請用此 Handle URI 來引用此文件:
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/52298
標題: | 免疫檢查點抑制劑作為非小細胞肺癌病人第二線治療之研究 Immune checkpoint inhibitors (anti-PD-1 or PD-L1 antibodies) as the second-line therapy (vs. docetaxel) in non-small cell lung cancer population |
作者: | Miao-Ting Lin 林妙亭 |
指導教授: | 林家齊(Chia-Chi Lin) |
關鍵字: | 歐洲紫杉醇,免疫檢查點抑制劑,非小細胞肺癌,PD-1,PD-L1, docetaxel,immune checkpoint inhibitors,NSCLC,PD-1,PD-L1, |
出版年 : | 2020 |
學位: | 碩士 |
摘要: | 1. 研究簡介 背景 歐洲紫杉醇(docetaxel)於1999年是第一個被美國FDA核准用於非小細胞肺癌(non-small cell lung cancer, NSCLC)第二線治療的藥物,並自此成為標準療法之一。然而,免疫檢查點疫制劑(immune checkpoint inhibitors)例如:anti-PD-1 or PD-L1 antibodies 的發展,其對病人較佳的存活益處和較低的毒性,對於晚期非小細胞肺癌的治療帶來很大的進步。 目的 本研究的目的主要是透過系統性文獻回顧和統合分析的方式,來整合評估免疫檢查點疫制劑(anti-PD-1 or PD-L1 antibodies)作為非小細胞肺癌第二線治療之整體有效性及安全性,納入分析的試驗將以隨機對照試驗為主。 2. 研究方法 資料搜尋策略 於2019年11月中至12月初經由PubMed/Medline電子資料庫進行文獻搜尋,使用的關鍵字為non-small cell lung cancer AND PD-L1 OR PD-1 AND docetaxel,並以Clinical Trial來篩選搜尋結果。 3. 研究結果 總共有5個符合條件的試驗納入統合分析。研究結果顯示,整體存活時間(overall survival, OS)在anti-PD-1 or PD-L1 antibodies治療組優於docetaxel 治療組(HR=0.72, 95% CI= 0.64-0.81, p=0.000),且在anti-PD-1 or PD-L1 antibodies治療組也有較佳的目標治療反應率(objective response rate, ORR)(OR=1.75, 95% CI= 1.33-2.31, p=0.000)。然而,無疾病惡化存活(progression-free survival, PFS)於兩種治療組的比較卻沒有達到統計上的顯著差異(HR=0.89, 95% CI= 0.77-1.02, p=0.088). 此外,anti-PD-1 or PD-L1 antibodies 治療相關的不良事件,無論在所有等級(OR=0.33, 95% CI=0.28-0.39, p=0.000)或第3和第4等級嚴重程度(OR=0.17, 95% CI=0.26-0.10, p=0.000)的事件,均少於化學治療組。 4. 研究結論 對於先前治療但失敗或疾病惡化的非小細胞肺癌病人,免疫檢查點疫制劑如anti-PD-1 or PD-L1 antibodies作為二線治療確實可改善病人的存活,且有較佳的抗腫瘤效果,並提供了良好的安全性。 1. Introduction Rationale Docetaxel was the first drug approved by FDA in 1999 as the second-line therapy in non-small cell lung cancer patients, and has been the standard of care since then. However, the development of immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies have been a great advance in treating advanced NSCLC, which have shown better surviv-al benefit and safety profile. Objective The aim of this systematic review and meta-analysis of randomized controlled trials is to evaluate the efficacy and safety of Immune checkpoint inhibitors (anti-PD-1 or PD-L1 antibodies)as second-line treatment in previously treated NSCLC patients. 2. Methods Search strategy Literature search was performed through the electronic database of PubMed/Medline between mid-November and early December 2019 by using keywords related to the PI-CO elements. The following keywords were used: non-small cell lung cancer AND PD-L1 OR PD-1 AND docetaxel, and are filtered by Clinical Trial. 3. Results Five studies were selected for the meta-analysis. Pooled analysis of OS (HR=0.72, 95% CI= 0.64-0.81, p=0.000) and ORR (OR=1.75, 95% CI= 1.33-2.31, p=0.000) fa-vored anti-PD-1 or PD-L1 antibodies. However, the analysis of PFS did not reach statis-tical significance (HR=0.89, 95% CI= 0.77-1.02, p=0.088). In addition, the analysis showed that anti-PD-1 or PD-L1 antibodies group has fewer TRAEs than docetaxel group, either in terms of any grade (OR=0.33, 95% CI=0.28-0.39, p=0.000) or grade 3/4 events (OR=0.17, 95% CI=0.26-0.10, p=0.000). 4. Conclusion Immune checkpoint inhibitors such as anti-PD-1 or PD-L1 antibodies could enhance the survival benefit and antitumor response as second-line treatment for previously treated advanced NSCLC. They also provide favorable safety profile. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/52298 |
DOI: | 10.6342/NTU202002595 |
全文授權: | 有償授權 |
顯示於系所單位: | 臨床醫學研究所 |
文件中的檔案:
檔案 | 大小 | 格式 | |
---|---|---|---|
U0001-0708202001073300.pdf 目前未授權公開取用 | 2.44 MB | Adobe PDF |
系統中的文件,除了特別指名其著作權條款之外,均受到著作權保護,並且保留所有的權利。