非小細胞肺癌接受同步化學放射治療的後設分析（meta-analysis）和臨床試驗計畫書

Meta-analysis and clinical trial protocol for non-small cell lung cancer receiving concurrent chemoradiotherapy

蕭亦秀(Yi-Hsiu Hsiao)

指導教授 ： 林家齊

國立臺灣大學/醫學院/臨床醫學研究所/碩士(2022年)

https://doi.org/10.6342/NTU202104452

摘要

1.研究背景
局部晚期不可切除（第三期）的非小細胞肺癌（NSCLC）患者的標準治療方法是同步放化療（CCRT）。然而肺癌病患在接受標準治療後很快的面臨疾病惡化。目前已有許多文獻針對局部晚期不可切除的非小細胞肺癌患者在接收同步放化療後，進行全身性治療包含化學治療，免疫療法等。我們主要想要收集在局部晚期無法切除的非小細胞肺癌患者接收不同治療方式後的資料（無進展生存期，總體生存率，不良事件），並且分析評估這類患者，在標準同步放化療後接受何種全身性治療（化學療法，免疫療法）對於患者較有幫助以達到延緩疾病惡化。
2.研究方法
於2019年12月中經由Pubmed 電子資料庫進行文獻搜尋,並使用關鍵字為non-small lung cancer、concurrent chemoradiotherapy、stage III、chemoradiotherapy、immunotherapy and durvalumab來搜尋結果。初步先以系統審查方式並利用我們設定的納入及排除條件篩選出六篇文獻，再針對這六篇文獻進行後設分析，評估病患於標準化放療後接受不同治療方式，對其總體存活率(OS)、無惡化存活時間(PFS)和不良事件發生率。
3.研究結果
針對非小細胞肺癌接受標準同步化學放射治療後接受不同治療進行後設分析，得到出非小細胞肺癌接受同步化學放射治療後接受免疫治療(抑癌寧)相較於化學治療其總體存活率(OS)、無惡化存活時間(PFS)有較好的優勢。在不良事件發生率上也沒有特別的差異。
4.研究結論
在局部晚期非小細胞肺癌患者中進行同步放化療後進行免疫療法（抑癌寧）相較化學治療有顯著優勢。抑癌寧也得到美國食藥署的藥證，但過去文獻有許多案例指出需要針對臨床試驗結果（尤其是不良事件）的結果進行驗證。我們將編寫第四期臨床試驗針對局部晚期非小細胞肺癌患者在接受同步放化療後使用抑癌寧，以前瞻性和系統地收集抑癌寧在現實世界中的不良反應。

關鍵字

肺癌 ； 非小細胞肺癌 ； 同步放化療 ； 免疫療法 ； 抑癌寧 ； 第三期無法切除肺癌

並列摘要

1.Research Background
The standard treatment for patients with locally advanced unresectable (stage III ) non-small cell lung cancer (NSCLC) is concurrent chemotherapy and radiotherapy (CCRT). However, patients with lung cancer face disease progression soon after receiving standard treatment. At present, there are many literatures for patients with locally advanced unresectable non-small cell lung cancer after receiving concurrent chemoradiation, systemic treatment including chemotherapy, immunotherapy, etc. We mainly want to collect data on patients with locally advanced unresectable non-small cell lung cancer after receiving different treatments (progression-free survival, overall survival, adverse events), and analyze and evaluate such patients after standard concurrent radiotherapy and chemotherapy What kind of systemic treatment (chemotherapy, immunotherapy) is more helpful for the patient to delay the progression of the disease.
2.Research Methods
A literature search was conducted through the Pubmed electronic database in December 2019, and the results were searched using keywords such as non-small lung cancer, concurrent chemoradiotherapy, stage III, chemotherapy, immunotherapy and durvalumab. Initially, the six documents were screened out by systematic review and using the inclusion and exclusion criteria we set, and then meta-analysis was performed on these six documents to evaluate the patients receiving different treatment methods after standardized radiotherapy, and their overall survival rate ( OS), progression-free survival time (PFS), and incidence of adverse events.
3.Research Results
A meta-analysis of different treatments for non-small cell lung cancer after receiving standard concurrent chemoradiotherapy showed that the overall survival of non-small cell lung cancer receiving immunotherapy (durvalumab) after receiving concurrent chemoradiotherapy was compared with overall survival ( OS) and progression-free survival (PFS) have better advantages. There is also no particular difference in the incidence of adverse events.
4.Research Conclusions
In patients with locally advanced non-small cell lung cancer, concurrent chemoradiotherapy followed by immunotherapy (durvalumab) has a significant advantage over chemotherapy. Durvalumab is also certified by the U.S. Food and Drug Administration(FDA), however there are many cases in the literature that need to be verified against the results of clinical trials (especially adverse events). We will prepare the phase Ⅳ clinical trials for patients with locally advanced non-small cell lung cancer who use durvalumab after concurrent chemoradiotherapy, and collect the adverse effects of durvalumab in the real world in a prospective and systematic manner.

並列關鍵字

lung cancer ； non-small cell lung cancer ； concurrent chemoradiotherapy ； immunotherapy ； durvalumab ； stage III unresectable lung cancer

參考文獻

M. Karpagam, E. Brumancia, Karunya Rathan, K.Geetha, C.Rajan’ Enhancing pathologic staging diagnosis of lung cancer Using datamining techniques’