Evidence map›Paper›PMID 27852036›Full record

Trial reportOncotarget2017

Interim analysis of a phase I/IIa trial assessing E39+GM-CSF, a folate binding protein vaccine, to prevent recurrence in ovarian and endometrial cancer patients.

Doreen O Jackson, Kevin Byrd, Timothy J Vreeland, Diane F Hale, Garth S Herbert, Julia M Greene, Erika J Schneble, John S Berry, Alfred F Trappey, G T Clifton and 8 more

Open access · diamondAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncotarget, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
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

18 authors at 7 institutions in 1 country.

Doreen O JacksonDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
Kevin ByrdNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Timothy J VreelandDepartment of Surgery, Womack Army Medical Center, Fayetteville, NC, USA.
Diane F HaleDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
Garth S HerbertDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
Julia M GreeneDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
Erika J SchnebleDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
John S BerryDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
Alfred F TrappeyDepartment of Surgery, San Antonio Military Medical Center, San Antonio, TX, USA.
G T CliftonDepartment of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Mark O HardinDepartment of Surgery, Madigan Army Medical Center, Tacoma, WA, USA.
Jonathan MartinCancer Vaccine Development Program, San Antonio, TX, USA.
John C ElkasDepartment of Obstetrics and Gynecology, Inova Fairfax Hospital, Annandale, VA, USA.
Thomas P ConradsNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Kathleen M DarcyNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Chad A HamiltonNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
George L MaxwellNational Capital Consortium Fellowship in Gynecologic Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
George E PeoplesCancer Vaccine Development Program, San Antonio, TX, USA.
San Antonio Military Medical Center · USWalter Reed National Military Medical Center · USInova Health System · USInova Fairfax Hospital · USMadigan Army Medical Center · USThe 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

backgroundFolate binding protein(FBP) is an immunogenic protein over-expressed in endometrial(EC) and ovarian cancer(OC). We are conducting a phase I/IIa trial of E39 (GALE 301)+GM-CSF, an HLA-A2-restricted, FBP-derived peptide vaccine to prevent recurrences in disease-free EC and OC patients. This interim analysis summarizes toxicity, immunologic responses, and clinical outcomes to date.

methodsHLA-A2+ patients were vaccinated(VG), and HLA-A2- or -A2+ patients were followed as controls(CG). Six monthly intradermal inoculations of E39+250mcg GM-CSF were administered to VG. Demographic, safety, immunologic, and recurrence rate(RR) data were collected and evaluated.

resultsThis trial enrolled 51 patients; 29 in the VG and 22 in the CG. Fifteen patients received 1000mcg E39, and 14 received <1000mcg. There were no clinicopathologic differences between groups(all p ≥ 0.1). E39 was well-tolerated regardless of dose. DTH increased pre- to post-vaccination (5.7±1.5 mm vs 10.3±3.0 mm, p = 0.06) in the VG, and increased more in the 1000mcg group (3.8±2.0 mm vs 9.5±3.5 mm, p = 0.03). With 12 months median follow-up, the RR was 41% (VG) vs 55% (CG), p = 0.41. Among the 1000mcg patients, the RR was 13.3% vs 55% CG, p = 0.01. Estimated 2-year DFS was 85.7% in the 1000mcg group vs 33.6% in the CG (p = 0.021).

conclusionsThis phase I/IIa trial reveals that E39+GM-CSF is well-tolerated and elicits a strong, dose-dependent in vivo immune response. Early efficacy results are promising in the 1000 mcg dose cohort. This study proves the safety and establishes the dose of E39 for a larger prospective, randomized, controlled trial in HLA-A2+ EC and OC patients to prevent recurrence.

Indexed as

AgedCarrier ProteinsEndometrial NeoplasmsFemaleFolic AcidGranulocyte-Macrophage Colony-Stimulating FactorHumansImmunotherapyMiddle AgedOvarian NeoplasmsCarrier ProteinsFolic AcidGranulocyte-Macrophage Colony-Stimulating Factorcancerendometrialfolate binding proteinimmunotherapyovarian

Identifiers

PMID27852036
PMCPMC5362533
OpenAlexW2555631417

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.