Randomized Phase II Trial of Onartuzumab in Combination With Erlotinib in Patients With Advanced Non–Small-Cell Lung Cancer
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- David R. Spigel
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Thomas J. Ervin
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Rodryg A. Ramlau
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Davey B. Daniel
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Jerome H. Goldschmidt
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- George R. Blumenschein
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Maciej J. Krzakowski
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Gilles Robinet
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Benoit Godbert
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Fabrice Barlesi
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Ramaswamy Govindan
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Taral Patel
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Sergey V. Orlov
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Michael S. Wertheim
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Wei Yu
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Jiping Zha
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Robert L. Yauch
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Premal H. Patel
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- See-Chun Phan
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
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- Amy C. Peterson
- David R. Spigel, Thomas J. Ervin, and Davey B. Daniel, Sarah Cannon Research Institute; David R. Spigel, Tennessee Oncology, Nashville; Davey B. Daniel, Chattanooga Oncology Hematology Associates, Chattanooga, TN; Thomas J. Ervin, Florida Cancer Specialists, Fort Myers; Michael S. Wertheim, Hematology/Oncology Associates, Port St Lucie, FL; Rodryg A. Ramlau, Poznan University of Medical Sciences, Poznan; Maciej J. Krzakowski, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw...
説明
<jats:sec><jats:title>Purpose</jats:title><jats:p> Increased hepatocyte growth factor/MET signaling is associated with poor prognosis and acquired resistance to epidermal growth factor receptor (EGFR) –targeted drugs in patients with non–small-cell lung cancer (NSCLC). We investigated whether dual inhibition of MET/EGFR results in clinical benefit in patients with NSCLC. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients with recurrent NSCLC were randomly assigned at a ratio of one to one to receive onartuzumab plus erlotinib or placebo plus erlotinib; crossover was allowed at progression. Tumor tissue was required to assess MET status by immunohistochemistry (IHC). Coprimary end points were progression-free survival (PFS) in the intent-to-treat (ITT) and MET-positive (MET IHC diagnostic positive) populations; additional end points included overall survival (OS), objective response rate, and safety. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> There was no improvement in PFS or OS in the ITT population (n = 137; PFS hazard ratio [HR], 1.09; P = .69; OS HR, 0.80; P = .34). MET-positive patients (n = 66) treated with erlotinib plus onartuzumab showed improvement in both PFS (HR, .53; P = .04) and OS (HR, .37; P = .002). Conversely, clinical outcomes were worse in MET-negative patients treated with onartuzumab plus erlotinib (n = 62; PFS HR, 1.82; P = .05; OS HR, 1.78; P = .16). MET-positive control patients had worse outcomes versus MET-negative control patients (n = 62; PFS HR, 1.71; P = .06; OS HR, 2.61; P = .004). Incidence of peripheral edema was increased in onartuzumab-treated patients. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Onartuzumab plus erlotinib was associated with improved PFS and OS in the MET-positive population. These results combined with the worse outcomes observed in MET-negative patients treated with onartuzumab highlight the importance of diagnostic testing in drug development. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 31 (32), 4105-4114, 2013-11-10
American Society of Clinical Oncology (ASCO)