探討卵巢癌早期病患對於Platinum合併Cyclophosphamide與Platinum合併Paclitaxel兩種處方之療效比較分析

Comparative Effectiveness of Platinum plus Paclitaxel versus Platinum plus Cyclophosphamide in Patients with Early-staged Ovarian Cancer

陳建安(Chien-An Chen)

指導教授 ： 湯澡薰

臺北醫學大學/公共衛生暨營養學院/醫務管理學研究所/碩士(2014年)

摘要

卵巢癌的治療方式為分期手術加上輔助性化療，大多數的臨床試驗研究都以晚期的卵巢癌患者為研究對象，對於早期的卵巢癌患者的研究較少，對於早期的患者而言，使用Platinum合併Cyclophosphamide化療處方與Platinum合併Paclitaxel化療處方的療效比較尚未定論，而在臺灣健保只給付Platinum合併Cyclophosphamide化療處方，對於使用Platinum合併Paclitaxel化療處方的患者則需要自費使用Paclitaxel。因此本研究的研究目的主要是比較早期卵巢癌患者接受Platinum 合併 Cyclophosphamide化療處方或Platinum合併Paclitaxel化療處方之無病存活率與整體存活率，並以45歲(停經開始)作為年齡分層，以及療程次數的分層研究。
本研究利用全民健保資料庫中的癌症特殊需求檔為資料來源，針對Platinum 合併 Cyclophosphamide治療處方與Platinum合併Paclitaxel治療處方以Kaplan-Meier計算存活率，並以Cox Proportional Hazard Model計算不同化療處方的危險性。
研究結果顯示，在638位納入研究的對象當中，其中使用Platinum 合併 Cyclophosphamide化療處方有376人，5年無病存活率為0.78，5年整體存活率為0.84；使用Platinum合併Paclitaxel化療處方有262人，5年無病存活率為0.82，5年整體存活率為0.86。在不同用藥處方的無病存活分析中，以Platinum 合併 Cyclophosphamide化療處方為比較組，Platinum合併Paclitaxel化療處方2年復發的危險性為0.57(95%信賴區間為0.33-0.97)，5年復發的危險性為0.73(95%信賴區間為0.46-1.14)，2年死亡的危險性為0.56(95%信賴區間為0.25-1.28)，5年死亡的危險性為0.73(95%信賴區間為0.41-1.27)。在合併不同療程次數的年齡分層分析中，針對45歲以上病患做為研究對象時，以使用Platinum 合併 Cyclophosphamide化療處方3次至5次療程為比較組，Platinum 合併 Cyclophosphamide化療處方6次療程的2年復發危險性為0.43(95%信賴區間為0.21-0.88)，使用Platinum合併Paclitaxel化療處方3次至5次療程的2年復發危險性為0.20(95%信賴區間為0.08-0.71)，使用Platinum合併Paclitaxel化療處方6次療程的2年復發危險性為0.18(95%信賴區間為0.09-0.56)；Platinum 合併 Cyclophosphamide化療處方6次療程的5年復發危險性為0.63(95%信賴區間為0.35-1.16)，使用Platinum合併Paclitaxel化療處方3次至5次療程的5年復發危險性為0.43(95%信賴區間為0.18-1.05)，使用Platinum合併Paclitaxel化療處方6次療程的5年復發危險性為0.36(95%信賴區間為0.19-0.89)。針對45歲以下的患者使用Platinum合併Paclitaxel化療處方與使用Platinum 合併 Cyclophosphamide化療處方於復發及死亡的危險性並未達顯著差異，
根據本研究的結果，建議，45歲以上的早期卵巢癌患者應使用Platinum合併Paclitaxel化療處方6次療程，以減少復發的危險性。

關鍵字

早期卵巢癌 ； Cyclophosphamide ； Paclitaxel ； 無病存活率 ； 整體存活率 ； 臺灣全民健保資料庫

並列摘要

The use of postoperative chemotherapy is standard for many patients with early-stage ovarian cancer. Previous studies have showed a survival advantage for patients treated with combinations of platinum and paclitaxel, as compared with those given a platinum plus cyclophosphamide in the first line therapy among patients with advanced ovarian cancer. However, little has been known if the incorporation of paclitaxel into first-line therapy improves the health outcomes in women with early stage ovarian cancer. This study aims to fill this knowledge gap.
The data source for this study is 2000-2011 National Health Insurance Research Database (NHIRD). The including and excluding criteria for the study subjects are (1) patients who were first diagnosed as ovarian cancer during 2001-2010 and had never had any other types of cancer during 2000-2011; (2) patients who received surgeries related to early-stage ovarian cancer; (3) patients who received platinum plus cyclophosphamide treatment (the PC group) or platinum plus paclitaxel treatment regimen (the PT group) within 60 days after the surgery; and (4) patients who received at least 3 cycles of the treatment and had never switched between the two regimens. There were 638 subjects identified, of which 376 patients were in the PT group and 262 patients in the PC group. The Kaplan-Meier method and the Cox proportional hazard model were used to estimate the duration of disease-free survival (DFS) and of overall survival (OS) between PC and PT.
When compared with PC, the hazard ratios of the 2-year DFS and OS for PT was 0.57 (95% CIs: 0.33-0.97) and 0.56 (95% CIs: 0.25-1.28), respectively. The hazard ratios of the 5-year DFS and the OS for PT was 0.73 (95% CIs : 0.46-1.14) and 0.73 (95%CIs : 0.41-1.27), respectively. The subgroup analysis showed that, for women aged 45 years and above, when compared with women who completed 3-5 cycles of PC, the 2-year hazard ratio of DFS for women with of 6 cycles of PC ws 0.43 (95% CIs: 0.21-0.88), for women with 3-5 cycles of PT was 0.20 (95% CIs: 0.08-0.71), and for women with 6 cycles of PT was 0.18 (95% CIs: 0.09-0.56). The 5-year hazard ratio of DFS for women with 6 cycles of PC was 0.63 (95% CIs: 0.35-1.16), for women with 3-5 cycles of PT was 0.43 (95% CIs: 0.18-1.05), and for women with 6 cycles of PT was 0.36 (95% CIs: 0.19-0.89).
It seems that the most effective treatment strategy for women > 45 years old with early ovarian cancer is the PT treatment for 6 cycles. For women <= 45 years old, however, PT was not found to significantly improve the treatment outcomes in terms of DFS and OS.

並列關鍵字

early-staged ovarian cancer ； Cyclophosphamide ； Paclitaxel ； disease-free survival ； overall survival ； National Health Insurance, Taiwan

參考文獻

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