Sang Hoon Chun, Seyoung Seo, Jang Ho Cho, Keon-Uk Park, Sang-Cheol Lee, Yong Won Choi, Tak Yun, Seong Hoon Shin, Sung-Bae Kim, Seungeun Lee, Chang Ho Ahn, Bhumsuk Keam
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The 3-year PFS rates were 56.5% and 57.8% in the pembrolizumab and placebo arms, respectively (one-sided <i>p</i> = 0.142; stratified HR, 0.408). Grade 3 or higher adverse events occurred only in the pembrolizumab arm (8.8%). In an exploratory analysis (<i>n</i> = 40), high intratumoral TIL density was associated with reduced recurrence in the pembrolizumab arm (OR, 0.04; <i>p</i> = 0.010) but not the placebo arm.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>Consolidation pembrolizumab did not improve PFS in unselected locally advanced NPC. 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引用次数: 0
摘要
背景：局部区域晚期鼻咽癌（NPC）放化疗后固结性程序性细胞死亡蛋白1 （PD-1）阻断的益处尚不清楚。方法：II-IVB期鼻咽癌患者在放化疗后每3周随机（2:1）接受200 mg派姆单抗或安慰剂治疗，最长可达17个周期。主要终点是3年无进展生存（PFS）。结果：53例患者被随机分配（pembrolizumab, n = 34；安慰剂，n = 19）。派姆单抗组和安慰剂组的3年PFS分别为56.5%和57.8%（单侧p = 0.142；分层HR， 0.408）。3级或以上不良事件仅发生在派姆单抗组（8.8%）。在一项探索性分析（n = 40）中，高瘤内TIL密度与派姆单抗组的复发减少相关（OR, 0.04; p = 0.010），而安慰剂组则没有。结论：巩固派姆单抗不能改善未选择的局部晚期鼻咽癌患者的PFS。探索性免疫分析提出了一个预测性信号，保证了前瞻性验证。
Randomized Phase II Trial of Consolidation Pembrolizumab After Definitive Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma: KCSG HN19-09, CONPELAN Study
Background
The benefit of consolidation programmed cell death protein 1 (PD-1) blockade after chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC) remains unclear.
Methods
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).
Results
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.
Conclusions
Consolidation pembrolizumab did not improve PFS in unselected locally advanced NPC. Exploratory immune profiling suggested a predictive signal warranting prospective validation.
期刊介绍：
Head & Neck is an international multidisciplinary publication of original contributions concerning the diagnosis and management of diseases of the head and neck. This area involves the overlapping interests and expertise of several surgical and medical specialties, including general surgery, neurosurgery, otolaryngology, plastic surgery, oral surgery, dermatology, ophthalmology, pathology, radiotherapy, medical oncology, and the corresponding basic sciences.
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