| 摘要: |
| ［摘要］ 目的 比较程序性死亡受体-1（PD-1）抑制剂联合新辅助化疗与单纯新辅助化疗对局部晚期头颈鳞状细胞癌（LA HNSCC）的疗效。方法 回顾性分析2012年2月至2023年2月中山大学肿瘤防治中心收治的140例LA HNSCC患者的临床资料，根据治疗方案不同将其分为免疫化疗组（118例）和单纯化疗组（22例）。通过倾向性评分重叠加权法平衡基线特征。单纯化疗组采用基于TP方案的新辅助化疗方案；免疫化疗组在TP方案基础上，于每个治疗周期第1天同步静脉输注PD-1抑制剂200 mg。新辅助化疗后行根治性手术治疗，比较两组客观缓解率（ORR）、病理降期发生率以及病理完全缓解率（pCR）、总体生存期（OS）和无进展生存期（PFS）。采用Cox回归分析影响LA HNSCC患者生存预后的因素。结果 免疫化疗组ORR、病理降期发生率以及pCR高于单纯化疗组，差异有统计学意义（P<0.05）。截至2025年8月，免疫化疗组中位随访时间为33.81个月，发生疾病进展22例，死亡15例；单纯化疗组中位随访时间为24.32个月，发生疾病进展12例，死亡12例。免疫化疗组OS和PFS显著优于单纯化疗组［HR（95%CI）=0.233（0.106～0.512），P<0.001；HR（95%CI）=0.323（0.155～0.672），P=0.002］。经倾向性评分重叠加权法匹配后，免疫化疗组OS和PFS仍显著优于单纯化疗组［HR（95%CI）=0.236（0.073～0.759），P=0.016；HR（95%CI）=0.337（0.122～0.936），P=0.037］。多因素Cox回归分析结果显示，年龄≥60岁是LA HNSCC患者OS、PFS缩短的独立危险因素（P<0.05），联合免疫治疗是LA HNSCC患者OS、PFS延长的独立保护因素（P<0.05）。结论 相比于单纯新辅助化疗，PD-1抑制剂联合新辅助化疗可显著改善LA HNSCC患者的生存预后，值得临床推荐。 |
| 关键词: 免疫治疗 头颈鳞状细胞癌 新辅助化疗 重叠加权 |
| DOI：10.3969/j.issn.1674-3806.2025.11.08 |
| 分类号:R 739.6 |
| 基金项目:国家自然科学基金项目（编号：82272649，82403855） |
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| 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 |
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JIAO Zan, YU Yongchao, JIANG Mingjie, WU Tong, PENG Jin, NING Kang, YANG Ankui
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Department of Head and Neck, Sun Yat-sen University Cancer Center, Guangzhou 510060, China
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| Abstract: |
| ［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. |
| Key words: Immunotherapy Head and neck squamous cell carcinoma(HNSCC) Neoadjuvant chemotherapy(NAT) Overlap weighting |
