Retrospective analysis of nanoparticle albumin-bound paclitaxel combined with toripalimab and platinum as first-line treatment for Chinese patients with recurrent or metastatic head and neck cancer.

Objective: To evaluate the clinical efficacy and safety of toripalimab combined with albumin-bound paclitaxel and cisplatin/carboplatin as first-line treatment for recurrent or metastatic head and neck squamous cell carcinoma (R/MHNSCC). Methods: Thirty-five patients with advanced R/MHNSCC admitted to Hunan Cancer Hospital (January 2021-December 2023) received first-line treatment with toripalimab plus albumin-bound paclitaxel and cisplatin/carboplatin. Efficacy was assessed using RECIST 1.1, and adverse events were evaluated according to NCI-CTCAE 5.0. Results: A total of 35 patients were assessed for efficacy, with partial response (PR) in 21 (60.0%), stable disease (SD) in 6 (17.1%), and progressive disease (PD) in 8 (22.9%). The overall response rate (ORR) was 60.0%, and the disease control rate (DCR) was 77.1%. The follow-up period concluded on August 10, 2024, with a median follow-up duration of 22.0 months (range: 15.0-27.0 months). Among the cohort, 8 patients experienced PD, and 7 patients succumbed to the disease; 13 patients continued treatment without disease progression. The median progression-free survival (PFS) for the entire cohort was 7.0 months (95% CI: 4.4-9.6 months), while the median overall survival (OS) had not yet been reached. Further results of Cox proportional hazards regression analysis showed that programmed death-ligand 1 (PD-L1) expression status was an independent risk factor for progression-free survival (PFS), whereas bone metastasis status and a history of surgery for head and neck squamous cell carcinoma were key risk factors for overall survival. The primary adverse reactions observed included bone marrow suppression, hypothyroidism, rash, neurotoxicity, pneumonia, and abnormal liver function. The majority of patients experienced grade I to II adverse reactions; however, one patient (4.3%) exhibited grade III adverse reactions, specifically an immune-related rash, and two patients experienced grade IV adverse reactions, one with leukopenia and the other with neutropenia. Notably, there were no deaths attributable to toxicity. Conclusion: Toripalimab combined with albumin-bound paclitaxel and cisplatin/carboplatin demonstrates promising efficacy with manageable adverse reactions as first-line treatment for R/MHNSCC. However, further research involving expanded sample sizes and randomized controlled trials is warranted to substantiate these findings.