Evidence map›Paper›PMID 28721067›Full record

ArticleOncoTargets and therapy2017

Phase I dose-escalation study of long-acting pasireotide in patients with neuroendocrine tumors.

James C Yao, Jennifer A Chan, Alain C Mita, Madan G Kundu, Karina Hermosillo Reséndiz, Ke Hu, Shoba Ravichandran, Jonathan R Strosberg, Edward M Wolin

Open access · goldAbstract read
In one paragraph

Article in OncoTargets and therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
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  6. Somatostatin Analogs in Clinical Practice: a Review.International journal of molecular sciences · 2020
    Review
  7. Review
  8. Article
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  11. Carcinoid-syndrome: recent advances, current status and controversies.Current opinion in endocrinology, diabetes, and obesity · 2018
    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

9 authors at 4 institutions in 1 country.

James C YaoGI Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Jennifer A ChanGastrointestinal Cancer Center, Dana-Farber Cancer Institute, Boston, MA.
Alain C MitaExperimental Therapeutics, Cedars-Sinai Medical Center, Los Angeles, CA.
Madan G KunduOncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
Karina Hermosillo ReséndizOncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
Ke HuOncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
Shoba RavichandranOncology, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
Jonathan R StrosbergDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Edward M WolinOncology, Montefiore Einstein Center for Cancer Care, Bronx, NY, USA.
Cedars-Sinai Medical Center · USDana-Farber Cancer Institute · USMoffitt Cancer Center · USThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase I study aimed at determining the maximum tolerated dose (MTD) and characterizing the safety, tolerability, pharmacokinetics (PKs), and efficacy of pasireotide in patients with advanced neuroendocrine tumors (NETs). Patients were enrolled in two phases: dose-escalation phase (to determine the MTD) at a starting dose of 80 mg pasireotide long-acting release (LAR) i.m. followed by a dose-expansion phase (to evaluate safety and prelimi-nary efficacy). Associations between PK/pharmacodynamic parameters and clinical outcomes were evaluated using linear regression analysis. A total of 29 patients were treated with 80 mg (n=13) and 120 mg (n=16) doses. Most common primary tumor sites included small intestine (44.8%), pancreas (24.1%), and lung (17.2%). No protocol-defined dose-limiting toxicities were observed in the study; however, in post hoc analysis, a higher incidence of bradycardia (heart rate [HR] <40 beats per minute [bpm]) was observed with 120 mg (31.3%) vs 80 mg (0%). Two partial responses (PRs) were observed, both in the 120 mg dose cohort. Pasireotide concentrations correlated with tumor shrinkage, although the association was not statistically significant (

Indexed as

Bayesian logistic regression modeldose escalation with overdose controlMTDpharmacodynamicspharmacokinetics

Identifiers

PMID28721067
PMCPMC5499931
OpenAlexW2734021371

What OpenQuestion holds

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LicenceCC BY-NC
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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.