ECE2016 Eposter Presentations Endocrine tumours and neoplasia (68 abstracts)
Real life data on Lanreotide Autogel in the treatment of patients with neuroendocrine tumors (NET) – an interim analysis from SOPRANo study
Anja Rinke 1 , Lothar Müller 2 , Christoph Maintz 3 , Claus Bolling 4 , Markus Raderer 5 , Mirjam Christ-Crain 6 , Philipp Hoffmanns 7 , Vitali Chevts 7 , Aude Houchard 8 & Stephan Petersenn 9
1Klinik für Gastroenterologie, Endokrinologie und Stoffwechselerkrankungen, Universitätsklinikum Gießen-Marburg, Marburg, Germany; 2Praxis für Onkologie Leer-Emden-Papenburg, Leer, Germany; 3Hämatologisch-Onkologische Praxis, Würselen, Germany; 4AGAPLESION– Markus Krankenhaus, Frankfurt am Main, Germany; 5AKH Wien, Wien, Austria; 6Klinik für Endokrinologie; Universitätsspital Basel; Universität Basel, Basel, Switzerland; 7Ipsen Pharma GmbH, Ettlingen, Germany; 8Ipsen Pharma, Boulogne-Billancourt, France; 9ENDOC – Center for Endocrine Tumors, Hamburg, Germany.
Introduction: This non-interventional study assesses real-life use and potential predictive parameters for lanreotide (LAN) in pts with either acromegaly (ACRO) or NET over a period of 24 months. We present a pre-specified interim analysis after first 6 months of therapy.
Methods: The primary objective is to evaluate the long term treatment response under LAN and to correlate it with early changes of biochemical markers. The planned sample size is 152 (76 ACRO and 76 NET) pts. Pts/disease characteristics, disease markers, treatment effectiveness are also analysed. The baseline (except CgA) and safety data are presented on 50 enrolled NET pts, other analyses are performed on the main NET analysis population (n=37).
Results: At baseline, median (± S.D.) age and duration of NET were 68.5 (±13.2) and 0.9 (±5.4) yrs, median (± S.D.) CgA level was 393.9% of ULN (±1409.7). Main tumor locations included ileum (46%) and pancreas (22%); 90% of pts had metastases. G1 and G2 tumors were observed in 51% and 43% respectively, G3 in 6%. Scintigraphy was positive in 58% pts. 89% of pts had prior therapy (88% surgery, 22% biotherapy). After first 6 months of therapy 70% and 85% of pts showed stability or improvement of carcinoid syndrome/diarrhea and flush, respectively. 22 adverse events (AEs) were reported in 16 pts (32%), wherefrom 11 pts developed a total of 16 serious AEs (15 unrelated and 1 related (choledocholithiasis)).
Conclusions: The study reflects the routine use of LAN in advanced/metastatic NET. This interim analysis shows favorable effectiveness with stabilization of disease related symptoms and good tolerability of LAN.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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