中国循证医学杂志

中国循证医学杂志

多西他赛与表柔比星化疗方案比较治疗晚期胃癌有效性和安全性的 Meta 分析

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目的 系统评价多西他赛与表柔比星的化疗方案比较治疗晚期胃癌的有效性和安全性。 方法 计算机检索 EMbase、PubMed、The Cochrane Library、Web of Science、CBM、CNKI 和 WanFang Data 数据库,搜集多西他赛和表柔比星的两种化疗方案治疗晚期胃癌的随机对照试验(RCT),检索时限均从建库至 2017 年 3 月。由 2 名研究者独立进行文献筛选、资料提取和评价纳入研究的偏倚风险后,采用 RevMan 5.3 软件进行 Meta 分析。 结果 共纳入 12 个 RCT,包括 984 例晚期胃癌患者。Meta 分析结果显示,与表柔比星化疗方案相比,多西他赛化疗方案可提高客观缓解率(ORR)[RR=1.21,95%CI(1.02,1.43),P=0.03]、疾病控制率(DCR)[RR=1.13,95%CI(1.01,1.26),P=0.03]、1 年生存率[RR=1.26,95%CI(1.01,1.56),P=0.04]和 2 年生存率[RR=3.03,95%CI(1.59,5.75),P=0.000 7];而在Ⅲ~Ⅳ级不良反应发生率方面,二者差异无统计学意义。敏感性分析结果显示,与表柔比星化疗方案相比,多西他赛化疗方案可提高 2 年生存率[RR=2.56,95%CI(1.06,6.19),P=0.04];但在两组在 ORR[RR=1.13,95%CI(0.88,1.45),P=0.34]、DCR[RR=1.02,95%CI(0.85,1.21),P=0.84]和 1 年生存率[RR=1.29,95%CI(0.92,1.80),P=0.14]方面差异均无统计学意义,这提示总体分析结果可能受到纳入研究偏倚风险的影响。在Ⅲ~Ⅳ级不良反应发生率方面,敏感性分析结果与总体分析结果保持一致。 结论 与表柔比星化疗方案相比,多西他赛化疗方案可能会增加晚期胃癌患者的临床获益。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objective To systematically review the efficacy and safety of docetaxel or epirubicin based regimens in the treatment of advanced gastric cancer. Methods We searched EMbase, PubMed, The Cochrane Library, Web of Science, CBM, CNKI and WanFang Data from inception to March 2017, to collect randomized controlled trials (RCTs) about docetaxel or epirubicin based regimens in the treatment of advanced gastric cancer. Two reviewers independently screened literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was performed by using RevMan 5.3 software. Results A total of 12 RCTs involving 984 advanced gastric cancer patients were included. The results of meta-analysis showed that docetaxel based regimens were superior to epirubicin based regimens in ORR (RR=1.21, 95%CI 1.02 to 1.43, P=0.03), DCR (RR=1.13, 95%CI 1.01 to 1.26, P=0.03), 1-year survival rate (RR=1.26, 95%CI 1.01 to 1.56, P=0.04) and 2-year survival rate (RR=3.03, 95%CI 1.59 to 5.75, P=0.000 7), while there was no statistical difference between two groups in the incidence of grade Ⅲ to Ⅳ adverse events. The results of sensitivity analysis showed that docetaxel based regimens were superior to epirubicin based regimens in 2-year survival rate (RR=2.56, 95%CI 1.06 to 6.19, P=0.04), but there were no statistical differences in ORR (RR=1.13, 95%CI 0.88 to 1.45, P=0.34), DCR (RR=1.02, 95%CI 0.85 to 1.21, P=0.84) and 1-year survival rate (RR=1.29, 95%CI 0.92 to 1.80, P=0.14). Sensitivity analysis indicated that the results of the overall analysis were affected by risk bias of included studies. Docetaxel based regimens and epirubicin based regimens were consistent with the overall analysis in the incidence of grade Ⅲ to Ⅳ adverse events. Conclusion Compared with epirubicin based regimens, docetaxel based regimens might have more clinical benefit for advanced gastric cancer patients. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.

