BACKGROUND: Neuroendocrine tumor patients report substantial burden from inadequate control of carcinoid syndrome diarrhea (CSD) with somatostatin analog (SSA) monotherapy. We report outcomes from patients receiving telotristat ethyl (TE) in the RELAX study.
METHODS: Patients can opt-in to online surveys before starting TE (baseline) and every 6 months for up to 3 years. Descriptive statistics summarized patient characteristics, rescue medications, clinical symptoms, weight, work productivity and activity impairment (WPAI), and satisfaction with TE treatment. Changes were evaluable for patients with pre- and post-TE responses.
RESULTS: A total of 215 patients completed pre-TE surveys (mean age, 61 years; 60% female). One-third (36%) were satisfied with control of their CSD before starting TE; 206 (96%) were taking long-acting SSAs and 47 (22%) were taking short-acting SSA rescue medication at baseline. Reduced or stable rescue medication use was reported at Months 6 (19% and 75%, respectively), 12 (16% and 76%) and 18 (17% and 83%). Among patients with pre- and post-TE responses (n=107), 84% reported reduced number of daily bowel movements and 80% reported improvement in CS symptoms after 6 months of TE treatment. Stable or increased weight was reported at Months 6 (76%, 81/107), 12 (80%, 53/66), and 18 (74%, 31/42). Of 22 employed patients, mean decrease in WPAI productivity loss was 13.2 (SD=18.31) points. Of 106 responders, mean decrease in WPAI overall activity impairment was 9.4 (SD=26.76) points. Patients were satisfied with 6-month TE control of CSD (78%), CS symptoms (76%) and NANETS 2021 Symposium Abstracts CS-related flushing (57%). Patient-reported changes in daily bowel movements and satisfaction with TE control of CS symptoms have been consistent from 2018-2021.
CONCLUSION: Patients receiving TE reported improved CSD, satisfaction with control of CS symptoms, weight gain or maintenance, and reduced WPAI impairments after 6 months of TE treatment in the context of stable or reduced rescue medication use.
