Centre de Recherche Epidémiologie et Statistique Paris Sorbonne Cité, INSERM U1153, Paris, France Université Paris Descartes-Sorbonne Paris cité, Paris, France.
Centre de Recherche Epidémiologie et Statistique Paris Sorbonne Cité, INSERM U1153, Paris, France Université Paris Descartes-Sorbonne Paris cité, Paris, France Centre d'Epidémiologie Clinique, Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Paris, France Cochrane France, Paris, France.
BMJ Open. 2016 Aug 3;6(8):e011841. doi: 10.1136/bmjopen-2016-011841.
Many second-line treatments for advanced non-small-cell lung cancer (NSCLC) have been assessed in randomised controlled trials, but which treatments work the best remains unclear. Novel treatments are being rapidly developed. We need a comprehensive up-to-date evidence synthesis of all these treatments. We present the protocol for a live cumulative network meta-analysis (NMA) to address this need.
We will consider trials of second-line treatments in patients with advanced NSCLC with wild-type or unknown epidermal growth factor receptor status. We will consider any single agent of cytotoxic chemotherapy, targeted therapy, combination of cytotoxic chemotherapy and targeted therapy and any combination of targeted therapies. The primary outcomes will be overall survival and progression-free survival. The live cumulative NMA will be initiated with a NMA and then iterations will be repeated at regular intervals to keep the NMA up-to-date over time. We have defined the update frequency as 4 months, based on an assessment of the pace of evidence production on this topic. Each iteration will consist of six methodological steps: adaptive search for treatments and trials, screening of reports and selection of trials, data extraction, assessment of risk of bias, update of the network of trials and synthesis, and dissemination. We will set up a research community in lung cancer, with different groups of contributors of different skills. We will distribute tasks through online crowdsourcing. This proof-of-concept study in second-line treatments of advanced NSCLC will allow one for assessing the feasibility of live cumulative NMA and opening the path for this new form of synthesis.
Ethical approval is not required because our study will not include confidential participant data and interventions. The description of all the steps and the results of this live cumulative NMA will be available online.
CRD42015017592.
许多针对晚期非小细胞肺癌（NSCLC）的二线治疗方法已经在随机对照试验中进行了评估，但哪种治疗方法效果最好仍不清楚。新的治疗方法正在迅速开发中。我们需要对所有这些治疗方法进行全面的最新证据综合。我们提出了一个实时累积网络荟萃分析（NMA）的方案来满足这一需求。
我们将考虑针对表皮生长因子受体野生型或未知状态的晚期 NSCLC 患者的二线治疗试验。我们将考虑任何单一的细胞毒性化疗药物、靶向治疗药物、细胞毒性化疗药物和靶向治疗药物的联合以及任何靶向治疗药物的联合。主要结局将是总生存期和无进展生存期。实时累积 NMA 将从 NMA 开始，然后每隔一段时间重复迭代，以随时间保持 NMA 的最新状态。我们根据对该主题证据产生速度的评估，将更新频率定义为 4 个月。每次迭代将包括六个方法步骤：治疗方法和试验的自适应搜索、报告筛选和试验选择、数据提取、偏倚风险评估、试验网络和综合更新以及传播。我们将在肺癌领域建立一个研究社区，不同技能的不同群体将成为贡献者。我们将通过在线众包分配任务。这项针对晚期 NSCLC 二线治疗的概念验证研究将评估实时累积 NMA 的可行性，并为这种新形式的综合研究开辟道路。
由于我们的研究不包括机密参与者数据和干预措施，因此不需要伦理批准。所有步骤的描述和实时累积 NMA 的结果将在网上提供。
CRD42015017592。
