小柯机器人

广东省鼻咽癌诊疗重点实验室Wenfeng Fang和Li Zhang共同合作，近期取得重要工作进展。他们进行了一项多中心3期试验(RATIONALE-309)，提出Tislelizumab联合化疗可以作为复发或转移性鼻咽癌的一线治疗方案。相关研究成果2023年5月18日在线发表于《癌细胞》杂志上。

据介绍，检查点抑制剂对复发/转移性鼻咽癌（R/M NPC）有效。

RATIONALE-309（NCT03924986）将263名未接受治疗的R/M NPC患者随机分组，每3周（Q3W）接受一次tislelizumab或安慰剂治疗，再加上化疗（Q3W，4-6个周期）。在中期分析中，与安慰剂化疗相比，tislelizumab化疗的无进展生存期（PFS）显著更长（风险比：0.52；95%置信区间：0.38，0.73；p<0.0001）。无论程序性死亡配体1的表达如何，tislelizumab化疗与安慰剂化疗的PFS益处都得到了观察。tislelizumab化疗与安慰剂化疗相比，下一轮治疗后的PFS和总生存率显示出有利的趋势。两者之间的安全状况相似。基因表达谱（GEP）鉴定出免疫“热”肿瘤，并显示活化的树突状细胞（DC）特征与tislelizumab化疗PFS获益相关。

总之，这一研究结果支持tislelizumab化疗应被视为R/M NPC的一线治疗方案，GEP和激活的DC信号结果可能有助于确定哪些患者可能从免疫化疗治疗中受益最大。

附：英文原文

Title: Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309)

Author: Yunpeng Yang, Jianji Pan, Hui Wang, Yuanyuan Zhao, Shenhong Qu, Nianyong Chen, Xiaozhong Chen, Yan Sun, Xiaohui He, Chaosu Hu, Lizhu Lin, Qitao Yu, Siyang Wang, Guihua Wang, Feng Lei, Jiyu Wen, Kunyu Yang, Zhixiong Lin, Ye Guo, Shaoqing Chen, Xiaoming Huang, Yanjie Wu, Liang Liang, Chenqi Chen, Fan Bai, Xiaopeng Ma, Yun Zhang, Shiangjiin Leaw, Li Zhang, Wenfeng Fang

Issue&Volume: 2023-05-18

Abstract: Checkpoint inhibitors are effective in recurrent/metastatic nasopharyngeal cancer (R/M NPC). RATIONALE-309 (NCT03924986) randomized 263 treatment-naive R/M NPC patients to tislelizumab or placebo every 3 weeks (Q3W), plus chemotherapy (Q3W for 4–6 cycles). At interim analysis, progression-free survival (PFS) was significantly longer with tislelizumab-chemotherapy versus placebo-chemotherapy (hazard ratio: 0.52; 95% confidence interval: 0.38, 0.73; p < 0.0001). PFS benefit for tislelizumab-chemotherapy versus placebo-chemotherapy was observed regardless of programmed death-ligand 1 expression. PFS after next line of treatment and overall survival showed favorable trends for tislelizumab-chemotherapy versus placebo-chemotherapy. The safety profile was similar between arms. Gene expression profiling (GEP) identified immunologically “hot” tumors, and showed an activated dendritic cell (DC) signature was associated with tislelizumab-chemotherapy PFS benefit. Our results support that tislelizumab-chemotherapy should be considered as first-line treatment for R/M NPC, and GEP and activated DC signature results may help identify patients who might benefit most from immunochemotherapy treatment.

DOI: 10.1016/j.ccell.2023.04.014

Source: https://www.cell.com/cancer-cell/fulltext/S1535-6108(23)00140-X

Cancer Cell：《癌细胞》，创刊于2002年。隶属于细胞出版社，最新IF：38.585
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