Jin Wenzhen, Zhang Yibin, Pang Shu, Yao Dongdong, Huang Yiwen
Scientific Affairs Department, Clinflash Healthcare Technology (Jiaxing) Co., Ltd, Room 813, 999 West Zhongshan Road, Huawen Plaza, Shanghai, 200051, People's Republic of China.
Syst Rev. 2025 Apr 9;14(1):82. doi: 10.1186/s13643-025-02826-y.
In China, sodium cantharidinate/vitamin B6 (SC/VB6) injection has been approved since 2002 for the treatment of lung cancer and primary liver cancer. In addition to these authorized indications, clinical application of SC/VB6 is also common in various other types of cancer. However, there is a lack of comprehensive understanding on this topic. Thus, this systematic review and meta-analysis aims to consolidate evidence regarding the efficacy and safety of off-label use of SC/VB6 in oncology.
International databases including PubMed, Embase, Cochrane Library, Web of Science, and CINAHL Plus, as well as Chinese databases including China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), and Wanfang, will be searched from the inception to 31 December 2024. Comparative studies that evaluated the add-on effect of SC/VB6 to conventional cancer treatments against the use of conventional treatments alone will be considered in the scope of this review. The primary outcomes are objective response rate and performance status. Secondary outcomes are disease control rate (DCR), progression-free survival (PFS), disease-free survival (DFS), overall survival (OS), and adverse events (AEs). Depending on heterogeneity, data will be synthesized using either the Mantel-Haenszel fixed-effect or the DerSimonian and Laird random-effect model. Subgroup analyses will be conducted for the following variables: type of cancer, study design, SC/VB6 dosage, treatment duration, and combined therapies, provided that each subgroup contains at least two studies. Sensitivity analyses will be performed on efficacy outcomes. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) will be utilized to appraise the overall quality of evidence.
This review will encompass both randomized controlled trials (RCTs) and cohort studies, thereby enabling us to synthesize and assess evidence across experimental and real-world observational settings. Our findings will contribute to a better understanding on the benefit-risk profile regarding the off-label use of SC/VB6 in oncology, guiding the trajectory of future research, and offering a robust scientific foundation to inform clinical and regulatory decision-making process.
PROSPERO CRD42024504977.
在中国，斑蝥酸钠维生素B6（SC/VB6）注射液自2002年起被批准用于治疗肺癌和原发性肝癌。除了这些获批适应症外，SC/VB6在各种其他类型癌症的临床应用也很常见。然而，对此主题缺乏全面的了解。因此，本系统评价和荟萃分析旨在整合关于SC/VB6在肿瘤学中标签外使用的疗效和安全性的证据。
将检索国际数据库，包括PubMed、Embase、Cochrane图书馆、Web of Science和CINAHL Plus，以及中国数据库，包括中国知网（CNKI）、中国生物医学文献数据库（CBM）和万方，检索时间从建库至2024年12月31日。本评价范围将考虑评估SC/VB6联合传统癌症治疗与单纯使用传统治疗相比附加效果的比较研究。主要结局是客观缓解率和体能状态。次要结局是疾病控制率（DCR）、无进展生存期（PFS）、无病生存期（DFS）、总生存期（OS）和不良事件（AE）。根据异质性，数据将使用Mantel-Haenszel固定效应模型或DerSimonian和Laird随机效应模型进行合并。将对以下变量进行亚组分析：癌症类型、研究设计、SC/VB6剂量、治疗持续时间和联合治疗，前提是每个亚组至少包含两项研究。将对疗效结局进行敏感性分析。将使用推荐分级评估、制定和评价（GRADE）来评估证据的总体质量。
本评价将涵盖随机对照试验（RCT）和队列研究，从而使我们能够综合和评估实验和现实世界观察环境中的证据。我们的研究结果将有助于更好地了解SC/VB6在肿瘤学中标签外使用的获益-风险概况，指导未来研究的方向，并为临床和监管决策过程提供坚实的科学基础。
PROSPERO CRD42024504977。
