CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
局部晚期鼻咽癌根治性放化疗后帕博利珠单抗巩固治疗的随机 II 期试验：KCSG HN19-09，CONPELAN 研究
英文原题：Randomized Phase II Trial of Consolidation Pembrolizumab After Definitive Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma: KCSG HN19-09, CONPELAN Study.
查看英文原题
Randomized Phase II Trial of Consolidation Pembrolizumab After Definitive Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma: KCSG HN19-09, CONPELAN Study.
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研究概要
巩固治疗帕博利珠单抗未能改善未经选择的局部晚期鼻咽癌患者的 PFS。
中文摘要
局部晚期鼻咽癌（NPC）放化疗后巩固性程序性死亡蛋白 1（PD-1）阻断的获益尚不明确。
II–IVB 期 NPC 患者按 2:1 随机分组，在放化疗后每 3 周接受 pembrolizumab 200 mg 或安慰剂，最多 17 个周期。主要终点为 3 年无进展生存期（PFS）。
共随机分配 53 名患者（pembrolizumab 组 n=34；安慰剂组 n=19）。pembrolizumab 组和安慰剂组 3 年 PFS 率分别为 56.5% 和 57.8%（单侧 p=0.142；分层 HR=0.408）。仅 pembrolizumab 组出现 3 级及以上不良事件（8.8%）。探索性分析（n=40）显示，瘤内 TIL 密度高与 pembrolizumab 组复发减少相关（OR=0.04；p=0.010），但在安慰剂组未见该关联。
对未筛选的局部晚期 NPC 患者，巩固性 pembrolizumab 未改善 PFS。探索性免疫分析提示可能存在预测信号，值得在前瞻性研究中验证。
展开英文摘要原文
The benefit of consolidation programmed cell death protein 1 (PD-1) blockade after chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC) remains unclear.
Patients with stages II-IVB NPC were randomized (2:1) to pembrolizumab 200 mg or placebo every 3 weeks for up to 17 cycles after chemoradiotherapy. The primary endpoint was 3-year progression-free survival (PFS).
Fifty-three patients were randomized (pembrolizumab, n = 34; placebo, n = 19). The 3-year PFS rates were 56.5% and 57.8% in the pembrolizumab and placebo arms, respectively (one-sided p = 0.142; stratified HR, 0.408). Grade 3 or higher adverse events occurred only in the pembrolizumab arm (8.8%). In an exploratory analysis (n = 40), high intratumoral TIL density was associated with reduced recurrence in the pembrolizumab arm (OR, 0.04; p = 0.010) but not the placebo arm.
Consolidation pembrolizumab did not improve PFS in unselected locally advanced NPC. Exploratory immune profiling suggested a predictive signal warranting prospective validation.
论文信息
- 作者
- Chun SH、Seo S、Cho JH、Park KU、Lee SC、Choi YW、Yun T、Shin SH
- 第一作者单位
- Division of Medical Oncology, Department of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.South Korea
- 通讯作者单位
- Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.South Korea
- 期刊
- Head & neck2026 May 21
- 原文标识
- PubMed 42168759 · DOI 10.1002/hed.70329