紫杉类化疗药物联合程序性死亡受体1抑制剂治疗复发/转移性头颈鳞癌的真实世界研究  

Taxane-based chemotherapy combined with programmed death-1 inhibitors in recurrent/metastatic head and neck squamous cell carcinoma:a real-world study

作　　者：刘晓宇 熊慧[1] 刘斌[1] 贺莎莎 刘平[1] Liu Xiaoyu;Xiong Hui;Liu Bin;He Shasha;Liu Ping(Department of Oncology,the Second Xiangya Hospital,Central South University,Changsha 410011,China)

机构地区：[1]中南大学湘雅二医院肿瘤中心,湖南长沙410011

出　　处：《实用肿瘤杂志》2025年第1期38-47,共10页Journal of Practical Oncology

基　　金：吴阶平医学基金会专项基金资助项目(320.6750.19088-61)。

摘　　要：目的明确紫杉类化疗药物联合免疫检查点抑制剂对复发/转移性头颈鳞癌(recurrent or metastatic head and neck squamous cell carcinoma,R/M HNSCC)患者的治疗效果与安全性。方法收集自2019年1月至2022年6月在中南大学湘雅二医院肿瘤中心一线使用程序性死亡受体1(programmed death-1,PD-1)抑制剂联合紫杉类化疗药物≥2个周期的76例R/M HNSCC患者的临床资料,并进行长期随访。研究主要终点为无进展生存期(progression free survival,PFS)和总生存期(overall survival,OS),次要终点为ORR(objective response rate,ORR)。采用Kaplan-Meier法绘制生存曲线比较不同临床特征下患者的PFS和OS差异。PFS和OS相关的单因素分析采用log-rank检验,多因素分析采用Cox回归模型。分析患者治疗后不良反应情况。结果中位随访时间为20.9个月。76例患者中位PFS为12.6个月,中位OS未达到,1年OS率为77.6%,1年PFS率为55.3%。完全缓解(complete response,CR)17例,部分缓解(partial response,PR)20例,疾病稳定(stable disease,SD)31例,疾病进展(progressive disease,PD)8例,客观缓解率(objective response rate,ORR)为48.7%,疾病控制率(disease control rate,DCR)为89.5%。单因素分析显示,R/M HNSCC患者使用PD-1抑制剂联合紫杉类化疗药物治疗后,进行与不进行放疗的患者和不同最佳疗效的患者PFS和OS比较,差异均具有统计学意义(均P<0.05)。治疗开始时有无远处转移的患者的PFS比较,差异具有统计学意义(P<0.05)。多因素分析显示,联合阳性评分(combined positive score,CPS)和最佳疗效评估结果均为影响R/M HNSCC患者PFS的独立危险因素(均P<0.05);最佳疗效评估结果为影响R/M HNSCC患者OS的独立危险因素(P<0.05)。安全性方面,治疗期间出现贫血66例(86.8%),白细胞减少39例(51.3%),中性粒细胞减少27例(35.5%),血小板减少19例(25.0%),肝脏毒性24例(31.6%),甲状腺功能减退24例(31.6%)。1例(1.3%)因严重不良反应停药。所有患者均未出�Objective To elucidate the efficacy and safety of taxane-based chemotherapy in combination with immune checkpoint inhibitors in patients diagnosed with recurrent or metastatic head and neck squamous cell carcinoma(R/M HNSCC).Methods The clinical data of 76 R/M HNSCC patients who received≥2 cycles of programmed death-1(PD-1)inhibitors combined with taxane-based chemotherapy as first-line treatment in the Department of Oncology of the Second Xiangya Hospital,Central South University,from January 2019 to June 2022,were collected,and followed up for long-term outcomes.The primary endpoints were progression free survival(PFS)and overall survival(OS),and the secondary endpoint was objective response rate(ORR).Kaplan-Meier method was used to plot survival curves and compare PFS and OS among patients with different clinical characteristics.Univariate analysis was performed using log-rank test,and multivariate analysis was conducted using Cox proportional hazards regression models.The adverse reactions after the treatment were analyzed.Results The median follow-up time was 20.9 months.Among the 76 patients,the median PFS was 12.6 months,and the median OS was not reached.The one-year OS and PFS rates were 77.6%and 55.3%,respectively.Complete response(CR)was achieved in 17 patients,partial response(PR)in 20 patients,stable disease(SD)in 31 patients,and progressive disease(PD)in 8 patients.The ORR was 48.7%,and the disease control rate(DCR)was 89.5%.Univariate analysis revealed significant differences in PFS and OS between patients with and without radiotherapy and among those with varying best treatment responses(all P<0.05).PFS was significantly different between patients with and without distant metastasis before treatment(P<0.05).Multivariate analysis identified combined positive score(CPS)and best treatment response as independent risk factors for PFS in R/M HNSCC patients,and best treatment response as an independent risk factor for OS(all P<0.05).In terms of safety,anemia was observed in 66 cases(86.8%)during treatm

关 键 词：复发/转移性头颈鳞癌 免疫治疗 化学治疗 真实世界研究 

分 类 号：R739.91[医药卫生—肿瘤]