Evidence map›Paper›PMID 35338369›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022

Phase II Clinical Trial of Neoadjuvant and Adjuvant Pembrolizumab in Resectable Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma.

Trisha M Wise-Draper, Shuchi Gulati, Sarah Palackdharry, Benjamin H Hinrichs, Francis P Worden, Matthew O Old, Neal E Dunlap, John M Kaczmar, Yash Patil, Muhammed Kashif Riaz and 16 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06814067 (Phase II Multicentered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care), which is not on this map. Cited by 125 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
125citing papers in PubMed, 7 pooled it
31.3field-weighted citation impact, top 1% 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.

NCT06814067 phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Phase II Multicentered Study of Perioperative Ivonescimab Versus Pembrolizumab Combined with Standard of Care (SOC) in Patients with Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

TypeinterventionalSponsorFudan UniversityRan2025 to 2030Enrolled80ConditionsHead and Neck Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma HNSCCArmsPembrolizumab, Ivonescimab, Surgery, Adjuvant radiotherapy
3 · Its place in the literature

Who cites it

125 citing papers in PubMed, 7 syntheses or guidelines pooled it, 163 citations in OpenAlex.

  1. Cancer-related fatigue during treatment with neoadjuvant and/or adjuvant immune checkpoint inhibitors: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Pooled it
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  4. Progress in immunotherapy for resectable head and neck squamous cell carcinoma.Medical oncology (Northwood, London, England) · 2025
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  14. Distinct CD8Cancer cell · 2025
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65 more citing papers are in PubMed but not listed here.

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

26 authors at 11 institutions in 1 country.

Trisha M Wise-DraperDivision of Hematology/Oncology, University of Cincinnati, Cincinnati, Ohio.ORCID 0000-0002-7279-4028
Shuchi GulatiDivision of Hematology/Oncology, University of Cincinnati, Cincinnati, Ohio.ORCID 0000-0001-6793-9694
Sarah PalackdharryUniversity of Cincinnati Cancer Center, Cincinnati, Ohio.
Benjamin H HinrichsDepartment of Pathology, University of Cincinnati, Cincinnati, Ohio.
Francis P WordenUniversity of Michigan Cancer Center, Ann Arbor, Michigan.
Matthew O OldDepartment of Otolaryngology, Ohio State University, Columbus, Ohio.
Neal E DunlapDepartment of Radiation Oncology, University of Louisville, Louisville, Kentucky.
John M KaczmarDivision of Hematology/Oncology, Medical University of South Carolina, Charleston, South Carolina.
Yash PatilDepartment of Otolaryngology, University of Cincinnati, Cincinnati, Ohio.
Muhammed Kashif RiazDivision of Hematology/Oncology, University of Cincinnati, Cincinnati, Ohio.
Alice TangDepartment of Otolaryngology, University of Cincinnati, Cincinnati, Ohio.
Jonathan MarkDepartment of Otolaryngology, Eastern Virginia Medical School, Norfolk, Virginia.
Chad ZenderDepartment of Otolaryngology, University of Cincinnati, Cincinnati, Ohio.
Ann M GillenwaterThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Diana BellThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Nicky KurtzweilUniversity of Cincinnati Cancer Center, Cincinnati, Ohio.
Maria MathewsUniversity of Cincinnati Cancer Center, Cincinnati, Ohio.
Casey L AllenUniversity of Cincinnati Cancer Center, Cincinnati, Ohio.
Michelle L MierzwaDepartment of Radiation Oncology, University of Michigan Cancer Center, Ann Arbor, Michigan.
Keith CasperDepartment of Otolaryngology, University of Michigan Cancer Center, Ann Arbor, Michigan.
Roman JandarovDepartment of Environmental Health, University of Cincinnati, Cincinnati, Ohio.
Mario MedvedovicDepartment of Environmental Health, University of Cincinnati, Cincinnati, Ohio.ORCID 0000-0003-4510-3102
J Jack LeeThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-5469-9214
Nusrat HarunDivision of Biostatistics and Epidemiology, Cincinnati Children's Medical Center, Cincinnati, Ohio.
Vinita TakiarDepartment of Radiation Oncology, University of Cincinnati and Cincinnati VA Medical Center, Cincinnati, Ohio.
Maura GillisonThe University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-8145-5749
University of Cincinnati · USThe University of Texas MD Anderson Cancer Center · USCincinnati Health Department · USMichigan Medicine · USCincinnati Children's Hospital Medical Center · USCincinnati VA Medical Center · USEastern Virginia Medical School · USMedical University of South Carolina · USThe Ohio State University · USUniversity of Louisville · USUniversity of Michigan · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI MEINZEN-DERR, JAREEN, STRAWN, JEFFREY ROBERT · 2015 to 2024
$37.5M
KL2 Training ProgramKL2TR001426 · NCATS · UNIVERSITY OF CINCINNATI · PI ZELLER, MARGARET H · 2015 to 2024
$6.8M
Translational Research Career Development: Overcoming Resistance to RadiotherapyIK2BX004360 · VA · CINCINNATI VA MEDICAL CENTER RESEARCH · PI Vinita Takiar · 2019 to 2026
–
BLRD VA IK2 BX004360NCATS NIH HHS KL2 TR001426NCATS NIH HHS UL1 TR001425NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposePatients with resected, local-regionally advanced, head and neck squamous cell carcinoma (HNSCC) have a one-year disease-free survival (DFS) rate of 65%-69% despite adjuvant (chemo)radiotherapy. Neoadjuvant PD-1 immune-checkpoint blockade (ICB) has demonstrated clinical activity, but biomarkers of response and effect on survival remain unclear. PATIENTS AND

methodsEligible patients had resectable squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or oropharynx (p16-negative) and clinical stage T3-T4 and/or two or more nodal metastases or clinical extracapsular nodal extension (ENE). Patients received neoadjuvant pembrolizumab 200 mg 1-3 weeks prior to surgery, were stratified by absence (intermediate-risk) or presence (high-risk) of positive margins and/or ENE, and received adjuvant radiotherapy (60-66 Gy) and concurrent pembrolizumab (every 3 weeks × 6 doses). Patients with high-risk HNSCC also received weekly, concurrent cisplatin (40 mg/m2). Primary outcome was one-year DFS. Secondary endpoints were one-year overall survival (OS) and pathologic response (PR). Safety was evaluated with CTCAE v5.0.

resultsFrom February 2016 to October 2020, 92 patients enrolled. The median age was 59 years (range, 27-80), 30% were female, 86% had stage T3-T4, and 69% had ≥N2. At a median follow-up of 28 months, one-year DFS was 97% (95% CI, 71%-90%) in the intermediate-risk group and 66% (95% CI, 55%-84%) in the high-risk group. Patients with a PR had significantly improved one-year DFS relative to patients without response (93% vs. 72%, hazard ratio 0.29; 95% CI, 11%-77%). No new safety signals were identified.

conclusionsNeoadjuvant and adjuvant pembrolizumab increased one-year DFS rate in intermediate-risk, but not high-risk, HNSCC relative to historical control. PR to neoadjuvant ICB is a promising surrogate for DFS.

Indexed as

Antibodies, Monoclonal, HumanizedHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckAdultAgedAged, 80 and overChemotherapy, AdjuvantCisplatinFemaleHumansMaleMiddle AgedNeoadjuvant TherapyAntibodies, Monoclonal, HumanizedCisplatinpembrolizumab

Identifiers

PMID35338369
PMCPMC8976828
OpenAlexW4220868504

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.