Summary of findings 9. Sunitinib compared to IMA901 + sunitinib (targeted agent versus tumour vaccine + targeted agent).
| Patient or population: Treatment‐naïve metastatic renal cell carcinoma (clear cell type) Setting: Multinational muticentre/likely outpatient Intervention: Sunitinib Comparison: IMA901 + Sunitinib | |||||
| Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
| Risk with IMA901 + Sunitinib | Risk difference with Sunitinib | ||||
|
Progression‐free survival (absolute effect size estimates based on survival rate at 12 months) follow‐up: median 33.27 months |
339 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | HR 0.95 (0.70 to 1.30) | Study population | |
| 590 per 1000 | 16 more per 1000 (86 fewer to 101 more) | ||||
|
Overall survival (absolute effect size estimates based on survival rate at 12 months) follow‐up: median 33.27 months |
339 (1 RCT) | ⊕⊕⊝⊝ LOW 3 4 | HR 0.75 (0.54 to 1.04) | Study population | |
| 800 per 1000 | 46 more per 1000 (7 fewer to 86 more) | ||||
| Serious adverse events (Grade 3 or 4) assessed with: CTCAE v4.0 | 334 (1 RCT) | ⊕⊕⊝⊝ LOW 2 5 | RR 0.74 (0.59 to 0.95) | Study population | |
| 550 per 1000 | 143 fewer per 1000 (225 fewer to 27 fewer) | ||||
| Health‐related quality of life6 | Not reported | ‐ | ‐ | ‐ | ‐ |
| *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; CTCAE: Common Terminology Criteria for Adverse Events;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 2 levels for imprecision; confidence interval crossed the line of no difference and the assumed threshold of a clinically important difference: wide confidence interval (included both benefit and harm)
2 Downgraded by 1 level for study limitations; high risk of performance and other bias
3 Downgraded by 1 level for imprecision; confidence interval crossed the line of no difference and the assumed threshold of a clinically important difference (included benefit and no benefit)
4 Downgraded by 1 level for study limitations: high risk of other bias
5 Downgraded by 1 level for imprecision; confidence interval crossed the assumed threshold of a clinically important difference (included benefit and little benefit)
6 Health‐related quality of life: no available data