Evidence map›Paper›PMID 35837107›Full record

ArticleFrontiers in oncology2022

A Prospective, Cohort Study of SITOIGANAP to Treat Glioblastoma When Given in Combination With Granulocyte-Macrophage Colony-Stimulating Factor/Cyclophosphamide/Bevacizumab/Nivolumab or Granulocyte-Macrophage Colony-Stimulating Factor/Cyclophosphamide/Bevacizumab/Pembrolizumab in Patients Who Failed Prior Treatment With Surgical Resection, Radiation, and Temozolomide.

Daniela A Bota, Thomas H Taylor, Naomi Lomeli, Xiao-Tang Kong, Beverly D Fu, Axel H Schönthal, Samuel Singer, Deborah T Blumenthal, Frank M Senecal, Helena Linardou and 6 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. Review
  7. Review
  8. 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

16 authors at 8 institutions in 3 countries.

Daniela A BotaDepartment of Neurology, University of California Irvine, Irvine, CA, United States.
Thomas H TaylorChao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA, United States.
Naomi LomeliDepartment of Neurology, University of California Irvine, Irvine, CA, United States.
Xiao-Tang KongDepartment of Neurology, University of California Irvine, Irvine, CA, United States.
Beverly D FuDepartment of Neurology, University of California Irvine, Irvine, CA, United States.
Axel H SchönthalDepartment of Molecular Microbiology and Immunology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.
Samuel SingerJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, United States.
Deborah T BlumenthalNeuro-oncology Division, Tel-Aviv Sourasky Medical Center, Tel-Aviv University, Tel-Aviv, Israel.
Frank M SenecalDepartment of Hematology and Oncology, Northwest Medical Specialties, Tacoma, WA, United States.
Helena LinardouFourth Oncology Department and Comprehensive Clinical Trials Center, Metropolitan Hospital, Athens, Greece.
Evangelos RokasDepartment of Neurosurgery, Henry Dunant Hospital Center, Athens, Greece.
Dimitris G AntoniouDepartment of Neurosurgery, Henry Dunant Hospital Center, Athens, Greece.
Virgil E J C SchijnsEpitopoietic Research Corporation (ERC), Gembloux, Belgium.
Thomas C ChenEpitopoietic Research Corporation (ERC), Pasadena, CA, United States.
Joseph ElliotEpitopoietic Research Corporation (ERC), Pasadena, CA, United States.
Apostolos StathopoulosDepartment of Neurosurgery, Henry Dunant Hospital Center, Athens, Greece.
University of California, Irvine · USUniversity of Southern California · USHenry Dunant Hospital · GRHackensack University Medical Center · USMetropolitan Hospital · GRNeurological Surgery · USNorthwest Medical Specialties · USTel Aviv University · IL

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Christine Hui · 1994 to 2026
$57.9M
NCI NIH HHS P30 CA062203
6 · The paper itself

Abstract

Background: Glioblastoma (GBM) is the most common primary, malignant brain tumor in adults and has a poor prognosis. The median progression-free survival (mPFS) of newly diagnosed GBM is approximately 6 months. The recurrence rate approaches 100%, and the case-fatality ratio approaches one. Half the patients die within 8 months of recurrence, and 5-year survival is less than 10%. Advances in treatment options are urgently needed. We report on the efficacy and safety of a therapeutic vaccine (SITOIGANAP: Epitopoietic Research Corporation) administered to 21 patients with recurrent GBM (rGBM) under a Right-to-Try/Expanded Access program. SITOIGANAP is composed of both autologous and allogeneic tumor cells and lysates. Methods: Twenty-one patients with rGBM received SITOIGANAP on 28-day cycles in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), cyclophosphamide, bevacizumab, and an anti-programmed cell death protein-1 (anti-PD-1) monoclonal antibody (either nivolumab or pembrolizumab). Results: The mPFS was 9.14 months, and the median overall survival (mOS) was 19.63 months from protocol entry. Currently, 14 patients (67%) are at least 6 months past their first SITOIGANAP cycle; 10 patients (48%) have received at least six cycles and have a mOS of 30.64 months and 1-year survival of 90%. The enrollment and end-of-study CD3 Conclusions: The addition of SITOIGANAP/GM-CSF/cyclophosphamide to bevacizumab and an anti-PD-1 monoclonal antibody resulted in a significant survival benefit compared to historic control values in rGBM with minimal toxicity compared to current therapy.

Indexed as

ERC1671GBM vaccineimmunotherapyrecurrent glioblastomaSITOIGANAP

Identifiers

PMID35837107
PMCPMC9273968
OpenAlexW4283639805

What OpenQuestion holds

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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.