Evidence map›Paper›PMID 35732348›Full record

Trial reportJournal for immunotherapy of cancer2022

The clinical relevance of humoral immune responses to Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 and expression of Globo H in metastatic breast cancer.

Jung-Tung Hung, I-Ju Chen, Shir-Hwa Ueng, Chiun-Sheng Huang, Shin-Cheh Chen, Mu-Yi Chen, Yung-Chang Lin, Chun-Yen Lin, Michael J Campbell, Hope S Rugo and 1 more

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

Trial report in Journal for immunotherapy of cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
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  11. [Research Progress of Lung Cancer Vaccines].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023
    Review
  12. Review
  13. Immunogenicity of peptide-based vaccine composed of epitopes from Echinococcus granulosus rEg.P29.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2023
    Article
  14. Article
  15. 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

11 authors at 5 institutions in 2 countries.

Jung-Tung HungInstitute of Stem Cell and Translational Cancer Research, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
I-Ju ChenOBI Pharma Inc, Taipei, Taiwan.
Shir-Hwa UengDepartment of Pathology, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
Chiun-Sheng HuangDepartment of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
Shin-Cheh ChenDepartment of General Surgery, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
Mu-Yi ChenOBI Pharma Inc, Taipei, Taiwan.
Yung-Chang LinDepartment of Internal Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.ORCID 0000-0002-2084-5348
Chun-Yen LinDepartment of Gastroenterology and Hepatology, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.ORCID 0000-0003-3007-3190
Michael J CampbellDepartment of Surgery, Division of Surgical Oncology, University of California San Francisco, San Francisco, California, USA.
Hope S RugoHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, California, USA.ORCID 0000-0001-6710-4814
Alice L YuInstitute of Stem Cell and Translational Cancer Research, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan a1yu@health.ucsd.edu.ORCID 0000-0003-2444-0505
Linkou Chang Gung Memorial Hospital · TWUniversity of California, San Francisco · USChang Gung Memorial Hospital · TWChang Gung University · TWNational Taiwan University Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An international randomized phase II trial of Globo H (GH) vaccine, adagloxad simolenin/OBI-821 in 349 patients with metastatic breast cancer showed longer progression-free survival (PFS) in vaccinated patients who developed anti-Globo H (anti-GH) IgG than those who did not and the placebo group. The impacts of anti-GH IgM and GH expression on peak anti-GH IgG and clinical outcome were further evaluated. The titers of anti-GH IgG and IgM were determined by ELISA. GH expression in tumor was examined by immunohistochemical staining. Immunophenotyping was conducted by flow cytometry. Adagloxad simolenin elicited anti-GH IgM which peaked at titers ≥1:80 between weeks 5 and 13. The mean anti-GH IgG titer peaked at week 41 and decreased thereafter on the completion of vaccination. One log increase in peak IgM was associated with 10.6% decrease in the HR of disease progression (HR: 0.894, 95% CI: 0.833 to 0.960, p=0.0019). Patients with anti-GH IgM ≥1:320 within first 4 weeks after vaccination had significantly higher maximum anti-GH IgM (p<0.0001) and IgG titers (p<0.0001) than those with <1:320. Moreover, the median PFS appears to be longer for patients with anti-GH IgM ≥1:320 within first 4 weeks than those with anti-GH IgM titer <1:320 (11.1 vs 7.3 months, p=0.164), but not statistically significant. Among patients with H score ≥80 for GH expression by immunohistochemistry, the vaccination group (n=42) seemed to have better PFS than the placebo group (n=23) (HR=0.59; 95% CI: 0.32 to 1.10, p=0.10), but the difference did not reach statistical significance. In addition, peak levels of anti-GH IgM were higher in patients who had lower percentage of activated regulatory T cells (Treg cells; CD4

Indexed as

Breast NeoplasmsAdjuvants, ImmunologicCancer VaccinesFemaleHemocyaninsHumansImmunity, HumoralImmunoglobulin GImmunoglobulin MVaccines, ConjugateAdjuvants, ImmunologicCancer Vaccinesglobo H-KLH vaccineHemocyaninsImmunoglobulin GImmunoglobulin MVaccines, ConjugateAntigens, Tumor-Associated, CarbohydrateBreast NeoplasmsClinical Trials as TopicImmunity, HumoralImmunization

Identifiers

PMID35732348
PMCPMC9226869
OpenAlexW4283360443

What OpenQuestion holds

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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.