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

Intragumtornchai 1999.

Methods Design:

  • RCT with two arms: IDA versus DOX


Recruitment period:

  • not stated


Median follow‐up:

  • not stated
Participants Eligibility criteria:

  • 15 to 60 years

  • newly diagnosed non‐M3‐AML


Patients randomised (n = 107)

  • IDA arm: n = 54

  • DOX arm: n = 53


Median age:

  • IDA arm: not stated

  • DOX arm: not stated


Gender (male, female):

  • IDA arm: not stated

  • DOX arm: not stated


Country:

  • not stated
Interventions IDA arm: IA regimen, 1 cycle

  • IDA: 12 mg/m²/d, days 1 to 3, IV

  • Ara‐C: 100 mg/m²/d, days 1 to 7, IV


DOX arm: DA regimen, 1 cycle

  • DOX: 30 mg/m²/d, days 1 to 3, IV

  • Ara‐C: 100 mg/m²/d, days 1 to 7, IV
Outcomes Outcomes and time‐points from the study that are considered in the review:

  • reported: CR

  • not reported: OS, DFS, death on induction therapy, relapse, AEs, quality of life
Notes Published as an abstract
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 assigned randomly 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 Unclear risk Not reported
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 High risk Quote: "Fifty‐four patients were assigned to receive IDR and 53 to DXR. Three patients in the DXR arm were excluded (2. AML, M3, I, ALL). Bone marrow examination was not available in 17 patients ( 8 in IDR and 9 in DXR arm) which were due to death from uncontrolled infection at time of severe granulocytopenia (6, IDR; 6, DXR), stroke on day 13 (1, DXR), hyperleukocytosis on day 2 (1, IDR)and loss to follow‐up (1, IDR; 2, DXR)"
Comment: Outcome data in 20 patients (19%) were not available. The review authors judge that this proportion of missing data will be highly possible to induce bias
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