Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label e
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ORIGINAL ARTICLE
Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study Martyn E. Caplin1 Marianne Pavel2 Alexandria T. Phan3,10 Jarosław B. Ćwikła4,11 Eva Sedláčková5 Xuan-Mai Truong Thanh6 Edward M. Wolin7,12 Philippe Ruszniewski8,9 on behalf of the CLARINET Investigators ●
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Received: 7 May 2020 / Accepted: 23 August 2020 © The Author(s) 2020
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.
Members of the CLARINET Investigators and their affiliations are presented in Supplementary material. Supplementary information The online version of this article (https:// doi.org/10.1007/s12020-020-02475-2) contains supplementary material, which is available to authorized users. * Martyn E. Caplin [email protected] 1
Department of Gastroenterology and Tumour Neuroendocrinology, Royal Free Hospital, London, UK
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Department of Medicine, Division of Endocrinology and Diabetology, Universitätsklinikum Erlangen, Friedrich Alexander University Erlangen-Nürnberg, Erlangen, Germany
3
Department of Hematology‐Oncology, University of Texas Health Science Center at Tyler, Tyler, TX, USA
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Department of Cardiology and Cardiac Surgery, School of Medicine, University of Warmia and Mazury, Olsztyn, Poland
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Department of Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic
6
Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France
7
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