Table 151GRADE evidence profile: Gemcitabine for second-line chemotherapy

Quality assessmentNo of patientsEffectQuality
No of studiesDesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsGemcitabineControlRelative
(95% CI)
Absolute
Overall survival
41observational studiesnonenoneserious2serious8noneN=133 3---⊕○○○
VERY LOW
Progression-free survival
34observational studiesnonenoneserious2serious8noneN=119 5---⊕○○○
VERY LOW
Overall tumour response (assessed with: WHO criteria)
41observational studiesnonenoneserious2serious8none28/127
(22%)
---⊕○○○
VERY LOW
Grade 3-4 Neutropenia
26observational studiesnonenoneserious2serious8none29/79
(36.7%)
---⊕○○○
VERY LOW
Grade 3-4 Thrombocytopenia
41observational studiesnonenoneserious2serious8none11/131
(8.4%)
---⊕○○○
VERY LOW
Grade 3-4 Anaemia
41observational studiesnonenoneserious2serious8none16/131
(12.2%)
---⊕○○○
VERY LOW
Grade 3-4 Leucopenia
41observational studiesnonenoneserious2serious8none29/131
(22.1%)
---⊕○○○
VERY LOW
Treatment-related mortality
17observational studiesnonenoneserious2serious8none0/44
(0%)
---
Health-related quality of life (measured with: Spitzer pain index; Better indicated by lower values)
19observational studiesnonenoneserious2serious8none2510--⊕○○○
VERY LOW
1
2

Adjuvant and neoadjuvant chemotherapy considered as first-line chemotherapy;

3

Median overall survival ranged from 5 months to 13 months across studies;

4
5

Median progression-free survival ranged from 3.1 months to 4.9 months;

6

Lorusso 1997, Akaza 2007;

7
8

Small sample size and/or low number of events limit the precision of this outcome;

9
10

Non-responders showed a decrease in pain values from 5.3 to 4.8 which corresponds to an increase in pain during treatment. Responders showed an improvement in pain values from 4.3 to 5.8 (p<0.05).

From: 5, Managing locally advanced or metastatic bladder cancer

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NICE Guideline, No. 2.
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