Summary of findings 2. Postoperative MMC‐EMDA induction versus MMC‐PD induction therapy for non‐muscle invasive bladder cancer.
|
Participants: people with non‐muscle invasive bladder cancer (carcinoma in situ or concurrent pT1, or both) Setting: multicentre study in Italy (all comparisons in the review stemmed from same study group) Intervention: initial 6 MMC‐EMDA intravesical instillations at weekly interval about 3 weeks after TURBT Control: initial 6 MMC‐PD intravesical instillations at weekly interval about 3 weeks after TURBT | |||||
| Outcomes | No of participants (studies) | Quality of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with MMC‐PD | Risk difference with postoperative MMC‐EMDA | ||||
|
Time to recurrence Follow‐up: mean 3 months |
72 (1 RCT) | ⊕⊕⊝⊝ Low1,2 | RR 0.65 (0.44 to 0.98) | Study population | |
| 722 per 1000 | 253 fewer per 1000 (404 fewer to 14 fewer) | ||||
| Moderate | |||||
| 420 per 1000 3 | 147 fewer per 1000 (235 fewer to 8 fewer) | ||||
|
Time to progression Follow‐up: mean 3 months |
72 (1 RCT) | ⊕⊕⊝⊝ Low1,4 | Not estimable | Study population | |
| ‐ | ‐ | ||||
|
Serious adverse events Follow‐up: mean 3 months |
72 (1 RCT) | ⊕⊝⊝⊝ Very low1,5 | RR 1.50 (0.27 to 8.45) | Study population | |
| 56 per 1000 | 28 more per 1000 (41 fewer to 414 more) | ||||
| High | |||||
| 30 per 10003 | 15 more per 1000 (22 fewer to 223 more) | ||||
|
Disease‐specific survival Follow‐up: mean 3 months |
72 (1 RCT) | ⊕⊕⊝⊝ Low1,4 | Not estimable | Study population | |
| ‐ | ‐ | ||||
| Disease‐specific quality of life ‐ not reported | ‐ | ‐ | ‐ | ‐ | ‐ |
| *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; MMC‐EMDA: electromotive drug administration of mitomycin C; MMC‐PD: passive diffusion of mitomycin C; RCT: randomised controlled trial; RR: risk ratio; TURBT: transurethral resection of bladder tumour. | |||||
| 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 Downgraded by one level for study limitations: unclear risk of selection bias, high risk of performance, detection and other bias.
2 Downgraded by one level for imprecision: confidence interval crossed assumed clinically meaningful threshold.
3Witjes 1998: recurrence rate of bladder cancer after TURBT with postoperative MMC‐PD instillations (total 5 instillations) was 42.8% and incidence of systemic adverse events was 3% based on a long‐term median follow‐up of more than 7 years.
4 Downgraded by one level for imprecision: no event.
5 Downgraded by two level for imprecision: confidence interval was wide and crossed assumed clinically meaningful threshold.