for the main comparison.
IDA compared with DNR in induction therapy of patients with newly diagnosed AML | ||||||
Patient or population: patients with newly diagnosed AML Settings: inpatients Intervention: IDA Comparison: DNR | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
DNR | IDA | |||||
Mortality at 2 years | Group with moderate risk1 | HR 0.90 (0.84 to 0.96) | 5976 (12 studies) | ⊕⊕⊕⊕ high | OS is calculated accordingly as mortality | |
698 per 1000 | 660 per 1000 (634 to 683) | |||||
Mortality/relapse at 2 years | Group with moderate risk2 | HR 0.88 (0.81 to 0.96) | 3070 (8 studies) | ⊕⊕⊕⊝ moderate3 | DFS is calculated accordingly as mortality or relapse | |
760 per 1000 | 715 per 1000 (685 to 746) | |||||
Complete remission | Study population | RR 1.04 (1.01 to 1.07) | 6692 (18 studies) | ⊕⊕⊕⊝ moderate3 | ||
698 per 1000 | 725 per 1000 (705 to 746) | |||||
Death on induction therapy | Study population | RR 1.18 (1.01 to 1.36) | 6349 (14 studies) | ⊕⊕⊕⊝ moderate3 | ||
90 per 1000 | 106 per 1000 (90 to 122) | |||||
Relapse | Study population | RR 0.88 (0.80 to 0.98) | 1091 (4 studies) | ⊕⊕⊕⊝ moderate3 | ||
550 per 1000 | 484 per 1000 (440 to 539) | |||||
Grade 3/4 cardiotoxicity | Study population | RR 0.98 (0.70 to 1.37) | 2795 (6 studies) | ⊕⊕⊕⊝ moderate3 | ||
46 per 1000 | 45 per 1000 (32 to 63) | |||||
Quality of life not reported |
Study population | Not estimable | 0 | See comment | No studies provided data on quality of life | |
See comment | See comment | |||||
*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; DFS: disease‐free survival; DNR: daunorubicin; HR: hazard ratio; IDA: idarubicin; OS: overall 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 The risk for the group with moderate risk was taken from the study with the moderate rate of mortality at two years (Pautas 2010)
2 The risk for the group with moderate risk was taken from the study with the moderate rate of mortality or relapse at seven years (Mandelli 1991)
3Lack of blinding (subjective outcomes are highly susceptible to biased assessment)