Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study

Caplin ME, Pavel ME, Phan AT, Cwikla JB, Sedlackova E, Thanh XMT, Wolin EM, Ruszniewski P (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Endocrine Springer

DOI: 10.1007/s12020-020-02475-2

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.

Authors with CRIS profile

Marianne Ellen Pavel Department of Medicine 1 – Gastroenterology, Pneumology and Endocrinology

Involved external institutions

Royal Free Hospital GB United Kingdom (GB) The University of Texas Health Science Center at Tyler (UTHSCT) / East Texas Tuberculosis Sanitarium / UT Health Northeast US United States (USA) (US) University of Warmia and Mazury in Olsztyn PL Poland (PL) Univerzita Karlova v Praze / Charles University in Prague CZ Czech Republic (CZ) Ipsen Pharma FR France (FR) Mount Sinai Hospital US United States (USA) (US) Beaujon Hospital / Hôpital Beaujon FR France (FR)

How to cite

APA:

Caplin, M.E., Pavel, M.E., Phan, A.T., Cwikla, J.B., Sedlackova, E., Thanh, X.-M.T.,... Ruszniewski, P. (2020). Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. https://doi.org/10.1007/s12020-020-02475-2

MLA:

Caplin, Martyn E., et al. "Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study." Endocrine (2020).

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