Summary of findings for the main comparison. Anti‐leukaemic therapy plus alemtuzumab versus anti‐leukaemic therapy alone (anti‐leukaemic therapy identical in both groups; unconfounded) for chronic lymphocytic leukaemia.
| Anti‐leukaemic therapy plus alemtuzumab versus anti‐leukaemic therapy alone (anti‐leukaemic therapy identical in both groups; unconfounded) for chronic lymphocytic leukaemia | ||||||
| Patient or population: patients with chronic lymphocytic leukaemia Settings: Intervention: Anti‐leukaemic therapy plus alemtuzumab versus anti‐leukaemic therapy alone (anti‐leukaemic therapy identical in both groups; unconfounded) | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | Anti‐leukaemic therapy plus alemtuzumab versus anti‐leukaemic therapy alone (anti‐leukaemic therapy identical in both groups; unconfounded) | |||||
|
Overall survival (median 2 years) |
Moderate risk | HR 0.65 (0.45 to 0.94) | 335 (1 study) | ⊕⊕⊕⊝ moderate1 | ||
| 250 per 1000 |
171 per 1000 (121 to 237) |
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| Progression free survival (median 2 years) | Moderate risk | HR 0.61 (0.47 to 0.81) | 356 (2 studies) | ⊕⊕⊝⊝ low2,3 | ||
| 500 per 1000 |
345 per 1000 (278 to 430) |
|||||
| Treatment related mortality | Study population | RR 0.57 (0.17 to 1.9) | 356 (2 studies) | ⊕⊕⊕⊝ moderate2 | ||
| 40 per 1000 | 23 per 1000 (7 to 75) | |||||
| Cytomegalovirus reactivation | Study population | RR 10.52 (1.42 to 77.68) | 350 (2 studies) | ⊕⊕⊕⊕ high2,4 | ||
| 10 per 1000 |
105 per 1000 (14 to 777) |
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| Complete response rate | Study population | RR 2.61 (1.26 to 5.42) | 356 (2 studies) | ⊕⊕⊝⊝ low2,3 | ||
| 51 per 1000 | 133 per 1000 (64 to 276) | |||||
| Infections (all grades) | Study population | RR 1.32 (1.01 to 1.74) | 356 (2 studies) | ⊕⊕⊝⊝ low2,3 | ||
| 331 per 1000 | 437 per 1000 (335 to 577) | |||||
| Serious adverse events | Study population | RR 1.34 (0.95 to 1.89) | 350 (2 studies) | ⊕⊕⊕⊝ moderate2 | ||
| 234 per 1000 | 314 per 1000 (223 to 443) | |||||
| *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; RR: Risk ratio; HR: Hazard 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. | ||||||
1One trial only
2 One trial stopped early due to high incidence of CMV reactivation in alemtuzumab arm; two of 23 patients randomised refused initiation of study treatment after randomisation and were excluded from analysis (no ITT analysis) 3 Heterogeneity between trials
4 Large effect