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

Author:

Rinke Anja1,Maintz Christoph2,Müller Lothar3,Weber Matthias M.4,Lahner Harald5,Pavel Marianne6,Saeger Wolfgang7,Houchard Aude8,Ungewiss Hanna9,Petersenn Stephan10

Affiliation:

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

Abstract

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.

Publisher

Georg Thieme Verlag KG

Subject

Endocrinology,General Medicine,Endocrinology, Diabetes and Metabolism,Internal Medicine

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