Table 164, GRADE evidence profile: Gemcitabine, Ifosfamide for second-line chemotherapy - Bladder Cancer

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Quality assessment							No of patients		Effect		Quality
No of studies	Design	Risk of bias	Inconsistency	Indirectness	Imprecision	Other considerations	Gemcitabine, ifosfamide	Control	Relative (95% CI)	Absolute	Quality
Overall survival
2¹	observational studies	none	none	none	serious²	none	N=57	-	Median OS = 4.8 and 9 months		⊕○○○ VERY LOW
Progression-free survival
2¹	observational studies	none	none	none	serious²	none	N=57	-	Median PFS = 3.5 and 4 months		⊕○○○ VERY LOW
Overall tumour response (assessed with: WHO criteria)
2¹	observational studies	none	none	none	serious²	none	12/57 (21.1%)	-	-	-	⊕○○○ VERY LOW
Grade 3-4 Neutropenia (assessed with: WHO criteria)
1³	observational studies	none	none	none	serious²	none	9/34 (26.5%)	-	-	-	⊕○○○ VERY LOW
Grade 3-4 Thrombocytopenia (assessed with: WHO/ECOG criteria)
2¹	observational studies	none	none	none	serious²	none	12/57 (21.1%)	-	-	-	⊕○○○ VERY LOW
Grade 3-4 Anaemia (assessed with: WHO/ECOG criteria)
2¹	observational studies	none	none	none	serious²	none	11/57 (19.3%)	-	-	-	⊕○○○ VERY LOW
Grade 3-4 Leucopenia (assessed with: ECOG criteria)
1⁴	observational studies	none	none	none	serious²	none	10/23 (43.5%)	-	-	-	⊕○○○ VERY LOW
Treatment-related mortality
1³	observational studies	none	none	none	serious²	none	0/34 (0%)	-	-	-	⊕○○○ VERY LOW
Health-related quality of life
0	No evidence available

1: Lin 2007, Pectasides 2001;
2: Small sample size / low number of events limit the precision of this outcome;
3: Pectasides 2001;
4: Lin 2007

Bladder Cancer: Diagnosis and Management.

NICE Guideline, No. 2.

National Collaborating Centre for Cancer (UK).

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