for the main comparison.
| Actinomycin D compared with methotrexate (MTX) for low‐risk gestational trophoblastic neoplasia (GTN) | ||||||
|
Patient or population: women withe low‐risk GTN Settings: outpatient or hospital Intervention: actinomycin D (Act D) Comparison: MTX | ||||||
| Outcomes |
Illustrative Assumed risk* (Act D) |
Illustrative Corresponding risk (MTX) |
Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments |
| Primary cure (remission) | 824 per 1000 | 536 per 1000 (470 to 618) |
RR 0.65 (0.57 to 0.75) | 577 women (6 studies) | ⊕⊕⊕⊝ moderate1 | Act D is probably more likely to achieve a primary cure than MTX. 55% of the data came from trials of weekly IM MTX, which may be less effective than the 5‐ or 8‐day MTX regimens. |
| Failure of first‐line therapy | 154 per 1000 | 547 per 1000 (279 to 1000) | RR 3.55 (1.81 to 6.95) | 577 women (6 studies) | ⊕⊕⊕⊝ moderate1 | Act D as a first‐line treatment is probably less likely to fail than MTX. 59% of the data came from trials of weekly IM MTX, which may be less effective than the 5‐ or 8‐day MTX regimens. |
| Severe adverse events (≥ grade 3) | 142 per 1000 | 50 per 1000 (11 to 235) |
RR 0.35 (0.08 to 1.66) | 515 women (5 studies) | ⊕⊕⊝⊝ low1,2 |
There may be little or no difference between interventions overall. However, the point estimate and subgroup analyses favoured MTX. SAEs occurred in 3 out of 6 studies, but one study did not contribute to the meta‐analysis due to insufficient data. |
| Nausea | 462 per 1000 | 282 per 1000 (134 to 582) |
RR 0.61 (0.29 to 1.26) | 466 women (4 studies) | ⊕⊕⊕⊝ moderate1 | There is probably little or no difference between MTX and Act D for nausea. |
| Alopecia | Subtotals only | ⊕⊕⊝⊝ low1,2 |
Data on alopecia were not pooled due to substantial subgroup differences. However, in general the evidence suggested that there may be little or no difference between MTX and Act D regimens with regard to alopecia, except for the five‐day Act D regimen, which may be more frequently associated with alopecia than the 8‐day MTX regimen. | |||
| *The basis for the assumed risk is the mean control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk Ratio | ||||||
| GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate. IM = intramuscular; SAE = severe adverse effects | ||||||
1 Downgraded for clinical or statistical inconsistency
2 Downgraded for imprecision