443P - Identifying Symptom and Quality of Life Improvements in Patients with Carcinoid Syndrome Treated with Telotristat Ethyl: Qualitative Patient Exit I...

Date 10 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Neuroendocrine Cancers
Endocrine Cancers
Palliative and Supportive Care
Presenter Florence Marteau
Citation Annals of Oncology (2017) 28 (suppl_5): v142-v157. 10.1093/annonc/mdx368
Authors F. Marteau1, P. Williams2, M. Feuilly1, B. Arnould2
  • 1Health Economics & Outcomes Research, Ipsen, 92100 - Boulogne-Billancourt/FR
  • 2Patient Centered Sciences, Mapi, Lyon/FR

Abstract

Background

Carcinoid syndrome (CS) is a rare condition in patients (pts) with neuroendocrine tumors (NETs), characterized by diarrhea, flushing, and abdominal pain that impact health-related quality of life (HRQoL). We assessed symptoms and HRQoL in pts with inadequately-controlled CS enrolled in TELESTAR (NCT01677910).

Methods

English or German-speaking pts randomized 1:1:1 to 12 wks of double-blinded (DB) treatment with telotristat ethyl (TE) 250mg, 500mg, placebo were invited to a blinded, qualitative, semi-structured exit interview after the DB period to assess symptoms, HRQoL concepts (improved/not changed/worsened), and TE treatment effects. Concepts were freely reported by pts and not solicited. EORTC QLQ-C30 and GINET21 questionnaires assessed HRQoL, daily diaries assessed baseline (BL) bowel movement (BM) frequency. Analyses compared pts with durable response (DRs; predefined as BM frequency reduction of ≥ 30% from BL for ≥50% of DB period) and without durable response.

Results

TELESTAR enrolled 135 pts, 45 per group; 34 pts (9, 16, 9 in TE 250mg, 500mg, placebo, respectively), including 10 DRs consented to interviews. BL age, gender, race, BMs/wk of interviewed pts (IPs) were similar to non-interviewed pts. Most qualitative concepts were captured, to an extent, by the QLQ-C30; most common HRQoL qualitative concepts identified were daily life activities, physical, and psychological, with most TE-treated pts improving in these over the DB period. The most common symptoms (improvement/no change) reported in all IPs were diarrhea consistency (n = 17/n=10), frequency (n = 17/n=9), urgency (n = 11/n=7); flushing (n = 11/n=7), and fatigue (n = 9/n=4). A higher proportion of TE-treated pts and DRs reported symptom and HRQoL concept improvements. Durable response (p 

Conclusions

The QLQ-C30 covered most qualitative concepts, but due to the lack of emphasis on key symptoms, may not adequately reflect pt perspectives. Interviews suggested improvements in symptoms and HRQoL with TE treatment and in DRs.

Clinical trial identification

NCT01677910

Legal entity responsible for the study

Lexicon Pharmaceuticals

Funding

Lexicon Pharmaceuticals and Ipsen Pharma SAS

Disclosure

F. Marteau, M. Feuilly: Employee of Ipsen. P. Williams, B. Arnould: Employee of Mapi.