Wu Kuanghao, Zheng Hong-Yan, Zhang Hao-Yu, Song Xin-Yu
China Three Gorges University, Yichang, China.
Department of Academic Management, China Three Gorges University, Yichang, China.
BMJ Open. 2025 Apr 22;15(4):e094632. doi: 10.1136/bmjopen-2024-094632.
Non-small cell lung cancer (NSCLC) is a leading cause of cancer-related mortality worldwide, with conventional treatments often limited by radiation resistance, systemic toxicity and poor outcomes in advanced stages. Iodine-125 (I-125) seed implantation, combined with chemotherapy and immunotherapy, has emerged as a promising therapeutic strategy, but its efficacy and safety compared with conventional external beam radiotherapy combined with systemic therapies remain unclear. This systematic review and meta-analysis aims to synthesise the available evidence to evaluate the comparative benefits and risks of these treatment modalities.
Two reviewers will independently search seven databases-PubMed, Embase, Web of Science and the Cochrane Library-for randomised controlled trials (RCTs). These RCTs should compare the efficacy and safety of I-125 seed implantations combined with chemotherapy and immunotherapy against chemoradiotherapy combined with immunotherapy in patients with NSCLC. The risk of bias in the included studies will be evaluated using the Revised Cochrane risk-of-bias tool V.2. Data synthesis will be conducted using RevMan software. Trial sequential analysis will be applied to the primary outcomes. Additionally, subgroup and sensitivity analyses will be performed to assess the robustness of the findings.
Ethical approval is not required because this study is a secondary analysis of existing data. We will disseminate the findings through peer-reviewed publications.
CRD42024591684.
非小细胞肺癌(NSCLC)是全球癌症相关死亡的主要原因,传统治疗通常受到放射抗性、全身毒性以及晚期疗效不佳的限制。碘-125(I-125)粒子植入联合化疗和免疫治疗已成为一种有前景的治疗策略,但其与传统外照射放疗联合全身治疗相比的疗效和安全性仍不明确。本系统评价和荟萃分析旨在综合现有证据,评估这些治疗方式的相对益处和风险。
两名研究者将独立检索七个数据库——PubMed、Embase、Web of Science和Cochrane图书馆——以查找随机对照试验(RCT)。这些RCT应比较I-125粒子植入联合化疗和免疫治疗与放化疗联合免疫治疗在NSCLC患者中的疗效和安全性。将使用修订后的Cochrane偏倚风险工具V.2评估纳入研究中的偏倚风险。将使用RevMan软件进行数据合成。试验序贯分析将应用于主要结局。此外,将进行亚组分析和敏感性分析以评估研究结果的稳健性。
本研究为对现有数据的二次分析,无需伦理批准。我们将通过同行评审出版物传播研究结果。
PROSPERO注册号:CRD42024591684。