Evidence map›Paper›PMID 41159027›Full record

Trial reportFrontiers in immunology2025

Chromosome 11q13 amplification as a decision-making biomarker for anti-PD-1 immunotherapy in recurrent or metastatic head and neck squamous cell carcinoma: a prospective cohort study.

Wen Jiang, Shengjin Dou, Lin Zhang, Minjun Dong, Jiang Li, Ge Wang, Ziyue Gu, Yining He, Debin Sun, Rongrong Li and 1 more

Abstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

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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

11 authors.

Wen JiangDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shengjin DouDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Lin ZhangDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Minjun DongDepartment of Radiology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China.
Jiang LiDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ge WangDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ziyue GuDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yining HeBiostatistics Office of Clinical Research Unit, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Debin SunDepartment of Medicine, Genecast Biotechnology Co., Ltd, Wuxi, China.
Rongrong LiDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Guopei ZhuDepartment of Oral and Maxillofacial Head & Neck Oncology, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Anti-programmed cell death protein 1 (anti-PD-1) immunotherapy has shown efficacy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC), but current biomarkers have limitations in predicting immunotherapy response accurately. Chromosome 11q13 amplification, prevalent in HNSCC, has been associated with reduced efficacy of anti-PD-1 therapy. This study aims to prospectively evaluate 11q13 amplification as a biomarker for guiding first-line treatment in R/M HNSCC. We hypothesize that excluding patients with 11q13 amplification from anti-PD-1 therapy may enhance survival outcomes. Methods: This single-institution prospective cohort study included previously untreated patients with R/M HNSCC. Based on 11q13 amplification status, non-amplified patients received PD-1 inhibitor monotherapy or combination therapy with chemotherapy, while amplified patients were treated with cetuximab and chemotherapy. Nedaplatin was used in place of cisplatin if necessary. Ten 11q13-amplified patients receiving anti-PD-1 therapy served as an external control group. Results: Between August 2020 and June 2023, 75 patients were enrolled prospectively, and an additional 10 patients with 11q13 amplification were included as an external control. Among R/M HNSCC patients without 11q13 amplification who received anti-PD-1-based therapy, the objective response rate (ORR) was 72.5%, with a median progression-free survival (PFS) of 14.3 months and an overall survival (OS) of 38.2 months. These survival outcomes were superior to those seen in other cohorts within this study and reported in other trials. Conclusions: Our study suggests that 11q13 amplification status could serve as a valuable biomarker for first-line treatment decisions in R/M HNSCC. Patients without 11q13 amplification exhibited better responses to anti-PD-1 therapy, providing insights into optimizing treatment strategies. Clinical trial registration: Chinese Clinical Trial Registry identifier, ChiCTR2000035635.

Indexed as

Biomarkers, TumorChromosomes, Human, Pair 11Gene AmplificationHead and Neck NeoplasmsImmune Checkpoint InhibitorsProgrammed Cell Death 1 ReceptorSquamous Cell Carcinoma of Head and NeckAdultAgedClinical Decision-MakingFemaleHumansImmunotherapyMaleMiddle AgedNeoplasm Recurrence, LocalBiomarkers, TumorImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 Receptor11q13 amplificationanti-pd 1 immunotherapybiomarkerpersonlised therapyrecurrent and metastatic head and neck cancer

Identifiers

PMID41159027
PMCPMC12554652

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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.