关键词: 晚期胃癌; 多西他赛; 表柔比星; Meta 分析; 系统评价; 随机对照试验

Key words: Advanced gastric cancer; Docetaxel; Epirubicin; Meta-analysis; Systematic review; Randomized controlled trial

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1. 陈万青, 郑荣寿, 张思维, 等. 2013 年中国恶性肿瘤发病和死亡分析. 中国肿瘤, 2017, 26(1): 1-7.
2. Marano L, Polom K, Patriti A, et al. Surgical management of advanced gastric cancer: an evolving issue. Eur J Surg Oncol, 2016, 42(1): 18.
3. 季加孚. 我国胃癌防治研究三十年回顾. 中国肿瘤临床, 2013, 40(22): 1345-1351.
4. Ajani JA, D'Amico TA, Almhanna K, et al. Gastric cancer, version 3.2016, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw, 2016, 14(10): 1286.
5. 韩晓娜, 曲颜丽, 唐勇, 等. 晚期胃癌 DCF 方案与 ECF 方案治疗的 Meta 分析. 肿瘤防治研究, 2014, 41(10): 1102-1106.
6. Petrioli R, Roviello G, Zanotti L, et al. Epirubicin-based compared with docetaxel-based chemotherapy for advanced gastric carcinoma: A systematic review and meta-analysis. Crit Rev Oncol Hematol, 2016, 102: 82-88.
7. Ochenduszko S, Puskulluoglu M, Konopka K, et al. Comparison of efficacy and safety of first-line palliative chemotherapy with EOX and mDCF regimens in patients with locally advanced inoperable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma: a randomized phase 3 trial. Med Oncol, 2015, 32(10): 242.
8. Roth AD, Fazio N, Stupp R, et al. Docetaxel, cisplatin, and fluorouracil; docetaxel and cisplatin; and epirubicin, cisplatin, and fluorouracil as systemic treatment for advanced gastric carcinoma: a randomized phase II trial of the Swiss Group for Clinical Cancer Research. J Clin Oncol, 2007, 25(22): 3217.
9. Sadighi S, Mohagheghi MA, Montazeri A, et al. Quality of life in patients with advanced gastric cancer: a randomized trial comparing docetaxel, cisplatin, 5-FU (TCF) with epirubicin, cisplatin, 5-FU (ECF). BMC Cancer, 2006, 6(1): 1-6.
10. Thusspatience PC, Kretzschmar A, Repp M, et al. Docetaxel and continuous-infusion fluorouracil versus epirubicin, cisplatin, and fluorouracil for advanced gastric adenocarcinoma: a randomized phase II study. J Clin Oncol, 2005, 23(3): 494-501.
11. 曹波, 姬乐, 樊华. EOX 和 mDCF 方案一线治疗晚期或转移性 HER2 阴性胃癌的疗效对比分析. 临床和实验医学杂志, 2016, 15(17): 1679-1682.
12. 戴鹏. ECF与DF方案治疗晚期胃癌效果比较. 山西职工医学院学报, 2012, 22(1): 14-16.
13. 高辉, 丁鑫, 魏东, 等. 多西他赛对比表柔比星联合顺铂、亚叶酸钙和氟尿嘧啶一线治疗进展期胃癌的随机对照研究. 临床肿瘤学杂志, 2010, 15(6): 529-533.
14. 洪专, 冯继锋, 陈嘉, 等. LFTP 序贯每周方案与 ECF 方案治疗晚期胃癌的比较研究. 临床肿瘤学杂志, 2007, 12(12): 933-935.
15. 李文, 季德林, 林华明. 多西他赛联合顺铂、5-Fu 及亚叶酸钙治疗晚期胃癌. 肿瘤防治研究, 2008, 35(8): 590-592.
