Safety and tolerability of lanreotide autogel/depot (LAN) in patients (pts) with neuroendocrine tumors (NETs): Pooled analysis of clinical studies.

398Background: Two international randomized double blind (DB) phase 3 trials provided evidence on LAN 120mg/4wks vs placebo in NETs: CLARINET reported on PFS improvements in metastatic intestinal/pancreatic NETs; ELECT on reduced use of short-acting rescue medication for carcinoid syndrome (CS) symptoms. ELECT and CLARINET open-label (OL) extensions recently provided further long-term (LT) data. Here, we pool all current data from LAN trials, to provide an overview of safety in functioning and nonfunctioning NETs. Methods: Data were pooled from CLARINET (96wk DB, ≤6yr LTOL), ELECT (16wk DB, 32wk initial OL, ≥2yr LTOL) and three other OL studies: 6mo study for CS symptom relief; 7–8mo study of self-administered LAN; and 92wk study of tumor-growth control. Occurrence of AEs was examined in all studies (except for diarrhea/flushing, an efficacy measure in ELECT DB + initial OL). Results: Of all 378 pts, 90% received LAN 120 mg (10% ≤90 mg). AE profiles were similar across DB, OL and all studies. GI events we...