Evidence map›Paper›PMID 40837213›Full record

ArticleAdvances in radiation oncology2025

Prospective Phase II Trial of Definitive Chemoradiation and Concurrent Nivolumab in Locally Advanced p16+ Oropharynx Cancer.

Samuel Nicholas Regan, Jennifer Shah, Krithika Suresh, Krystal A Morales, Yue Cao, Madhava Aryal, Benjamin S Rosen, Heather Walline, Choonik Lee, Jessica Aldous and 14 more

Abstract read
In one paragraph

Article in Advances in radiation oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. In Regard to Regan et al.Advances in radiation oncology · 2026
    Article
  2. Article
  3. Review
  4. 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

24 authors.

Samuel Nicholas ReganDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Jennifer ShahDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Krithika SureshDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Krystal A MoralesDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Yue CaoDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Madhava AryalDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Benjamin S RosenDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Heather WallineDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Choonik LeeDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Jessica AldousDepartment of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan.
Paul L SwiecickiDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan.
Keith A CasperDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Steven B ChinnDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Kelly M MalloyDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Mark E P PrinceDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Chaz L StuckenDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Andrew G ShumanDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Molly Heft-NealDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Teresa H LydenDepartment of Speech and Language Pathology, University of Michigan, Ann Arbor, Michigan.
Anna BlakelyDepartment of Speech and Language Pathology, University of Michigan, Ann Arbor, Michigan.
Madison AmbroseDepartment of Speech and Language Pathology, University of Michigan, Ann Arbor, Michigan.
John Chad BrennerDepartment of Otolaryngology - Head and Neck Surgery, University of Michigan, Ann Arbor, Michigan.
Francis P WordenDepartment of Internal Medicine, Division of Hematology/Oncology, University of Michigan, Ann Arbor, Michigan.
Michelle L MierzwaDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

Funding

Biostatistics Training Program in Cancer ResearchT32CA083654 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Veerabhadran Baladandayuthapani, Kelley McLain Kidwell · 2002 to 2026
$4.3M
NCI NIH HHS T32 CA083654
6 · The paper itself

Abstract

Purpose: We conducted a prospective, single-institution phase II trial to test the hypothesis that the addition of nivolumab to definitive chemoradiation would improve the progression-free survival (PFS) among patients with high-risk p16+ oropharyngeal squamous cell carcinoma (OPSCC). Methods and Materials: Patients with previously-untreated locoregionally advanced, p16+ OPSCC (clinical T4/N3, matted lymph nodes, and/or retropharyngeal lymphadenopathy) were enrolled. Patients received a priming dose of nivolumab, concurrent nivolumab and chemoradiation (70 Gy to PTVhigh, 56 Gy to PTVlow, weekly carboplatin/paclitaxel), and 4 cycles of adjuvant nivolumab over 12 weeks. The primary endpoint was 2-year PFS compared to an institutional historic control of 68%. Exploratory endpoints included associations between survival and circulating tumor DNA kinetics during treatment and pretreatment/midtreatment Results: Twenty-six patients were enrolled prior to an interim analysis; 65% cT4, 46% with matted nodes, with a median total gross tumor volume of 60 cc (range, 36-165). Estimated 2-year PFS was 65% (2-sided 90% CI, 46%-79%) and 2-year distant metastasis-free survival was 84% (66%-93%). The majority (69%) did not complete the full course of nivolumab because of toxicity, and 54% experienced grade ≥3 acute dysphagia. Statistical analyses showed that increasing values of imaging-defined primary tumor subvolumes were significant associated with inferior PFS (eg, midtreatment low apparent diffusion coefficient: HR, 5.61; Conclusions: Concurrent and adjuvant nivolumab did not improve PFS in locoregionally advanced Human papillomavirus+ OPSCC and was associated with significant toxicity. Physiological magnetic resonance imaging and

Identifiers

PMID40837213
PMCPMC12363458

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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.