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PD-1抑制剂联合白蛋白结合型紫杉醇和顺铂在局部晚期下咽鳞状细胞癌新辅助治疗中的疗效

[Efficacy of PD-1 inhibitors combined with nab-paclitaxel and cisplatin in the neoadjuvant treatment of locally advanced hypopharyngeal squamous cell carcinoma].

作者信息

Fang Q, Xu P F, Cao F, Zhao Z, Zhang X R, Wu D, Chen C Y, Li Z M, Han F, Liu X K

机构信息

Department of Head and Neck Surgery, Center for Cancer Prevention and Control, Sun Yat-sen University, South China State Key Laboratory of Oncology, Collaborative Innovation Center of Oncology, Guangdong Clinical Medical Research Center for Malignant Tumors, Guangzhou 510060, China.

Department of Otorhinolaryngology, the Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou 510799, China.

出版信息

Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2024 Jul 7;59(7):750-757. doi: 10.3760/cma.j.cn115330-20231016-00152.

DOI:10.3760/cma.j.cn115330-20231016-00152
PMID:39107124
Abstract

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. 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/m) and cisplatin (60 mg/m) 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. The overall efficiency was 90.6% (48/53). The 1-year and 2-year LDFS rates were 83.8% (95%: 74.0% to 94.8%) and 50.3% (95%: 22.1% to 91.6%), the 1-year and 2-year OS rates were 95.2% (95%: 88.9% to 100.0%) and 58.2% (95%: 25.6% to 81.8%), and the 1-year and 2-year PFS rates were 83.9% (95%: 74.2% to 94.9%) and 53.5% (95%: 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%). 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.

摘要

评估程序性死亡蛋白1(PD-1)抑制剂联合白蛋白结合型紫杉醇和顺铂(TP方案)新辅助治疗局部晚期下咽鳞状细胞癌及保留喉器官功能的疗效。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的53例患者的数据,其中男性51例,女性2例,年龄38-70岁,经组织学和增强CT确诊为局部晚期下咽鳞状癌。所有患者接受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至4个周期。主要观察指标为无喉功能障碍生存期(LDFS)、总生存期(OS)和无进展生存期(PFS)。采用Kaplan-Meier法绘制生存曲线,若Cox单因素分析有统计学意义,则进一步进行Cox多因素分析。总有效率为90.6%(48/53)。1年和2年LDFS率分别为83.8%(95%CI:74.0%至94.8%)和50.3%(95%CI:22.1%至91.6%),1年和2年OS率分别为95.2%(95%CI:88.9%至100.0%)和58.2%(95%CI:25.6%至81.8%),1年和2年PFS率分别为83.9%(95%CI:74.2%至94.9%)和53.5%(95%CI:32.1%至89.1%)。新辅助治疗相关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%)。采用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状细胞癌可提高生存率并改善喉器官功能保留率。

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