Efficacy of PD-1 inhibitors combined with nab-paclitaxel and cisplatin in the neoadjuvant treatment of locally advanced hypopharyngeal squamous cell carcinoma
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目的 分析程序性细胞死亡蛋白1(programmed cell death protein 1,PD-1)抑制剂联合紫杉醇(白蛋白结合型)和顺铂(TP方案)新辅助治疗局部晚期下咽鳞状细胞癌(简称鳞癌)的疗效,并评估喉器官功能保留率.方法 回顾性分析2019年1月1日至2023年1月15日在中山大学肿瘤防治中心初治,经组织学和增强CT确诊为局部晚期下咽鳞癌的53例患者资料,其中男性51例,女性2例,年龄38～70岁.患者均接受PD-1抑制剂联合白蛋白结合型紫杉醇(260mg/m2)和顺铂(60mg/m2)新辅助治疗3～4周期.主要观察指标为喉器官功能保全生存期(larynx dysfunction-free survival,LDFS)、总生存期(OS)和无进展生存期(PFS).使用Kaplan-Meier法绘制生存曲线,Cox单因素分析有统计学意义者进一步行Cox多因素分析.结果 总体治疗有效率为90.6％(48/53).1年、2年LDFS率为83.8％(95％CI:74.0％～94.8％)和 50.3％(95％CI:22.1％～91.6％),1 年、2 年 OS 率为 95.2％(95％CI:88.9％～100.0％)和 58.2％(95％CI:25.6％～81.8％),1 年、2 年 PFS 率为 83.9％(95％CI:74.2％～94.9％)和 53.5％(95％CI:32.1％～89.1％).新辅助治疗相关的不良事件主要为骨髓抑制(45.3％)、胃肠道反应(37.7％)和甲状腺功能减退(20.8％).结论 在PD-1抑制剂联合紫杉醇和顺铂新辅助治疗局部晚期下咽鳞癌中,可在保证较高生存率的同时提高患者喉器官功能保留率.
Objective To assess the efficacy of neoadjuvant treatment with PD-1(programmed cell death protein 1)inhibitors combined with paclitaxel(albumin-conjugated)and cisplatin(TP regimen)for locally advanced hypopharyngeal squamous cell carcinoma and laryngeal organ function preservation.Methods Data of 53 patients,including 51 males and 2 females,aged 38-70 years old,who were diagnosed with locally advanced hypopharyngeal squamous carcinoma confirmed by histology and enhanced CT at the Cancer Prevention and Control Center of Sun Yat-sen University during the initial treatment from January 1,2019 to January 15,2023,were retrospectively analyzed.All patients received neoadjuvant therapy with PD-1 inhibitors combined with albumin-bound paclitaxel(260 mg/m2)and cisplatin(60 mg/m2)for 3 to 4 cycles.The main outcome measures were larynx dysfunction-free survival(LDFS),overall survival(OS),and progression-free survival(PFS).Survival curves were plotted using the Kaplan-Meier method,and Cox multifactorial analysis was further performed if Cox univariate analysis was statistically significant.Results The overall efficiency was 90.6％(48/53).The 1-year and 2-year LDFS rates were 83.8％(95％CI:74.0％to 94.8％)and 50.3％(95％CI:22.1％to 91.6％),the 1-year and 2-year OS rates were 95.2％(95％CI:88.9％to 100.0％)and 58.2％(95％CI:25.6％to 81.8％),and the 1-year and 2-year PFS rates were 83.9％(95％CI:74.2％to 94.9％)and 53.5％(95％CI:32.1％to 89.1％).Adverse events associated with the neoadjuvant therapy were mainly myelosuppression(45.3％),gastrointestinal reactions(37.7％)and hypothyroidism(20.8％).Conclusion The neoadjuvant treatment of locally advanced hypopharyngeal squamous cell carcinoma using PD-1 inhibitors combined with paclitaxel and cisplatin can provide with a higher survival rate with a improved laryngeal organ function preservation rate.
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