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CC BY-NC-ND 4.0 · Exp Clin Endocrinol Diabetes 2021; 129(07): 500-509
DOI: 10.1055/a-1342-2755
Article

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

Anja Rinke
1   Department of Gastroenterology and Endocrinology, University Hospital Gießen and Marburg, Marburg, Germany
,
Christoph Maintz
2   Hämatologisch-Onkologische Praxis, MVZ West GmbH, Würselen, Germany
,
Lothar Müller
3   Onkologie Unter-Ems, Leer, Germany
,
Matthias M. Weber
4   Unit of Endocrinology, Department of Medicine 1, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany
,
Harald Lahner
5   Department of Endocrinology, Diabetes and Metabolism, Division of Laboratory Research, University Hospital Essen, Germany
,
Marianne Pavel
6   Department of Medicine 1, Division of Endocrinology, Universitätsklinikum Erlangen, Erlangen, Germany
,
Wolfgang Saeger
7   Department of Neuropathology, Pituitary Pathologist, University Hospital Eppendorf, Hamburg, Germany
,
Aude Houchard
8   Ipsen, Boulogne Billancourt, France
,
Hanna Ungewiss
9   Ipsen, München, Germany
,
Stephan Petersenn
10   ENDOC Center for Endocrine Tumors, Hamburg, Germany
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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.

Key words

chromogranin A - carcinoid syndrome - diarrhea - flushing - quality of life


Publication History

Received: 18 September 2020
Received: 07 December 2020

Accepted: 22 December 2020

Article published online:
22 July 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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