Evidence map›Paper›PMID 25012985›Full record

Trial reportEndocrine-related cancer2014

Telotristat etiprate, a novel serotonin synthesis inhibitor, in patients with carcinoid syndrome and diarrhea not adequately controlled by octreotide.

Matthew H Kulke, Thomas O'Dorisio, Alexandria Phan, Emily Bergsland, Linda Law, Phillip Banks, Joel Freiman, Kenny Frazier, Jessica Jackson, James C Yao and 5 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Endocrine-related cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 2 pooled it
11.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 2 syntheses or guidelines pooled it, 127 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Use of healthcare REsources and associated COsts in controlled versus uncontrolled carcinoid SYndrome in patients with neuroendocrine tumours: the RECOSY study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Observational
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Review
  17. Carcinoid Heart Disease: How to Diagnose and Treat in 2020?Clinical Medicine Insights. Cardiology · 2020
    Review
  18. Article
  19. Article
  20. Carcinoid Syndrome: Updates and Review of Current Therapy.Current treatment options in oncology · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 1 country.

Matthew H KulkeDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA Matthew_Kulke@dfci.harvard.edu.
Thomas O'DorisioDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Alexandria PhanDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Emily BergslandDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Linda LawDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Phillip BanksDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Joel FreimanDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Kenny FrazierDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Jessica JacksonDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
James C YaoDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Larry KvolsDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Pablo LapuertaDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Brian ZambrowiczDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Douglas FlemingDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
Arthur SandsDepartment of Medical OncologyDana-Farber Cancer Institute, 450 Brookline Avenue, Boston, Massachusetts 02115, USAUniversity of Iowa Hospitals and ClinicsIowa City, Iowa, USAThe University of Texas M.D. Anderson Cancer CenterHouston, Texas, USAUCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, USALexicon Pharmaceuticals Inc.The Woodlands, Texas, USAH. Lee Moffitt Cancer CenterTampa, Florida, USA.
The University of Texas at Austin · USDana-Farber Cancer Institute · USUniversity of California, San Francisco · US

Funding

Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Douglas Robert Spitz · 2000 to 2026
$70.0M
NCI NIH HHS P30 CA086862
6 · The paper itself

Abstract

Serotonin produced by neuroendocrine tumors is believed to be a principal cause of the diarrhea in carcinoid syndrome. We assessed the safety and efficacy of telotristat etiprate, an oral serotonin synthesis inhibitor, in patients with diarrhea associated with carcinoid syndrome. In this prospective, randomized study, patients with evidence of carcinoid tumor and ≥4 bowel movements (BMs)/day despite stable-dose octreotide LAR depot therapy were enrolled in sequential, escalating, cohorts of four patients per cohort. In each cohort, one patient was randomly assigned to placebo and three patients to telotristat etiprate, at 150, 250, 350, or 500 mg three times a day (tid). In a subsequent cohort, one patient was assigned to placebo and six patients to telotristat etiprate 500 mg tid. Patients were assessed for safety, BM frequency (daily diary), 24 h urinary 5-hydroxyindoleacetic acid (u5-HIAA), and adequate relief of carcinoid gastrointestinal symptoms (using a weekly questionnaire). Twenty-three patients were treated: 18 received telotristat etiprate and five received placebo. Adverse events were generally mild. Among evaluable telotristat etiprate-treated patients, 5/18 (28%) experienced a ≥30% reduction in BM frequency for ≥2 weeks, 9/16 (56%) experienced biochemical response (≥50% reduction or normalization in 24-h u5-HIAA) at week 2 or 4, and 10/18 (56%) reported adequate relief during at least 1 of the first 4 weeks of treatment. Similar activity was not observed in placebo-treated patients. Telotristat etiprate was well tolerated. Our observations suggest that telotristat etiprate has activity in controlling diarrhea associated with carcinoid syndrome. Further studies confirming these findings are warranted.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, HormonalDiarrheaFemaleGastrointestinal AgentsHumansHydroxyindoleacetic AcidMaleMalignant Carcinoid SyndromeMiddle AgedOctreotidePhenylalaninePyrimidinesSerotonin AntagonistsAntineoplastic Agents, HormonalGastrointestinal AgentsHydroxyindoleacetic AcidOctreotidePhenylalaninePyrimidinesSerotonin Antagoniststelotristatadultcarcinoid syndromediarrheaneuroendocrine tumorserotonintryptophan hydroxylase

Identifiers

PMID25012985
PMCPMC4295770
OpenAlexW2017099595

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.