| Quality assessment | No of patients | Effect | Quality | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Gemcitabine, paclitaxel | Control | Relative (95% CI) | Absolute | |
| Overall survival | |||||||||||
| 41 | observational studies | none | none | none | serious13 | none | N=92 2 | - | - | - | ⊕○○○ VERY LOW |
| Progression-free survival (follow-up median 20.4 months) | |||||||||||
| 13 | observational studies | none | none | serious4 | serious13 | none | N=24 5 | - | - | - | ⊕○○○ VERY LOW |
| Overall tumour response (assessed with: RECIST/WHO criteria) | |||||||||||
| 66 | observational studies | none | none | none | serious13 | none | 33/109 (30.3%)7 | - | - | - | ⊕○○○ VERY LOW |
| Grade 3-4 Neutropenia (assessed with: NCI-CTC) | |||||||||||
| 41 | observational studies | none | none | none | serious13 | none | 50/118 (42.4%)8 | - | - | - | ⊕○○○ VERY LOW |
| Grade 3-4 Thrombocytopenia (assessed with: NCI-CTC) | |||||||||||
| 41 | observational studies | none | none | none | serious13 | none | 10/92 (10.9%)9 | - | - | - | ⊕○○○ VERY LOW |
| Grade 3-4 Anaemia (assessed with: NCI-CTC) | |||||||||||
| 310 | observational studies | none | none | none | serious13 | none | 5/68 (7.4%)11 | - | - | - | ⊕○○○ VERY LOW |
| Grade 3-4 Leucopenia | |||||||||||
| 0 | No evidence available | ||||||||||
| Treatment-related mortality | |||||||||||
| 41 | observational studies | none | none | none | serious13 | none | 1/92 (1.1%)12 | - | - | - | ⊕○○○ VERY LOW |
| Health-related quality of life | |||||||||||
| 0 | No evidence available | ||||||||||
Median overall survival reported were 8 months (Sternberg 2001), 11.3 months (Suyama 2009),11.5 months (Kanai 2008), and 12.4 months (Ikeda, 2011). Takahashi (2006) reported a median overall survival of 12.1 months, but this included patients receiving both first-line and second-line GP chemotherapy;
Neoadjuvant and adjuvant chemotherapy considered first-line therapy. Proportion of participants not reported;
Median progression-free survival was 6.1 months;
Kaufman 2000, Sternberg 2001, Takahashi 2006, Kanai 2008, Suyama 2009, Ikeda 2011;
Overall tumour response rate ranged from 17% to 42% across studies;
Rate of grade 3-4 neutropenia ranged from 30% to 67% across studies;
Rates of grade 3-4 thrombocytopenia ranged from 0% to 29% across studies;
Rates of grade 3-4 anaemia ranged from 0% to 15%
One treatment related death reported by Sternberg 2001;
Small sample size/low number of events reduces precision
From: 5, Managing locally advanced or metastatic bladder cancer
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