TY - JOUR
TI - 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
AU - Koumarianou, A.
AU - Pectasides, D.
AU - Koliou, G.-A.
AU - Dionysopoulos, D.
AU - Kolomodi, D.
AU - Poulios, C.
AU - Skondra, M.
AU - Sgouros, J.
AU - Pentheroudakis, G.
AU - Kaltsas, G.
AU - Fountzilas, G.
JO - EMC. Biologie mιdicale
PY - 2020
VL - 9
TODO - 3
SP - null
PB - MDPI AG
SN - null
TODO - 10.3390/biology9030051
TODO - null
TODO - 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 (<4 nmol/l) confirmed a longer PFS (HR = 0.25, 95% CI 0.08–0.77, p = 0.016). Seven patients (28%) achieved an objective response (one complete response and six partial responses) in a median of 2.6 months. Twenty-three grade 3–4 events were recorded (14 patients). No fatal reactions occurred. This prospective phase II study unravels the notable activity of everolimus as a first-line treatment in patients with GEP NETS and contributes valuable information about the high activity of the combination of everolimus and octreotide LAR in this setting. Clinical trial information: NCT01648465. © 2020 by the authors. Licensee MDPI, Basel, Switzerland.
ER -