化療聯合貝伐單抗治療Her-2陰性乳腺癌有效性和安全性的Meta分析_《中國循證醫學雜志》

作者：

徐龍 ^1,2 , 章國晶 ¹ ,  謝曉冬 ¹

1. 沈陽軍區總醫院全軍腫瘤診治中心（沈陽 110840）；2. 第四軍醫大學研究生管理大隊（西安 710032）;

關鍵詞：

乳腺癌 Her-2 貝伐單抗隨機對照試驗系統評價 Meta分析

DOI：

10.7507/1672-2531.20120210

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目的　系統評價化療聯合貝伐單抗治療Her-2陰性復發或轉移性乳腺癌的有效性及安全性。
方法　計算機檢索PubMed、EMbase、The Cochrane Library、SCI引文數據庫和CBM數據庫，收集采用化療聯合與不聯合貝伐單抗治療Her-2陰性復發或轉移性乳腺癌的Ⅲ期臨床隨機對照試驗（RCT），并查閱ASCO、ESMO近三年相關會議摘要和2012年NCCN指南，以及手工檢索相關中文期刊，檢索時限均截至2012年2月。由2位研究者按照納入和排除標準獨立篩選文獻、評價質量并交叉核對，如遇分歧則討論解決或請專家協商決定而后，采用STATA SE 12.0軟件進行Meta分析。
結果　初檢出文獻132篇，最終納入4個RCT，共3 131例患者。Meta分析結果顯示，與單純化療相比，化療聯合貝伐單抗可延長Her-2陰性復發或轉移性乳腺癌患者無進展生存期［HR=0.67，95%CI（0.57，0.79），P lt;0.001］，但未能延長總生存期［HR=0.92，95%CI（0.82，1.02），P=0.121］；在安全性方面，化療聯合貝伐單抗組患者高血壓、蛋白尿、出血不良反應較單純化療組增多，而血栓、中性粒細胞減少及感覺障礙發生率方面，兩組差異無統計學意義。
結論　貝伐單抗可延長Her-2陰性復發或轉移性乳腺癌患者的無進展生存期，但未能延長總生存期，與單純化療相比3至4度不良反應有所增加。今后尚需進一步探索貝伐單抗用于乳腺癌解救治療的最佳適應人群。

引用本文： 徐龍,章國晶,謝曉冬. 化療聯合貝伐單抗治療Her-2陰性乳腺癌有效性和安全性的Meta分析. 中國循證醫學雜志, 2012, 12(11): 1347-1353. doi: 10.7507/1672-2531.20120210 復制

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8.	Brufsky AM, Hurvitz S, Perez E, et al. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol, 2011, 29(32): 4286-4293.
9.	Tanne JH. FDA cancels approval for bevacizumab in advanced breast cancer. BMJ, 2011, 343: d7684.
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12.	Gray R, Bhattacharya S, Bowden C, et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol, 2009, 27(30): 4966-4972.
13.	Spruance SL, Reid JE, Grace M, et al. Hazard ratio in clinical trials. Antimicrob Agents Chemother, 2004, 48(8): 2787-2792.
14.	Carpenter D, Kesselheim AS, Joffe S. Reputation and precedent in the bevacizumab decision. N Engl J Med, 2011, 365(2): e3.
15.	Bergers G, Hanahan D. Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer, 2008, 8(8): 592-603.
16.	Smith IE, Pierga JY, Biganzoli L, et al. First-line bevacizumab plus taxane-based chemotherapy for locally recurrent or metastatic breast cancer: safety and efficacy in an open-label study in 2,251 patients. Ann Oncol, 2011, 22(3): 595-602.
17.	Lee JB, Woo OH, Park KH, et al. Bevacizumab for salvage treatment of metastatic breast cancer: a systemic review and meta-analysis of randomized controlled trials. Invest New Drugs, 2011, 29(1): 182-188.
18.	Cuppone F, Bria E, Vaccaro V, et al. Magnitude of risks and benefits of the addition of bevacizumab to chemotherapy for advanced breast cancer patients: Meta-regression analysis of randomized trials. J Exp Clin Cancer Res, 2011, 30: 54.
19.	Yang SX. Bevacizumab and breast cancer: current therapeutic progress and future perspectives. Expert Rev Anticancer Ther, 2009, 9(12): 1715-1725.

