Evidence map›Paper›PMID 40403207›Full record

Trial reportJCO precision oncology2025

Palbociclib, a Selective CDK4/6 Inhibitor, Administered Before and After Chemoradiotherapy for Human Papillomavirus-Negative, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Single-Arm, Phase II Trial.

Peter J Oppelt, Jessica C Ley, Sidharth V Puram, Ryan S Jackson, Randall C Paniello, Jason T Rich, Patrik Pipkorn, Jingxia Liu, Wade L Thorstad, Douglas R Adkins

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in JCO precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Trial
  2. 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

10 authors.

Peter J OppeltDivision of Medical Oncology, Washington University School of Medicine, St Louis, MO.
Jessica C LeyDivision of Medical Oncology, Washington University School of Medicine, St Louis, MO.
Sidharth V PuramAlvin J. Siteman Cancer Center, St Louis, MO.ORCID 0000-0003-3543-889X
Ryan S JacksonAlvin J. Siteman Cancer Center, St Louis, MO.ORCID 0000-0003-4626-2324
Randall C PanielloAlvin J. Siteman Cancer Center, St Louis, MO.
Jason T RichAlvin J. Siteman Cancer Center, St Louis, MO.
Patrik PipkornAlvin J. Siteman Cancer Center, St Louis, MO.ORCID 0000-0002-4118-7743
Jingxia LiuDivision of Public Health Sciences, Washington University School of Medicine, St Louis, MO.ORCID 0000-0002-9434-7907
Wade L ThorstadAlvin J. Siteman Cancer Center, St Louis, MO.ORCID 0000-0002-2757-0543
Douglas R AdkinsDivision of Medical Oncology, Washington University School of Medicine, St Louis, MO.ORCID 0000-0003-3207-8227

Funding

Washington University Center for Cellular ImagingP30CA091842 · NCI · WASHINGTON UNIVERSITY · PI AIMEE S JAMES · 2001 to 2026
$128.0M
NCI NIH HHS P30 CA091842
6 · The paper itself

Abstract

purposeThe primary aim of this single-arm, phase II trial was to determine the objective response rate (ORR) with palbociclib, a selective CDK4/6 inhibitor, administered before chemoradiotherapy (CRT) in patients with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC). PATIENTS AND

methodsEligibility required untreated stage III-IVB HPV-negative HNSCC. Palbociclib 125 mg once daily was administered on days 1-21 of each 28-day cycle for two cycles before and six cycles after CRT. Pretreatment tumor samples underwent genome sequencing. The primary end point was tumor response to palbociclib given before CRT, assessed by RECIST1.1. A sample of 24 evaluable patients (those with response assessment) yielded an 80% power at a one-sided significance level of 0.05 if the ORR was ≥38% (null ORR 17%). A key secondary end point was relapse.

resultsWe enrolled 26 patients with HPV-negative, locally advanced HNSCC. Alterations in

conclusionPalbociclib is an active drug in previously untreated HPV-negative, locally advanced HNSCC. Alterations in

Indexed as

Antineoplastic AgentsChemoradiotherapyHead and Neck NeoplasmsPiperazinesProtein Kinase InhibitorsPyridinesSquamous Cell Carcinoma of Head and NeckAdultAgedCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FemaleHuman Papillomavirus VirusesHumansMaleMiddle AgedAntineoplastic AgentsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6palbociclibPiperazinesProtein Kinase InhibitorsPyridines

Identifiers

PMID40403207
PMCPMC12147653

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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.