Combination Therapy of Anti-PD-1 Immunotherapy and Taxanes in Relapsed and/or Metastatic Head and Neck Squamous Cell Carcinoma: A Real-world Single-center Retrospective Study

Abstract Background: Recurrent/metastatic head and neck squamous cell carcinoma (R/M-HNSCC) carries a poor prognosis despite the current standard of care. This study aimed to investigate the efficacy and safety of a novel non-cisplatin-containing chemo-immunotherapy regimen combining a programmed cell death protein 1 (PD-1) inhibitor and a taxane, in platinum-ineligible or platinum-refractory R/M-HNSCC patients. Materials and Methods: This retrospective analysis of medical charts included 24 patients aged ≥18 with unresectable R/M-HNSCC, eastern cooperative oncology group performance status ≤2, no prior immune checkpoint inhibitor (ICI) therapy, and adequate follow-up. All patients received a PD-1 inhibitor and a taxane. The primary endpoints were progression-free survival (PFS) and objective response rate (ORR), and the secondary endpoints were overall survival (OS) and toxicity. Results: The ORR was 50%, the disease control rate was 66.7%, the median PFS was 6.4 months, and the median OS was 11.6 months. The average time to response was 3.3 months, with a median duration of response of 5.0 months. Common adverse events included anemia (58.3%), hypothyroidism (29.2%), and dermatitis (25%). Grade ≥ 3 adverse events occurred in 20.8% (5/24) of the patients, with one ICI discontinuation due to severe dermatitis; others were manageable. Conclusion: The results of this real-world retrospective analysis showed satisfactory efficacy including ORR, PFS, and OS, and manageable toxicity for PD-1 inhibitor/taxane combination therapy as first-or later-line treatment in ICI-naïve R/M-HNSCC patients. Larger prospective studies are warranted.