Evidence map›Paper›PMID 30768575›Full record

Trial reportPancreas2019

A Phase II Trial of Ziv-Aflibercept in Patients With Advanced Pancreatic Neuroendocrine Tumors.

Daniel M Halperin, J Jack Lee, Chaan S Ng, Jonathan R Strosberg, Jeannelyn S Estrella, Cecile G Dagohoy, Arvind Dasari, James C Yao

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Pancreas, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
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  5. 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

8 authors at 3 institutions in 1 country.

Daniel M HalperinFrom the Departments of Gastrointestinal Medical Oncology.
J Jack LeeBiostatistics.
Chaan S NgRadiology, University of Texas M.D. Anderson Cancer Center, Houston, TX.
Jonathan R StrosbergDepartment of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center, Tampa, FL.
Jeannelyn S EstrellaDepartment of Pathology, University of Texas M.D. Anderson Cancer Center, Houston, TX.
Cecile G DagohoyFrom the Departments of Gastrointestinal Medical Oncology.
Arvind DasariFrom the Departments of Gastrointestinal Medical Oncology.
James C YaoFrom the Departments of Gastrointestinal Medical Oncology.
The University of Texas MD Anderson Cancer Center · USCancer Research And Biostatistics · USMoffitt Cancer Center · US

Funding

Texas EXperimental Cancer Therapeutics Network - TEX CTNUM1CA186688 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI FUNDA MERIC-BERNSTAM, John Sarantopoulos · 2014 to 2026
$20.4M
NCI NIH HHS UM1 CA186688
6 · The paper itself

Abstract

objectivesTherapies for patients with advanced well-differentiated pancreatic neuroendocrine tumors (pNETs) are insufficient, with patients succumbing to disease despite recent treatment advances. Ziv-aflibercept is a fusion protein of portions of the vascular endothelial growth factor (VEGF) receptors 1 and 2, fused to the Fc portion of immunoglobulin G1, forming a VEGF trap. Perfusion computed tomography (CT) has previously defined hyperperfused neuroendocrine tumors, potentially predicting antiangiogenic benefit.

methodsWe performed a single-arm open-label study, using the Simon optimal 2-stage design, of 6 mg/kg ziv-aflibercept in patients with advanced pNETs. The primary end point was objective radiographic response, with a hierarchically tested co-primary end point of response prediction by baseline hyperperfusion, defined as blood volume greater than 5.25 mL/100 g and permeability surface area product greater than 25 mL/min per 100 g.

resultsBetween July 3, 2014, and September 28, 2016, 21 patients were treated. Two patients (9.5%; 95% confidence interval, 1.1%-30.4%) demonstrated objective response, satisfying criteria to open the second stage, but the study was terminated for accrual. Perfusion CT could not be confirmed to predict radiographic response. Toxicities include 1 grade 5 gastrointestinal hemorrhage and 5 incidents of proteinuria requiring treatment discontinuation.

conclusionsResponses with ziv-aflibercept were consistent with other VEGF inhibitors in pNET, but perfusion CT could not be confirmed to predict outcome.

Indexed as

AdultAgedAged, 80 and overFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNeuroendocrine TumorsPancreatic NeoplasmsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID30768575
PMCPMC10807548
OpenAlexW2916432310

What OpenQuestion holds

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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.