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標題: | 標靶治療加化療對於可能可切除的致癌基因驅動型非小細胞肺癌(NSCLC)作為術前輔助療法:系統性回顧、整合分析以及後續之傘形設計、隨機、雙盲、安慰劑對照試驗 Targeted Therapy Plus Chemotherapy versus Chemotherapy Alone as Neoadjuvant Treatment for Potentially Resectable Oncogene Driven Non-Small-Cell Lung Cancer (NSCLC): Systemic Review and Meta-Analysis and an Umbrella Design, Double Blind, Randomized, Placebo Controlled Trial |
作者: | 林士森 Shih-Sen Lin |
指導教授: | 林家齊 Chia-Chi Lin |
關鍵字: | 肺癌,腺癌,術前,標靶治療,致癌基因驅動,表皮生長因子受體,酪氨酸激酶抑制劑, lung cancer,adenocarcinoma,neodadjuvant,target therapy,ncogene driven,epidermal growth factor receptor,tyrosine kinase inhibitor, |
出版年 : | 2023 |
學位: | 碩士 |
摘要: | 研究目的:
在術前治療中使用標靶治療來治療由致癌基因驅動的非小細胞肺癌(NSCLC)的效用仍存在爭議。在本研究中,我們旨在評估術前標靶治療與國家綜合癌症網絡(NCCN)指南推薦的標準術前化療方案相比的療效。 材料和方法: 我們在三個資料庫(PubMed、Cochrane Library 和 Embase)中對於2021年10月之前發表的術前治療研究中進行了系統搜索。為了確保更客觀的療效評估,我們選擇了客觀反應(OR)、病理反應(PR)、病理分期降低率和手術切除率等終點。由於整體生存(OS)和無疾病進展生存(PFS)的非硬終點特性以及高統計偏倚的可能性,我們未對生存結果進行評估。我們使用R進行統計分析和偏倚評估。 結果: 我們的統合分析包括了一個隨機對照試驗,兩個非隨機對照試驗和一個回溯性觀察研究的共213名患者。對於EGFR突變陽性的NSCLC患者,統合分析顯示EGFR-TKI與化療相比顯著改善了OR(比值比[OR]:3.01,95%信賴區間[CI]:1.70-5.30)。然而,在病理反應方面,兩種治療選擇之間沒有顯著差異(比值比1.52,95%信賴區間[CI]:0.34-6.84)。此外,病理分期降低和手術切除率在兩種治療選擇之間也沒有顯著差異。 結論: 我們的統合分析結果顯示,對於局部晚期EGFR突變陽性的NSCLC患者,應將由致癌基因驅動的標靶治療作為誘導治療的首選。儘管在某些情況下,有限的樣本量限制了統計顯著性,但在我們對所包括研究的分析中,每個術前標靶治療(NTT)組的OR始終較高。EGFR突變狀態可以預測在接受EGFR-TKI治療後的腫瘤縮小,EGFR突變陽性患者接受NTT與EGFR突變陰性患者接受術前化療(NCT)相比,觀察到更明顯的縮小。本研究表明,在本研究中分析的其他主要結果,如病理反應和手術率,在統合分析中並未顯示出顯著差異。 Purpose: The utility of targeted therapy in the preoperative setting for oncogene-driven non-small cell lung cancer (NSCLC) remains a matter of debate. In this study, we aimed to assess the efficacy of neoadjuvant targeted therapy compared with standard neoadjuvant chemotherapy regimens recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Materials and Methods: We conducted a systematic search in three databases (PubMed, Cochrane Library, and Embase) for studies on neoadjuvant therapy published before October 2021. To ensure a more objective efficacy assessment, we selected endpoints such as objective response (OR), pathological response (PR), pathological downstaging rate, and surgical resection rate. Survival outcomes, including overall survival (OS) and progression-free survival (PFS), were not evaluated due to their non-hard endpoint nature and the potential for high statistical bias. Statistical analysis and bias assessment were performed using R. Results: Our meta-analysis included a total of 213 patients from one randomized controlled trial, two non-randomized controlled trials, and one retrospective cohort study. For EGFR mutation-positive NSCLC patients, the meta-analysis showed that EGFR-TKIs significantly improved OR compared to chemotherapy (odds ratio [OR]: 3.01, 95% confidence interval [CI]: 1.70-5.30). However, no significant difference was observed in pathological response between the two treatment options (odds ratio 1.52, 95% confidence interval [CI]: 0.34-6.84). Additionally, pathological downstaging and surgical resection rates did not show significant differences between the two treatment options. Conclusion: Our meta-analysis suggests that oncogene-driven targeted therapy should be prioritized as induction therapy for locally advanced EGFR mutation-positive NSCLC patients. The OR for each neoadjuvant targeted therapy (NTT) group was consistently higher in our analysis of the included studies, although limited sample sizes restricted the statistical significance in some cases. EGFR mutation status can predict tumor regression following EGFR-TKI treatment, with more substantial regression observed in EGFR mutation-positive patients receiving NTT compared to EGFR mutation-negative patients receiving neoadjuvant chemotherapy (NCT). The current study demonstrates that other primary outcomes analyzed in this study, such as pathological response and surgery rate, did not exhibit significant differences in the meta-analysis. |
URI: | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/87381 |
DOI: | 10.6342/NTU202300707 |
全文授權: | 同意授權(限校園內公開) |
電子全文公開日期: | 2028-03-30 |
顯示於系所單位: | 臨床醫學研究所 |
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