Yarandi 2015.
| Methods | Single‐centre RCT (Iran) | |
| Participants | 62 women with LRGTN | |
| Interventions | Group 1: 5‐day MTX (0.4 mg/kg IM) (25 mg max) Group 2: bi‐weekly Act D (1.25 mg/m2 IV bolus) (2mg max) |
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| Outcomes | Primary: primary remission, resistance to chemotherapy | |
| Notes | Conference abstract only. Numbers randomised to each arm was not stated in the abstract, therefore data could not be extracted/included in the review. Results were reported as follows: "Complete remission after receiving first‐line chemotherapy was achieved in 79% of all cases, 80% of Act‐D and 78.1% of MTX group (P value = 0.86) 20% of Act‐D and 21.9% of MTX cases showed resistance to the first chemotherapy, of which 16.7% and 15.6% respectively responded completely to the second‐line mono therapy. 3.3% of Act‐D and 6.,3% of MTX group needed multiple drug therapy (P value = 0.86) Side‐effects were not significantly different in both groups." Baseline characteristics were reported to be similar viz. BhCG level, uterine mass size, lung metastasis, antecedent pregnancy and the duration from diagnosis to treatment. Authors were emailed for info but the email bounced back. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
| Allocation concealment (selection bias) | Unclear risk | Allocation concealment not described. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not described. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient information in conference abstract |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information; no study protocol identified |
| Other bias | Unclear risk | Insufficient information in conference abstract. Attempts to contact study investigators (F Yarandi) were unsuccessful. |
Abbreviations: Act D = Actinomycin D or Dactinomycin; BhCG = beta human chorionic gonadotrophin; CR = Complete response; CT = chemotherapy; FIGO = International Federation of Gynecology and Obstetrics; GOG = Gynecologic Oncology Group; GTN = Gestational trophoblastic neoplasia; IM = intramuscular; ITT = Intention‐to‐treat; IV = intravenous; LRGTN = low‐risk gestational trophoblastic neoplasia; MTX = Methotrexate; MTX‐FA = methotrexate‐folinic acid; RCT = randomised controlled trial; WHO = World Health Organization