Evidence map›Paper›PMID 38847087›Full record

ArticleCancer medicine2024

Predictive capacity of immune-related adverse events and cytokine profiling in neoadjuvant immune checkpoint inhibitor trials for head and neck squamous cell carcinoma.

Angela E Alnemri, Sruti Tekumalla, Annie E Moroco, Ioannis Vathiotis, Madalina Tuluc, Stacey Gargano, Tingting Zhan, David M Cognetti, Joseph M Curry, Athanassios Argiris and 5 more

3 registry-linked trialsAbstract read
In one paragraph

Article in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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.

NCT03238365 early_phase1completednot on this map

Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRan2017 to 2022Enrolled50ConditionsLip, Oral Cavity and Pharynx, LarynxArmsNivolumab, Tadalafil, Therapeutic Conventional Surgery
NCT03618654 early_phase1completednot on this map

Window of Opportunity for Durvalumab (MEDI4736) Plus Metformin Trial of in Squamous Cell Carcinoma of the Head and Neck

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityRan2018 to 2022Enrolled38ConditionsHead and Neck Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell CarcinomaArmsMetformin, Durvalumab
NCT03854032 phase2active not recruitingnot on this map

Window-of-Opportunity Trial of Nivolumab and BMS986205 in Patients With Squamous Cell Carcinoma of the Head and Neck (CA017-087)

TypeinterventionalSponsorThomas Jefferson UniversityRan2019 to 2025Enrolled45ConditionsLip, Oral Cavity Squamous Cell Carcinoma, Pharynx, LarynxArmsNivolumab, IDO1 Inhibitor BMS-986205, Therapeutic Conventional Surgery, Questionnaire Administration
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. High-Grade Immune-Related Adverse Events Resulting from Immune Checkpoint Inhibitor Treatment: Evaluation of Diagnostics and Outcomes in Admitted Patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. 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

15 authors.

Angela E AlnemriDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.ORCID 0000-0001-5521-6261
Sruti TekumallaDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Annie E MorocoDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Ioannis VathiotisDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Madalina TulucDepartment of Pathology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Stacey GarganoDepartment of Pathology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-2780-1866
Tingting ZhanDepartment of Biostatistics, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
David M CognettiDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Joseph M CurryDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Athanassios ArgirisDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Alban LinnenbachDepartment of Dermatology and Cutaneous Biology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Andrew P SouthDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Larry A HarshyneDepartment of Microbiology & Immunology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Jennifer M JohnsonDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Adam J LuginbuhlDepartment of Otolaryngology - Head & Neck Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.

Funding

X-Ray Crystallography and Macromolecular CharacterizationP30CA056036 · NCI · THOMAS JEFFERSON UNIVERSITY · PI DANIEL P SILVER · 1995 to 2026
$94.8M
Tissue Damage-Driven Squamous Cell CarcinomaR01CA244522 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI SOUTH, ANDREW · 2021 to 2025
$1.7M
Biostatistics Shared Resource at the Sidney Kimmel Cancer Center - Jefferson Health 5P30CA056036-18NCI NIH HHS P30 CA056036
6 · The paper itself

Abstract

objectivesCertain low-level immune-related adverse events (irAEs) have been associated with survival benefits in patients with various solid tumors on immune checkpoint inhibitors (ICIs). We aimed to investigate the association between irAEs and response to neoadjuvant ICIs in patients with head and neck squamous cell carcinoma (HNSCC) and to identify differences in circulating cytokine levels based on irAE status.

methodsThis was a retrospective cohort study including three neoadjuvant clinical trials from July 2017 to January 2022: NCT03238365 (nivolumab ± tadalafil), NCT03854032 (nivolumab ± BMS986205), NCT03618654 (durvalumab ± metformin). The presence and type of irAEs, pathologic treatment response, and survival were compared. Canonical linear discriminant analysis (LDA) was performed to identify combinations of circulating cytokines predictive of irAEs using plasma sample multiplex assay.

resultsOf 113 participants meeting inclusion criteria, 32 (28.3%) developed irAEs during treatment or follow-up. Positive p16 status was associated with irAEs (odds ratio [OR] 2.489; 95% CI 1.069-6.119; p = 0.043). irAEs were associated with pathologic treatment response (OR 3.73; 95% CI 1.34-10.35; p = 0.011) and with higher OS in the combined cohort (HR 0.319; 95% CI 0.113-0.906; p = 0.032). Patients with irAEs within the nivolumab cohort had significant elevations of select cytokines pre-treatment. Canonical LDA identified key drivers of irAEs among all trials, which were highly predictive of future irAE status.

conclusionsirAEs are associated with response to neoadjuvant ICI therapy in HNSCC and can serve as clinical indicators for improved clinical outcomes. irAEs can be predicted by concentrations of several circulating cytokines prior to treatment.

Indexed as

CytokinesHead and Neck NeoplasmsImmune Checkpoint InhibitorsNeoadjuvant TherapySquamous Cell Carcinoma of Head and NeckAgedFemaleHumansMaleMiddle AgedNivolumabRetrospective StudiesCytokinesImmune Checkpoint InhibitorsNivolumabcytokineshead and neck neoplasmsimmunotherapytumor biomarkers

Identifiers

PMID38847087
PMCPMC11157197

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.