[Efficacy and safety of programmed death receptor-1 inhibitor combined with albumin-bound paclitaxel and cisplatin in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma].

Objective: To investigate the efficacy and safety of the programmed death receptor-1 inhibitor (anti-PD-1 monoclonal antibody) combined with albumin-bound paclitaxel and cisplatin (PTP) in the neoadjuvant treatment of locally advanced head and neck squamous cell carcinoma (HNSCC). Methods: The data of HNSCC patients from the Center for Cancer Prevention and Control, Sun Yat-sen University between November 2019 and October 2023 were retrospectively analyzed. Patients received the PTP regimen as neoadjuvant therapy every 21 days for 2 to 4 cycles. The objective response rate (ORR), pathological complete response (pCR), adverse reaction, 2-year progression-free survival, and 2-year overall survival were observed and evaluated. The disease-free survival and overall survival rates were calculated using the Kaplan-Meier method. Multivariate Cox regression models were employed to analyze the influencing factors for disease-free survival and overall survival. Results: A total of 240 patients were included (203 males and 37 females), with a median (Q1, Q3) age of 56 (48, 63) years. The ORR was 77.1% (185/240), including 26 cases (10.8%) of complete response (CR), 159 cases (66.3%) of partial response (PR), 49 cases (20.4%) of stable disease (SD), and 6 cases (2.5%) of progressive disease (PD). Among the 128 patients who underwent surgery, 53 patients (41.4%) achieved pCR. Common adverse reactions included alopecia (98.8%, 237/240), nausea/vomiting (71.3%, 171/240), exanthem (57.5%, 138/240), and myelosuppression (47.1%, 113/240), and no grade 4 adverse reactions were reported. The median (Q1, Q3) follow-up time was 22.8 (14.1, 31.8) months, and 54 cases (22.5%) experienced recurrence or metastasis. The 1-year and 2-year overall survival rates were 95.0% and 91.6%, respectively, while the 1-year and 2-year progression-free survival rates were 84.9% and 76.2%, respectively. Multivariate Cox analysis revealed that T stage (T2/T3) (HR=0.528, 95%CI: 0.304-0.918, P=0.024), neoadjuvant treatment response (CR/PR) (HR=0.470, 95%CI: 0.270-0.816, P=0.007), and surgical intervention (HR=0.536, 95%CI: 0.312-0.919, P=0.023) were protective factors for progression-free survival. In oral/oropharyngeal cancer, surgical treatment (HR=0.252, 95%CI: 0.077-0.827, P=0.023) was associated with prolonged overall survival. Conclusion: The PTP regimen for locally advanced HNSCC patients can achieve a high ORR and pathological response rate, with a favorable safety profile and the potential for prolonged progression-free survival and overall survival.