Summary of findings 10. Sunitinib compared to interferon‐α (IFN‐α) (targeted agent versus classic immunotherapy).
| Patient or population: Treatment‐naïve metastatic renal cell carcinoma (clear cell type) Setting: Multinational muticentre/likely outpatient Intervention: Sunitinib Comparison: Interferon‐α (IFN‐α) | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with Interferon‐α (IFN‐α) | Risk difference with Sunitinib | ||||
|
Progression‐free survival (absolute effect size estimates based on survival rate at 6 months) follow‐up: median 31 months |
750 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | HR 0.54 (0.45 to 0.64) | Study population | |
| 400 per 1000 | 210 more per 1000 (156 more to 262 more) | ||||
|
Overall survival (absolute effect size estimates based on survival rate at 24 months) follow‐up: median 31 months |
750 (1 RCT) | ⊕⊕⊝⊝ LOW 2 3 | HR 0.82 (0.67 to 1.00) | Study population | |
| 480 per 1000 | 68 more per 1000 (0 fewer to 132 more) | ||||
| Serious adverse events (Grade 3 or 4) assessed as: CTCAE v3.0 | 735 (1 RCT) | ⊕⊕⊕⊝ MODERATE 1 | RR 1.75 (1.43 to 2.16) | Study population | |
| 258 per 1000 | 194 more per 1000 (111 more to 300 more) | ||||
|
Health‐related quality of life
assessed with: EQ‐5D Health State Index
Scale from: ‐0.59 (worst health state) to 1 (best health state) follow‐up: after 2 cycle |
544 (1 RCT) | ⊕⊕⊕⊝ MODERATE 4 | ‐ | The mean health‐related quality of life was 0.74 | MD 0.01 lower (0.05 lower to 0.03 higher) |
| *The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval;EQ‐5D: EuroQol‐5D; HR: Hazard ratio; RCT: Randomized controlled trial; RR: Risk ratio | |||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | |||||
1 Downgraded by 1 level for study limitations; unclear risk of selection bias and high risk of performance and other bias
2 Downgraded by 1 level for study limitations; unclear risk of selection bias and high risk of other bias
3 Downgraded by 1 level for imprecision; confidence interval reached the line of no difference and crossed the assumed threshold of a clinically important difference (included benefit and no benefit)
4 Downgraded by 1 level for study limitations; unclear risk of selection and attrition bias and high risk of performance and other bias