5. Gemcitabine compared to one‐third dose BCG.
| Patient or population: participants with non‐muscle invasive bladder cancer (103 men, 17 women) Country: Italy, Germany, and the US Setting: multicenter (3 centers), likely inpatients Intervention: gemcitabine Comparison: 1/3 dose BCG | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with 1/3 dose BCG | Risk difference with gemcitabine | ||||
|
Time to recurrence Follow‐up: 1 year MCID: 5% absolute difference |
118 (1 RCT) | ⊕⊝⊝⊝ Verylowa,b | HR 1.17 (0.57 to 2.42) | Study population | |
| 237 per 1000 | 34 more per 1000 (94 fewer to 243 more) | ||||
|
Time to progression Follow‐up: 1 year MCID: 5% absolute difference |
118 (1 RCT) | ⊕⊕⊝⊝ Lowa,c | HR 1.63 (0.39 to 6.83) | Study population | |
| 51 per 1000 | 31 more per 1000 (31 fewer to 250 more) | ||||
|
Grade III–V adverse events
assessed with: CTCAE version 3.0 Follow‐up: 1 year MCID: 5% absolute difference |
88 (1 RCT) | ⊕⊝⊝⊝ Verylowa,d | Not estimable | No events | No events |
| Time to death from bladder cancer | Not reported | — | — | — | — |
| Time to death from any cause | Not reported | — | — | — | — |
|
Grade I or II adverse events
assessed with: CTCAE version 3.0 Follow‐up: 1 year MCID: 5% absolute difference |
88 (1 RCT) | ⊕⊝⊝⊝ Verylowa,b | RR 0.84 (0.49 to 1.46) | Study population | |
| 404 per 1000 | 65 fewer per 1000 (206 fewer to 186 more) | ||||
|
Disease‐specific quality of life
assessed with: EORTC QLQ‐C30 (Global health status scale: higher score represents better functioning) Scale: 0–100 Follow‐up: 1 year MCID: 10e |
88 (1 RCT) | ⊕⊕⊝⊝ Lowa,c | — | The mean disease‐specific quality of life was 80.9 | MD 4.5 higher (1.6 lower to 10.6 higher) |
| *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). BCG: Bacillus Calmette‐Guérin; CI: confidence interval; CTCAE: Common Terminology Criteria for Adverse Events; EORTC QLQ‐C30: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30; MD: mean difference; RCT: randomized controlled trial; RR: risk ratio. | |||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: 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 certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | |||||
aDowngraded one level for study limitations: high risk of bias on one or more domains. bDowngraded two levels for imprecision: confidence intervals crossed a clinically important threshold and no effect; wide confidence intervals. cDowngraded one level for imprecision: confidence intervals crossed a clinically important threshold and no effect. dDowngraded two levels for imprecision: no events in either arm. eMCID: came from Osoba 1998.