| Quality assessment | Summary of findings | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of patients | Effect | Quality | |||||||||
| No of studies | Design | Limitations | Inconsistency | Indirectness | Imprecision | Other considerations | CM | C | Relative (95% CI) | Absolute | |
| Overall survival (follow-up range 2-5 years) | |||||||||||
| 11 | randomised trials | none | none | none | very serious2 | none | N=53 | N=55 | HR not reported | Median OS, 8.7 months vs. 7.2 months3 | ⊕⊕○○ LOW |
| Progression-free survival (follow-up 2-5 years) | |||||||||||
| 11 | randomised trials | none | none | none | very serious2 | none | N=53 | N=55 | HR not reported | Median PFS, 5 months vs. 2.8 months4 | ⊕⊕○○ LOW |
| Toxicity - Grade 3-4 Haematological | |||||||||||
| 1 | randomised trials | none | none | none | very serious2 | none | 14/53 (26.4%) | 4/55 (7.3%) | RR 3.63 (1.28 to 10.33) | 191 more per 1000 (from 20 more to 679 more) | ⊕⊕○○ LOW |
| Toxicity - Grade 3-4 Mucositis | |||||||||||
| 11 | randomised trials | none | none | none | very serious5 | none | 10/53 (18.9%) | 0/55 (0%) | RR 21.78 (1.31 to 362.56) | - | ⊕⊕○○ LOW |
| Toxicity - Grade 3-4 Nausea/Vomiting | |||||||||||
| 11 | randomised trials | none | none | none | very serious5 | none | 23/53 (43.4%) | 14/55 (25.5%) | RR 1.70 (0.99 to 2.95) | 178 more per 1000 (from 3 fewer to 496 more) | ⊕⊕○○ LOW |
| Treatment-related mortality | |||||||||||
| 11 | randomised trials | none | none | none | very serious5 | none | 2/53 (3.8%) | 1/55 (1.8%)6 | RR 2.08 (0.19 to 22.22) | 20 more per 1000 (from 15 fewer to 386 more) | ⊕⊕○○ LOW |
| Health-related quality of life | |||||||||||
| 0 | no evidence available | ||||||||||
Small sample size/low number of events limit precision of this outcome;
Median overall survival was 8.7 months with CM, and 7.2 months with C (p=0.7). Number of events in each arm during follow-up was not reported. Hazard ratios were not reported;
Median time-to-progression was 5 months with CM, and 2.8 months with C (the log rank test was not significant, p=0.13, but the Wilcoxon test was significant, p=0.02). Hazard ratios not reported. By the end of the second year after randomisation 10% of patients in both arms remained progression free (no significant differences between arms);
Wide confidence intervals/low number of events limits the precision of this outcome;
One death on the C arm resulted from neutropenic sepsis following M therapy given after C treatment
From: 5, Managing locally advanced or metastatic bladder cancer
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.