Relationship Between Symptoms and Health-Related Quality-of-Life Benefits in Patients With Carcinoid Syndrome: Post Hoc Analyses From TELESTAR.

Cella D1Beaumont JL2Hudgens S3Marteau F4Feuilly M4Houchard A4Lapuerta P5Ramage J6Pavel M7Hörsch D8Kulke MH9.

Clin Ther. 2018 Nov 23 (epub ahead of print)

Abstract

PURPOSE:

Patients with metastatic neuroendocrine tumors and carcinoid syndrome (CS) may experience chronic, recurring symptoms despite somatostatin analogue therapy. Little is known about the relationship between bowel movement (BM) frequency, patient-reported symptoms and health-related quality of life (QoL). Data from the TELESTAR study were used in exploratory, post hoc analyses to understand the relationship between durable reductions in BM frequency, symptom relief, and health-related QoL.

METHODS:

Patients with metastatic neuroendocrine tumors and CS in the Phase III TELESTAR study were randomized (1:1:1) to receive telotristat ethyl (TE) 250 mg, TE 500 mg, or placebo three times daily (TID) during a 12-week double-blind treatment period (DBTP). All patients received TE 500 mg TID in an open-label extension (OLE) to Week 48. Durable response was predefined. Analyses compared durable responders (DRs) and non-durable responders (NDRs), irrespective of treatment group, at Weeks 12, 24, and 48.

 

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