[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.