Efficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period

Hörsch, Dieter; Kulke, Matthew H.; Caplin, Martyn; Anthony, Lowell; Bergsland, Emily K.; Öberg, Kjell; Welin, Staffan; Warner, Richard R.P.; Lombard‐Bohas, Catherine; Kunz, Patrik; Valle, Juan W.; Fleming, Douglas; Lapuerta, Pablo; Banks, Phillip; Pavel, M

doi:10.1530/endoabs.46.oc3

Cited by 2 publications

(6 citation statements)

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“…In a number of recent studies[1••14, ••116, •117] including a Phase 3 prospective randomized trial(TELESTAR)[•115, ••116], telotristat has been shown to decrease the occurrence of diarrhea, as well as markedly decrease or normalize urinary serotonin/5-HIAA levels in patients with the carcinoid syndrome. The telotristat decrease in the diarrhea had a large impact on the emotional, social and physical aspects of the patient’s lives[113, •117, 118].…”

Section: Summary Of Recent Advances/controversies In Management Ofmentioning

confidence: 99%

“…Both studies and case reports have reported the successful use in patients with carcinoid syndrome of the control of the symptoms of the hormone-excess state by using: everolimus[•38]; PRRT[•56, 57, 66, 95, •96, •148]; liver-directed therapies including TACE/TAE[70, 72, •73, 77, 95, 98, 149]; radioembolization[70, 150, 151]; RFA[80, 81, 83, 95, 152]; by increasing the dosage of octreotide/Lanreotide in refractory cases[94, 97, 153–155]; use of cytoreductive surgery[23, 95, 156–160]; use of 131 I-MIBG[95, 105, 106, 108, 110, •161, 162–164]; with the use of the tryptophan hydroxylase inhibitor, Telotristat[108, 113, 114, ••116, •117, 118, 119] and with pasireotide in octreotide resistant cases[•122]. …”

Section: Summary Of Recent Advances In Management Of Specific Hormmentioning

confidence: 99%

“…The TELESTAR study[•115, ••116] is ongoing and is a phase 3 randomized trial of the efficacy/safety of the 11B-hydroxylase inhibitor required for serotonin synthesis, in patients with carcinoid syndrome, Telotristat resulted in a 29%(250 mg) and 35%(500 mg) decrease in bowel movement frequency and was well tolerated[•115, ••116], suggesting it may be a valuable addition to control some aspects of the carcinoid syndrome. In a Phase 2, multicenter study[•122] involving 45 patients with carcinoid syndrome with refractory symptoms to octreotide-LAR, pasireotide controlled the diarrhea and/or flushing in 27%.…”

Section: Summary Of Recent Advances In Management Of Specific Hormmentioning

confidence: 99%

“…High doses of somatostatin anlogues are used prophylactically prior to these procedures, as well as intravenously during the procedure, but are not always successful [2]. Whether telotristat[••116, •117, 118] will prevent the development of carcinoid crises is unclear at present.…”

Section: Summary Of Recent Advances In Management Of Specific Hormmentioning

confidence: 99%

“…While the TELESTAR study established that telotristat, by inhibiting the synthesis of serotonin[•115, ••116], markedly ameliorated the diarrhea in patients with carcinoid syndrome, its effect on a number of other important manifestations of carcinoid syndrome will be very important, and are at present unclear. Part of the uncertainty is due to the release of numerous other biologically active amines/peptides by the carcinoid tumor, which are reported to contribute to the symptoms of the hormone-excess state[2].…”

Section: Controversies/unresolved Issues In Current Management Of mentioning

confidence: 99%

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Treatment of symptomatic neuroendocrine tumor syndromes: recent advances and controversies

Ito¹,

Lee²,

Jensen³

2016

Expert Opinion on Pharmacotherapy

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Introduction Neuroendocrine tumors(NETs), once thought rare, are increasing in frequency in most countries and receiving increasing-attention. NETs present two-treatment problems. A proportion is functional, hormone-excess-state(F-NET), each of which must be treated. Recently, there are many advances, well-covered in reviews/consensus papers on imaging-NETs;new, novel anti-tumor treatments and understanding their pathogenesis. However, little attention has been paid to advances in the treatment of the hormone-excess-state. These advances are usually reported in case-series, and case-reports with few large studies. In this paper these advances are reviewed. Areas covered Advances in the last 5-years are concentrated on, but a review up to 10-years was performed. PubMed and other databases(Cochrane, etc) were searched for F-NET-syndromes including carcinoid-syndrome, as well as meeting-abstracts on NETs. All advances that controlled hormone-excess-states or facilitated-control were covered. These include new medical-therapies[serotonin-synthesis inhibitors(telotristat), Pasireotide, new agents for treating ACTHomas], increased dosing with conventional therapies(octreotide-LAR, Lanreotide-Autogel), mTor inhibitors(everolimus), Tyrosine-kinase inhibitors(sunitinib), cytoreductive surgery, liver-directed therapies(embolization, chemoembolization, radioembolization, RFA), peptide radio-receptor-therapy(PRRT) and 131I-MIBG, ablation of primary F-NETs. Expert Opinion Although many of the newer therapies controlling the hormone-excess-states in F-NETs are reported in relatively few patients, all the approaches show promise. Their description also generates some controversies/unresolved areas, such as the order of these new treatments, their longterm-efficacy, and effectiveness of combinations which may require large, controlled studies.

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Section: Summary Of Recent Advances/controversies In Management Ofmentioning

confidence: 99%

Section: Summary Of Recent Advances In Management Of Specific Hormmentioning

confidence: 99%

Section: Summary Of Recent Advances In Management Of Specific Hormmentioning

confidence: 99%

Section: Summary Of Recent Advances In Management Of Specific Hormmentioning

confidence: 99%

Section: Controversies/unresolved Issues In Current Management Of mentioning

confidence: 99%

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Treatment of symptomatic neuroendocrine tumor syndromes: recent advances and controversies

Ito¹,

Lee²,

Jensen³

2016

Expert Opinion on Pharmacotherapy

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Practical management of toxicities associated with targeted therapies for advanced gastroenteropancreatic neuroendocrine tumors

Cuyle

Prenen²

2018

aog

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Neuroendocrine tumors are heterogeneous, rare malignancies that arise most frequently in the gastroenteropancreatic tract (GEPNET). The therapeutic armamentarium for the treatment of GEPNETs has expanded significantly over the last two decades, however the ideal sequencing strategy remains controversial. As this disease may be relatively slow-growing, patients are expected to be treated for longer periods, so that even mild toxicities can influence quality of life, compliance and outcome in the long run. Prospective data on optimal adverse event management are lacking and recommendations are largely based on expert opinion and drug prescribing information. This review summarizes practical recommendations for toxicity management associated with the most commonly used GEPNET treatment options and stresses important focus points for future clinical trials.

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Efficacy and safety of telotristat etiprate in patients with carcinoid syndrome not adequately controlled by somatostatin analog therapy: Analysis of the ongoing TELESTAR extension period

Cited by 2 publications

References 0 publications

Treatment of symptomatic neuroendocrine tumor syndromes: recent advances and controversies

Treatment of symptomatic neuroendocrine tumor syndromes: recent advances and controversies

Practical management of toxicities associated with targeted therapies for advanced gastroenteropancreatic neuroendocrine tumors

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