Article

Telotristat Ethyl Improves Symptoms and Patient Satisfaction in Carcinoid Syndrome

Author(s):

Patients with carcinoid syndrome reported improved symptoms following treatment with telotristat ethyl.

Daneng Li, MD

Daneng Li, MD

Patients with carcinoid syndrome reported improved symptoms following treatment with telotristat ethyl (Xermelo), according to results presented in a poster during the 2021 NANETS Annual Meeting.1

In findings from a survey of 215 patients treated in the RELAX study (NCT03223428), investigators found that 78% of 107 patients with baseline and month 6 responses were satisfied or very satisfied with control of their carcinoma syndrome and diarrhea (CSD) symptoms following 6 months of treatment with telotristat ethyl. At 6 months, 76% of patients reported stable or increased weight.

“Results of this long-term follow-up from the RELAX patient registry continues to show very encouraging sustained benefit with [telotristat ethyl] in helping neuroendocrine tumor patients control the symptoms of carcinoid syndrome, maintain weight, and reduce impairments to work productivity and activity,” lead author Daneng Li, MD, said in a news release.2 Li is an assistant professor in the Department of Medical Oncology and Therapeutics Research, and is co-director of the Neuroendocrine Tumor Program at City of Hope.

Carcinoid syndrome is a rare condition that occurs in patients with metastatic neuroendocrine tumors. It is characterized by frequent and debilitating diarrhea, as well as by facial flushing, abdominal pain, fatigue and, over time, heart valve damage.

RELAX is an ongoing, real-world, noninterventional prospective registry of US patients with carcinoid syndrome. Study participants completed online surveys at baseline and every 6 months for up to 3 years. At each time interval, patients reported on changes in their clinical symptoms, use of rescue medication, weight, and work productivity and activity impairment (WPAI). Investigators also assessed patient satisfaction with telotristat ethyl treatment at each 6-month interval.

The primary objective of the study is to estimate the proportion of patients with carcinoid syndrome who are satisfied with their overall symptom control 6 months after initiating treatment with telotristat ethyl. Key secondary end points include the proportion of patients reporting satisfaction with their CS-related diarrhea and flushing control, effect of telotristat ethyl on work productivity and activity impairment, and the effect of telotristat ethyl on weight gain or maintenance.

At 6 months, investigators found that patient satisfaction with control of CSD improved from 47% at baseline to 78% in those with baseline and month 6 responses. Most patients reported improvement in number of daily bowel movements (84%) and control of CS symptoms (80%).

Most patients reported reduced or stable use of rescue medication after 6 (75%), 12 (76%), and 18 (83%) months of treatment. Furthermore, 76% of patients reported stable or increased weight after 6 months; 80% after 12 months of treatment and 74% did so after 18 months of treatment.

Of 69 participants who were employed at baseline, the mean number of work hours missed due to carcinoid syndrome over the previous 7 days declined from 3.7 hours at baseline to 1.5 hours at 6 months. Similarly, presenteeism (–14.1%), impaired work productivity (–13.2%), and impaired activity (–9.4%) all declined from baseline to 6 months. However, there was a slight increase in absenteeism (5.2%). Although there were numerical improvements in work productivity and activity impairment, investigators cautioned that these results came from small sample sizes.

References

  1. Li D, Darden C, Sayeed S, et al. Patient-reported clinical and productivity outcomes from the longitudinal telotristat ethyl treatment registry. Presented at: 2021 NANETS Annual Meeting; November 3-6, 2021; virtual. Abstract 98.
  2. TerSera presents patient-reported clinical and productivity outcomes associated with Xermelo® (telotristat ethyl): long-term registry trial of patients with carcinoid syndrome diarrhea. News release. TerSera Therapeutics. November 9, 2021. Accessed November 9, 2021. https://prn.to/3bYBU42
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