- 學位論文
抗骨吸收藥物對於乳癌骨轉移病人存活時間的影響–單一醫學中心經驗
The effects of antiresorptive agents on the survival of patients with breast cancer and bone metastasis–a single medical center experience
摘要
腫瘤產生的骨骼轉移好發於乳癌患者。已有研究指出抗骨吸收藥物可以降低癌症的復發機率，然而抗骨吸收藥物對於癌症患者的骨骼相關事件、無疾病惡化與整體存活時間的影響，研究報導比較侷限。本研究目的在於分析來自於某醫學中心之乳癌癌症登記病患資料，比較病患投予第一代與第二代雙磷酸鹽類藥物或單株抗體藥物，是否有無延長無疾病惡化與整體存活時間的影響。 本研究利用回溯性方法，收集並分析來自高雄某私立醫學中心從2000年1月到2014年12月的乳癌癌症登記病患資料。本研究收案條件為診斷為乳癌併發骨轉移的患者且接受過雙磷酸鹽類藥物或單株抗體藥物Denosumab。雙磷酸鹽類藥物包含了第一代的Clodronate與Pamidronate以及第二代的Zoledronic acid，共有444位患者納入本研究之分析。本研究統計分析使用獨立樣本t檢定(Student's t-test)、單因子變異數分析(one-way ANOVA)、卡方適合度檢定(chi-square Goodness of Fit Test)、邏輯斯回歸(Logistic Regression)探討使用不同藥物治療之病人間各重要變項之差異，並使用存活分析進一步探討病人的存活率。 研究結果指出接受第一代雙磷酸鹽類藥物與新藥物治療病患的無疾病惡化存活時間(Progression Free Survival, PFS)沒有達到顯著差異(p=0.062)。但仍能看出接受新藥物治療病患的PFS確實有存活延長的趨勢。接受第一代雙磷酸鹽類藥物病患的整體存活時間(Overall Survival, OS)與接受新藥物的病患具有統計上的顯著差異(p<0.001)。接受Zoledronic acid與Denosumab的新藥治療對於OS有較佳的存活情形。 本研究證實新藥物包含第二代雙磷酸鹽類Zoledronic acid與單株抗體Denosumab可以有意義的延長病患存活時間。但是在PFS的比較上，與Zoledronic acid沒有達到統計上的差異。這結果可能的原因是因為Denosumab上市時間較晚，統計時接受治療的病人數較少的關係。隨著未來更多資料的取得，將更有機會可進一步分析對於Zoledronic acid與Denosumab在病人存活時間上的效果。
並列摘要
Bone metastases are common in breast cancer. While antiresorptive agents has been shown to effectively reduce cancer relapse, the effect of antiresorptive agents on skeletal-related events, overall survival and progression-free survival time has been rarely studied. This study aims to analyze the effects of first and second generation bisphosphonates and a monoclonal antibody drug on the prevention of overall survival and progression-free survival time based on clinical data from a medical center. We collected data from a private medical center in Kaohsiung between January 2000 and December 2014 in a retrospective way. A total of 444 patients diagnosed with breast cancer and prescribed bisphosphonates and an antibody drug of Denosumab were included in this study. The bisphosphonates considered in this study include the first generation drugs of Clodronate and Pamidronate and the second generation drug of Zoledronic acid. Student's t-test and chi-square Goodness of Fit Test were applied to evaluate the significance of factors. The logistic regression model was applied to calculate the odds ratios. Our results show that there is no significant difference in the survival time between the first generation bisphosphonates and new drugs (p=0.062). However, the progression-free survival time of patients using new drugs has been significantly prolonged. The overall survival time of patients using the first generation of bisphosphonates is significantly different (p<0.001) from that of patients using new drugs. The overall survival time also benefits from the use of new drugs including the Zoledronic acid and Denosumab. This study confirms that the new drugs of a second generation bisphosphonate Zoledronic acid and an antibody drug Denosumab significantly increase the therapeutic effects of prolonged survival time of patients. Although a few benefits have been shown in this study, there is no significant difference of survival time observed in this study between patients using Zoledronic acid and the new single-body antibody drug Denosumab. This could be due to the small sample size of patients using Denosumab as it came to market late. With more data available, the effects of Zoledronic acid and Denosumab on survival time could be further analyzed with higher confidence.
參考文獻
延伸閱讀
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