Summary of findings 3.
IFN‐α alone versus IFN‐α + bevacizumab in first‐line therapy of mRCC | ||||||
Patient population: previously untreated patient with mRCC Setting: phase III, international, multicentre, Escudier 2007: double‐blind, placebo‐controlled; Rini 2010: open‐label Intervention: IFN‐α alone Comparison: IFN‐α alone + bevacizumab | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | ||||||
Risk with standard therapy (IFN‐α + bevacizumab) | Risk difference with IFN‐α alone (95% CI) | |||||
1‐year mortality Follow‐up: 13.3 to 22 months | Low | RR 1.17 (1.00 to 1.36) | 1381 (2 studies) | ⊕⊕⊝⊝ Low1,2 | ‐ | |
150 per 1000 | 25 more per 1000 (from 0 more to 54 more) | |||||
Moderate | ||||||
280 per 1000 | 48 more per 1000 (from 0 more to 101 more) | |||||
High | ||||||
550 per 1000 | 93 more per 1000 (from 0 more to 198 more) | |||||
Quality of life | No evidence available | |||||
Adverse events (grade ≥ 3) Follow‐up: up to 28 days after last dose to 65 months |
705 per 1000 | 162 fewer per 1000 (from 113 fewer to 205 fewer) | RR 0.77 (0.71 to 0.84) | 1350 (2 studies) | ⊕⊕⊕⊝ Moderate3 | ‐ |
*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; IFN‐α: interferon‐α; mRCC: metastatic renal cell carcinoma; RR: risk 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 for selection bias and performance bias due to substantial cross‐over. 2 Downgraded for imprecision due to wide confidence intervals; clinical action would differ between lower and upper boundary of the confidence interval. 3 Downgraded for performance and detection bias.