Z Gastroenterol 2015; 53 - KG220
DOI: 10.1055/s-0035-1559246

Antitumor Activity of Lanreotide Autogel 120 mg in Enteropancreatic Neuroendocrine Tumour (NET) Patients: The Clarinet Open-Label Extension Study

M Pavel 1, M Caplin 2, JB Ćwikła 3, A Phan 4, M Raderer 5, E Sedláčková 6, G Cadiot 7, E Wolin 8, J Capdevila 9, L Wall 10, G Rindi 11, A Langley 12, E Gomez-Panzani 12 P Ruszniewski 13 on behalf of the CLARINET study group
  • 1Campus Virchow-Klinikum, Charite, Medizinische Klinik m. S. Hepatologie und Gastroenterologie, Berlin, Deutschland
  • 2Royal Free Hospital, London, UK
  • 3University of Varmia and Masuria, Olsztyn, Poland
  • 4Houston Methodist Hospital Cancer Center, Houston, TX, USA
  • 5University Hospital, Vienna, Austria
  • 6First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic
  • 7Robert-Debré Hospital, Reims, France
  • 8Markey Cancer Center, Lexington, KY, USA
  • 9Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain
  • 10Western General Hospital, Edinburgh, UK
  • 11Università Cattolica del Sacro Cuore, Rome, Italy
  • 12Ipsen, Les Ulis, France
  • 13Beaujon Hospital, Clichy, France

Introduction: CLARINET core study data has demonstrated the efficacy and safety/tolerability of lanreotide as an antitumor treatment in patients with metastatic enteropancreatic NETs. Here, we report updated PFS data and safety findings from the CLARINET open-label extension (OLE; NCT00842348).

Methods: In the core study, patients with metastatic well/moderately differentiated non-functioning enteropancreatic NETs, Ki-67 Ki-67 < 10%, no prior medical therapy in last 6 months were randomized to lanreotide Autogel 120 mg (n = 101) or placebo (n = 103) for 96 weeks or until progressive disease (PD)/death. In the OLE, patients with stable disease (SD) at core-study end or progressive disease (PD) on core-study placebo entered single-arm OLE on lanreotide. The primary objective was to evaluate longer-term safety of lanreotide; a secondary objective was to investigate further lanreotide efficacy based on PFS (i.e. time from randomization in core study to PD/death) for the core study intent-to-treat population, using survival analysis based on Kaplan-Meier estimates.

Results: 88 patients from the core-study (41 on lanreotide, 47 on placebo) entered the OLE. At core-study enrolment, 96% of OLE patients had SD; 38% had pancreatic and 39% midgut primary tumours. For patients continuing on lanreotide, median PFS reached during the OLE was 32.8 months [95% CI: 30.9 – 68.0]. For patients who switched from placebo to lanreotide after PD in the core study, median time to further PD with lanreotide in the OLE was 14.0 months. During the OLE, 66% who continued lanreotide vs. 81% who switched to lanreotide experienced adverse events (of which, 27% vs. 40% were treatment-related); most frequent events were diarrhea. No new safety concerns were identified during the OLE.

Conclusions: The OLE study further demonstrates favourable lanreotide safety/tolerability in enteropancreatic NETs. It also provides data on the continued antitumor effects in patients with SD on lanreotide in the core study, and on antitumor effects in patients after PD with placebo.