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.
GEP NET
liver
lymph node
metastases
octreotide LAR
targeted therapy
Journal
Biology
ISSN: 2079-7737
Titre abrégé: Biology (Basel)
Pays: Switzerland
ID NLM: 101587988
Informations de publication
Date de publication:
09 Mar 2020
09 Mar 2020
Historique:
received:
21
01
2020
revised:
24
02
2020
accepted:
03
03
2020
entrez:
19
3
2020
pubmed:
19
3
2020
medline:
19
3
2020
Statut:
epublish
Résumé
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,
Identifiants
pubmed: 32182791
pii: biology9030051
doi: 10.3390/biology9030051
pmc: PMC7150771
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT01648465']
Types de publication
Journal Article
Langues
eng
Références
Oncotarget. 2018 Apr 10;9(27):19245-19254
pubmed: 29721198
Lancet. 2016 Mar 5;387(10022):968-977
pubmed: 26703889
N Engl J Med. 2011 Feb 10;364(6):501-13
pubmed: 21306237
Oncotarget. 2017 Jul 11;8(28):46624-46634
pubmed: 28402955
N Engl J Med. 2011 Feb 10;364(6):514-23
pubmed: 21306238
Cell Metab. 2008 Jan;7(1):11-20
pubmed: 18177721
JAMA Oncol. 2017 Oct 1;3(10):1335-1342
pubmed: 28448665
J Clin Endocrinol Metab. 2012 Mar;97(3):727-37
pubmed: 22170729
Ann Oncol. 2017 Jun 1;28(6):1309-1315
pubmed: 28327907
Lancet. 2011 Dec 10;378(9808):2005-2012
pubmed: 22119496
Lancet Oncol. 2008 Jan;9(1):61-72
pubmed: 18177818
J Clin Oncol. 2009 Oct 1;27(28):4656-63
pubmed: 19704057
Neuroendocrinology. 2015;102(1-2):18-25
pubmed: 25824001
Neuroendocrinology. 2018;106(4):307-311
pubmed: 28743120
Virchows Arch. 2018 Mar;472(3):341-349
pubmed: 29134440
Ann Oncol. 2017 Jul 1;28(7):1569-1575
pubmed: 28444114
Mol Cell Endocrinol. 2008 May 14;286(1-2):230-7
pubmed: 18359151
Eur J Cancer. 2016 Jul;62:132-7
pubmed: 27189322
J Clin Oncol. 2008 Sep 10;26(26):4311-8
pubmed: 18779618
Cancer. 2014 Aug 15;120(16):2457-63
pubmed: 24752410
J Clin Oncol. 2010 Jan 1;28(1):69-76
pubmed: 19933912
Biometrics. 1982 Mar;38(1):143-51
pubmed: 7082756
N Engl J Med. 2014 Jul 17;371(3):224-33
pubmed: 25014687
BMC Cancer. 2015 Jul 04;15:495
pubmed: 26138480