摘要
目的系统评价凡德他尼治疗晚期非小细胞肺癌(NSCLC)的疗效及其安全性。方法电子检索Medline(1966～2011),Cochrane Library(2011年第11期),EM base(1974～2011),CNKI(1978～2011),维普(1989～2011),CBM disc(1978～2011)等数据库,对符合纳入标准的随机对照试验(RCT),采用Rev Man 5.1.2软件进行Meta分析。结果共纳入5个RCT,共3473例病。Meta分析结果显示:在所有入选的文献当中,凡德他尼单用或联合化疗药物治疗晚期NSCLC能显著提高客观缓解率(ORR)[OR=1.66,95%CI(1.13,2.46),P=0.01],在无进展生存期(PFS)方面,只有1个RCT结果显示与对照组相比,试验组PFS显著提高且有统计学意义[HR=0.79,97.58%CI(0.70,0.90),P<0.0001],其余RCT结果均显示两组间差异无统计学意义;所有RCT结果均显示总生存率(OS)在试验组与对照组间均无明显差异;在症状恶化时间(TDS)方面,有两个RCT进行了分析且差异具有统计学意义,分别是[HR=0.77,97.5%CI(0.65,0.92),P=0.0008]和[HR=0.71,97.5%CI(0.54,0.94),P=0.0052(2-sided)]。在不良反应方面,凡德他尼单用或联合化疗会使腹泻[RR=1.34,95%CI(1.23,1.46),P<0.00001]、高血压[RR=6.00,95%CI(3.75,9.62),P<0.00001],粒细胞减少[RR=1.19,95%CI(1.02,1.39),P=0.02]、失眠[RR=1.32,95%CI(1.01,1.72),P=0.05]的发生率显著增加,且具有统计学意义。结论凡德他尼单用或联合其它化疗药物治疗NSCLC疗效比不含凡德他尼的化疗方案更好,但同时也增加了腹泻、高血压、粒细胞减少和失眠的发生率,在临床应用时需注意预防和对症治疗。
Objective To evaluate the efficacy and safety of vandetanib as the treatment drug for patients with ad vanced non-small-cell lung cancer （NSCLC）. Methods Several databases including Medline（1966 - 2011）, Cochrane Library （Issue 11, 2011）, EMbase （1974 - 2011）, CNKI（1978 - 2011）, VIP（1989 - 2011） and CBMdisc （1978 - 2011） were electronically searched, and meta-analysis was undertaken to analyze the randomized controlled trials （RCTs） that met the inclusion criteria by using the Cochrane Collaboration＇ s RevMan 5.1.2 soft-vare. Results Five RCTs with a total of 3473 cases were included. According to the results of Meta-analysis, in comparison with the control group, vandetanib increased the objective response rate（ORR）[OR=1.66, 95 % CI（1.13, 2.46）, P= 0.01]. Only one of the RCTs showed the significant increase in progression-free survival （PFS） [HR=0.79, 97.58 % CI （0.70, 0.90）, P 〈 0.000 1]. None of the study showed the significant improvement in overall survival（OS） in vandetanib-treated group. Two RCTs had reported the TDS significantly raised in vandetanib-treated groups [HIL=0.77, 97.5%CI（0.65, 0.92）, and HR=0.71, 97.5 % Cl （0.54, 0.94） respectively]. The incidence of adve-e effects happened during the treatment were also analyzed, and treatment with vandetanib significantly increased the incidence rates of diarrhea [RR=l,34, 95%CI （1.23, 1.46）, P 〈 0,000 01 ], hypertension [RR=6.00, 95 % CI （3.75, 9.62）, P 〈 0.000 01 ], neutropenia [R1L= 1.19, 95 % CI （1.02, 1.39）, P = 0.02 ], insomnia [ RR= 1.32, 95 % CI （ 1.01, 1.72）, P = 0.05 ]. Conclusion In comparison with other chemotherapy regimens, vandetanib alone or combined with other chemotherapetltics had better therapeutic effects on NSCLC, mean- while, it increased the incidence rates of adverse effects such as diarrhea, hypertension, neutropenia and insomnia, which should be prevented and symptomatically treated.
出处
《肿瘤药学》
CAS
2012年第5期385-391,共7页
Anti-Tumor Pharmacy
基金
湖南省科技厅科技计划项目资助(2012SK3249)
关键词
凡德他尼
非小细胞肺癌
治疗
META分析
Vandetanib
NSCLC
Non-srmall-cell lung cancer
Treatment
Meta-analysis
