Comparison of therapeutic effects of PD-1 inhibitors combined with neoadjuvant chemotherapy versus simple neoadjuvant chemotherapy in treatment of locally advanced head and neck squamous cell carcinoma

JIAO Zan; YU Yongchao; JIANG Mingjie; WU Tong; PENG Jin; NING Kang; YANG Ankui

doi:10.3969/j.issn.1674-3806.2025.11.08

Abstract：Objective To compare therapeutic effects of programmed cell death protein-1(PD-1)inhibitors combined with neoadjuvant chemotherapy(NAT)versus simple NAT in treatment of locally advanced head and neck squamous cell carcinoma(LA HNSCC).Methods A retrospective analysis was conducted on the clinical data of 140 patients with LA HNSCC who were admitted to Sun Yat-sen University Cancer Center from February 2012 to February 2023.According to different therapeutic regimens received by the patients,they were divided into immunochemotherapy group(118 patients)and simple chemotherapy group(22 patients).The baseline characteristics were balanced by using propensity score overlap weighting method.The simple chemotherapy group received a TP-based NAT regimen.The immunochemotherapy group received a regimen of intravenous infusion of a PD-1 inhibitor(200 mg)on the first day of each treatment cycle in addition to the TP-based NAT.After the NAT,the patients underwent radical surgical treatment.The objective response rate(ORR),pathological downstaging rate,pathological complete response(pCR)rate,overall survival(OS),and progression-free survival(PFS)were compared between the two groups.Cox regression model was used to analyze the factors influencing the survival prognosis of the LA HNSCC patients.Results The ORR,pathological downstaging rate and pCR rate in the immunochemotherapy group were higher than those in the simple chemotherapy group,with statistically significant differences between the two groups(P＜0.05).By August 2025,the median follow-up time for the immunochemotherapy group was 33.81 months,with 22 cases of disease progression and 15 deaths,and the median follow-up time for the simple chemotherapy group was 24.32 months,with 12 cases of disease progression and 12 deaths.The OS and PFS in the immunochemotherapy group were significantly better than those in the simple chemotherapy group[HR(95％CI)=0.233(0.106-0.512),P＜0.001;HR(95％CI)=0.323(0.155-0.672),P=0.002].After the matching of propensity score overlap weighting method,the OS and PFS in the immunochemotherapy group were still significantly better than those in the simple chemotherapy group[HR(95％CI)=0.236(0.073-0.759),P=0.016;HR(95％CI)=0.337(0.122-0.936),P=0.037].The results of multivariate Cox regression analysis showed that age ≥60 years was an independent risk factor for shortening OS and PFS in the LA HNSCC patients(P＜0.05),and the combined immunotherapy was an independent protective factor for prolonging OS and PFS in the LA HNSCC patients(P＜0.05).Conclusion Compared with the simple NAT,the combination of PD-1 inhibitors and NAT can significantly improve the survival prognosis of LA HNSCC patients and the combination therapy is worthy of clinical recommendation.