Summary of findings 8. Sunitinib compared to atezolizumab + bevacizumab (targeted agent versus immunotherapy + targeted agent).
Patient or population: Treatment‐naïve metastatic renal cell carcinoma (clear cell type) Setting: Multinational muticentre/likely outpatient Intervention: Sunitinib Comparison: Atezolizumab + Bevacizumab | |||||
Outcomes | № of participants (studies) | Certainty of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects* (95% CI) | |
Risk with Atezolizumab + Bevacizumab | Risk difference with Sunitinib | ||||
Progression‐free survival
(absolute effect size estimates based on survival rate at 12 months) follow‐up: range 15 months to 20.7 months |
1117 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | HR 1.18 (1.02 to 1.36) | Study population | |
480 per 1000 | 59 fewer per 1000 (111 fewer to 7 fewer) | ||||
Overall survival
(absolute effect size estimates based on survival rate at 24 months) follow‐up: range 20.7 months to 24 months |
1117 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 3 | HR 0.99 (0.73 to 1.33) | Study population | |
630 per 1000 | 3 more per 1000 (89 fewer to 84 more) | ||||
Serious adverse events (Grade 3 or 4) assessed with: CTCAE v4.0 | 1098 (2 RCTs) | ⊕⊝⊝⊝ VERY LOW 2 4 5 | RR 1.22 (1.00 to 1.49) | Study population | |
446 per 1000 | 98 more per 1000 (0 fewer to 218 more) | ||||
Health‐related quality of life assessed with: MDASI (high score indicates worse QoL) Scale from: 0 to 10 follow‐up: 12 weeks | 691 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 2 | ‐ | The mean health‐related quality of life ranged from 0.56 to 1.57 | MD 1 higher (0.68 higher to 1.32 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; CTCAE: Common Terminology Criteria for Adverse Events;HR: Hazard ratio; MDASI: MD Anderson Symptom Inventory; 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 imprecision; confidence interval crossed the assumed threshold of a clinically important difference (included harm and little harm)
2 Downgraded by 1 level for study limitations; high and unclear risk of 1 or more domains.
3 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)
4 Downgraded by 1 level for inconsistency; moderate to substantial heterogeneity: unexplained differences between study results
5 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 harm and no harm)