Skip to main content
. 2014 Sep 4;2014(9):CD006647. doi: 10.1002/14651858.CD006647.pub4

Van der Does 1989.

Methods Randomisation by the DCLSG Central Office (patients were stratified by institution and sex)
Participants 240 children (age 0 to 15 years; 119 boys and 121 girls) with standard risk acute lymphocytic leukaemia (nm if primary disease or relapse)
Prior treatment nm
Prior cardiac dysfunction nm
Interventions Chemotherapy without daunorubicin (N = 122) versus chemotherapy including daunorubicin (N = 118)
Cumulative daunorubicin dose nm (according to protocol 100 mg/m2); peak dose (i.e. the maximal dose received in one week) 25 mg/m2; infusion duration nm.
Patients achieving complete remission within 6 weeks of the start of induction chemotherapy underwent cranial irradiation (dose adjusted to age) in combination with intrathecal methotrexate and prednisone
No surgery
No cardioprotective interventions
Outcomes Overall survival (defined as time from diagnosis to time of death)
Event‐free survival (defined as time from diagnosis to induction failure, relapse, death in remission, or the occurrence of a second tumour)
Tumour response (complete remission defined as < 5% blast cells and normal hematopoiesis in the bone marrow without evidence of disease at any other site)
Notes Median follow‐up for all patients 64 months (range 34 to 87 months)
Age in treatment group ranged from 0 to 15 years; age in the control group ranged from 1 to 15 years
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk It was stated that randomisation was peformed by the DCLSG Central Office, but no further information on the methods of randomization was provided
Allocation concealment (selection bias) Low risk Randomisation was performed by the DCLSG Central Office
Blinding of participants and personnel (performance bias) Unclear risk No information on blinding of participants and personnel was provided
Blinding of outcome assessment (detection bias): overall survival Low risk No information on blinding of outcome assessors was provided, but since this is not applicable for overall survival we judged this as a low risk of bias
Blinding of outcome assessment (detection bias): outcomes other than overall survival Unclear risk No information on blinding of outcome assessors was provided for event‐free survival and tumour response
Incomplete outcome data (attrition bias): overall survival Low risk All patients were included in the analyses
Incomplete outcome data (attrition bias): event‐free survival Low risk All patients were included in the analyses
Incomplete outcome data (attrition bias): tumour response Low risk All patients were included in the analyses
Selective reporting (reporting bias) High risk There was no protocol mentioned in the manuscript (and we did not search for it), but not all expected outcomes were reported
Other bias Unclear risk Block randomisation in unblinded trials: unclear (see information provided at earlier associated risk of bias items)
Baseline imbalance between treatment arms related to outcome (prior cardiotoxic treatment, age, sex and/or prior cardiac dysfunction): unclear (age and sex were balanced between treatment arms; this was unclear for prior cardiotoxic treatment and prior cardiac dysfunction)
Difference in length of follow‐up between treatment arms: unclear (not reported)
Inappropriate influence of funders: unclear (no information provided)

nm: not mentioned; DCLSG: Dutch Childhood Leukemia Study Group; CNS: central nervous system; FH: favourable histology; UH: unfavourable histology; FAB: French‐American‐British