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

Anja Rinke, Christoph Maintz, Lothar Müller, Matthias M Weber, Harald Lahner, Marianne Pavel, Wolfgang Saeger, Aude Houchard, Hanna Ungewiss, Stephan Petersenn, Anja Rinke, Christoph Maintz, Lothar Müller, Matthias M Weber, Harald Lahner, Marianne Pavel, Wolfgang Saeger, Aude Houchard, Hanna Ungewiss, Stephan Petersenn

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.

Conflict of interest statement

A.R. has received honoraria for presentations by AAA, Falk, IPSEN and Novartis. She also received honoraria for attendance at advisory board meetings (Ipsen, Novartis) and travel/congress reimbursements (Ipsen, Novartis). H.L. has received honoraria for presentations by Pfizer, Ipsen and Novartis. He also received honoraria for attendance at advisory board meetings (Pfizer, Ipsen, Novartis) and travel/congress reimbursements (Pfizer, Ipsen, Novartis). C.M. has no COI. S.P. has served as an advisory board member for Ipsen, Crinetics, Takeda, and Novartis, and has received honoraria for speaking at symposia for Ipsen, Novartis, Takeda, and Pfizer. A.H., H.U. are Ipsen employee. L.M. has served as an advisory board member for Ipsen. M.P. received honoraria for presentations by IPSEN, AAA, Novartis, Falk, and Boehringer-Ingelheim, and for advisory role from AAA, IPSEN, Riemser, Lilly, Amgen. W.S. has no COI. M.M.W. has received honoraria as a speaker and consultant from Ipsen and Novartis.

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/).

Figures

Fig. 1
Fig. 1
Expression of SSTR subtypes at baseline (n=17) (enrolled population); SSTR: somatostatin receptor.
Fig. 2
Fig. 2
LAN doses during the course of the study (efficacy population); LAN: lanreotide autogel.
Fig. 3
Fig. 3
Mean change of CgA values (95% CI) from baseline during the course of the study in the patients of the efficacy population, and post hoc in patients with carcinoid syndrome; mean values at the baseline visit: efficacy population: 13.2 x ULN (95% CI, 0.61–25.81); patients with carcinoid syndrome: 21.13 × ULN (95% CI, 0.0–42.98); CgA: chromogranin A, ULN: upper limit of normal.
Fig. 4
Fig. 4
Patients with carcinoid syndrome reporting no, occasional or dailya. diarrhea orb. flushing episodes during the course of the study (efficacy population).
Fig. 5
Fig. 5
Global evaluation of LAN treatment effectiveness by physicians at months 12 and 24; LAN: lanreotide.

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