Abstract | BACKGROUND: SUBJECTS, MATERIALS, AND METHODS: Adverse events reported during telotristat ethyl treatment were pooled from two phase II and three phase III clinical trials in 239 patients with carcinoid syndrome. Long-term safety of telotristat ethyl and causes of hospitalization and death were reviewed; overall survival was estimated. RESULTS: Mean (median; range) duration of exposure and follow-up was 1.3 years (1.1 years; 1 week to 5.7 years), with 309 total patient-years of exposure. Leading causes of hospitalization were gastrointestinal disorders or were related to the underlying tumor and related treatment. Survival estimates at 1, 2, and 3 years were 93%, 88%, and 77%. Nearly all deaths were due to progression or complication of the underlying disease; none were attributable to telotristat ethyl. There was one death in year 4. CONCLUSION: Based on long-term safety data, telotristat ethyl is well tolerated and has a favorable long-term safety profile in patients with carcinoid syndrome. IMPLICATIONS FOR PRACTICE:
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Authors | Lowell B Anthony, Matthew H Kulke, Martyn E Caplin, Emily Bergsland, Kjell Öberg, Marianne Pavel, Dieter Hörsch, Richard R P Warner, Thomas M O'Dorisio, Joseph S Dillon, Pablo Lapuerta, Kenneth Kassler-Taub, Wenjun Jiang |
Journal | The oncologist
(Oncologist)
Vol. 24
Issue 8
Pg. e662-e670
(08 2019)
ISSN: 1549-490X [Electronic] England |
PMID | 30651397
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © AlphaMed Press 2019. |
Chemical References |
- Antineoplastic Agents
- Pyrimidines
- Phenylalanine
- telotristat ethyl
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(administration & dosage, adverse effects)
- Clinical Trials, Phase II as Topic
- Clinical Trials, Phase III as Topic
- Diarrhea
(chemically induced, drug therapy, etiology, pathology)
- Female
- Humans
- Male
- Malignant Carcinoid Syndrome
(drug therapy, pathology, physiopathology)
- Middle Aged
- Patient Safety
- Phenylalanine
(adverse effects, analogs & derivatives, therapeutic use)
- Pyrimidines
(adverse effects, therapeutic use)
- Randomized Controlled Trials as Topic
- Retrospective Studies
- Treatment Outcome
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