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Sökning: (WFRF:(Öberg Kjell 1946 )) pers:(Caplin Martyn) > Long-Term Safety Ex...

LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00005138naa a2200517 4500
001oai:DiVA.org:uu-393745
003SwePub
008191111s2019 | |||||||||||000 ||eng|
024a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3937452 URI
024a https://doi.org/10.1634/theoncologist.2018-02362 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
100a Anthony, Lowell B.u Univ Kentucky, Markey Canc Ctr, Lexington, KY USA4 aut
2451 0a Long-Term Safety Experience with Telotristat Ethyl Across Five Clinical Studies in Patients with Carcinoid Syndrome
264 c 2019-01-16
264 1b WILEY,c 2019
338 a print2 rdacarrier
520 a Background Patients with neuroendocrine tumors (NETs) and carcinoid syndrome experience considerable morbidity and mortality; carcinoid syndrome may be associated with shorter survival. Carcinoid syndrome is linked to tumoral secretion of serotonin and other bioactive substances. The subsequent debilitating diarrhea and urgency to defecate pose significant health risks. In previous studies, telotristat ethyl, a tryptophan hydroxylase inhibitor, was effective and well tolerated in treating carcinoid syndrome diarrhea. We present pooled safety data from five clinical trials with telotristat ethyl in patients with carcinoid syndrome. 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 Carcinoid syndrome can cause persistent diarrhea, even in patients treated with somatostatin analogs. Across five clinical trials in patients with carcinoid syndrome, telotristat ethyl has been well tolerated and efficacious, providing clinicians with a new approach to help control carcinoid syndrome diarrhea, in addition to somatostatin analog therapy. By reducing the stool frequency in patients with carcinoid syndrome whose diarrhea is refractory to anticholinergics, such as loperamide and atropine/diphenoxylate, and somatostatin analog dose escalation, improvement in quality of life becomes an achievable goal.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Cancer och onkologi0 (SwePub)302032 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Cancer and Oncology0 (SwePub)302032 hsv//eng
653 a Malignant carcinoid syndrome
653 a Tryptophan hydroxylase
653 a Telotristat ethyl
653 a Serotonin
653 a Diarrhea
653 a Neuroendocrine tumors
700a Kulke, Matthew H.u Boston Univ, Med Ctr, Boston, MA USA4 aut
700a Caplin, Martyn E.u Royal Free Hosp, ENETS Ctr Excellence, Neuroendocrine Tumor Unit, London, England4 aut
700a Bergsland, Emilyu Univ Calif San Francisco, Dept Med, San Francisco, CA USA4 aut
700a Öberg, Kjell,d 1946-u Uppsala universitet,Endokrin tumörbiologi4 aut0 (Swepub:uu)kjellob
700a Pavel, Marianneu Charite, Dept Hepatol & Gastroenterol, Berlin, Germany4 aut
700a Hoersch, Dieteru Zentralklin Bad Berka, Ctr Neuroendocrine Tumors, Dept Gastroenterol Endocrinol, Bad Berka, Germany4 aut
700a Warner, Richard R. P.u Icahn Sch Med Mt Sinai, Div Gastroenterol, New York, NY 10029 USA4 aut
700a O'Dorisio, Thomas M.u Univ Iowa, Dept Internal Med Endocrinol & Metab, Iowa City, IA USA4 aut
700a Dillon, Joseph S.u Univ Iowa, Dept Internal Med Endocrinol & Metab, Iowa City, IA USA4 aut
700a Lapuerta, Pablou Lexicon Pharmaceut Inc, The Woodlands, TX USA4 aut
700a Kassler-Taub, Kennethu Lexicon Pharmaceut Inc, The Woodlands, TX USA4 aut
700a Liang, Wenjunu Lexicon Pharmaceut Inc, The Woodlands, TX USA4 aut
710a Univ Kentucky, Markey Canc Ctr, Lexington, KY USAb Boston Univ, Med Ctr, Boston, MA USA4 org
773t The Oncologistd : WILEYg 24:8, s. E662-E670q 24:8<E662-E670x 1083-7159x 1549-490X
856u https://theoncologist.onlinelibrary.wiley.com/doi/pdfdirect/10.1634/theoncologist.2018-0236
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-393745
8564 8u https://doi.org/10.1634/theoncologist.2018-0236

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