@article{3000243,
    title = "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",
    author = "Koumarianou, A. and Pectasides, D. and Koliou, G.-A. and Dionysopoulos, D. and Kolomodi, D. and Poulios, C. and Skondra, M. and Sgouros, J. and Pentheroudakis, G. and Kaltsas, G. and Fountzilas, G.",
    journal = "EMC. Biologie mιdicale",
    year = "2020",
    volume = "9",
    number = "3",
    publisher = "MDPI AG",
    doi = "10.3390/biology9030051",
    abstract = "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."
}