Evidence map›Paper›PMID 41590377›Full record

ArticleCurrent oncology (Toronto, Ont.)2026

Clinical Outcomes of Pembrolizumab in Head and Neck Squamous Cell Carcinoma Subsites Excluded from the KEYNOTE-048 Trial.

Gai Yamashita, Takuro Okada, Isaku Okamoto, Takahito Kondo, Tatsuya Ito, Shota Fujii, Takuma Kishida, Yusuke Aihara, Kenji Hanyu, Yuri Ueda and 10 more

Abstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Current oncology (Toronto, Ont.), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

20 authors.

Gai YamashitaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Takuro OkadaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Isaku OkamotoDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.ORCID 0000-0002-9819-1137
Takahito KondoDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Tatsuya ItoDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Shota FujiiDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, Tokyo 193-0998, Japan.
Takuma KishidaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Yusuke AiharaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Kenji HanyuDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Yuri UedaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.ORCID 0000-0002-8630-1001
Kunihiko TokashikiDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, Tokyo 193-0998, Japan.
Hiroki SatoDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.
Yuki HaradaDepartment of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, Sagamihara 252-0374, Japan.
Kaho MomiyamaDepartment of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, Sagamihara 252-0374, Japan.ORCID 0000-0002-8051-9384
Takashi MatsukiDepartment of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, Sagamihara 252-0374, Japan.ORCID 0000-0001-7633-3512
Yukiomi KushihashiDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo 108-8329, Japan.
Tatsuo MasubuchiDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo 108-8329, Japan.
Yuichiro TadaDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo 108-8329, Japan.
Taku YamashitaDepartment of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, Sagamihara 252-0374, Japan.
Kiyoaki TsukaharaDepartment of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo 160-0023, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) carries a poor prognosis; however, immune checkpoint inhibitors have emerged as critical therapeutic options. Although the KEYNOTE-048 trial established the efficacy of pembrolizumab, the population was restricted to major sites (e.g., oral cavity, oropharynx, hypopharynx, and larynx), excluding subsites such as the paranasal sinuses and nasopharynx. To evaluate outcomes in these populations, we conducted a multicenter retrospective study of 167 patients with R/M SCCHN treated with pembrolizumab between December 2019 and February 2022. The cohort comprised 127 patients with tumors in included sites and 27 in excluded subsites. Primary endpoints included overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), and immune-related adverse events (irAEs). In the excluded subsite group, median OS was 15.2 months (1-year rate: 70.6%), and median PFS was 4.9 months (1-year rate: 21.2%). The ORR was 22.2% and the DCR was 59.3%. The incidence of irAEs was 25.9%, with Grade ≥ 3 events in 3.7%. Survival outcomes did not differ significantly from those in included sites. These findings suggest the potential efficacy and safety of pembrolizumab in subsites excluded from KEYNOTE-048, warranting validation in prospective trials.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabexcluded subsitesKEYNOTE-048pembrolizumabrecurrent or metastatic squamous cell carcinoma of the head and neck

Identifiers

PMID41590377
PMCPMC12840263

What Socratic holds

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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 Socratic graph.