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Multicenter, Observational Study of Lanreotide Autogel for the Treatment of Patients with Neuroendocrine Tumors in Routine Clinical Practice in Germany and Austria

Authors
  • Rinke, Anja1
  • Maintz, Christoph2
  • Müller, Lothar3
  • Weber, Matthias M.4
  • Lahner, Harald5
  • Pavel, Marianne6
  • Saeger, Wolfgang7
  • Houchard, Aude8
  • Ungewiss, Hanna9
  • Petersenn, Stephan10
  • 1 Department of Gastroenterology and Endocrinology, University Hospital Gießen and Marburg, Marburg, Germany
  • 2 Hämatologisch-Onkologische Praxis, MVZ West GmbH, Würselen, Germany
  • 3 Onkologie Unter-Ems, Leer, Germany
  • 4 Unit of Endocrinology, Department of Medicine 1, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany
  • 5 Department of Endocrinology, Diabetes and Metabolism, Division of Laboratory Research, University Hospital Essen, Germany
  • 6 Department of Medicine 1, Division of Endocrinology, Universitätsklinikum Erlangen, Erlangen, Germany
  • 7 Department of Neuropathology, Pituitary Pathologist, University Hospital Eppendorf, Hamburg, Germany
  • 8 Ipsen, Boulogne Billancourt, France
  • 9 Ipsen, München, Germany
  • 10 ENDOC Center for Endocrine Tumors, Hamburg, Germany
Type
Published Article
Journal
Experimental and Clinical Endocrinology & Diabetes
Publisher
Georg Thieme Verlag KG
Publication Date
Jul 22, 2021
Volume
129
Issue
7
Pages
500–509
Identifiers
DOI: 10.1055/a-1342-2755
PMID: 34293802
PMCID: PMC8298132
Source
PubMed Central
Keywords
Disciplines
  • Article
License
Unknown

Abstract

Background The long-acting somatostatin analog lanreotide autogel is effective in the treatment of patients with neuroendocrine tumors. Objective To evaluate the long-term treatment response in patients with neuroendocrine tumors receiving lanreotide autogel in routine clinical practice. Methods Non-interventional, 24-month study in patients with neuroendocrine tumors treated with lanreotide autogel (NCT01840449). Results Patients (n=80) from 26 centers in Germany and Austria were enrolled. Neuroendocrine tumors were mainly grade 1/2, metastasized, intestinal, and associated with carcinoid syndrome; 88.9% had received previous neuroendocrine tumor treatment. Of those, 84.4% had previous surgery, 18.7% had received octreotide. The primary endpoint, defined by a <50% chromogranin A increase at month 12 compared with the lowest value between baseline and month 3 was achieved by 89.5% patients. Stable disease according to Response Evaluation Criteria in Solid Tumors 1.1 was observed in 76.9 and 75.0% patients at months 12 and 24 of lanreotide treatment, respectively. Mean change of chromogranin A levels from baseline to month 24 was −0.12 × upper limit of normal (95% CI, −0.22; −0.45). In a post hoc analysis, 38.5% of the subgroup of patients with carcinoid syndrome had daily diarrhea at baseline vs. 21.4% at month 24. At baseline, 27.8% of patients received lanreotide 120 mg every 4 weeks vs. 56.7% at month 24. Quality of life data were heterogeneous. No new safety issues arose and/or required further investigation. Conclusions Our study reflects routine lanreotide autogel use in patients with advanced/metastatic neuroendocrine tumors. This analysis shows effectiveness with stabilization of disease-related symptoms and good tolerability of lanreotide autogel in clinical practice.

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