Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl

被引：35

作者：

Anthony, Lowell ^{[1
]}

Ervin, Claire ^{[2
]}

Lapuerta, Pablo ^{[3
]}

Kulke, Matthew H. ^{[4
]}

Kunz, Pamela ^{[5
]}

Bergsland, Emily ^{[6
]}

Hoersch, Dieter ^{[7
]}

Metz, David C. ^{[8
]}

Pasieka, Janice ^{[9
]}

Paylakis, Nick ^{[10
]}

Pavel, Marianne ^{[11
]}

Caplin, Martyn ^{[12
]}

Oberg, Kjell ^{[13
]}

Ramage, John ^{[14
]}

Evans, Emily ^{[2
]}

Yang, Qi Melissa ^{[3
]}

Jackson, Shanna ^{[3
]}

Arnold, Katie ^{[3
]}

Law, Linda ^{[3
,15
]}

DiBenedetti, Dana B. ^{[2
]}

机构：

[1] Univ Kentucky, Markey Canc Ctr, Lexington, KY USA

[2] RTI Hlth Solut, Res Triangle Pk, NC USA

[3] Lexicon Pharmaceut Inc, 8800 Technol Forest Pl, The Woodlands, TX 77385 USA

[4] Dana Farber Canc Inst, Boston, MA 02115 USA

[5] Stanford Canc Ctr, Stanford, CA USA

[6] UCSF Helen Diller Family Comprehens Canc Ctr, San Francisco, CA USA

[7] Zent Klin Bad Berka GmbH, Klin Innerre Med Gastroenterol & Endokrinol, Bad Berka, Germany

[8] Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA

[9] Tom Baker Canc Clin, Calgary, AB, Canada

[10] Royal North Shore Hosp, St Leonards, NSW, Australia

[11] Charite, Berlin, Germany

[12] Royal Free Hosp, London, England

[13] Uppsala Univ, Uppsala, Sweden

[14] Hampshire Hosp NHS Trust, Basingstoke & North Hampshire Hosp, Basingstoke, Hants, England

[15] BioHealthConsult, 2143 Riverside Dr, Cincinnati, OH 45202 USA

来源：

CLINICAL THERAPEUTICS | 2017年 / 39卷 / 11期

关键词：

bowel movement; carcinoid syndrome; diarrhea; exit interviews; patient interviews; telotristat ethyl; QUALITY-OF-LIFE; GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS; QUESTIONNAIRE; MANAGEMENT; DIAGNOSIS;

D O I：

10.1016/j.clinthera.2017.09.013

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Purpose: Telotristat ethyl, an oral tryptophan hydroxylase inhibitor, is intended to treat carcinoid syndrome by reducing serotonin production. Telotristat ethyl was evaluated in FELESTAR, a Phase HI study for patients who had carcinoid syndrome with at least 4 bowel movements (BMs) per day and who were receiving somatostatin analogue therapy. This interview sub study was conducted to provide insight into the patient experience in ILLESTAR and to help understand whether reductions in BM frequency (the primary end point) and other symptoms were clinically meaningful. Methods: Participating sites were asked to invite (before randomization) all eligible patients to telephone interviews scheduled at the end of the double-blind treatment period. Patients and interviewers were blinded to treatment. Findings: All 35 interviewed participants reported diarrhea and/or excessive BMs at baseline. Patients reported that these symptoms negatively affected emotional, social, physical, and occupational well-being. Prespecified criteria for treatment response (achieving >= 30% reduction in BM frequency for at least 50% of the days) were met by 8 of 26 patients taking telotristat ethyl and 1 of 9 patients taking placebo. All 8 patients taking telotristat ethyl described clinically meaningful reductions in BM frequency and were very satisfied with the ability of the study drug to control their carcinoidsyndrome symptoms. Overall, reports of being very satisfied were observed in 12 patients taking telotristat ethyl and 0 taking placebo. Implications: Patient interviews revealed that I ELESTAR patients, at baseline, were significantly affected by their high BM frequency. Patient reports of their clinical trial experience supported the significance of the primary end point and clinical responder analysis in TELESTAR, helping identify and understand clinically meaningful change produced by telotristat ethyl. (C) 2017 The Authors. Published by Elsevier HS Journals, Inc.

引用

页码：2158 / 2168

页数：11

共 23 条

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