Efficacy and Safety of First-Line Everolimus Therapy Alone or in Combination with Octreotide in Gastroenteropancreatic Neuroendocrine Tumors. A Hellenic Cooperative Oncology Group (HeCOG) Study

The purpose of this study was to explore the efficacy and safety of everolimus administered as a first-line treatment in newly diagnosed patients with metastatic or inoperable gastroenteropancreatic neuroendocrine tumors (GEP NETs). This phase II, multicenter, single-arm study included patients with...

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Veröffentlicht in:Biology (Basel, Switzerland) Switzerland), 2020-03, Vol.9 (3), p.51
Hauptverfasser: Koumarianou, Anna, Pectasides, Dimitrios, Koliou, Georgia-Angeliki, Dionysopoulos, Dimitrios, Kolomodi, Dionysia, Poulios, Christos, Skondra, Maria, Sgouros, Joseph, Pentheroudakis, George, Kaltsas, Gregory, Fountzilas, George
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Sprache:eng
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Zusammenfassung:The purpose of this study was to explore the efficacy and safety of everolimus administered as a first-line treatment in newly diagnosed patients with metastatic or inoperable gastroenteropancreatic neuroendocrine tumors (GEP NETs). This phase II, multicenter, single-arm study included patients with well-differentiated GEP NETs and a Ki67 < 20%. Everolimus, at 10 mg/day, was administered until disease progression; 18 patients (72%) concomitantly received octreotide long-acting release (LAR), at 30 mg/month. The primary endpoint was the 15-month progression-free survival (PFS) rate. Twenty-five patients (grade 1: 11 patients, grade 2: 14 patients) were enrolled between August 2012 and October 2015. At a median follow-up of 58.1 months, the median PFS was 14.6 months, while the 15-month PFS rate was 48%; median overall survival had not been reached yet. Normal baseline chromogranin A (
ISSN:2079-7737
2079-7737
DOI:10.3390/biology9030051