Evidence map›Paper›PMID 19903777›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2009

Effect of granulocyte/macrophage colony-stimulating factor on vaccination with an allogeneic whole-cell melanoma vaccine.

Mark B Faries, Eddy C Hsueh, Xing Ye, Mary Hoban, Donald L Morton

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
3.9field-weighted citation impact, top 6% 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, 91 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Trial
  4. Trial
  5. Trial
  6. A viral vaccine encoding prostate-specific antigen induces antigen spreading to a common set of self-proteins in prostate cancer patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2010
    Trial
  7. Review
  8. Innate Immunity in Cancer Biology and Therapy.International journal of molecular sciences · 2023
    Review
  9. A Bayesian network meta-analysis of comparison of cancer therapeutic vaccines for melanoma.Journal of the European Academy of Dermatology and Venereology : JEADV · 2021
    Review
  10. Article
  11. Review
  12. Review
  13. Vaccine Strategy in Melanoma.Surgical oncology clinics of North America · 2019
    Review
  14. Article
  15. The CD14Frontiers in immunology · 2019
    Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

5 authors at 1 institution in 1 country.

Mark B FariesSonya Valley Ghidossi Vaccine Laboratory of the Roy E. Coats Research Laboratories of the John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA 90404, USA. fariesm@jwci.org
Eddy C Hsueh
Xing Ye
Mary Hoban
Donald L Morton
Saint John's Health Center · US

Funding

TUMOR ANTIGENS THAT ELICIT HUMORAL IMMUNE RESPONSES IN CANCER PATIENTSP01CA012582 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MORTON, DONALD L · 1985 to 2010
$40.8M
POLYVALENT VACCINE--PHASE III TRIAL IN STAGE IV MELANOMAR01CA076489 · NCI · JOHN WAYNE CANCER INSTITUTE · PI MORTON, DONALD L · 1998 to 2002
$4.2M
ENHANCEMENT OF IMMUNOGENICITY OF HUMAN MELANOMA VACCINEK08CA087071 · NCI · SAINT LOUIS UNIVERSITY · PI HSUEH, EDDY · 2000 to 2005
$648k
NCI NIH HHS CA12582NCI NIH HHS CA76489NCI NIH HHS CA87071NCI NIH HHS K08 CA087071NCI NIH HHS P01 CA012582NCI NIH HHS R01 CA076489
6 · The paper itself

Abstract

purposeThe availability of a variety of immune response modifiers creates an opportunity for improved efficacy of immunotherapy, but it also leads to uncertainty in how to combine agents and how to assess those combinations. We sought to assess the effect of the addition of granulocyte/macrophage colony-stimulating factor (GM-CSF) to vaccination with a melanoma vaccine. EXPERIMENTAL

designNinety-seven patients with resected melanoma (stage II-IV) were enrolled, stratified by stage, and randomized to receive a cellular melanoma vaccine with or without GM-CSF. The primary endpoint was delayed-type hypersensitivity (DTH) response to melanoma cells. Antibody responses, peripheral leukocyte counts, and survival were also examined.

resultsThe GM-CSF arm showed enhanced antibody responses with an increase in IgM titer against the TA90 antigen and increased TA90 immune complexes. This arm also had diminished antimelanoma cell delayed-type hypersensitivity response. Peripheral blood leukocyte profiles showed increases in eosinophils and basophils with decreased monocytes in the GM-CSF arm. These immune changes were accompanied by an increase in early melanoma deaths and a trend toward worse survival with GM-CSF.

conclusionThese data suggest that GM-CSF is not helpful as an immune adjuvant in this dose and schedule and raise concern that it may be harmful. Based on the discordant findings of an immune endpoint and clinical outcome, the use of such surrogate endpoints in selecting treatments for further evaluation must be done with a great deal of caution.

Indexed as

Adjuvants, ImmunologicAgedCancer VaccinesCell Line, TumorFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunoglobulin GImmunoglobulin MLeukocytesMaleMelanomaMiddle AgedPilot ProjectsSkin NeoplasmsAdjuvants, ImmunologicCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorImmunoglobulin GImmunoglobulin M

Identifiers

PMID19903777
PMCPMC2920049
OpenAlexW2165502771

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.