Summary of findings 1. Leuprorelin compared with treosulfan for relapsed epithelial ovarian cancer.
Leuprorelin compared with treosulfan for relapsed epithelial ovarian cancer | |||||
Patient or population: Platinum‐resistant and refractory (relapsed) epithelial ovarian cancer Setting: Hospital outpatients Intervention: Leuprorelin Comparison: Treosulfan | |||||
Outcomes | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | Quality of the evidence (GRADE) | ||
Without Leuprorelin | With Leuprorelin | Difference | |||
Progression‐free survival at 6 months № of participants: 73 (1 RCT) | RR 0.61 (0.22 to 1.68) | Study population | ⊕⊝⊝⊝ VERY LOW 1 2 3 4 | ||
22.2% | 13.6% (4.9 to 37.3) | 8.7% fewer (17.3 fewer to 15.1 more) | |||
Progression‐free survival at 12 months № of participants: 73 (1 RCT) | RR 0.65 (0.12 to 3.66) | Study population | ⊕⊝⊝⊝ VERY LOW 1 2 3 4 | ||
8.3% | 5.4% (1.0 to 30.5) | 2.9% fewer (7.3 fewer to 22.2 more) | |||
Overall survival follow‐up: median 22 months № of participants: 73 (1 RCT) | HR 0.98 (0.58 to 1.67) | Study population | ⊕⊝⊝⊝ VERY LOW 1 4 5 | ||
19.4% | 19.1% (11.8 to 30.3) | 0.3% fewer (7.7 fewer to 10.9 more) | |||
Skin toxicity (alopecia) № of participants: 73 (1 RCT) | RR 0.32 (0.12 to 0.91) | Study population | ⊕⊝⊝⊝ VERY LOW 2 3 4 | ||
33.3% | 10.7% (4.0 to 30.3) | 22.7% fewer (29.3 fewer to 3.0 fewer) | |||
Gastrointestinal toxicity (nausea and vomiting) № of participants: 73 (1 RCT) | RR 0.65 (0.12 to 3.66) | Study population | ⊕⊝⊝⊝ VERY LOW 1 2 3 4 | ||
8.3% | 5.4% (1.0 to 30.5) | 2.9% fewer (7.3 fewer to 22.2 more) | |||
Neurotoxicity № of participants: 73 (1 RCT) | RR 0.32 (0.01 to 7.71) | Study population | ⊕⊝⊝⊝ VERY LOW 1 2 4 | ||
2.8% | 0.9% (0.0 to 21.4) | 1.9% fewer (2.7 fewer to 18.6 more) | |||
Neutropenia grade 3/4 № of participants: 73 (1 RCT) | not estimable | Study population | ⊕⊝⊝⊝ VERY LOW 1 2 4 | ||
2.8% | 0.0% (0.0 to 0.0) | 2.8% fewer (2.8 fewer to 2.8 fewer) | |||
*The risk in the intervention group (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; HR: Hazard ratio; RR: Risk ratio | |||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
1 Imprecision 2 No confidence intervals or HR reported 3 Significant cross‐over between the two treatment groups 4 Trial at overall high risk of bias 5 Treosulfan group had more refractory stage patients compared to the leuprorelin group.
Quality of life data were not reported in this study.