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

Feng 2010.

Methods Design:
  • RCT with three arms: IDA versus DNR versus MIT


Recruitment period:
  • January 2000 to December 2009


Median follow‐up:
  • not stated

Participants Eligibility criteria:
  • >18 years

  • newly diagnosed non‐M3‐AML


Patients randomised (n = 105):
  • IDA arm: n = 35

  • DNR arm: n = 36

  • MIT arm: n = 34


Mean age:
  • IDA arm: 47 years (range: 18 to 70 years)

  • DNR arm: 47 years (range: 18 to 69 years)

  • MIT arm: 47 years (range: 19 to 71 years)


Gender (male, female):
  • IDA arm: n = 19, n = 16

  • DNR arm: n = 21, n = 15

  • MIT arm: n = 18, n = 16


Country:
  • China, single centre

Interventions IDA arm: IA regimen, 2 cycles
  • IDA: 8 to 10 mg/m²/d, days 1 to 3, IV

  • Ara‐C: 100 to 150 mg/m²/d, days 1 to 7, IV


DNR arm: DA regimen, 2 cycles
  • DNR: 40 to 50 mg/m²/d, days 1 to 3, IV

  • Ara‐C: 100 to 150 mg/m²/d, days 1 to 7, IV


MIT arm: MA regimen, 2 cycles
  • MIT: 8 to 12 mg/m²/d, days 1 to 3, IV

  • Ara‐C: 100 to 150 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 a journal article in Chinese
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 randomly assigned 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 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