Summary of findings 4. Anti‐CTLA4 monoclonal antibodies with versus without anti‐PD1 monoclonal antibodies.
| Anti‐CTLA4 plus anti‐PD1 monoclonal antibodies compared with anti‐CTLA4 monoclonal antibodies for the treatment of metastatic melanoma | ||||||
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Patient or population: people with cutaneous melanoma Settings: hospital (metastatic disease) Intervention: Anti‐CTLA4 plus Anti‐PD1 monoclonal antibodies (combo) Comparison: Anti‐CTLA4 monoclonal antibodies | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Anti‐CTLA4 | Combo | |||||
| Overall survival | See comment | See comment | See comment | See comment | See comment | Outcome not measured |
| Progression‐free survival† | 750 per 1000† | 425 per 1000† (375 to 478) |
HR 0.40 (0.35 to 0.46) |
N = 738 (n = 2) | ⊕⊕⊕⊕ higha | ‐ |
| Tumour response | 182 per 1000 | 636 per 1000 (376 to 1073) | RR 3.50 (2.07 to 5.92) | N = 738 (n = 2) | ⊕⊕⊕⊕ higha | ‐ |
| Toxicity (≥ G3) | 521 per 1000 | 818 per 1000 (442 to 1521) | RR 1.57 (0.85 to 2.92) | N = 764 (n = 2) | ⊕⊕⊝⊝ lowb | ‐ |
| * 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). † Numbers presented refer to event rates (i.e. progression rates). CI: confidence interval | ||||||
| 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. | ||||||
Assumed risk in the control population: 1‐year progression‐free survival rate = 25%.
Assumed risk in the control population: tumour response rate across control arms of included trials.
Assumed risk in the control population: toxicity rate across control arms of included trials.
a Not downgraded: high‐quality evidence.
b Downgraded by two levels: inconsistency (between‐study heterogeneity) and imprecision (CI includes both a meaningful harm (relative risk increase > 25%) and a beneficial effect)