Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jun 20;20(6):e0326216.
doi: 10.1371/journal.pone.0326216. eCollection 2025.

The adverse events of toripalimab in nasopharyngeal carcinoma based on FAERS database and bibliometric analysis

Qian Guo  1 , Dong Dong  1 , Zihan Dang  2 , Shuman Huang  1 , Xinjie Qiao  1 , Baiquan Zhang  3 , Yulin Zhao  1
Affiliations

The adverse events of toripalimab in nasopharyngeal carcinoma based on FAERS database and bibliometric analysis

Qian Guo et al. PLoS One. .

Abstract

Background: Toripalimab, a monoclonal antibody designed to target PD-1, has recently received approval from the U.S. Food and Drug Administration (FDA) for use as a first-line treatment in adults diagnosed with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The purpose of this study is to utilize the FAERS database and bibliometric analysis to examine adverse events associated with toripalimab in real-world settings, thereby enhancing the safety management of clinical medications.

Methods: This research implemented a disproportionality analysis to assess the safety of toripalimab by reviewing all adverse event reports from the FAERS database dating back to 2004, wherein toripalimab was recognized as the main suspected medication. Various statistical techniques were applied in the analysis, such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN), to evaluate the adverse events linked to toripalimab. CiteSpace is utilized to search for authors, countries, keywords, and various indicators within research fields, facilitating the identification of research hotspots and future trends.

Results: From 2004 to 2024, 441 AEs linked to toripalimab were recorded across 27 SOCs. The top five SOCs were procedural complications, investigations, blood/lymphatic disorders, gastrointestinal disorders, and skin/subcutaneous disorders. At the PT level, the top five AEs by ROR were myelosuppression (n = 192, ROR 687.41), decreased granulocyte count (n = 11, ROR 515.72), immune-mediated hepatic disorder (n = 7, ROR 343.20), immune-mediated myocarditis (n = 3, ROR 214.68), and bicytopenia (n = 3, ROR 117.49). Additionally, 91.62% of AEs occurred within the first 30 days, and immune-related AEs were highlighted in bibliometric analysis.

Conclusion: This research provides initial safety information regarding the real-world application of toripalimab, affirming previously acknowledged adverse effects and concurrently uncovering new possible risks. These results could act as important cautionary evidence for healthcare professionals and pharmacists engaged in administering toripalimab for NPC.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Fig 1
Fig 1. Flow diagram for the selection of AEs associated with toripalimab from FAERS database.
Fig 2
Fig 2. Proportion of adverse events by system organ class for toripalimab.
Fig 3
Fig 3. Time to onset of adverse events induced by toripalimab.
Fig 4
Fig 4. Cumulative incidence of adverse events related to toripalimab over time.
Fig 5
Fig 5. Bibliometric analysis.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Su ZY, Siak PY, Lwin YY, Cheah S-C. Epidemiology of nasopharyngeal carcinoma: current insights and future outlook. Cancer Metastasis Rev. 2024;43(3):919–39. doi: 10.1007/s10555-024-10176-9 - DOI - PubMed
    1. Shield KD, Ferlay J, Jemal A, Sankaranarayanan R, Chaturvedi AK, Bray F, et al. The global incidence of lip, oral cavity, and pharyngeal cancers by subsite in 2012. CA Cancer J Clin. 2017;67(1):51–64. doi: 10.3322/caac.21384 - DOI - PubMed
    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–49. doi: 10.3322/caac.21660 - DOI - PubMed
    1. Yang Y, Pan J, Wang H, Zhao Y, Qu S, Chen N, et al. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: a multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023;41(6):1061–1072.e4. doi: 10.1016/j.ccell.2023.04.014 - DOI - PubMed
    1. Chen Y, et al. The current advances and future directions of PD-1/PD-L1 blockade in head and neck squamous cell carcinoma (HNSCC) in the era of immunotherapy. Int Immunopharmacol. 2023;120:110329. - PubMed

MeSH terms

Substances

LinkOut - more resources