UKINETS2016 Poster Presentations (1) (35 abstracts)
Assessing treatment benefit of telotristat etiprate in patients with carcinoid syndrome: Patient exit interviews
Lowell Anthony 1 , Dieter Horsch 2 , Claire Ervin 3 , Matthew H. Kulke 4 , Marianne Pavel 5 , Emily Bergsland 6 , Martyn Caplin 7 , Kjell Oberg 8 , Richard Warner 9 , Pamela Kunz 10 , David C. Metz 11 , Janice Pasieka 12 , Nick Pavlakis 13 , Dana DiBenedetti 3 , Emily Haydysch 3 , Qi Melissa Yang 14 , Shanna Jackson 14 , Karie Arnold 13 , Linda Law 14 & Pablo Lapuerta 14
1University of Kentucky, Lexington, KY, USA; 2Zentralklinik Bad Berka, Bad Berka, Germany; 3RTI Health Solutions, Research Triangle Park, NC, USA; 4Dana-Farber Cancer Institute, Boston, MA, USA; 5Charitè–Universitätsmedizin 13353, Berlin, Germany; 6UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; 7Royal Free Hospital, London, UK; 8Uppsala University, Uppsala, Sweden; 9Icahn School of Medicine at Mount Sinai, New York, USA; 10Stanford University, Palo Alto, CA, USA; 11University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA, USA; 12Tom Baker Cancer Centre Calgary, AB, Canada; 13Royal North Shore Hospital, St Leonards NSW, Australia; 14Lexicon Pharmaceuticals, Inc., The Woodlands, TX, USA.
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 baseline symptoms and clinical trial experiences.
Materials and Methods: Participating sites were asked to invite all TELESTAR patients (consent obtained prior to randomization) to phone interviews scheduled between Weeks 12 and 14. Patients and interviewers remained blinded to treatment assignment. Interview data were summarized with standard qualitative analysis methods.
Result: All interview participants (n=35) reported diarrhea and/or excessive BMs at baseline. Diarrhea (n=17), followed by BM frequency (n=9), and urgency (n=5) were identified as the most bothersome and important symptoms to treat. BM frequency negatively affected emotional, social, physical, and occupational well-being. When probed, most participants reported that a reduction of ≥30% would be considered meaningful. Improvements in CS symptoms were reported by 69% of participants. Among these, 88% reported reductions in BM frequency and 79% reported improvements in stool consistency. About 95% who reported reductions in BM frequency noted that it was meaningful, describing a better ability to enjoy life, leave the house, and participate in social and other activities. Among the 33 participants answering a question about treatment satisfaction, 55% reported being somewhat or very satisfied with TE in relieving CS symptoms. Reports of “very satisfied” were 0% (0/9) on placebo (SOC) and 50% (12/24) on TE, with similar results in the 2 TE dosage groups.
Conclusions: Diarrhea and BM frequency were identified as the most impactful CS symptoms. The primary endpoint of TELESTAR is very meaningful to patients.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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