社團法人臺灣臨床藥學會

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【綜合評述】Pembrolizumab、Nivolumab 與Avelumab合併放療+/- 化療用於頭頸鱗狀細胞癌治療相關臨床試驗與台灣臨床使用現況
Review of Clinical Trials of Pembrolizumab, Nivolumab and Avelumab Combined with Radiotherapy and/or Chemotherapy in Head and Neck Squamous Cell Carcinoma and Taiwan Experience
Head and Neck Squamous Cell Carcinoma, Immune Checkpoint Inhibitor, Chemotherapy, Radiotherapy、頭頸鱗狀細胞癌、化療、免疫檢查點抑制劑、放射線療法
吳雨靜Yu-Ching Wu1,*
1新竹馬偕紀念醫院藥劑科
摘要
頭頸鱗狀細胞癌 (head and neck squamous cell carcinoma, HNSCC) 是頭頸癌(head and neck cancer, HNC) 最主要的亞型,亞洲地區因嚼食檳榔與飲食習慣相較西方國家有較高的盛行率。本文回顧PD-1 inhibitor (pembrolizumab、nivolumab)、PD-L1 inhibitor (avelumab)、放射治療與化療對局部晚期 (locally advanced) 和復發轉移型 (recurrent/metastatic, R/M) HNSCC 的治療效果。研究顯示, 對於R/M HNSCC PD-1 inhibitor 如pembrolizumab 和nivolumab 已被證實能顯著延長患者生存期,特別是在PD-L1 陽性患者中。此外使用pembrolizumab 和nivolumab 患者發生不良事件的機率也較化療減少許多,這種安全性優勢使患者能夠維持較佳的生活品質。然而,對於locally advanced HNSCC KEYNOTE-412 和JAVELIN 100 臨床試驗結果顯示,同步放化療合併pembrolizumab 或avelumab 治療效果未顯著優於標準同步放化療也未能降低不良事件的發生。總體而言,儘管免疫療法在R/M HNSCC 中已成為標準治療選項,但在locally advanced HNSCC 的治療中,免疫檢查點抑制劑與放化療的合併療法仍需進一步優化,以提升臨床效益。
 
ABSTRACT
Head and neck squamous cell carcinoma (HNSCC) is the most common subtype of head and neck cancer (HNC). In Asia, the prevalence is higher compared to Western countries due to betel nut chewing and dietary differences. This article reviews the efficacy of PD-1 inhibitors (pembrolizumab and nivolumab) and the PD-L1 inhibitor avelumab, alone or in combination with radiotherapy and chemotherapy, in locally advanced and recurrent/metastatic (R/M) HNSCC. Studies have shown that for R/M HNSCC, pembrolizumab and nivolumab have been proven to extend patient survival, especially in PD-L1 high expression patients. Moreover, the adverse event rates are significantly reduced in patients using pembrolizumab or nivolumab compared to those receiving chemotherapy, which enhances patients’ quality of life. However, for locally advanced HNSCC, clinical trials (KEYNOTE-412 and JAVELIN 100) show that combining concurrent chemoradiotherapy and immune checkpoint inhibitor (pembrolizumab or avelumab) does not significantly improve the efficacy over standard concurrent chemoradiotherapy, nor does it reduce adverse event rates. Overall, while PD-1 inhibitors have become a standard treatment option for R/M HNSCC, the combination with chemoradiotherapy for locally advanced HNSCC still requires further optimization to improve clinical outcomes.
 
 
Submitted for publication: 2025.03.30; Accepted for publication: 2025.10.22
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