Cancer Management and Research (Sep 2021)
Changes in Carcinoid Syndrome Symptoms Among Patients Receiving Telotristat Ethyl in US Clinical Practice: Findings from the TELEPRO-II Real-World Study
Abstract
Matthew H Kulke,1 Hagen F Kennecke,2 Kris Murali,3 Vijay N Joish4 1Section of Hematology/Oncology, Boston University and Boston Medical Center, Boston, MA, USA; 2Gastrointestinal Oncology, Providence Cancer Institute and Chiles Research Institute, Providence Portland Medical Center, Portland, OR, USA; 3DataWave Solutions, Cranberry, NJ, USA; 4Lexicon Pharmaceuticals, Inc., The Woodlands, TX, USACorrespondence: Matthew H KulkeSection of Hematology/Oncology, Boston University and Boston Medical Center, 72 East Concord Street, Boston, MA, 02118, USAEmail [email protected]: Inadequately controlled symptoms incur a substantial burden on patients with neuroendocrine tumors and carcinoid syndrome (CS). The effectiveness of telotristat ethyl (TE) with a somatostatin analog for uncontrolled CS diarrhea has been demonstrated in clinical trials and observational studies. TELEPRO-II was a prospective observational study evaluating TE’s effectiveness in clinical practice over the first 3 months of treatment.Methods: Patients initiating TE in 2018 participated in an optional nurse support program reporting CS symptoms during interviews at baseline and 1, 2, and 3 months after TE initiation. Eligible patients received TE for ≥ 3 months and reported symptom burden at baseline and ≥ 1 follow-up visit within the first 3 months. Daily bowel movement (BM) frequency and flushing episodes were reported as events/episodes per day. Stool consistency, nausea severity, urgency severity, and abdominal pain were reported on a severity scale (1– 10). Symptom changes were evaluated using paired-sample t-tests and Wilcoxon signed-rank tests. Analysis of symptoms based on achievement of < 30% or ≥ 30% reduction in daily BM frequency was conducted using a cumulative distribution function.Results: A total of 684/1603 (43%) patients were eligible for analysis. At baseline, patients reported a mean of 6.3 BM/day, nausea severity of 8.4/10 and stool urgency of 8.2/10. Significant improvements in all CS symptoms were observed after 3 months of TE. Mean daily BMs were reduced 64% after 3 months of TE (mean reduction [SD], – 3.99 [3.8]; P< 0.0001). Most patients (74%, n=503) reported ≥ 30% reduction in daily BM frequency; these patients also reported improvements in other symptoms (76– 87%). Patients with < 30% reduction in daily BMs also reported improvements in nausea severity (62%, n=24), daily flushing episodes (66%, n=98), abdominal pain (50%, n=60), urgency severity (38%, n=64), and stool consistency (24%, n=44).Conclusion: Patients treated with TE in a real-world setting experienced significant, clinically meaningful improvements in CS symptoms.Keywords: carcinoid syndrome, carcinoid syndrome diarrhea, neuroendocrine tumor, telotristat ethyl, somatostatin analog
