Durvalumab with or without tremelimumab for patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a systematic review and meta-analysis

Front Immunol. 2024 Jan 17:14:1302840. doi: 10.3389/fimmu.2023.1302840. eCollection 2023.


Objective: Head and neck squamous cell carcinoma (HNSCC) ranks as the sixth most prevalent cancer worldwide, significantly impacting patients' quality of life. Immune checkpoint inhibitors (ICI) have been employed in the treatment of recurrent/metastatic (R/M)-HNSCC patients. This meta-analysis aims to assess the efficacy and safety of durvalumab monotherapy compared to the combination of durvalumab and tremelimumab in R/M-HNSCC patients.

Methods: Relevant studies were systematically searched in PubMed, Embase, and Cochrane Library databases. All articles comparing durvalumab monotherapy with the combination with durvalumab and tremelimumab in R/M-HNSCC treatment were included. Additionally, the references of identified studies were screened if necessary.

Result: A total of 1298 patients from three studies comparing durvalumab with durvalumab and tremelimumab in treating R/M-HNSCC were include in this meta-analysis. Our findings revealed no significant difference in objective response rate (ORR) [odds ratio (OR): 1.15, 95% confidence interval (CI): 0.85 to 1.56, P = 0.36] and disease control rate (DCR) (OR=1.08, 95%CI: 0.86 to 1.37, P = 0.51). Similar outcomes were observed in overall survival (OS), progression-free survival (PFS), and duration of response (DoR). Regarding safety, there was no significant difference in the incidence of treatment-related adverse events (trAEs) between the two groups (OR=1.26, 95%CI: 0.81 to 1.94, P = 0.30). However, patients treated with the combination therapy exhibited a higher incidence of grade 3-4 trAEs (OR=1.93, 95%CI: 1.36 to 2.73, P = 0.0002) and a greater likelihood of discontinuing treatment due to trAEs (OR=2.07, 95%CI: 1.12 to 3.85, P = 0.02). There was no significant difference in the occurrence of severe trAEs leading to death (OR=1.36, 95%CI: 0.47 to 3.96, P = 0.57).

Conclusion: This meta-analysis suggests that R/M-HNSCC patients receiving the combination of durvalumab and tremelimumab may achieve comparable outcomes in terms of ORR, DCR, OS, PFS, and DoR, without significant differences. However, the combination therapy is associated with a higher incidence of grade 3-4 trAEs and an increased likelihood of treatment discontinuation due to trAEs. These findings highlight the need for cautious consideration of the combination of durvalumab and tremelimumab in R/M-HNSCC patients, which should be further evaluated in high-quality studies.

Keywords: durvalumab; immunotherapy; meta-analysis; recurrent or metastatic HNSCC; tremelimumab.

Publication types

  • Meta-Analysis
  • Systematic Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Monoclonal*
  • Antibodies, Monoclonal, Humanized*
  • Carcinoma, Squamous Cell* / drug therapy
  • Head and Neck Neoplasms* / drug therapy
  • Humans
  • Neoplasm Recurrence, Local / drug therapy
  • Quality of Life
  • Squamous Cell Carcinoma of Head and Neck / drug therapy


  • durvalumab
  • tremelimumab
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was funded by Programs of the Jiangsu Provincial Commission of Health and Family Planning Funding (K2019015), the Foundation of Nanjing Medical University (NMUB20220141), and Priority Academic Program Development of Jiangsu Higher Education Institutions.