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.

Cancer Treatment Centers of America at South Eastern Regional Center Atlanta GA USA

Center for Carcinoid and Neuroendocrine Tumors New York NY USA

Department of Cardiology and Cardiac Surgery School of Medicine University of Warmia and Mazury Olsztyn Poland

Department of Gastroenterology and Tumour Neuroendocrinology Royal Free Hospital London UK

Department of Hematology Oncology University of Texas Health Science Center at Tyler Tyler TX USA

Department of Medicine Division of Endocrinology and Diabetology Universitätsklinikum Erlangen Friedrich Alexander University Erlangen Nürnberg Erlangen Germany

Department of Oncology 1st Faculty of Medicine and General Teaching Hospital Prague Czech Republic

Diagnostic and Therapeutic Center Gammed Warsaw Poland

Division of Gastroenterology and Pancreatology Beaujon Hospital Clichy France

Medical Affairs Ipsen Pharma Boulogne Billancourt France

Tisch Cancer Institute at Mount Sinai and Icahn School of Medicine at Mount Sinai New York NY USA

Université de Paris Paris France

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ClinicalTrials.gov
NCT00353496, NCT00842348