Evidence map›Paper›PMID 33344227›Full record

ArticleFrontiers in oncology2020

Discordant Responses Between Primary Head and Neck Tumors and Nodal Metastases Treated With Neoadjuvant Nivolumab: Correlation of Radiographic and Pathologic Treatment Effect.

Dante J Merlino, Jennifer M Johnson, Madalina Tuluc, Stacey Gargano, Robert Stapp, Larry Harshyne, Benjamin E Leiby, Adam Flanders, Ralph Zinner, Rita Axelrod and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03238365 (Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
5.0field-weighted citation impact, top 3% 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.

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
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 49 citations in OpenAlex.

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  4. Phase II Clinical Trial of Neoadjuvant and Adjuvant Pembrolizumab in Resectable Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  5. Tadalafil Enhances Immune Signatures in Response to Neoadjuvant Nivolumab in Resectable Head and Neck Squamous Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
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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

17 authors at 2 institutions in 1 country.

Dante J MerlinoDepartment of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, United States.
Jennifer M JohnsonDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, United States.
Madalina TulucDepartment of Pathology, Thomas Jefferson University, Philadelphia, PA, United States.
Stacey GarganoDepartment of Pathology, Thomas Jefferson University, Philadelphia, PA, United States.
Robert StappDepartment of Pathology, Thomas Jefferson University, Philadelphia, PA, United States.
Larry HarshyneDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, United States.
Benjamin E LeibyDepartment of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, United States.
Adam FlandersDepartment of Radiology, Thomas Jefferson University, Philadelphia, PA, United States.
Ralph ZinnerDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, United States.
Rita AxelrodDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, United States.
Joseph CurryDepartment of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, United States.
David M CognettiDepartment of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, United States.
Kyle MannionDepartment of Otolaryngology- Head and Neck Surgery, Vanderbilt University, Nashville, TN, United States.
Young J KimDepartment of Otolaryngology- Head and Neck Surgery, Vanderbilt University, Nashville, TN, United States.
Ulrich RodeckDepartment of Dermatology and Cutaneous Biology, Thomas Jefferson University, Philadelphia, PA, United States.
Athanassios ArgirisDepartment of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, United States.
Adam J LuginbuhlDepartment of Otolaryngology - Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, United States.
Thomas Jefferson University · USVanderbilt University · US

Funding

Head & Neck Cancer Neoantigen Characterization & Therapeutic TargetingR01DE027749 · NIDCR · VANDERBILT UNIVERSITY MEDICAL CENTER · PI JOYCE, SEBASTIAN · 2018 to 2022
$2.3M
Cyclic Dinucleotides in Combinatorial Immunotherapy for CancerR01CA178613 · NCI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI KIM, YOUNG J. · 2013 to 2017
$1.7M
NCI NIH HHS R01 CA178613NIDCR NIH HHS R01 DE027749
6 · The paper itself

Abstract

PD-1 blockade represents a promising treatment in patients with head and neck squamous cell carcinoma (HNSCC). We analyzed results of a neoadjuvant randomized window-of-opportunity trial of nivolumab plus/minus tadalafil to investigate whether immunotherapy-mediated treatment effects vary by site of involvement (primary tumor, lymph nodes) and determine how radiographic tumor shrinkage correlates with pathologic treatment effect. PATIENTS AND

methodsForty-four patients enrolled in trial NCT03238365 were treated with nivolumab 240 mg intravenously on days 1 and 15 with or without oral tadalafil, as determined by random assignment, followed by surgery on day 31. Radiographic volumetric response (RVR) was defined as percent change in tumor volume from pretreatment to posttreatment CT scan. Responders were defined as those with a 10% reduction in the volume of the primary tumor or lymph nodes (LN). Pathologic treatment effect (PTE) was defined as the area showing fibrosis or lymphohistiocytic inflammation divided by total tumor area.

resultsSixteen of 32 patients (50%) with pathologic evidence of LN involvement exhibited discordant PTE between primary sites and LN. In four patients with widely discordant adjacent LN, increased PTE was associated with increased infiltration of tumor CD8

conclusionNivolumab often induces discordant treatment effects between primary tumor sites and metastatic lymph nodes within subjects. This treatment discordance was also demonstrated in adjacent lymph nodes, which may correlate with local immune cell makeup. Finally, although these data were generated by a relatively small population size, our data support the use of early radiographic response to assess immunotherapy treatment effect in HNSCC.

Indexed as

computed tomography imagingimmunotherapylymph nodesnivolumabsquamous cell carcinoma of head and neck

Identifiers

PMID33344227
PMCPMC7738605
OpenAlexW3107427403

What OpenQuestion holds

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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.