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Jonathan R Strosberg Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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James C Yao Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Emilio Bajetta Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Mounir Aout Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Bert Bakker Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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John D Hainsworth Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Philippe B Ruszniewski Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Eric Van Cutsem Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Kjell Öberg Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Marianne E Pavel Department of Medicine, Division of Cancer Medicine, Istituto di Oncologia, Novartis International AG, Novartis Pharmaceuticals Corporation, Sarah Cannon Research Institute, University of Paris VII and Beaujon Hospital, Digestive Oncology, Uppsala University Hospital, Department of Hepatology and Gastroenterology, Moffitt Cancer Center, Tampa, Florida, USA

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Somatostatin analogues (SSA) have demonstrated antiproliferative activity in addition to efficacy for carcinoid symptom control in functional neuroendocrine tumors (NET). A post hoc analysis of the placebo arm of the RAD001 In Advanced Neuroendocrine Tumors-2 (RADIANT-2) study was conducted to assess the efficacy of octreotide long-acting repeatable (LAR) on progression-free survival (PFS) and overall survival (OS) estimated using the Kaplan–Meier method. Out of 213 patients randomized to placebo plus octreotide LAR in RADIANT-2, 196 patients with foregut, midgut, or hindgut NET were considered for present analysis. Of these, 41 patients were SSA-treatment naïve and 155 had received SSA therapy before study entry. For SSA-naïve patients, median PFS by adjudicated central review was 13.6 (95% CI 8.2–22.7) months. For SSA-naïve patients with midgut NET (n=24), median PFS was 22.2 (95% CI 8.3–29.5) months. For patients who had received SSA previously, the median PFS was 11.1 (95% CI 8.4–14.3) months. Among the SSA-pretreated patients who had midgut NET (n=119), the median PFS was 12.0 (95% CI 8.4–19.3) months. Median OS was 35.8 (95% CI 32.5–48.9) months for patients in the placebo plus octreotide LAR arm; 50.6 (36.4 – not reached) months for SSA-naïve patients and 33.5 (95% CI 27.5–44.7) months for those who had received prior SSA. This post hoc analysis of the placebo arm of the large phase 3 RADIANT-2 study provides data on PFS and OS among patients with progressive NET treated with octreotide therapy.

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Martyn E Caplin Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Marianne Pavel Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Jarosław B Ćwikła Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Alexandria T Phan Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Markus Raderer Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Eva Sedláčková Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Guillaume Cadiot Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Edward M Wolin Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Jaume Capdevila Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Lucy Wall Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Guido Rindi Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Alison Langley Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Séverine Martinez Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Edda Gomez-Panzani Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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Philippe Ruszniewski Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK
Royal Free Hospital, Charité University Medicine Berlin, University of Warmia and Mazury, University of Texas MD Anderson Cancer Center, University Hospital, Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Robert‐Debré Hospital, Markey Cancer Center, Vall d'Hebron University Hospital, Western General Hospital, Università Cattolica del Sacro Cuore, Ipsen, Ipsen, Beaujon Hospital, Paris Diderot University, London, UK

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on behalf of the CLARINET Investigators
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In the CLARINET study, lanreotide Autogel (depot in USA) significantly prolonged progression-free survival (PFS) in patients with metastatic pancreatic/intestinal neuroendocrine tumours (NETs). We report long-term safety and additional efficacy data from the open-label extension (OLE). Patients with metastatic grade 1/2 (Ki-67 ≤10%) non-functioning NET and documented baseline tumour-progression status received lanreotide Autogel 120 mg (n=101) or placebo (n=103) for 96 weeks or until death/progressive disease (PD) in CLARINET study. Patients with stable disease (SD) at core study end (lanreotide/placebo) or PD (placebo only) continued or switched to lanreotide in the OLE. In total, 88 patients (previously: lanreotide, n=41; placebo, n=47) participated: 38% had pancreatic, 39% midgut and 23% other/unknown primary tumours. Patients continuing lanreotide reported fewer adverse events (AEs) (all and treatment-related) during OLE than core study. Placebo-to-lanreotide switch patients reported similar AE rates in OLE and core studies, except more diarrhoea was considered treatment-related in OLE (overall diarrhoea unchanged). Median lanreotide PFS (core study randomisation to PD in core/OLE; n=101) was 32.8 months (95% CI: 30.9, 68.0). A sensitivity analysis, addressing potential selection bias by assuming that patients with SD on lanreotide in the core study and not entering the OLE (n=13) had PD 24 weeks after last core assessment, found median PFS remaining consistent: 30.8 months (95% CI: 30.0, 31.3). Median time to further PD after placebo-to-lanreotide switch (n=32) was 14.0 months (10.1; not reached). This OLE study suggests long-term treatment with lanreotide Autogel 120 mg maintained favourable safety/tolerability. CLARINET OLE data also provide new evidence of lanreotide anti-tumour benefits in indolent and progressive pancreatic/intestinal NETs.

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