中国循证医学杂志

中国循证医学杂志

第二代ALK抑制剂治疗 ALK+ 非小细胞肺癌有效性单组率的Meta分析

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目的 系统评价第二代 ALK 抑制剂(色瑞替尼和艾洛替尼)治疗 ALK+ 非小细胞肺癌的疗效及颅内病灶控制效果。 方法 计算机检索 PubMed、EMbase、The Cochrane Library、ClinicalTrials.gov、WanFang Data 和 VIP 数据库,搜集色瑞替尼或艾洛替尼治疗 ALK+非小细胞肺癌的临床研究,检索时限为建库至 2017 年 12 月 31 日。由 2 位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 Stata 12.0 软件进行 Meta 分析。 结果 共纳入 11 个研究。Meta 分析结果显示:色瑞替尼和艾洛替尼治疗非小细胞肺癌的客观缓解率(ORR)为 57%[95%CI(0.48,0.66),P<0.001];对于克唑替尼耐药患者,ORR 为 51%[95%CI(0.44,0.57),P<0.001];对于存在脑转移的患者,其颅内病灶控制率(IDCR)为 78%[95%CI(0.71,0.86),P<0.001]。 结论 第二代 ALK 抑制剂显示出明显的抗肿瘤效果。受纳入研究质量和数量限制,上述结论仍需更多大样本、高质量研究予以验证。

Objectives To systematically evaluate the effects of second-generation ALK-inhibitors: Ceritinib and Alectinib on ALK+ NSCLC patients. Methods PubMed, EMbase, The Cochrane Library, WanFang Data, ClinicalTrials.gov and VIP databases were systematically searched for clinical trials containing treatment of two principal second-generation ALK-inhibitors for ALK (+) NSCLC patients from inception to December 31st, 2017. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias included in the studies. Stata 12.0 software was used for meta-analysis. Results Eleven studies were included. Meta-analysis showed that the ORR of all was 57% (95%CI 0.48 to 0.66, P<0.001). The ORR of patients with Crizotinib-resistance was 51% (95%CI 0.44 to 0.57,P<0.001). The IDCR of patients who had brain metastases was 78% (95%CI 0.71 to 0.86,P<0.001). Conclusions The second-generation ALK-inhibitors has effect on ALK (+) NSCLC. Due to limitation of the included studies, more larger sample studies are required to verify above conclusions.

关键词: 色瑞替尼; 艾洛替尼; 非小细胞肺癌; Meta分析; 单组率

Key words: Ceritinib; Alectinib; Non-small-cell lung cancer (NSCLC); Meta-analysis; Single-arm

引用本文: 胡鑫, 张会云, 边南南, 封国生. 第二代ALK抑制剂治疗 ALK+ 非小细胞肺癌有效性单组率的Meta分析 . 中国循证医学杂志, 2018, 18(9): 918-923. doi: 10.7507/1672-2531.201803048 复制

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