非小细胞肺癌的维持或巩固治疗：一项纳入5841名受试者的荟萃分析。

Maintenance or Consolidation Therapy for Non--Small-Cell Lung Cancer: A Meta-Analysis Involving 5841 Subjects.

作者信息

Zhang Cuicui, Huang Chun, Wang Jing, Wang Xinyue, Li Kai

机构信息

Departments of Thoracic Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre for Cancer, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin Lung Cancer Diagnosis and Treatment Centre, Tianjin, China.

出版信息

Clin Lung Cancer. 2015 Sep;16(5):e15-23. doi: 10.1016/j.cllc.2015.01.002. Epub 2015 Jan 10.

DOI:10.1016/j.cllc.2015.01.002

PMID:25676720

Abstract

INTRODUCTION

Maintenance therapy is a new treatment paradigm for advanced non-small-cell lung cancer (NSCLC). We conducted a meta-analysis to evaluate its clinical efficacy in NSCLC and compared the efficacy of chemotherapy, epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), and other treatment approaches.

MATERIALS AND METHODS

Electronic databases were obtained from published reports of randomized controlled trials (RCTs) that compared maintenance or consolidation therapy with placebo, best supportive care (BSC) or just observation. Hazard ratios for progression-free survival (PFS) and overall survival (OS), with their relative 95% confidence intervals (CIs), were derived. All statistical analyses were conducted with RevMan 5.0 software, and statistical significance was defined as P < .05.

RESULTS

A total of 14 RCTs involving 5841 patients were eligible for our analysis, including chemotherapy used in 5 RCTs, EGFR-TKI in 6, and others (eg, biotherapy) in 3. Our study showed that compared with the control, maintenance or consolidation therapy could prolong the OS (odds ratio [OR], 0.84; 95% CI, 0.75-0.95; P = .005) and PFS (OR, 0.63; 95% CI, 0.54-0.73; P < .00001) periods. Subgroup analysis showed that chemotherapy can improve PFS but not OS, EGFR-TKI can improve PFS and OS, and other therapies can improve neither PFS nor OS.

CONCLUSION

Our meta-analysis demonstrated that maintenance therapy for advanced NSCLC patients can decrease the PFS risk to 0.63 and OS to 0.84. However, its clinical effect has yet to be confirmed by further studies.

摘要

引言

维持治疗是晚期非小细胞肺癌（NSCLC）的一种新治疗模式。我们进行了一项荟萃分析，以评估其在NSCLC中的临床疗效，并比较化疗、表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）及其他治疗方法的疗效。

材料与方法

从已发表的随机对照试验（RCT）报告中获取电子数据库，这些试验比较了维持或巩固治疗与安慰剂、最佳支持治疗（BSC）或仅观察。得出无进展生存期（PFS）和总生存期（OS）的风险比及其相对95%置信区间（CIs）。所有统计分析均使用RevMan 5.0软件进行，统计学显著性定义为P <.05。

结果

共有14项涉及5841例患者的RCT符合我们的分析标准，其中5项RCT使用了化疗，6项使用了EGFR-TKI，3项使用了其他（如生物治疗）。我们的研究表明，与对照组相比，维持或巩固治疗可延长OS（优势比[OR]，0.84；95% CI，0.75 - 0.95；P =.005）和PFS（OR，0.63；95% CI，0.54 - 0.73；P <.00001）期。亚组分析表明，化疗可改善PFS但不能改善OS，EGFR-TKI可改善PFS和OS，其他疗法既不能改善PFS也不能改善OS。