Direct comparisons of efficacy and safety between actinomycin-D and methotrexate in women with low-risk gestational trophoblastic neoplasia: A meta-analysis of randomized and high-quality nonrandomized studies
- trophoblastic neoplasia: a meta-analysis of randomized and high-quality non-. - The primary objective of this meta-analysis is to compare Act-D with MTX in the treatment of LRGTN.. - 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.. - 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:. - vs OR 2.17, 95%CI 1.49 to 3.16. - non-RCTs vs OR 2.14, 95%CI 1.57 to 2.92). - Keywords: Actinomycin-D, Gestational trophoblastic neoplasia, Low risk, meta-analysis, Methotrexate. - Gestational trophoblastic neoplasia (GTN) is a spectrum of interrelated but distinct conditions including invasive mole, choriocarcinoma, and the rare placental-site and epithelioid trophoblastic tumor, with metastatic and fatal potentiality [1]. - gestational trophoblastic disease. - gestational trophoblastic tumor. - gestational trophoblastic neoplasm. - low risk. - and toxicity in this meta-analysis. - 1 The flow diagram of the selection process for studies included in the present meta-analysis. - For the meta-analysis of first-line and single-agent regimens, studies comparing the use of Act-D-based regimen (5d-IV Act-D and pulsed IV Act- D) with MTX-based regimen (5d-IV MTX, 5d-IM MTX, w-IM MTX, and MTX-FA) were included. - A total of 1674 patients were included in the meta-analysis. - Meta-analysis for efficacy profile. - The upfront drug-based meta-analysis was conducted to compare the proportion of complete responders to Act- D-based regimen and MTX-based regimen. - OR 2.15, 95%CI 1.70 to 2.73), although there was substantial variation between the results of the individual studies (I P = 0.000). - the superiority of complete remission seen for Act-D- based regimen remained (OR 2.51, 95%CI 1.63 to 3.86).. - OR 2.17, 95%CI 1.49 to 3.16) with no evidence of heterogeneity. - OR 2.14, 95%CI 1.57 to 2.92). - mg/m2 biweekly. - Act-D, IV, 1.25 mg/m2 biweeklyAct-D, IV, 1.25 mg/m2 biweekly. - Act-D, IV, 1.25 mg/m2 biweekly or Act-D, IV, 12 μ g/kg daily for 5 days. - effects model was applied (OR 2.77, 95%CI 1.47 to 5.21) (Fig. - Meta-analysis for hematological toxicities. - Figure 3 detailed the hematological toxicities of Act-D- based regimen and MTX-based regimen. - I 2 = 0.0%, P = 0.361), leucocytopenia (OR 1.06, 95%CI 0.58 to 1.94;. - I 2 = 0.0%, P = 0.678), neutropenia (OR 1.14, 95%CI 0.65 to 2.01. - I P = 0.253), and thrombocytopnia (OR 1.52, 95%CI 0.71 to 3.26. - Meta-analysis for gastrointestinal toxicities. - 0.92, 95%CI 0.44 to 1.90. - I 2 = 0.0%, P = 0.812) and diar- rhea (OR 0.82, 95%CI 0.49 to 1.38. - Meta-analysis for toxicities from other systems. - I P = 0.191) and fatigue (OR 1.04, 95%CI 0.59 to 1.82. - Notably, liver toxicity (OR 0.38, 95%CI 0.19 to 0.76. - OR 1.41, 95%CI 0.45 to 4.40. - non-RCTs: OR 1.32, 95%CI 0.34 to 5.17) (Fig. - However, a previous net-work meta-analysis by Li et al.. - However, the network meta-analysis by Li et al. - Some limitations of this meta-analysis should be stated. - GTN: Gestational trophoblastic neoplasia. - org/10.1186/s . - Gestational trophoblastic neoplasia--pathogenesis and potential therapeutic targets. - https://doi.org/10.1016/. - Gestational trophoblastic neoplasia, FIGO 2000 staging and classification. - https://doi.org/10.1016/S . - Gestational trophoblastic disease II: classification and management of gestational trophoblastic neoplasia. - https://doi.org/10.1016/j.ajog . - Treatment of nonmetastatic and metastatic low-risk gestational trophoblastic neoplasia: factors associated with resistance to single-agent methotrexate chemotherapy. - https://doi.. - Current management of gestational trophoblastic diseases. - https://doi.org/1 0.1016/j.ygyno . - Phase III trial of weekly methotrexate or pulsed dactinomycin for low-risk gestational trophoblastic neoplasia: a gynecologic oncology group study. - https://doi.org/10.1200/JCO . - 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