Evaluation of efficacy and safety of chemotherapy in the treatment of recurrent or resistant gestational trophoblastic neoplasia: A protocol for systematic review and meta-analysis

BACKGROUND: Gestational Trophoblastic Neoplasia (GTN) is a spectrum of pregnancy-associated tumours emerging from placental tissue. Generally, GTN patients are considered to have a high rate of recovery. However, almost 25 per cent of GTN tumours resist, or have a high probability of relapsing following the first line of chemo treatment. Thus, tumours that resist or relapse requires salvage chemotherapy, sometimes accompanied by surgery. Globally, clinicians utilize a range of salvage regimens. Currently, ongoing debates are centred around choosing the best regimens in terms of safety and efficacy. Therefore, the current research aims to appraise the success and level of safeness using chemotherapy to treat patients with resistant or recurrent GTN. METHODS: The authors will conduct a methodological exploration in online-based databases to find Randomized Controlled Trials related to the adoption of chemotherapy agents as treatment for resistant or recurrent GTN patients. The databases are as follows: EMBASE, PubMed, Cochrane Database Central, UpToDate, Chinese National Knowledge Infrastructure, Web of Science, and WanFang Database. The search will be limited to articles published in either English or Chinese. Moreover, the authors will also perform a search for ongoing trials on online-based clinical trial registries. Two independent authors will screen and select articles for review. A similar process will be followed by two independent authors to complete the extraction of data and evaluate the bias risk. In relevant cases, the authors will contract trial investigators to obtain related, unpublished data. The authors will use the random-effects model for pooling data in RevMan software (v5.3). RESULTS: The present systematic review aims to evaluate the efficacy and level of safeness associated with using chemotherapy for resistant or recurrent GTN patients. CONCLUSION: The results of the proposed systematic analysis could summarize the most recent evidence for the use of chemotherapy agents on GTN patients. ETHICS AND DISSEMINATION: Since the proposed study uses pre-published data, an ethical approval is not required. REVIEW REGISTRATION NUMBER: Aug 25, 2021.osf.io/rgzbn. (https://osf.io/rgzbn/).