Abstract
BackgroundActinomycin-D (Act-D) and Methotrexate (MTX) are both effective first-line agents for low-risk gestational trophoblastic neoplasia (LRGTN) with no consensus regarding which is more effective or less toxic. The primary objective of this meta-analysis is to compare Act-D with MTX in the treatment of LRGTN.MethodsWe systematically searched electronic databases, conferences abstracts and trial registries for randomized controlled trials (RCTs) and high-quality non-randamized controlled trials (non-RCTs), comparing Act-D with MTX for patients with LRGTN. Studies were full-text screened for quality assessment and data extraction. Eligible studies must have reported complete remission rate. A fixed-effects meta-analysis was conducted to quantify the efficacy and safety of Act-D and MTX on odds ratios (ORs) and 95% confidence intervals (95%CIs), respectively.ResultsA total of 8 RCTs and 9 non-RCTs (1674 patients) were included. In terms of efficacy, Act-D is superior to MTX in complete remission (80.2% [551/687] vs 65.1% [643/987]; OR 2.15, 95%CI 1.70 to 2.73). In the stratified analysis, patients from RCTs and non-RCTs both had a better complete remission from Act-D-based regimen (RCTs: 81.2% [259/319] vs 66.1% [199/301], OR 2.17, 95%CI 1.49 to 3.16; non-RCTs: 79.3% [292/368] vs 65.0% [444/686], OR 2.14, 95%CI 1.57 to 2.92). In terms of safety, patients receiving Act-D had higher risks of suffering nausea (OR 2.35, 95%CI 1.68 to 3.27), vomiting (OR 2.40, 95%CI 1.63 to 3.54), and alopecia (OR 2.76, 95%CI 1.60 to 4.75). Notably, liver toxicity (OR 0.38, 95%CI 0.19 to 0.76) was the only one that was conformed to have a higher risk for patients receiving MTX. In addition, the pooled results showed no significant difference of anaemia, leucocytopenia, neutropenia, thrombocytopnia, constipation, diarrhea, anorexia, and fatigue between Act-D and MTX.ConclusionsOur meta-analysis suggests that Act-D had better efficacy profile in general, and MTX had less toxicities in LRGTN. Future clinical trials should be better orchestrated to provide more valid data on efficacy and toxicity.
Highlights
Actinomycin-D (Act-D) and Methotrexate (MTX) are both effective first-line agents for low-risk gestational trophoblastic neoplasia (LRGTN) with no consensus regarding which is more effective or less toxic
Our meta-analysis suggests that Act-D had better efficacy profile in general, and MTX had less toxicities in LRGTN
According to a combined anatomic staging and modified World Health Organization (WHO) risk-factor scoring system that adopted by the International Federation of Gynecology and Obstetrics (FIGO) in 2002, Gestational trophoblastic neoplasia (GTN) with non-metastatic and low-risk metastatic are defined as low-risk GTN (LRGTN) [2, 3]
Summary
The present study was performed in line with the PRISMA (preferred reporting items for systematic reviews and meta-analysis) [11]. Data extraction and definitions Two authors independently evaluated the main text and supplementary materials to extract detailed data on the first author, year of publication, country of origin, study design, total number of patients, number of patients in efficacy and safety analysis, arms and chemotherapy regimens, and the frequency of complete remission and specific adverse events. Quality assessment We assessed the risk of bias for individual RCTs based on the original study and supplementary materials by adopting the Cochrane Risk of Bias Tool which includes the following domains: random sequence generation, allocation concealment, blinding method, assessment of outcomes, and reporting of results. Data synthesis In this meta-analysis, ORs and 95%CIs were used as summary statistics to quantify the efficacy and toxicity of Act-D and MTX. All statistical tests were two-sided and the P value threshold for statistical significance was set at 0.05 for effect sizes
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