Endocrine Abstracts

Background: Neuroendocrine tumor (NET) symptoms are often similar to common conditions or may not arise until metastasis occurs, delaying diagnosis and impacting survival. We present data on time to diagnosis from the European (EU) NET patient perspective.Methods: In 2014, 1928 NET patients from >12 countries (Europe (n=763): Belgium, Bulgaria, France, Germany, Norway, UK, and other EU countries (not specified); Americas; Asia; Oceania) part...

Background: The safety and efficacy of telotristat ethyl (TE) in patients (pts) with metastatic neuroendocrine tumors (NETs) and carcinoid syndrome (CS) not adequately controlled with somatostatin analogs (SSAs) have been demonstrated. TE-treated pts showed significantly greater reductions in bowel movement (BM) frequency and more presented with durable response than placebo (PBO)-treated pts. These post-hoc analyses examined the relationship between improvements in symptoms a...

Background: Octreotide s.c. depot is a novel, ready-to-use formulation administered via a thin needle, which may allow self-administration. In a phase 1 study in healthy volunteers, octreotide s.c. depot provided greater bioavailability with faster onset and greater IGF1 suppression than long-acting octreotide. Here, we present data from a phase 2 study evaluating pharmacokinetics (PK), efficacy, safety, and tolerability of octreotide s.c. depot in patients with acromegaly and...

Introduction: Data demonstrating antiproliferative effects of somatostatin analogs (SSAs) in enteropancreatic NETs are limited; only one prospective trial so far has shown this for patients with midgut tumors and low hepatic tumor load (HTL). CLARINET is the first large phase 3, randomized, placebo-controlled trial evaluating such effects for the SSA lanreotide in patients with non-functioning enteropancreatic NETs.Methods: Patients who had well/moderate...

Background: Well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are commonly characterized by overexpression of somatostatin receptor subtype 2 (SSTR2), which can be targeted by radiopharmaceutical therapy (RPT) via radiolabeled somatostatin analogues (SSAs). RYZ101 (Ac-225 DOTATATE) is a first-in-class, highly potent alpha-emitting RPT being developed for the treatment of SSTR2+ solid tumors. Alpha-particles (such as emitted by Actinium-225) have a sho...

Background: Telotristat etiprate (TE), an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome (CS) by reducing serotonin production. TE was evaluated in TELESTAR, a phase 3 study; the primary endpoint showed significant reductions in bowel movement (BM) frequency for 2 TE dosages + standard of care (SOC) vs. SOC. TELESTAR patients had CS inadequately controlled on somatostatin analog therapy with ≥4 BMs per day. They were interviewed about base...

Background: TGR represents the percentage change in tumour volume per month (%/m). Previous results from the GREPONET study (A. Lamarca et al, ENETS 2018) showed that TGR measured after 3 months (TGR3m) of starting systemic treatment (ST) or watch and wait (WW) was an early biomarker predicting progression-free survival (PFS) in NETs.Methods: Pts from 7 centres with advanced grade (G) 1/2 NETs from the pancreas (P)/small bowel (SB) initiating ST...

Background: There is no universally accepted first-line (1L) therapy for higher grade, well-differentiated gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The Phase 3 NETTER-2 study (NCT03972488) evaluated [177 Lu]Lu-DOTA-TATE (hereafter177 Lu-DOTATATE) as 1L treatment in patients with grade (G)2 and G3 advanced GEP-NETs. This is the first trial to assess 1L radioligand therapy (RLT) in any solid tumor.Methods: Eligible pat...