Medical College of Wisconsin
CTSIResearch InformaticsREDCap

Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine 2021 Feb;71(2):502-513

Date

10/15/2020

Pubmed ID

33052555

Pubmed Central ID

PMC7881960

DOI

10.1007/s12020-020-02475-2

Scopus ID

2-s2.0-85092563674 (requires institutional sign-in at Scopus site)   73 Citations

Abstract

PURPOSE: In the phase III CLARINET study (NCT00353496), lanreotide autogel/depot (lanreotide) significantly improved progression-free survival (PFS) vs placebo in patients with non-functioning intestinal or pancreatic neuroendocrine tumours (NETs). The aim of CLARINET open-label extension (OLE) (NCT00842348) was to evaluate long-term safety and efficacy of lanreotide in these patients.

METHODS: Patients from the CLARINET study were eligible for the OLE if they had stable disease (irrespective of treatment group) or progressive disease (PD) (placebo-treated patients only). All patients in the OLE received lanreotide 120 mg every 28 days. Computed tomography or magnetic resonance imaging scans were conducted every 6 months and assessed locally for PD (the final scan was also assessed centrally).

RESULTS: Overall, 89 patients took part in the OLE (lanreotide, n = 42; placebo, n = 47). Median (range) exposure to lanreotide in patients who received lanreotide in the core study and OLE (LAN-LAN group) was 59.0 (26.0-102.3) months. In this group, the overall incidences of adverse events (AEs) and treatment-related AEs were lower in the OLE than in the core study. Median [95% CI] PFS in the LAN-LAN group was 38.5 [30.9; 59.4] months. In placebo-treated patients with PD at the end of the core study, time to death or subsequent PD during the OLE was 19 [10.1; 26.7] months.

CONCLUSIONS: This study provides new evidence on the long-term safety profile and sustained anti-tumour effects of lanreotide autogel/depot in indolent and progressive metastatic intestinal or pancreatic NETs.

Author List

Caplin ME, Pavel M, Phan AT, Ćwikła JB, Sedláčková E, Thanh XT, Wolin EM, Ruszniewski P, CLARINET Investigators

Author

Alexandria T. Phan MD Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Antineoplastic Agents
Humans
Neuroendocrine Tumors
Pancreatic Neoplasms
Peptides, Cyclic
Somatostatin