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Antiproliferative Effects of Telotristat Ethyl in Patients with Neuroendocrine Tumors: The TELEACE Real-World Chart Review Study

Authors Morse MA, Liu E, Joish VN, Huynh L, Cheng M, Duh MS, Seth K, Lapuerta P, Metz DC

Received 6 May 2020

Accepted for publication 13 July 2020

Published 30 July 2020 Volume 2020:12 Pages 6607—6614

DOI https://doi.org/10.2147/CMAR.S261257

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 3

Editor who approved publication: Dr Yong Teng


Michael A Morse,1 Eric Liu,2 Vijay N Joish,3 Lynn Huynh,4 Mu Cheng,4 Mei Sheng Duh,4 Kiernan Seth,3 Pablo Lapuerta,3 David C Metz5

1Duke Cancer Institute, School of Medicine, Duke University, Durham, NC, USA; 2The Neuroendocrine Institute at Rocky Mountain Cancer Centers, Denver, CO, USA; 3Lexicon Pharmaceuticals, Inc., The Woodlands, TX, USA; 4Analysis Group, Boston, MA, USA; 5Neuroendocrine Tumor Program at Penn Medicine, Philadelphia, PA, USA

Correspondence: Michael A Morse, 10 Bryan Searle Drive, Box 3233, Durham, NC 27710, USA
Tel +1 919 681– 3480
Email michael.morse@duke.edu

Purpose: Neuroendocrine tumors (NETs) associated with carcinoid syndrome (CS) overproduce serotonin, mediated by tryptophan hydroxylase-1 (TPH1). The TPH inhibitor telotristat ethyl (TE) reduces peripheral serotonin and relieves CS symptoms. We conducted a real-world clinical practice study to explore the effects of TE on tumor growth in patients with NETs and CS.
Patients and Methods: Single-arm, pre/post chart review study of patients with advanced NETs who received TE for ≥ 6 months and had ≥ 2 radiological scans within 12 months before and ≥ 1 scan after TE initiation. Linear regression and longitudinal analyses assessed changes in tumor size controlling for background NET treatment.
Results: Two hundred patients were enrolled, most (61%) had well-differentiated gastrointestinal NETs (61%) and received TE for an average of 12 months (SD, 7.3). Mean reduction in tumor size after TE initiation was 0.59 cm (p=0.006). Longitudinal analysis showed an 8.5% reduction in tumor size (p=0.045) from pre- to post-TE periods. Documented NET treatment prior to initiating TE and time between scans were not significant predictors of changes in tumor size. Results were consistent in a subgroup of patients with the same documented NET treatment before and after initiating TE.
Conclusion: TE may have antitumor effects consistent with serotonin overproduction in tumor growth.

Keywords: neuroendocrine tumors, carcinoid tumor, malignant carcinoid syndrome, telotristat ethyl, octreotide, lanreotide

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