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Multicenter phase 2 trial of nintedanib in advanced nonpancreatic neuroendocrine tumors
Author(s) -
Iyer Renuka V.,
Konda Bhavana,
Fountzilas Christos,
Mukherjee Sarbajit,
Owen Dwight,
Attwood Kristopher,
Wang Chong,
Maguire Orla,
Minderman Hans,
Suffren SherylAnn,
Hicks Karen,
Wilton John,
Bies Robert,
Casucci Danielle,
ReidyLagunes Diane,
Shah Manisha
Publication year - 2020
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.32994
Subject(s) - nintedanib , medicine , clinical endpoint , somatostatin , neuroendocrine tumors , gastroenterology , oncology , clinical trial , idiopathic pulmonary fibrosis , lung
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.