Multicenter phase 2 trial of nintedanib in advanced nonpancreatic neuroendocrine tumors
Autor: | Sheryl-Ann Suffren, Chong Wang, Diane Reidy-Lagunes, Hans Minderman, Danielle Casucci, Manisha H. Shah, Karen A. Hicks, Kristopher Attwood, Sarbajit Mukherjee, Robert R. Bies, Renuka Iyer, Christos Fountzilas, Orla Maguire, John Wilton, Bhavana Konda, Dwight H. Owen |
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Rok vydání: | 2020 |
Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty Indoles Angiogenesis Angiogenesis Inhibitors Neuroendocrine tumors Article 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Primary outcome Quality of life Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Humans Medicine In patient 030212 general & internal medicine Aged Neoplasm Staging Neovascularization Pathologic business.industry Middle Aged medicine.disease Progression-Free Survival Clinical trial Neuroendocrine Tumors Treatment Outcome chemistry 030220 oncology & carcinogenesis Disease Progression Female Nintedanib Somatostatin business |
Zdroj: | Cancer |
ISSN: | 1097-0142 0008-543X |
Popis: | Background Antiangiogenic-targeting agents have low response rates in patients with nonpancreatic neuroendocrine tumors (NETs). Nintedanib is an oral antiangiogenic agent that has inhibitory effects on the fibroblast growth factor receptor, which is highly expressed in NETs. The authors hypothesized that nintedanib would be active in patients with nonpancreatic NETs. Methods Patients with advanced, grade 1 or 2, nonpancreatic NETs who were receiving a stable dose of somatostatin analogue were enrolled. Nintedanib was administered at a dose of 200 mg twice daily in 28-day cycles. The primary endpoint was progression-free survival (PFS) at 16 weeks. Results Thirty-two patients were enrolled, and 30 were evaluable for the primary outcome. Most had radiographic disease progression within 12 months before enrollment. The 16-week PFS rate was 83%, and the median PFS and overall survival were 11.0 months and 32.7 months, respectively. Nintedanib was well tolerated and delayed deterioration in quality of life. The baseline serotonin level had a strong, positive correlation with activated but exhausted T cells. Conclusions Nintedanib is active in nonpancreatic NETs. The immunosuppressive effect of serotonin should be targeted in future clinical trials. |
Databáze: | OpenAIRE |
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