Evidence map›Paper›PMID 34980038›Full record

Trial reportBMC cancer2022

Prospective study evaluating dynamic changes of cell-free HPV DNA in locoregional viral-associated oropharyngeal cancer treated with induction chemotherapy and response-adaptive treatment.

Ari J Rosenberg, Evgeny Izumchenko, Alexander Pearson, Zhen Gooi, Elizabeth Blair, Theodore Karrison, Aditya Juloori, Daniel Ginat, Nicole Cipriani, Mark Lingen and 9 more

Open access · goldAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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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

19 authors at 3 institutions in 2 countries.

Ari J RosenbergDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA. arirosenberg@medicine.bsd.uchicago.edu.
Evgeny IzumchenkoDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.
Alexander PearsonDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.
Zhen GooiSection of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, IL, USA.
Elizabeth BlairSection of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, IL, USA.
Theodore KarrisonDepartment of Public Health Sciences, University of Chicago, Chicago, IL, USA.
Aditya JulooriDepartment of Radiation and Cellular Oncology, University of Chicago, Chicago, IL, USA.
Daniel GinatDepartment of Radiology, University of Chicago, Chicago, IL, USA.
Nicole CiprianiDepartment of Pathology, University of Chicago, Chicago, IL, USA.
Mark LingenDepartment of Pathology, University of Chicago, Chicago, IL, USA.
Hillary SloaneSysmex Inostics, Inc., Baltimore, MD, USA.
Daniel L EdelsteinSysmex Inostics, Inc., Baltimore, MD, USA.
Kirsten KeyserSysmex Inostics GmbH, Hamburg, Germany.
Johannes FredebohmSysmex Inostics GmbH, Hamburg, Germany.
Frank HoltrupSysmex Inostics GmbH, Hamburg, Germany.
Frederick S JonesSysmex Inostics, Inc., Baltimore, MD, USA.
Daniel HarafDepartment of Radiation and Cellular Oncology, University of Chicago, Chicago, IL, USA.
Nishant AgrawalSection of Otolaryngology-Head and Neck Surgery, University of Chicago, Chicago, IL, USA.
Everett E VokesDepartment of Medicine, Section of Hematology and Oncology, University of Chicago, Chicago, IL, USA.
University of Chicago · USSysmex (Germany) · DEChicago Department of Public Health · US

Funding

Delineating chromatin-related gene expression signatures as a function of HNSCC progressionR01DE027809 · NIDCR · UNIVERSITY OF MARYLAND BALTIMORE · PI GAYKALOVA, DARIA A, IZUMCHENKO, EVGENY (EUGENE) G · 2019 to 2023
$2.6M
American Cancer Society IRG-19-136-59NIDCR NIH HHS R01 DE027809
6 · The paper itself

Abstract

backgroundHuman papillomavirus (HPV)-associated oropharyngeal cancer (OPC) has a favorable prognosis which has led to efforts to de-intensify treatment. Response-adaptive de-escalated treatment is promising, however improved biomarkers are needed. Quantitative cell-free HPV-DNA (cfHPV-DNA) in plasma represents an attractive non-invasive biomarker for grading treatment response and post-treatment surveillance. This prospective study evaluates dynamic changes in cfHPV-DNA during induction therapy, definitive (chemo)radiotherapy, and post-treatment surveillance in the context of risk and response-adaptive treatment for HPV + OPC.

methodsPatients with locoregional HPV + OPC are stratified into two cohorts: High risk (HR) (T4, N3, [Formula: see text] 20 pack-year smoking history (PYH), or non-HPV16 subtype); Low risk (LR) (all other patients). All patients receive induction chemotherapy with three cycles of carboplatin and paclitaxel. LR with ≥ 50% response receive treatment on the single-modality arm (minimally-invasive surgery or radiation alone to 50 Gy). HR with ≥ 50% response or LR with ≥ 30% and < 50% response receive treatment on the intermediate de-escalation arm (chemoradiation to 50 Gy with cisplatin). All other patients receive treatment on the regular dose arm with chemoradiation to 70 Gy with concurrent cisplatin. Plasma cfHPV-DNA is assessed during induction, (chemo)radiation, and post-treatment surveillance. The primary endpoint is correlation of quantitative cfHPV-DNA with radiographic response. DISCUSSION: A de-escalation treatment paradigm that reduces toxicity without compromising survival outcomes is urgently needed for HPV + OPC. Response to induction chemotherapy is predictive and prognostic and can select candidates for de-escalated definitive therapy. Assessment of quantitative cfHPV-DNA in the context of response-adaptive treatment of represents a promising reliable and convenient biomarker-driven strategy to guide personalized treatment in HPV + OPC.

trial registrationThis trial is registered with ClinicalTrials.gov on October 1

Indexed as

AdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCell-Free Nucleic AcidsChemoradiotherapyCisplatinDNA, ViralDrug MonitoringFeasibility StudiesFemaleHumansInduction ChemotherapyMaleMiddle AgedBiomarkers, TumorCarboplatinCell-Free Nucleic AcidsCisplatinDNA, ViralPaclitaxelChemotherapyHead and neck cancerHuman papillomavirusRadiotherapyTreatment de-escalation

Identifiers

PMID34980038
PMCPMC8722316
OpenAlexW4205986246

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Registered trials

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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.