Evidence map›Paper›PMID 30575560›Full record

Trial reportThe oncologist2018

Modulation of Premetastatic Niche by the Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor Pazopanib in Localized High-Risk Prostate Cancer Followed by Radical Prostatectomy: A Phase II Randomized Trial.

Benjamin L Maughan, Sumanta K Pal, David Gill, Kenneth Boucher, Christopher Martin, Meghan Salgia, Roberto Nussenzveig, Ting Liu, Josiah L Hawks, Julia Batten and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01832259 (A Neoadjuvant, Randomized, Phase II Study of Vascular Endothelial Growth Factor), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

NCT01832259 phase2completednot on this map

A Neoadjuvant, Randomized, Phase II Study of Vascular Endothelial Growth Factor (VEGF) Tyrosine Kinase Inhibitor (Pazopanib) in Men With High-Risk Prostate Cancer Followed by Radical Prostatectomy and Pelvic Lymph Node Dissection

TypeinterventionalSponsorUniversity of UtahRan2013 to 2018Enrolled30ConditionsAdenocarcinoma of the ProstateArmsPazopanib, Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

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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

16 authors at 3 institutions in 1 country.

Benjamin L MaughanDepartment of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Sumanta K PalDepartment of Medical Oncology, City of Hope, Duarte, California, USA.
David GillDepartment of Internal Medicine, University of Utah, Salt Lake City, Utah, USA.
Kenneth BoucherDepartment of Biostatistics, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Christopher MartinDepartment of Urology, University of Utah, Salt Lake City, Utah, USA.
Meghan SalgiaDepartment of Medical Oncology, City of Hope, Duarte, California, USA.
Roberto NussenzveigDepartment of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Ting LiuDepartment of Pathology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Josiah L HawksDepartment of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Julia BattenDepartment of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Gayatri NachaegariDepartment of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Robert StephensonDepartment of Urology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
William LowranceDepartment of Urology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.
Jeremy JonesDepartment of Medical Oncology, City of Hope, Duarte, California, USA.
Christopher DechetDepartment of Urology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA christopher.dechet@hci.utah.edu neeraj.agarwal@hci.utah.edu.
Neeraj AgarwalDepartment of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA christopher.dechet@hci.utah.edu neeraj.agarwal@hci.utah.edu.
University of Utah · USHuntsman Cancer Institute · USCity Of Hope National Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPazopanib was not effective in altering the premetastatic niche in the neoadjuvant setting.Pazopanib was safe and well tolerated without any new safety signals.

backgroundVascular endothelial growth factor receptor 1 (VEGFR1) expressing myeloid-derived suppressor cells (VEGFR1+ MDSCs) potentially foster metastases by establishing a premetastatic niche. In a preclinical study, VEGFR1+ clustering in lymph nodes (LNs) independently predicted time to biochemical recurrence (TTBR) in localized prostate cancer [1]. The hypothesis was that neoadjuvant pazopanib therapy will decrease VEGFR1+ clusters in pelvic lymph nodes and improve outcomes.

methodsThis is a phase II trial (NCT01832259) of neoadjuvant pazopanib 800 mg versus placebo daily for 4 weeks in high-risk localized prostate cancer. The primary endpoint was a decrease in VEGFR1+ MDSC clustering assessed by immunohistochemistry (IHC) analysis. Secondary endpoints were safety, feasibility, and TTBR.

resultsThirty patients were randomized to pazopanib versus placebo, with 15 patients randomized to each arm. Demographic and disease characteristics were similar in both arms. There was no difference in the VEGFR1+ clustering between the treatment arms (p = .345). Neoadjuvant therapy with pazopanib was well tolerated, and surgical complications were similar in both arms.

conclusionNeoadjuvant pazopanib therapy did not alter the premetastatic niche; however, treatment targeting vascular endothelial growth factor (VEGF) in the preoperative period was safe and feasible, which may open up the avenue to investigate novel combinatorial regimens, including a VEGF inhibitor in combination with immune checkpoint inhibitor in this setting.

Indexed as

HumansIndazolesMaleProstatectomyProstatic NeoplasmsProtein Kinase InhibitorsPyrimidinesSulfonamidesVascular Endothelial Growth Factor AIndazolespazopanibProtein Kinase InhibitorsPyrimidinesSulfonamidesVascular Endothelial Growth Factor A

Identifiers

PMID30575560
PMCPMC6292560
OpenAlexW2899377701

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.