Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: The CLARINET open-label extension study

Guido Rindi, Martyn E. Caplin, Marianne Pavel, Jarosław B. Ćwikła, Alexandria T. Phan, Markus Raderer, Eva Sedláčkova, Guillaume Cadiot, Edward M. Wolin, Jaume Capdevila, Lucy Wall, Alison Langley, Séverine Martinez, Edda Gomez-Panzani, Philippe Ruszniewski

Research output: Contribution to journalArticle

137 Citations (Scopus)

Abstract

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 %) nonfunctioning 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.
Original languageEnglish
Pages (from-to)191-199
Number of pages9
JournalEndocrine-Related Cancer
Volume23
DOIs
Publication statusPublished - 2016

Keywords

  • Anti-tumour effects
  • Antineoplastic Agents
  • Disease-Free Survival
  • Humans
  • Intestinal Neoplasms
  • Lanreotide Autogel
  • Neuroendocrine Tumors
  • Neuroendocrine tumours
  • Open-label extension
  • Pancreatic Neoplasms
  • Peptides, Cyclic
  • Somatostatin
  • Treatment Outcome

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