Escherich 2007.
| Study characteristics | ||
| Methods | Method of randomisation not clear (stratified according to white blood cell count < 25/nl or >= 25/nl) | |
| Participants | 178 children (of which 101 children were evaluable; these evaluable children were aged 1.1 to 17.9 years; 60 boys and 41 girls) with low‐ or high‐risk B‐precursor ALL or T‐ALL treated with a multidrug regimen including daunorubicin. No prior anthracycline therapy; no prior cardiac radiotherapy; prior cardiac dysfunction nm. | |
| Interventions | Daunorubicin (peak dose 36 mg/m2) on day 1 with either bolus (1 hour) infusion (N = 85; cumulative anthracycline dose 36 mg/m2 on day 7; see notes) or continuous (24 hours) infusion (N = 93; cumulative anthracycline dose 36 mg/m2 on day 7; see notes) | |
| Outcomes | Heart failure (i.e. clinical heart failure defined as clinical signs of cardiac insufficiency; subclinical heart failure defined as LVSF < 25%) Response rate (i.e. good response defined as an absolute blast cell count < 1000/µl at day 7) |
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| Notes | Only 101 of the 178 children were evaluable for in‐vivo cell kill; the other 77 children (42 in the 1‐hour infusion group and 35 in the 24‐hours infusion group) had incomplete data or insufficient smears. However, we performed an intention‐to‐treat analysis. After the first daunorubicin administration, all children received additional daunorubicin with an infusion duration of 1 hour. Therefore, only data for the first 7 days are eligible for this review. Length of follow‐up 7 days. The study was supported in part by Fördergemeinschaft Kinderkrebszentrum Hamburg e.V. and Elterninitiative Kinderkrebsklinik Düsseldorf e.V., but no information on the influence of funders was provided. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | It was stated that this was a randomised study, but no further information on the methods of randomisation was provided |
| Allocation concealment (selection bias) | Unclear risk | It was stated that this was a randomised study, but no further information on the methods of randomisation was provided |
| Blinding of participants and personnel (performance bias) | Unclear risk | No information on blinding of participants and personnel was provided, although due to the nature of the interventions, this was most likely not the case |
| Blinding of outcome assessment (detection bias): clinical heart failure | Unclear risk | No information on blinding of outcome assessors was provided for clinical heart failure |
| Blinding of outcome assessment (detection bias): subclinical heart failure (dichotomous and/or continuous) | Unclear risk | No information on blinding of outcome assessors was provided for subclinical heart failure |
| Blinding of outcome assessment (detection bias): tumour response | Unclear risk | No information on blinding of outcome assessors was provided for tumour response |
| Incomplete outcome data (attrition bias): clinical heart failure | High risk | 43% of children lost to follow‐up |
| Incomplete outcome data (attrition bias): subclinical heart failure (dichotomous and/or continuous) | High risk | 43% of children lost to follow‐up |
| Incomplete outcome data (attrition bias): tumour response | High risk | 43% of children lost to follow‐up |
| Selective reporting (reporting bias) | High risk | There was no reference to a protocol provided in the manuscript (and we did not search for it), but not all expected outcomes were reported in a useful manner |
| Other bias | Unclear risk |
Baseline imbalance between treatment arms related to outcome (prior cardiotoxic treatment, age, sex, and/or prior cardiac dysfunction): unclear (unclear if prior cardiac dysfunction was balanced between treatment groups; the other items were balanced between treatment groups) Difference in length of follow‐up between treatment arms: no |