Evidence map›Paper›PMID 39754263›Full record

ArticleWorld journal of surgical oncology2025

The efficacy and safety of a taxane-based chemotherapy regimen combined with a PD-1 inhibitor in HNSCC: a multicenter real-world study.

Min Ouyang, Hanquan Sun, Xiaoyu Liu, Haijun Wu, Feilong Deng, Erdong Shen, Guozheng Peng, Hanbing Wu, Yinshan Zhao, Hui Xiong and 4 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in World journal of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07211139 (Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT07211139 recruitingnot on this map

Head and Neck Advanced Research for Multi-Omics and Optimized Immunotherapy(HARMONI)

Typeobservational_patient_registrySponsorSamsung Medical CenterRan2025 to 2027Enrolled30ConditionsHead and Neck Cancer
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Observational
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

14 authors.

Min Ouyang *Department of Gerontology, The Second Xiangya Hospital of Central South University, Changsha, China.
Hanquan Sun *Department of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.
Xiaoyu Liu *Department of Oncology, Loudi City Central Hospital, Loudi, China.
Haijun WuDepartment of Oncology, Xiangya Hospital of Central South University, Changsha, China.
Feilong DengDepartment of Oncology, Liling Traditional Chinese Medicine Hospital, Liling, China.
Erdong ShenDepartment of Oncology, Yueyang Central Hospital, Yueyang, China.
Guozheng PengDepartment of Oncology, Hengyang Central Hospital, Hengyang, China.
Hanbing WuDepartment of Oncology, Hunan University of Medicine General Hospital, Changsha, China.
Yinshan ZhaoDepartment of Oncology, The Fifth People's Hospital of Huaihua, Huaihua, China.
Hui XiongDepartment of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.
Bin LiuDepartment of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.
Shasha HeDepartment of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.
Ying HuDepartment of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China.
Ping LiuDepartment of Oncology, The Second Xiangya Hospital of Central South University, Changsha, China. liuping3600@csu.edu.cn.

Funding

China International Medical Exchange Foundation ChiCTR1900022364
6 · The paper itself

Abstract

objectiveThis study aims to elucidate the therapeutic efficacy and safety of a taxane-based chemotherapy in combination with immune checkpoint inhibitors regimen in patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

methodsWe retrospectively collected clinical data from 154 patients who received at least two cycles of PD-1 inhibitors in combination with a taxane-based chemotherapy as first-line treatment in seven hospitals in Hunan Province, between December 2018 and December 2023. These patients were subjected to long-term follow-up.

resultsThe study included 154 eligible patients, with a median follow-up period of 21.5 months. The median PFS was 8.7 months, while the median OS was 16.7 months. The 12-month PFS rate was 43.6%, and the 12-month OS rate was 60.1%. At 24 months, the PFS rate was 34.4%, and the OS rate was 36.9%. With 26 complete responses (16.9%) and 52 partial responses (33.8%), the ORR was 50.6%. Stable disease was observed in 54 patients (35.1%), resulting in a disease control rate of 85.7%, while 22 patients showed progressive disease. In the univariate analysis, the distant organ metastasis had a statistically significant impact on both PFS and OS. Subsequent radiotherapy following this protocol also showed a statistically significant effect on PFS and OS. However, radiotherapy before recurrent metastasis did not significantly affect PFS, though it did have a significant impact on OS. Other factors analyzed did not show a statistically significant effect on PFS and OS. Multivariate analysis indicated that the distant organ metastasis and subsequent radiotherapy following this protocol were independent prognostic factors for PFS in patients with R/M HNSCC, and the latter was also an independent prognostic factor for OS in these patients. Regarding safety, during treatment anemia was observed in 97 patients, leukopenia in 64, neutropenia in 33, thrombocytopenia in 28, transaminase elevation in 46, hypothyroidism in 46 patients, and one patient stopped taking the medication due to a serious adverse reaction. No treatment-related deaths occurred.

conclusionThe combination of PD-1 inhibitors with a a taxane-based chemotherapy regimen as a first-line treatment for R/M HNSCC patients demonstrates good therapeutic efficacy and acceptable safety profiles.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsHead and Neck NeoplasmsImmune Checkpoint InhibitorsSquamous Cell Carcinoma of Head and NeckTaxoidsAdultAgedAged, 80 and overBridged-Ring CompoundsFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalPrognosisBridged-Ring CompoundsImmune Checkpoint InhibitorstaxaneTaxoidsChemotherapyImmunotherapyPrognostic analysisReal-world studyRecurrent/Metastatic Head and Neck squamous cell carcinoma

Identifiers

PMID39754263
PMCPMC11699790

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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.