Evidence map›Paper›PMID 37935055›Full record

ArticleJournal for immunotherapy of cancer2022

Effect of CD4+ T cell count on treatment-emergent adverse events among patients with and without HIV receiving immunotherapy for advanced cancer.

Thomas A Odeny, Kathryn Lurain, Julius Strauss, Steven P Fling, Elad Sharon, Anna Wright, Javier Martinez-Picado, Teresa Moran, James L Gulley, Maria Gonzalez-Cao and 3 more

Open access · goldAbstract read
In one paragraph

Article 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 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.2field-weighted citation impact, top 20% 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

11 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. The standardization and efficacy of fermentedOpen veterinary journal · 2024
    Article
  6. Cancer in People with HIV.Infectious disease clinics of North America · 2024
    Review
  7. Article
  8. Review
  9. Treating Cancer in People With HIV.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Review
  10. Article
  11. 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

13 authors at 6 institutions in 2 countries.

Thomas A OdenyHIV and AIDS Malignancy Branch, Center for Cancer Research, National Institutes of Health, Bethesda, Maryland, USA.
Kathryn LurainHIV and AIDS Malignancy Branch, Center for Cancer Research, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-5794-7292
Julius StraussLaboratory of Tumor Immunology and Biology, Center for Cancer Research, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-7550-4938
Steven P FlingCancer Immunotherapy Trials Network, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Elad SharonCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland, USA.ORCID 0000-0002-0044-9719
Anna WrightCancer Immunotherapy Trials Network, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Javier Martinez-PicadoIrsiCaixa AIDS Research Institute, Research Institute Germans Trias i Pujol, University of Vic-Central University of Catalonia, CIBERINFECT, ICREA, Barcelona, Spain.
Teresa MoranMedical Oncology Department, Catalan Institute of Oncology (ICO), Germans Trias i Pujol Hospital, Badalona-Applied Research Group in Oncology, Badalona, Spain.ORCID 0000-0001-9172-0035
James L GulleyCenter for Immuno-Oncology, Center for Cancer Research, National Institutes of Health, Bethesda, Maryland, USA.ORCID 0000-0002-6569-2912
Maria Gonzalez-CaoTranslational Cancer Research Unit, Instituto Oncológico Dr Rosell, Dexeus University Hospital, Barcelona, Spain.ORCID 0000-0003-3791-540X
Thomas S UldrickCancer Immunotherapy Trials Network, Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID 0000-0001-6959-0924
Robert YarchoanHIV and AIDS Malignancy Branch, Center for Cancer Research, National Institutes of Health, Bethesda, Maryland, USA.
Ramya RamaswamiHIV and AIDS Malignancy Branch, Center for Cancer Research, National Institutes of Health, Bethesda, Maryland, USA ramya.ramaswami@nih.gov.ORCID 0000-0001-5709-4675
National Institutes of Health · USFred Hutch Cancer Center · USInstitut Català d'Oncologia · ESInstituto Oncológico Dr. Rosell · ESNational Cancer Institute · USUniversitat de Vic - Universitat Central de Catalunya · ES

Funding

Cancer Immunotherapy Trials Network Central Operations and Statistical CenterUM1CA154967 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DAVIDSON, NANCY ELLEN · 2017 to 2022
$20.7M
NCI NIH HHS UM1 CA154967
6 · The paper itself

Abstract

backgroundThe Food and Drug Administration recommends that people living with HIV (PWH) with a CD4+ T cell count (CD4) ≥350 cells/µL may be eligible for any cancer clinical trial, but there is reluctance to enter patients with lower CD4 counts into cancer studies, including immune checkpoint inhibitor (ICI) studies. Patients with relapsed or refractory cancers may have low CD4 due to prior cancer therapies, irrespective of HIV status. It is unclear how baseline CD4 prior to ICI impacts the proportion of treatment-emergent adverse events (TEAE) and whether it differs by HIV status in ICI treated patients.

methodsWe conducted a pilot retrospective cohort study of participants eligible for ICI for advanced cancers from three phase 1/2 trials in the USA and Spain. We determined whether baseline CD4 counts differed by HIV status and whether the effect of CD4 counts on incidence of TEAE was modified by HIV status using a multivariable logistic regression model.

resultsOf 122 participants, 66 (54%) were PWH who received either pembrolizumab or durvalumab and 56 (46%) were HIV-negative who received bintrafusp alfa. Median CD4 at baseline was 320 cells/µL (IQR 210-495) among PWH and 356 cells/µL (IQR 260-470) among HIV-negative participants (p=0.5). Grade 3 or worse TEAE were recorded among 7/66 (11%) PWH compared with 7/56 (13%) among HIV-negative participants. When adjusted for prior therapies, age, sex, and race, the effect of baseline CD4 on incidence of TEAE was not modified by HIV status for any TEAE (interaction term p=0.7), or any grade ≥3 TEAE (interaction term p=0.1).

conclusionsThere was no significant difference in baseline CD4 or the proportions of any TEAE and grade ≥3 TEAE by HIV status. CD4 count thresholds for cancer clinical trials should be carefully reviewed to avoid unnecessarily excluding patients with HIV and cancer.

Indexed as

HIV InfectionsNeoplasmsCD4 Lymphocyte CountCD4-Positive T-LymphocytesHumansImmunotherapyRetrospective StudiesUnited StatesCD4-Positive T-LymphocytesClinical Trials as TopicImmunotherapyOncolytic Viruses

Identifiers

PMID37935055
PMCPMC9442492
OpenAlexW4294266904

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.