Evidence map›Paper›PMID 31274231›Full record

Trial reportCancer medicine2019

Final analysis of a phase I/IIa trial of the folate-binding protein-derived E39 peptide vaccine to prevent recurrence in ovarian and endometrial cancer patients.

Tommy A Brown, Kevin Byrd, Timothy J Vreeland, Guy T Clifton, Doreen O Jackson, Diane F Hale, Garth S Herbert, John W Myers, Julia M Greene, John S Berry and 7 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
1.2field-weighted citation impact, top 21% 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

26 citing papers in PubMed, 36 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Epigenetic regulation in gynecological cancers: a paradigm shift in immunotherapy strategies.Journal of experimental & clinical cancer research : CR · 2025
    Review
  7. Review
  8. Folate Receptor Alpha-A Secret Weapon in Ovarian Cancer Treatment?International journal of molecular sciences · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Bioactive peptides for anticancer therapies.Biomaterials translational · 2023
    Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Nucleic acid vaccination strategies for ovarian cancer.Frontiers in bioengineering and biotechnology · 2022
    Review
  19. Review
  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

17 authors at 7 institutions in 2 countries.

Tommy A BrownDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.
Kevin ByrdNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.
Timothy J VreelandDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4593-7502
Guy T CliftonDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.ORCID 0000-0001-5962-3876
Doreen O JacksonDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.
Diane F HaleDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.
Garth S HerbertDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.
John W MyersDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.
Julia M GreeneDepartment of Surgery, San Antonio Military Medical Center, San Antonio, Texas.
John S BerryDepartment of Surgery, Womack Army Medical Center, Fayetteville, North Carolina.
Jonathan MartinCancer Vaccine Development Program, San Antonio, Texas.
John C ElkasDepartment of Obstetrics and Gynecology, Inova Fairfax Hospital, Annandale, Virginia.
Thomas P ConradsNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.
Kathleen M DarcyNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.
Chad A HamiltonNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.
George L MaxwelNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center Bethesda, Bethesda, Maryland.
George E PeoplesDepartment of Obstetrics and Gynecology, Inova Fairfax Hospital, Annandale, Virginia.
Brooke Army Medical Center · USWalter Reed National Military Medical Center · USInova Fairfax Hospital · USInova Health System · USInstitut de Recherche Vaccinale · FRThe University of Texas MD Anderson Cancer Center · USWomack Army Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundE39, an HLA-A2-restricted, immunogenic peptide derived from the folate-binding protein (FBP), is overexpressed in multiple malignancies. We conducted a phase I/IIa trial of the E39 + GM-CSF vaccine with booster inoculations of either E39 or E39' (an attenuated version of E39) to prevent recurrences in disease-free endometrial and ovarian cancer patients(pts). Here, we present the final 24-month landmark analysis. PATIENTS AND

methodsHLA-A2 + patients receiving E39 + GM-CSF were included in the vaccine group (VG), and HLA-A2- pts (or HLA-A2 + patients refusing vaccine) were followed as the control group (CG). VG group received 6 monthly inoculations as the primary vaccine series (PVS) and were randomized to receive either E39 or E39' booster inoculations. Demographic, safety, immunologic, and disease-free survival (DFS) data were collected and evaluated.

resultsFifty-one patients were enrolled; 29 in the VG and 22 in the CG. Fourteen patients received <1000 μg and 15 received 1000 μg of E39. There were no clinicopathologic differences between VG and CG or between dose groups. E39 was well tolerated. At the 24 months landmark, DFS was 55.5% (VG) vs 40.0% (CG), P = 0.339. Patients receiving 1000 μg and boosted patients also showed improved DFS (P < 0.03). DFS was improved in the 1000 μg group after treatment of primary disease (90.0% vs CG:42.9%, P = 0.007), but not in recurrent patients. In low-FBP expressing patients, DFS was 100.0% (1000 μg), 50.0% (<1000 μg), and 25.0% (CG), P = 0.029.

conclusionsThis phase I/IIa trial reveals that E39 + GM-CSF is safe and may be effective in preventing recurrence in high-risk ovarian and endometrial cancer when optimally dosed (1000 μg) to FBP low patients being treated for primary disease.

Indexed as

AgedCancer VaccinesDose-Response Relationship, DrugEndometrial NeoplasmsFemaleFolate Receptors, GPI-AnchoredGranulocyte-Macrophage Colony-Stimulating FactorHLA-A2 AntigenHumansImmunization, SecondaryMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsProspective StudiesSurvival AnalysisTreatment OutcomeCancer VaccinesFolate Receptors, GPI-AnchoredGranulocyte-Macrophage Colony-Stimulating FactorHLA-A2 AntigenVaccines, SubunitE39endometrial cancerFBPimmunotherapyovarian cancervaccine

Identifiers

PMID31274231
PMCPMC6712444
OpenAlexW2955264956

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.