Medical Oncology, Gustave Roussy, Villejuif, France.
Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou, Taoyuan, Taiwan.
Clin Cancer Res. 2021 Dec 1;27(23):6413-6423. doi: 10.1158/1078-0432.CCR-21-0822. Epub 2021 Aug 25.
No standard treatment exists for platinum-refractory, recurrent/metastatic nasopharyngeal cancer (NPC). This phase II study (NCT02605967) evaluated progression-free survival (PFS) of spartalizumab, an antiprogrammed cell death protein-1 (PD-1) monoclonal antibody, versus chemotherapy, in NPC.
Patients with nonkeratinizing recurrent/metastatic NPC who progressed on/after platinum-based chemotherapy were enrolled. Spartalizumab was dosed 400 mg once every 4 weeks, and chemotherapy was received per investigator's choice.
Patients were randomized to receive either spartalizumab (82 patients) or chemotherapy (40 patients). The most common spartalizumab treatment-related adverse events were fatigue (10.3%) and pruritus (9.3%). Median PFS in the spartalizumab arm was 1.9 months versus 6.6 months in the chemotherapy arm ( = 0.915). The overall response rate in the spartalizumab arm was 17.1% versus 35.0% in the chemotherapy arm. Median duration of response was 10.2 versus 5.7 months in the spartalizumab versus chemotherapy arms, respectively. Median overall survival was 25.2 and 15.5 months in the spartalizumab and chemotherapy arms, respectively. Tumor RNA sequencing showed a correlation between response to spartalizumab and , and gene expression.
Spartalizumab demonstrated a safety profile consistent with other anti-PD-1 antibodies. The primary endpoint of median PFS was not met; however, median overall survival and median duration of response were longer with spartalizumab compared with chemotherapy.
铂类难治性复发性/转移性鼻咽癌（NPC）尚无标准治疗方法。这项 II 期研究（NCT02605967）评估了 spartalizumab（一种抗程序性细胞死亡蛋白 1 [PD-1] 单克隆抗体）与化疗相比在 NPC 中的无进展生存期（PFS）。
入组了铂类化疗后进展的非角化复发性/转移性 NPC 患者。Spartalizumab 剂量为每 4 周 400mg，化疗根据研究者的选择进行。
患者被随机分配接受 spartalizumab（82 例）或化疗（40 例）。Spartalizumab 治疗相关的最常见不良事件是疲劳（10.3%）和瘙痒（9.3%）。Spartalizumab 组的中位 PFS 为 1.9 个月，化疗组为 6.6 个月（=0.915）。Spartalizumab 组的总缓解率为 17.1%，化疗组为 35.0%。Spartalizumab 组和化疗组的中位缓解持续时间分别为 10.2 个月和 5.7 个月。Spartalizumab 组和化疗组的中位总生存期分别为 25.2 个月和 15.5 个月。肿瘤 RNA 测序显示，对 spartalizumab 的反应与、和基因表达相关。
Spartalizumab 的安全性与其他抗 PD-1 抗体一致。主要终点中位 PFS 未达到；然而，与化疗相比，Spartalizumab 的中位总生存期和中位缓解持续时间更长。