16. 梁冰, 韩娜, 杨家梅. DCF 和 ECF 方案治疗进展期胃癌的疗效观察. 中国肿瘤临床与康复, 2010, 17(1): 59-61.
17. 刘军. DCF 方案与 ECF 方案治疗进展期胃癌的临床研究. 中国医师进修杂志, 2013, 36(17): 17-19.
18. 杨蕴, 徐燕, 李玉芳, 等. 多西紫杉醇联合顺铂、氟尿嘧啶治疗晚期胃癌的临床研究. 中国肿瘤外科杂志, 2011, 3(5): 294-297.
19. Wagner AD, Grothe W, Haerting J, et al. Chemotherapy in advanced gastric cancer: a systematic review and meta-analysis based on aggregate data. J Clin Oncol, 2006, 24(24): 2903-2909.
20. Webb A, Cunningham D, Scarffe JH, et al. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol, 1997, 15(1): 261.
21. Van CE, Moiseyenko VM, Tjulandin S, et al. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol, 2006, 24(31): 4991.
22. Yao Z, Guo H, Yuan Y, et al. Retrospective analysis of docetaxel, oxaliplatin plus fluorouracil compared with epirubicin, cisplatin and fluorouracil as first-line therapy for advanced gastric cancer. J Chemother, 2014, 26(2): 117.
23. Teker F, Yilmaz B, Kemal Y, et al. Efficacy and safety of docetaxel or epirubicin, combined with cisplatin and fluorouracil (DCF and ECF), regimens as first line chemotherapy for advanced gastric cancer: a retrospective analysis from Turkey. Asian Pac J Cancer Prev, 2014, 15(16):6727-6732.
24. Kilickap S, Yalcin S, Ates O, et al. The first line systemic chemotherapy in metastatic gastric carcinoma: A comparison of docetaxel, cisplatin and fluorouracil (DCF) versus cisplatin and fluorouracil (CF); versus epirubicin, cisplatin and fluorouracil (ECF) regimens in clinical setting. Hepatogastroenterology, 2011, 58(105): 208.
25. 刘宁, 陆建伟, 丁选胜. 晚期胃癌化疗三药联合方案对比两药联合方案有效性及安全性 meta 分析. 中国医院药学杂志, 2012, 32(18):1467-1472.
26. Smyth EC, Verheij M, Allum W, et al. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol, 2016, 27(suppl 5): v38-v49.
27. 中华人民共和国卫生部医政司. 胃癌诊疗规范(2011 年版). 中国医学前沿杂志电子版, 2012, 4(5): 62-71.
28. Bojic M, Pluschnig U, Zacherl J, et al. Docetaxel, cisplatin and 5-fluorouracil plus granulocyte colony-stimulating factor prophylaxis in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: experience at the Medical University of Vienna. Anticancer Res, 2011, 31(6): 2379-2382.
29. 徐俊丽, 和水祥, 张明丽, 等. 胸腺法新注射液联合化疗对老年胃癌伴肝转移患者的疗效观察. 疑难病杂志, 2016, 15(7): 694-697.
30. 邵晶, 刘敬杨, 徐睿玲, 等. 注射液胸腺法新(日达仙)辅助希罗达联合奥沙利铂(XELOX 方案)治疗晚期胃癌的临床疗效观察. 现代生物医学进展, 2016, 16(23): 4468-4471.
31. 李龙, 展昊, 龙勃, 等. 盐酸帕洛诺司琼注射液预防中重度化疗所致恶心呕吐疗效和安全性的 Meta 分析. 中国普外基础与临床杂志, 2017, 24(1): 48-58.
32. 中国研究型医院学会消化道肿瘤专业委员会, 中国医师协会外科医师分会多学科综合治疗专业委员会. 胃癌多学科综合治疗协作组诊疗模式专家共识. 中国实用外科杂志, 2017, 37(1): 37-38.