expression of vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR) is an independent prognostic indicator of worse outcome in gastric cancer patients, Ann Surg Oncol, 15, 69, 10.1245/s10434-007-9596-0

Song, 2002, Relationship between the expression of iNOS, VEGF, tumor angiogenesis and gastric cancer, World J Gastroenterol, 8, 591, 10.3748/wjg.v8.i4.591

Cabuk, 2007, Vascular endothelial growth factor, hypoxia-inducible factor 1 alpha and CD34 expressions in early-stage gastric tumors: relationship with pathological factors and prognostic impact on survival, Oncology, 72, 111, 10.1159/000111118

Juttner, 2006, Vascular endothelial growth factor-D and its receptor VEGFR-3: two novel independent prognostic markers in gastric adenocarcinoma, J Clin Oncol, 24, 228, 10.1200/JCO.2004.00.3467

Murukesh, 2010, Biomarkers of angiogenesis and their role in the development of VEGF inhibitors, Br J Cancer, 102, 8, 10.1038/sj.bjc.6605483

Oh, 2008, Clinicopathologic significance of HIF-1alpha, p53, and VEGF expression and preoperative serum VEGF level in gastric cancer, BMC Cancer, 8, 123, 10.1186/1471-2407-8-123

Okines, 2011, Targeting angiogenesis in esophagogastric adenocarcinoma, Oncologist, 16, 844, 10.1634/theoncologist.2010-0387

Suzuki, 2010, Clinicopathological significance of platelet-derived growth factor (PDGF)-B and vascular endothelial growth factor-A expression, PDGF receptor-β phosphorylation, and microvessel density in gastric cancer, BMC Cancer, 10, 659, 10.1186/1471-2407-10-659

Zhao, 2006, Microvessel density is a prognostic marker of human gastric cancer, World J Gastroenterol, 12, 7598, 10.3748/wjg.v12.i47.7598

Spratlin, 2010, Phase I pharmacologic and biologic study of ramucirumab (IMC-1121B), a fully human immunoglobulin G1 monoclonal antibody targeting the vascular endothelial growth factor receptor-2, J Clin Oncol, 28, 780, 10.1200/JCO.2009.23.7537

Therasse, 2000, New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada, J Natl Cancer Inst, 92, 205, 10.1093/jnci/92.3.205

Aaronson, 1993, The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology, J Natl Cancer Inst, 85, 365, 10.1093/jnci/85.5.365

DeMets, 1982, Asymmetric group sequential boundaries for monitoring clinical trials, Biometrika, 69, 661, 10.1093/biomet/69.3.661

Osoba, 1998, Interpreting the significance of changes in health-related quality-of-life scores, J Clin Oncol, 16, 139, 10.1200/JCO.1998.16.1.139

Carmeliet, 2000, Angiogenesis in cancer and other diseases, Nature, 407, 249, 10.1038/35025220

Kang, 2012, Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone, J Clin Oncol, 30, 1513, 10.1200/JCO.2011.39.4585

Ford H, Marshall A, Wadsley J, et al. Cougar-02: a randomized phase III study of docetaxel versus active symptom control in advanced esophagogastric adenocarcinoma. 10th Annual Gastrointestinal Cancer Symposium; San Francisco, CA; Jan 24–26, 2013. LBA4.

Thuss-Patience, 2011, Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer—a randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO), Eur J Cancer, 47, 2306, 10.1016/j.ejca.2011.06.002

Ohtsu, 2011, Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study, J Clin Oncol, 29, 3968, 10.1200/JCO.2011.36.2236

Bang, 2010, Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial, Lancet, 376, 687, 10.1016/S0140-6736(10)61121-X

Blumenschein, 2012, Targeting the hepatocyte growth factor-cMET axis in cancer therapy, J Clin Oncol, 30, 3287, 10.1200/JCO.2011.40.3774

Li, 2011, Insulin-like growth factor-I receptor blockade reduces tumor angiogenesis and enhances the effects of bevacizumab for a human gastric cancer cell line, MKN45, Cancer, 117, 3135, 10.1002/cncr.25893

Paterson, 2013, A systematic approach to therapeutic target selection in oesophago-gastric cancer, Gut, 62, 1415, 10.1136/gutjnl-2012-302039

Seto, 2009, Regulation of the hedgehog signaling by the mitogen-activated protein kinase cascade in gastric cancer, Mol Carcinog, 48, 703, 10.1002/mc.20516

Song, 2011, Sonic hedgehog pathway is essential for maintenance of cancer stem-like cells in human gastric cancer, PloS One, 6, e17687, 10.1371/journal.pone.0017687

Waddell, 2012, A randomized, multicenter trial of epirubicin, oxaliplatin, and capecitabine (EOC) plus panitumumab in advanced esophagogastric cancer (REAL3), J Clin Oncol, 30, LBA4000, 10.1200/jco.2012.30.18_suppl.lba4000