Evidence map›Paper›PMID 25678394›Full record

Trial reportJournal of vascular and interventional radiology : JVIR2015

Double-blinded, randomized phase II study using embolization with or without granulocyte-macrophage colony-stimulating factor in uveal melanoma with hepatic metastases.

Matias E Valsecchi, Mizue Terai, David J Eschelman, Carin F Gonsalves, Inna Chervoneva, Jerry A Shields, Carol L Shields, Akira Yamamoto, Kevin L Sullivan, MaryAnn Laudadio and 3 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of vascular and interventional radiology : JVIR, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
5.4field-weighted citation impact, top 4% 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

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pooled it
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  8. Article
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  11. Article
  12. Management of liver metastases from uveal melanoma.The British journal of surgery · 2025
    Review
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  14. Article
  15. Review
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  17. Article
  18. Review
  19. The Contemporary Landscape and Future Directions of Intratumoral Immunotherapy.Journal of immunotherapy and precision oncology · 2023
    Review
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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

13 authors at 3 institutions in 2 countries.

Matias E ValsecchiDepartment of Medical Oncology, Jefferson Medical College of Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Mizue TeraiDepartment of Medical Oncology, Jefferson Medical College of Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
David J EschelmanDepartment of Radiology, Division of Interventional Radiology, Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Carin F GonsalvesDepartment of Radiology, Division of Interventional Radiology, Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Inna ChervonevaDivision of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Jerry A ShieldsOcular Oncology Service, Wills Eye Hospital, Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Carol L ShieldsOcular Oncology Service, Wills Eye Hospital, Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Akira YamamotoDepartment of Radiology, Graduate School of Medicine, Osaka City University, Osaka. Japan.
Kevin L SullivanFresenius Vascular Care, Decatur, Georgia.
MaryAnn LaudadioDepartment of Medical Oncology, Jefferson Medical College of Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
David BerdDepartment of Medical Oncology, Jefferson Medical College of Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Michael J MastrangeloDepartment of Medical Oncology, Jefferson Medical College of Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107.
Takami SatoDepartment of Medical Oncology, Jefferson Medical College of Thomas Jefferson University, 1015 Walnut St., Suite 1024, Philadelphia, PA 19107. Electronic address: takami.sato@jefferson.edu.
Thomas Jefferson University · USFresenius Medical Care (United States) · USOsaka City University · JP

Funding

X-Ray Crystallography and Macromolecular CharacterizationP30CA056036 · NCI · THOMAS JEFFERSON UNIVERSITY · PI DANIEL P SILVER · 1995 to 2026
$94.8M
Immunoembolization of the Hepatic Artery with (GM-CSF)R21CA103250 · NCI · THOMAS JEFFERSON UNIVERSITY · PI SATO, TAKAMI · 2004 to 2005
$579k
NCI NIH HHS 5R21CA103250-02NCI NIH HHS P30 CA056036NCI NIH HHS R21 CA103250
6 · The paper itself

Abstract

purposeTo investigate the effects of immunoembolization with granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with uveal melanoma (UM) with liver-only metastasis. MATERIALS AND

methodsIn this double-blind phase II clinical trial, patients were randomized to undergo immunoembolization or bland embolization (BE). Lobar treatment was performed with GM-CSF or normal saline solution mixed with ethiodized oil followed by embolization with gelatin sponge emulsified with iodinated contrast medium. Fifty-two patients (immunoembolization, n = 25; BE, n = 27) were enrolled. Response was assessed after every two treatments. The primary endpoint was overall response rate (ORR) of liver metastases. Progression-free survival (PFS), overall survival (OS), and immunologic responses were secondary endpoints.

resultsThere were five partial responses in the immunoembolization group (ORR, 21.2%; 90% confidence interval [CI], 10.3%-30.5%) and three in the BE group (ORR, 16.7%; 90% CI, 6.3%-26.9%). Stable disease was seen in 12 patients in the immunoembolization group and 19 in the BE group. OS times were 21.5 months (95% CI, 18.5-24.8 mo) with immunoembolization and 17.2 months (95% CI, 11.9-22.4 mo) with BE. The degree of proinflammatory cytokine production was more robust after immunoembolization and correlated with time to "systemic" extrahepatic progression. In the immunoembolization group, interleukin (IL)-6 levels at 1 hour (P = .001) and IL-8 levels at 18 hours after the procedure (P < .001) were significant predictors of longer systemic PFS. Moreover, a dose-response pattern was evident between posttreatment serum cytokine concentrations and systemic PFS.

conclusionsImmunoembolization induced more robust inflammatory responses, which correlated with the delayed progression of extrahepatic systemic metastases.

Indexed as

AdultAgedAged, 80 and overChemoembolization, TherapeuticDouble-Blind MethodEthiodized OilFemaleGranulocyte-Macrophage Colony-Stimulating FactorHemostaticsHumansLiver NeoplasmsMaleMelanomaMiddle AgedTreatment OutcomeUveal NeoplasmsEthiodized OilGranulocyte-Macrophage Colony-Stimulating FactorHemostatics

Identifiers

PMID25678394
PMCPMC4417549
OpenAlexW2140312356

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.