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)