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研究生:郭躍虹
研究生(外文):Yao-HungKuo
論文名稱:以全國食道癌個案傾向分數配對探討引導性放射化學治療及食道切除術間隔對病人影響之回溯性研究
論文名稱(外文):Impact of the interval between neoadjuvant concurrent chemoradiotherapy and esophagectomy : a population -based propensity-score matched retrospective cohort study
指導教授:簡玉雯
指導教授(外文):Yu-Wen Chien
學位類別:碩士
校院名稱:國立成功大學
系所名稱:公共衛生研究所碩士在職專班
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2020
畢業學年度:108
語文別:中文
論文頁數:81
中文關鍵詞:食道癌傾向分數間隔引導性治療
外文關鍵詞:esophageal cancerpropensity scoreintervalneoadjuvant
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研究背景
局部嚴重型食道癌為一預後不良之疾病,單純以手術切除效果並不佳。目前依照臨床試驗的結果以引導性放射化學治療及食道切除術施行,病人的存活率最高。然而由於引導性治療需要時間以讓腫瘤緩解,並且讓引導性治療的副作用恢復,往往在引導性治療結束後到手術之間需要一個時間間隔。然而目前並沒有以探討此間隔長短對病人預後的第三期臨床試驗可做為參考。所以,將進行一個回溯性的研究來探討,長短間隔可能對病人存活造成的影響。
研究目的
探討引導性放射化學治療及手術之間的時間間隔對食道癌患者的影響。
材料與方法
本研究為一回溯性世代分析,利用衛生福利部資料科學中心所提供的癌症登記長表及死因資料檔來做分析。利用長表找出患有食道癌並引導性放射化學治療與手術的病人。將手術與引導性治療的間隔的病人分為兩個或數個間隔,將病人本身因素、疾病因素及治療因素和存活有關的十六個共變數以及本研究主要所欲探討的引導性治療及手術間隔來討論對病人的存活影響。統計方法以文獻上建議7-8周為切點將病人在7周前接受手術的為短間隔組及8周之後接受的為長間隔組。利用羅吉斯回歸中對數模型建立傾向分數,並進行傾向分數配對,最後計算兩組的長期存活是否有所不同。輔助研究則探討兩組之間的病理完全緩解率,手術後30天死亡率,手術後90天死亡率、局部控制率及因食道癌死亡率的差異。完成主要分析後,將進行敏感性分析,方法是藉由調整切割時間點以及增加醫院治療量及陽性淋巴結數建立四個傾向分數配對族群來測試主要分析結果的穩健度。
研究結果
自2011年至2015年共256位食道癌病人符合我們的選擇條件並且沒有相關資料缺失。將病人依照放射化學治療到手術時間分組,4-7周為短間隔組,8-12周為長間隔組。再將選定和預後相關的16個基礎共變數建立傾向分數,建立了1:1傾向分數配對的族群,並比較存活率以及次級結果。整體中位數追蹤期限達到30個月,短間隔組的五年存活率為45%,長間隔組的五年存活率為35%,風險比為1.22,95%信賴區間則是0.78到1.91,p = 0.39,兩者差異並未達到統計上的明顯意義。其他選定的次級目標包括:病理完全緩解率,手術後30天死亡率,手術後90天死亡率,兩組差距都沒有達到統計上明顯意義。
在敏感性分析中,我們試著以不同的條件來針對短間隔組和長間隔組來重新定義,並建構新的傾向分數配對族群,經過四種不同的調整方法,仍然沒有發現不同定義下,長間隔組的整體存活率會較短間隔組有明顯的統計差異。
結論
本研究結果顯示在台灣地區鱗狀細胞食道癌病人經過引導性放射化學治療之後,於4-7周後接受手術或是8-12周內接受手術,對病人在整體存活率並沒有明顯影響。臨床工作者可以考慮病人自身的條件及體力狀況和病人及家屬做適當的討論來達到最佳照護。
SUMMARY
In Taiwan, esophageal cancer is the 5th leading cause of cancer-specific mortality for the male population. Neoadjuvant chemoradiotherapy followed by surgery is suggested for locally advanced esophageal cancer. However, the interval between neoadjuvant treatment and esophagectomy is not well studied. The aim of this study was to evaluate the impact of different intervals on esophageal cancer patients’ overall survival. The secondary endpoints included pathological complete response, esophageal cancer mortality, incidence of local or regional recurrence, and postoperative mortality at 30 days and 90 days.
We enroll patients diagnosed with esophageal squamous cell carcinoma in 2011 and 2015. The data was retrieved from the Taiwan cancer registry database. Patients received esophagectomy 4-7 weeks after neoadjuvant concurrent chemoradiotherapy were grouped as short interval, and 8-12 weeks as long interval group. A propensity-score-matched cohort was constructed for comparing the survival between the short and long interval groups. Sensitivity analyses were also planned.
The primary study included 80 patients for each group. No statistical significant difference was noted on the overall survival. Between the two groups, the secondary endpoints were not significantly different, either. Using different definition of the short/long intervals and different propensity-score matching for four sensitivity analysis, the overall survival between the two groups was not statistically different.
Our study suggested that the interval within 4-12 weeks is not influential on the patients’ overall survival. Surgeons and patients should choose the optimal timing based on clinical judgment.

Key words:esophageal cancer, propensity score, interval, neoadjuvant
摘要 i
Abstract iv
誌謝 vii
第一章 前言 1
第一節 研究背景 1
第二節 研究目的 4
第二章 文獻回顧 5
第一節 病人相關共變數 11
第二節 食道癌診斷和治療相關的因子 21
第三節 方法學討論 26
第三章 材料與方法 36
第一節 研究問題 36
第二節 研究資料來源 39
第三節 研究設計 40
第四節 其他可解釋變數(other explanatory variables) 43
第四章 研究結果 48
第五章 討論 60
參考文獻 75
中文參考文獻 75
英文參考文獻 75
中文參考文獻
衛生福利部國民健康署:中華民國 104 年台灣癌症登記報告。2018 年 6 月 30 號,取自https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=8084
衛生福利部國民健康署:癌症登記線上 互動查詢系統。2018 年 6 月 30 日,取自https://cris.hpa.gov.tw/.

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