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. 2016 Feb 12;2016(2):CD008593. doi: 10.1002/14651858.CD008593.pub3

Summary of findings for the main comparison. IRI with fluoropyrimidines versus single agent IRI for advanced and/or metastatic colorectal cancer.

IRI with fluoropyrimidines versus single agent IRI for advanced and/or metastatic colorectal cancer
Patient or population: patients with advanced and/or metastatic colorectal cancer
 Settings: first‐ and second‐ line treatments
 Intervention: IRI with fluoropyrimidines
Control: Single agent IRI.
Outcomes Illustrative comparative risks* (95% CI) Relative effect
 (95% CI) No of Participants
 (studies) Quality of the evidence
 (GRADE)
Assumed risk Corresponding risk
Control IRI with fluoropyrimidines
Overall survival 
 (Death)
 Follow‐up: 12 months 47 per 100 44 per 100 
 (40 to 48) HR 0.91 
 (0.81 to 1.02) 1728
 (5 studies) ⊕⊕⊝⊝
 low1
Progression‐free survival 
 (Disease progression)
 Follow‐up: 12 months 92 per 100 81 per 100 
 (74 to 88) HR 0.68 
 (0.53 to 0.83) 600
 (3 studies) ⊕⊕⊕⊝
 moderate2
Grade 3/4 diarrhea
Follow‐up:
Study Population RR 0.66 
 (0.51 to 0.85) 1179
 (5 studies) ⊕⊕⊕⊝
 moderate3
213 per 1000 140 per 1000 
 (109 to 181)
Moderate
185 per 1000 122 per 1000 
 (94 to 157)
Grade 3/4 nausea
Follow‐up:
Study Population RR 0.33 
 (0.07 to 1.58) 209
 (3 studies) ⊕⊕⊝⊝
 low4
49 per 1000 16 per 1000 
 (3 to 77)
Moderate
33 per 1000 11 per 1000 
 (2 to 52)
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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).
 CI: Confidence interval; HR: Hazard ratio.
GRADE Working Group grades of evidence
 High quality: Further research is very unlikely to change our confidence in the estimate of effect.
 Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
 Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
 Very low quality: We are very uncertain about the estimate.

1 Downgraded one level for study limitations (Allocation concealment was only clear for one of the five studies, open‐label intervention) and one level for imprecision (Lack of sufficient number of samples may have reduced the statistical power of the analysis)
 2 Downgraded one level for study limitations (Allocation concealment was only clear for one of the five studies, open‐label intervention)

3 Downgraded one level for study limitations (Allocation concealment was only clear for one of the five studies, open‐label intervention)

4 Downgraded one level for study limitations (Allocation concealment was only clear for one of the five studies, open‐label intervention) and one level for imprecision (Lack of sufficient number of samples may have reduced the statistical power of the analysis)