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Long-Term Treatment...
Long-Term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms : Results from the TELEPATH Study
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- Hörsch, Dieter (författare)
- Zent Klin Bad Berka, Ctr Neuroendocrine Tumors, Dept Gastroenterol Endocrinol, Bad Berka, Germany.
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- Anthony, Lowell (författare)
- Univ Kentucky, Markey Canc Ctr, Lexington, KY USA.
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- Gross, David J. (författare)
- Hadassah Hebrew Univ Med Ctr, European Neuroendocrine Tumor Soc Ctr Excellence, Dept Med, Endocrine Serv,Neuroendocrine Tumor Unit, Jerusalem, Israel.
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- Valle, Juan (författare)
- Univ Manchester, Christie NHS Fdn Trust, Manchester, Lancs, England.
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- Welin, Staffan (författare)
- Uppsala universitet,Onkologisk endokrinologi
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- Benavent, Marta (författare)
- Virgen del Rocio Univ Hosp, Inst Biomed Sevilla, Med Oncol Dept, Seville, Spain.
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- Caplin, Martyn (författare)
- Royal Free Hosp, Dept Gastroenterol & Hepatobiliary Med, Pond St Ctr Gastroenterol, London, England.
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- Pavel, Marianne (författare)
- Charite, Dept Gastroenterol & Hepatol, Berlin, Germany.
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- Bergsland, Emily (författare)
- Univ Calif San Francisco, Helen Diller Family Comprehens Canc Ctr, San Francisco, CA 94143 USA.
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- Öberg, Kjell, 1946- (författare)
- Uppsala universitet,Endokrin tumörbiologi
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- Kassler-Taub, Kenneth B. (författare)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA.
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- Binder, Polina (författare)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA.
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- Banks, Phillip (författare)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA.
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- Lapuerta, Pablo (författare)
- Lexicon Pharmaceut Inc, The Woodlands, TX USA.
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- Kulke, Matthew H. (författare)
- Boston Univ, Sect Hematol Oncol, Boston, MA 02215 USA.;Boston Med Ctr, Boston, MA USA.
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Zent Klin Bad Berka, Ctr Neuroendocrine Tumors, Dept Gastroenterol Endocrinol, Bad Berka, Germany Univ Kentucky, Markey Canc Ctr, Lexington, KY USA. (creator_code:org_t)
- 2021-05-03
- 2022
- Engelska.
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Ingår i: Neuroendocrinology. - : S. Karger. - 0028-3835 .- 1423-0194. ; 112:3, s. 298-309
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
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- Introduction: Telotristat ethyl is indicated for use in combination with somatostatin analogs (SSAs) to treat carcinoid syndrome (CS) diarrhea uncontrolled by SSAs alone in adults, but long-term safety and efficacy data beyond 48 weeks are needed.Objectives: The aims of the study were to evaluate the long-term safety and tolerability of telotristat ethyl and its effect on quality of life (QOL) in patients with CS.Methods: In this phase 3, nonrandomized, multicenter, open-label, long-term extension study (TELEPATH), patients who participated in phase 2 or 3 trials of telotristat ethyl continued treatment at their present dose level (250 or 500 mg thrice daily) for 84 weeks. Safety and tolerability, the primary endpoint, were assessed by monitoring adverse events (AEs), serious AEs, AEs of special interest (AESIs; including liver-related AEs, depression, and gastrointestinal AEs), and deaths. The secondary objective was to evaluate changes in patients’ QOL using validated cancer questionnaires and a subjective global assessment of CS symptoms.Results: In 124 patients exposed to telotristat ethyl for a mean of 102.6 ± 53.2 weeks, the type and frequency of AEs were consistent with those reported in previous trials. The occurrence of AESIs was not related to dosage or duration of therapy. Most AEs were mild to moderate in severity, and no deaths were related to telotristat ethyl. QOL scores remained stable, and the majority of patients reported adequate symptom relief throughout the study.Conclusions: Safety results of TELEPATH support the long-term use of telotristat ethyl in patients with CS diarrhea. Telotristat ethyl was well-tolerated and associated with sustained improvement in QOL scores (NCT02026063).
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Nyckelord
- Telotristat ethyl
- Carcinoid syndrome
- Diarrhea
- Safety and tolerability
- Quality of life
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Hörsch, Dieter
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Anthony, Lowell
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Gross, David J.
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Valle, Juan
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Welin, Staffan
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Benavent, Marta
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Caplin, Martyn
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Pavel, Marianne
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Bergsland, Emily
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Öberg, Kjell, 19 ...
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Kassler-Taub, Ke ...
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Binder, Polina
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Banks, Phillip
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Lapuerta, Pablo
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Kulke, Matthew H ...
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