Summary of findings 4. Single‐dose, preoperative MMC‐EMDA versus single‐dose, postoperative MMC‐PD for non‐muscle invasive bladder cancer.
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Participants: people with non‐muscle invasive bladder cancer (primary pTa and pT1 urothelial carcinoma) Setting: multicentre study in Italy (all comparisons in the review stemmed from same study group) Intervention: single MMC‐EMDA intravesical instillation about 30 minutes before spinal or general anaesthesia for TURBT Control: single MMC‐PD intravesical instillation immediately 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 preoperative MMC‐EMDA | ||||
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Time to recurrence Follow‐up: median 86 months |
236 (1 RCT) | ⊕⊕⊕⊝ Moderate1 | HR 0.47 (0.32 to 0.69) | Study population | |
| 588 per 1000 | 247 fewer per 1000 (341 fewer to 130 fewer) | ||||
| Low 2 | |||||
| 100 per 1000 | 52 fewer per 1000 (67 fewer to 30 fewer) | ||||
| High 2 | |||||
| 500 per 1000 | 222 fewer per 1000 (301 fewer to 120 fewer) | ||||
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Time to progression Follow‐up: median 86 months |
236 (1 RCT) | ⊕⊝⊝⊝ Very low1,3 | HR 0.81 (0.00 to 259.93) | Study population | |
| 193 per 1000 | 34 fewer per 1000 (193 fewer to 807 more) | ||||
| Low 2 | |||||
| 20 per 1000 | 4 fewer per 1000 (20 fewer to 975 more) | ||||
| High 2 | |||||
| 100 per 1000 | 18 fewer per 1000 (100 fewer to 900 more) | ||||
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Serious adverse events Follow‐up: median 86 months |
236 (1 RCT) | ⊕⊝⊝⊝ Very low1,3 | RR 0.79 (0.30 to 2.05) | Study population | |
| 76 per 1000 | 16 fewer per 1000 (53 fewer to 79 more) | ||||
| High 4 | |||||
| 30 per 1000 | 6 fewer per 1000 (21 fewer to 31 more) | ||||
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Disease‐specific survival Follow‐up: median 86 months |
236 (1 RCT) | ⊕⊕⊝⊝ Low3 | HR 0.99 (0.74 to 1.32) | Study population | |
| 126 per 1000 | 1 fewer per 1000 (31 fewer to 37 more) | ||||
| Low 2 | |||||
| 20 per 1000 | 0 fewer per 1000 (5 fewer to 6 more) | ||||
| High 2 | |||||
| 60 per 1000 | 1 fewer per 1000 (15 fewer to 18 more) | ||||
| 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; HR: hazard ratio; 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: high risk of performance bias.
2Sylvester 2016: baseline risks of time to recurrence and progression, and disease‐specific survival were estimated from included studies in a systematic review and meta‐analysis of RCTs comparing the efficacy of a single instillation of MMC after TURBT with TURBTs alone.
3 Downgraded by two level for imprecision: confidence interval was wide and crossed clinically meaningful threshold.
4Witjes 1998: incidence of systemic adverse events after TURBT with postoperative MMC‐PD instillations (total 5 instillations) was 3% based on a long‐term median follow‐up of more than 7 years.