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. 2015 Jun 3;2015(6):CD010432. doi: 10.1002/14651858.CD010432.pub2

Reiffers 1996.

Methods Design:

  • RCT with two arms: IDA versus DNR


Recruitment period:

  • April 1987 to February 1991


Median follow‐up:

  • not stated
Participants Eligibility criteria:
Inclusion criteria:

  • 55 to 75 years

  • untreated de novo AML defined by FAB criteria

  • normal cardiac with left ventricular ejection fraction > 50%, unimpaired renal and liver functions


Exclusion criteria:

  • have myeloproliferative syndromes prior to diagnosis of AML

  • have MDS diagnosed on blood/marrow abnormalities

  • ECOG PS 3 or 4


Patients randomised (n = 220)

  • IDA arm: n = 112

  • DNR arm: n = 108


Median age:

  • IDA arm: not stated

  • DNR arm: not stated


Gender (male, female):

  • IDA arm: n = 58, n = 54

  • DNR arm: n = 58, n = 50


Country:

  • France, 6 centres
Interventions IDA arm: IA regimen, 1 to 2 cycles

  • IDA: 8 mg/m²/d for 5 days, IV

  • Ara‐C: 100 mg/m²/d for 7 days, IV


DNR arm: DA regimen, 1 to 2 cycles

  • DNR: 50 mg/m²/d for 3 days, IV

  • Ara‐C: 100 mg/m²/d for 7 days, IV
Outcomes Outcomes and time‐points from the study that are considered in the review:

  • reported: OS, DFS, CR, death on induction therapy, relapse, AEs

  • not reported: quality of life
Notes Published as a journal article
Funding: not stated
No conflict of interest statement
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomized to"
Comment: the study probably had an adequate sequence generation
Allocation concealment (selection bias) Unclear risk No information provided
Blinding (performance bias and detection bias) 
 Overall survival Low risk Comment: the review authors judge that the outcome OS is unlikely to be influenced by lack of blinding
Blinding (performance bias and detection bias) 
 All other outcomes High risk Comment: blinding was not explicitly stated
Incomplete outcome data (attrition bias) 
 OS and DFS Low risk Comment: all randomised patients were included in the analyses
Selective reporting (reporting bias) Unclear risk Comment: the study has no registered study protocol. The review authors have no information to permit judgement
Other bias Unclear risk No information provided