Summary of findings 2.
| Anti‐leukaemic therapy with monoclonal anti‐CD20 compared with anti‐leukaemic therapy without monoclonal anti‐CD20 antibody (anti‐leukaemic therapy not identical in both groups) for newly diagnosed or relapsed patients with CLL | ||||||
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Patient or population: newly diagnosed or relapsed patients with CLL Intervention: anti‐leukaemic therapy plus monoclonal anti‐CD20 antibody Comparison: anti‐leukaemic therapy alone (anti‐leukaemic therapy not identical in both groups) | ||||||
| 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‐leukaemic therapy alone | Anti‐leukaemic therapy plus monoclonal anti‐CD20 antibody | |||||
| OS not reported | Study population | |||||
| See comment | See comment | Not estimable | 0 | See comment | Neither study provided data on OS | |
| PFS not reported | See comment | See comment | Not estimable | 0 | See comment | Neither study provided data on PFS |
| Time to next treatment | See comment | See comment | Not estimable | 0 | See comment | Neither study provided data on time to next treatment |
| CRR | Study population | RR 1.18 (0.93 to 1.49) | 170 (2) | ⊕⊕⊕⊝ moderate1 | ||
| 566 per 1000 | 668 per 1000 (527 to 844) |
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| TRM | Study population | RR 0.31 (0.06 to 1.51) | 177 (2) | ⊕⊕⊝⊝ low1,2 | ||
| 58 per 1000 | 18 per 1000 (3 to 88) |
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| *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; CRR: complete response rate; OS: overall survival; PFS: progression‐free survival; 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 One trial stopped prematurely owing to an excess of mortality in the alemtuzumab arm.
2 The trials included a few events for this outcome and thus have wide confidence intervals.