Martyn E Caplin1, Marianne Pavel2, Alexandria T Phan3,4, Jarosław B Ćwikła5,6, Eva Sedláčková7, Xuan-Mai Truong Thanh8, Edward M Wolin9,10, Philippe Ruszniewski11,12. 1. Department of Gastroenterology and Tumour Neuroendocrinology, Royal Free Hospital, London, UK. m.caplin@ucl.ac.uk. 2. 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. 4. Cancer Treatment Centers of America at South Eastern Regional Center, Atlanta, GA, USA. 5. Department of Cardiology and Cardiac Surgery, School of Medicine, University of Warmia and Mazury, Olsztyn, Poland. 6. Diagnostic and Therapeutic Center - Gammed, Warsaw, Poland. 7. Department of Oncology, First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic. 8. Medical Affairs, Ipsen Pharma, Boulogne-Billancourt, France. 9. Tisch Cancer Institute at Mount Sinai and Icahn School of Medicine at Mount Sinai, New York, NY, USA. 10. Center for Carcinoid and Neuroendocrine Tumors, New York, NY, USA. 11. Division of Gastroenterology and Pancreatology, Beaujon Hospital, Clichy, France. 12. Université de Paris, Paris, France.
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 theOLE (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.
RCT Entities:
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: Martyn E Caplin; Marianne Pavel; Jarosław B Ćwikła; Alexandria T Phan; Markus Raderer; Eva Sedláčková; Guillaume Cadiot; Edward M Wolin; Jaume Capdevila; Lucy Wall; Guido Rindi; Alison Langley; Séverine Martinez; Joëlle Blumberg; Philippe Ruszniewski Journal: N Engl J Med Date: 2014-07-17 Impact factor: 91.245
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Authors: Martyn E Caplin; Marianne Pavel; Jarosław B Ćwikła; Alexandria T Phan; Markus Raderer; Eva Sedláčková; Guillaume Cadiot; Edward M Wolin; Jaume Capdevila; Lucy Wall; Guido Rindi; Alison Langley; Séverine Martinez; Edda Gomez-Panzani; Philippe Ruszniewski Journal: Endocr Relat Cancer Date: 2016-01-07 Impact factor: 5.678