Ma Jiandi, Zhou Yixiao, Yao Jun
Center for Reproductive Medicine, Department of Obstetrics, Zhejiang Provincial People's Hospital, (Affiliated People's Hospital, Hangzhou Medical College), Hangzhou, Zhejiang, China.
Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
BMJ Open. 2025 Aug 26;15(8):e106582. doi: 10.1136/bmjopen-2025-106582.
Placental site trophoblastic tumour (PSTT) is a rare type of gestational trophoblastic malignancy. Despite different guidelines recommending surgery, chemotherapy or immunotherapy, there has been no optimal first-line treatment owing to its rarity. Direct comparisons of efficacy and safety across interventions remain limited. We aim to perform a systematic review and network meta-analysis (NMA) to explore each PSTT treatment and to help develop individualised, evidence-based clinical decisions.
This systematic review, registered on PROSPERO and adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-P 2015 guidelines, will evaluate all available treatments for PSTT. Databases (PubMed, Scopus, Embase, Web of Science) will be searched from inception to 31 May 2025 using Medical Subject Headings terms and keywords related to PSTT. The inclusion criteria will be studies reporting confirmed PSTT patients and treatment outcomes; the exclusion criteria will be non-human studies, abstracts and reviews. Two researchers will independently screen studies, resolving discrepancies via discussion or a third reviewer. Manual reference checks will complement searches. Data on study characteristics, interventions (chemotherapy, surgery or other treatments) and outcomes (overall survival (OS), progression-free survival, adverse events, fertility) will be extracted. The primary outcome will be the OS. Quality will be assessed using the Newcastle-Ottawa Scale (NOS) for observational studies and V.2 Cochrane Risk of Bias Assessment Tool (RoB 2) for randomised controlled trials. Statistical analyses will be conducted via Review Manager 5.4.1 and Stata 16.0. The ORs, along with 95% CIs will be calculated with random-effects or fixed-effects models depending on the heterogeneity between studies. The sensitivity analyses and publication bias (funnel plots, Begg's/Egger's tests) will be assessed if indicated.
As this study analyses previously published data, no additional ethical approval is required, nor will patient safety be compromised. The collected results will be submitted for publication in a peer-reviewed journal following PRISMA-NMA guidelines. No datasets will be generated or analysed during the current study.
CRD420251013082.
胎盘部位滋养细胞肿瘤（PSTT）是一种罕见的妊娠滋养细胞恶性肿瘤。尽管不同的指南推荐了手术、化疗或免疫治疗，但由于其罕见性，目前尚无最佳的一线治疗方案。不同干预措施在疗效和安全性方面的直接比较仍然有限。我们旨在进行一项系统评价和网状Meta分析（NMA），以探索PSTT的各种治疗方法，并帮助制定基于证据的个体化临床决策。
这项在PROSPERO注册并遵循系统评价和Meta分析优先报告项目（PRISMA）-P 2015指南的系统评价，将评估PSTT的所有可用治疗方法。从数据库建立至2025年5月31日，将使用医学主题词以及与PSTT相关的关键词检索数据库（PubMed、Scopus、Embase、Web of Science）。纳入标准为报告确诊PSTT患者及治疗结果的研究；排除标准为非人类研究、摘要和综述。两名研究人员将独立筛选研究，通过讨论或第三名评审员解决分歧。人工参考文献检查将补充检索。将提取关于研究特征、干预措施（化疗、手术或其他治疗）和结果（总生存期（OS）、无进展生存期、不良事件、生育能力）的数据。主要结局将为OS。对于观察性研究，将使用纽卡斯尔-渥太华量表（NOS）评估质量；对于随机对照试验，将使用V.2 Cochrane偏倚风险评估工具（RoB 2）评估质量。将通过Review Manager 5.4.1和Stata 16.0进行统计分析。根据研究间的异质性，将使用随机效应或固定效应模型计算OR值及95%可信区间。如有需要，将评估敏感性分析和发表偏倚（漏斗图、Begg检验/Egger检验）。
由于本研究分析的是既往发表的数据，无需额外的伦理批准，也不会损害患者安全。收集到的结果将按照PRISMA-NMA指南提交至同行评审期刊发表。在本研究期间不会生成或分析数据集。
PROSPERO注册号：CRD420251013082。
