A Single-center Prospective Study on the Efficacy of Nivolumab Against Platinum-sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
A Single-center Prospective Study on the Efficacy of Nivolumab Against Platinum-sensitive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
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纳武利尤单抗 (Nivolumab) 对抗铂敏感复发性或转移性头颈鳞状细胞癌疗效的单中心前瞻性研究
DOI：
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Hiroki Sato
中科院分区：
文献类型：
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作者：
I. Okamoto;K. Tsukahara;Hiroki Sato
据报道，免疫检查点抑制剂nivolumab对铂类耐药的复发或转移性头颈部鳞状细胞癌(R/M-HNSCC)患者有利。然而，铂敏感的R/M-HNSCC尚未被研究。因此，这项前瞻性研究评估了nivolumab在铂敏感的R/M-HNSCC患者中的疗效和安全性。这项前瞻性单臂研究是在日本的一家机构进行的。纳入对铂敏感的R/M-HNSCC患者(定义为头颈癌，在以铂为基础的化疗或放化疗后至少6个月后复发或转移)。主要终点是总存活率(OS)。次要终点为无进展生存期(PFS)、总应答率(ORR)、免疫相关不良事件(IrAEs)和生活质量(QOL)。这项研究登记在大学医院医学信息网临床试验登记处(UMIN000031324)。22例铂敏感的R/M-HNSCC患者入选。中位数OS为17.4，1年OS率为73%。中位PFS为9.6个月，1年PFS率为48%。ORR为36%。12例患者共记录到16个irAEs，但未发现4级或5级irAEs。生活质量评估显示，尼伏卢单抗不会降低患者的生活质量。Nivolumab对铂敏感的R/M-HNSCC有效，安全性可接受。
Nivolumab, an immune checkpoint inhibitor, reportedly benefits patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC). However, platinum-sensitive R/M-HNSCC has not yet been studied. Hence, this prospective study evaluated the efficacy and safety of nivolumab in patients with platinum-sensitive R/M-HNSCC. This prospective single-arm study was conducted in a single institution in Japan. Patients with platinum-sensitive R/M-HNSCC (defined as head and neck cancer that recurred or metastasized at least 6 months after platinum-based chemotherapy or chemoradiotherapy) were enrolled. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), overall response rate (ORR), immune-related adverse events (irAEs), and quality of life (QOL). This study was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN000031324). Twenty-two patients with platinum-sensitive R/M-HNSCC were enrolled. The median OS was 17.4, and the 1-year OS rate was 73%. The median PFS was 9.6 months, and the 1-year PFS rate was 48%. The ORR was 36%. In total, 16 irAEs were recorded in 12 patients; however, no grade 4 or 5 irAEs were observed. The QOL assessments revealed that nivolumab did not decrease the QOL of patients. Nivolumab is effective against platinum-sensitive R/M-HNSCC with acceptable safety.
影响因子：
11.2
作者：
Jie HB;Schuler PJ;Lee SC;Srivastava RM;Argiris A;Ferrone S;Whiteside TL;Ferris RL
通讯作者：
Ferris RL