Evidence map›Paper›PMID 28275117›Full record

Trial reportThe oncologist2017

Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with FOLFOX and Bevacizumab for First-Line Metastatic Colorectal Cancer.

Rocío García-Carbonero, Eric van Cutsem, Fernando Rivera, Jacek Jassem, Ira Gore, Niall Tebbutt, Fadi Braiteh, Guillem Argiles, Zev A Wainberg, Roel Funke and 10 more

Erratum issuedAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  7. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Rocío García-CarboneroOncology Department, Hospital Universitario Doce de Octubre, Madrid, Spain.
Eric van CutsemUZ Leuven Oncologie, Leuven, Belgium.
Fernando RiveraHospital Universitario Marqués de Valdecilla, Santander, Spain.
Jacek JassemMedical University of Gdansk, Gdansk, Poland.
Ira GoreBirmingham Hematology Oncology Associates, LLC, Birmingham, Alabama, USA.
Niall TebbuttAustin Health, Medical Oncology, Heidelberg, Victoria, Australia.
Fadi BraitehComprehensive Cancer Centers of Nevada, Las Vegas, Nevada, USA.
Guillem ArgilesHospital Universitario Vall d'Hebron, Departamento de Oncología, Barcelona, Spain.
Zev A WainbergUniversity of California, Los Angeles, Los Angeles, California, USA.
Roel Funke
Maria Anderson
Bruce McCall
Mark Stroh
Eric Wakshull
Priti Hegde
Weilan Ye
Daniel Chen
Ilsung Chang
Ina Rhee
Herbert HurwitzDuke Clinical Research Institute, Durham, North Carolina, USA Herbert.hurwitz@duke.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedThese negative phase II results for parsatuzumab highlight the challenges of developing an agent intended to enhance the efficacy of vascular endothelial growth factor inhibition without the benefit of validated pharmacodynamic biomarkers or strong predictive biomarker hypotheses.Any further clinical development of anti-EGFL7 is likely to require new mechanistic insights and biomarker development for antiangiogenic agents.

backgroundEGFL7 (epidermal growth factor-like domain 7) is a tumor-enriched vascular extracellular matrix protein that supports endothelial cell survival. This phase II trial evaluated the efficacy of parsatuzumab (also known as MEGF0444A), a humanized anti-EGFL7 IgG

methodsOne-hundred twenty-seven patients were randomly assigned to parsatuzumab, 400 mg, or placebo, in combination with mFOLFOX6 plus bevacizumab, 5 mg/kg. Treatment cycles were repeated every 2 weeks until disease progression or unacceptable toxicity for a maximum of 24 months, with the exception of oxaliplatin, which was administered for up to 8 cycles.

resultsThe progression-free survival (PFS) hazard ratio was 1.17 (95% confidence interval [CI], 0.71-1.93;

conclusionsThere was no evidence of efficacy for the addition of parsatuzumab to the combination of bevacizumab and chemotherapy for first-line mCRC.

Indexed as

AdultAgedAged, 80 and overAntibodies, Anti-IdiotypicAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCalcium-Binding ProteinsColorectal NeoplasmsDisease-Free SurvivalEGF Family of ProteinsEndothelial Growth FactorsFemaleFluorouracilGene Expression Regulation, NeoplasticAntibodies, Anti-IdiotypicAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedBevacizumabCalcium-Binding ProteinsEGF Family of ProteinsEGFL7 protein, humanEndothelial Growth FactorsFluorouracilLeucovorinOrganoplatinum Compoundsparsatuzumab

Identifiers

PMID28275117
PMCPMC5388369

What OpenQuestion holds

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Registered trials

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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.