1. Simon-Yarza T, Formiga FR, Tamayo E, et al. Vascular endothelial growth factor-delivery systems for cardiac repair: an overview. Theranostics, 2012, 2(6): 541-552.
2. Konno H, Yamamoto M, Ohta M. Recent concepts of antiangiogenic therapy. Surg Today, 2010, 40(6): 494-500.
3. Ferrara N, Hillan KJ, Gerber HP, et al. Discovery and development of bevacizumab, an anti-VEGF antibody for treating cancer. Nat Rev Drug Discov, 2004, 3(5): 391-400.
4. Miller KD, Chap LI, Holmes FA, et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol, 2005, 23(4): 792-799.
5. Miller K, Wang M, Gralow J, et al. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med, 2007, 357(26): 2666-2676.
6. Miles DW, Chan A, Dirix L Y, et al. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol, 2010, 28(20): 3239-3247.
7. Robert NJ, Dieras V, Glaspy J, et al. RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol, 2011, 29(10):1252-1260.
8. Brufsky AM, Hurvitz S, Perez E, et al. RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol, 2011, 29(32): 4286-4293.
9. Tanne JH. FDA cancels approval for bevacizumab in advanced breast cancer. BMJ, 2011, 343: d7684.
10. Parmar MK, Torri V, Stewart L. Extracting summary statistics to perform meta-analyses of the published literature for survival endpoints. Stat Med, 1998, 17(24): 2815-2834.
11. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials, 1986, 7(3): 177-188.
12. Gray R, Bhattacharya S, Bowden C, et al. Independent review of E2100: a phase III trial of bevacizumab plus paclitaxel versus paclitaxel in women with metastatic breast cancer. J Clin Oncol, 2009, 27(30): 4966-4972.
13. Spruance SL, Reid JE, Grace M, et al. Hazard ratio in clinical trials. Antimicrob Agents Chemother, 2004, 48(8): 2787-2792.
14. Carpenter D, Kesselheim AS, Joffe S. Reputation and precedent in the bevacizumab decision. N Engl J Med, 2011, 365(2): e3.
15. Bergers G, Hanahan D. Modes of resistance to anti-angiogenic therapy. Nat Rev Cancer, 2008, 8(8): 592-603.
16. Smith IE, Pierga JY, Biganzoli L, et al. First-line bevacizumab plus taxane-based chemotherapy for locally recurrent or metastatic breast cancer: safety and efficacy in an open-label study in 2,251 patients. Ann Oncol, 2011, 22(3): 595-602.
17. Lee JB, Woo OH, Park KH, et al. Bevacizumab for salvage treatment of metastatic breast cancer: a systemic review and meta-analysis of randomized controlled trials. Invest New Drugs, 2011, 29(1): 182-188.
18. Cuppone F, Bria E, Vaccaro V, et al. Magnitude of risks and benefits of the addition of bevacizumab to chemotherapy for advanced breast cancer patients: Meta-regression analysis of randomized trials. J Exp Clin Cancer Res, 2011, 30: 54.
19. Yang SX. Bevacizumab and breast cancer: current therapeutic progress and future perspectives. Expert Rev Anticancer Ther, 2009, 9(12): 1715-1725.

《中國循證醫學雜志》

化療聯合貝伐單抗治療Her-2陰性乳腺癌有效性和安全性的Meta分析

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《中國循證醫學雜志》

化療聯合貝伐單抗治療Her-2陰性乳腺癌有效性和安全性的Meta分析

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