No Survival Gain From High-Dose Cytarabine Consolidation in AML

M. Alexander Otto, PA, MMS

June 23, 2022

The study was published on as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Regarding consolidation therapy for younger patients with acute myeloid leukemia (AML), there was no survival benefit from taking high-dose vs intermediate-dose cytarabine.

Why This Matters

  • Numerous trials comparing high and intermediate doses for consolidation have not shown an advantage for cytarabine doses above 1000 mg/m2 twice daily.

  • However, the induction protocols in the trials often differed; in some trials, higher doses of cytarabine were used during induction, or multiagent protocols were used in consolidation, which may have confounded the results.

  • The current study used real-world data from the German Study Alliance Leukemia–Acute Myeloid Leukemia registry to compare high- and intermediate-dose cytarabine after uniform 7 + 3 induction treatment among all patients, including patients outside of clinical trials.

  • The findings bolster recommendations for intermediate dosing in consolidation chemotherapy.

Study Design

  • The retrospective analysis included patients younger than 65 years who were registered from 2005 to 2020. The patients achieved complete remission after intensive induction and received at least one consolidation cycle with intermediate- or high-dose cytarabine.

  • The intermediate-dose group included 178 patients treated with approximately 6 g/m2 cytarabine per cycle, corresponding to six applications of 1 g/m² cytarabine, and received treatment for a median of two cycles.

  • The 642 patients in the high-dose arm received approximately 18 g/m² cytarabine per cycle, corresponding to six applications at 3 g/m². These patients were treated for a median of three cycles.

  • To account for differences in patient and disease characteristics between the groups, the average treatment effect was estimated by propensity score weighting.

Key Results

  • Relapse-free survival after 2 years was essentially the same for the high-dose group (55.3%) and the intermediate-dose group (55.6%).

  • No significant differences in overall survival were observed after 2 years — 84.7% in the high-dose group, vs 80.6% in the intermediate-dose group.

  • Censoring for allogeneic hematopoietic cell transplantation in first remission also revealed no significant survival differences between the high- and intermediate-dose groups.

  • Significantly more infectious complications occurred in the high-dose group, but there were no other significant differences in tolerability.

  • There was a nonsignificant trend for superior relapse-free survival among European LeukemiaNet favorable-risk patients who received the high dose, but there was no difference in overall survival.


  • There were no data on minimal residual disease levels after induction, so the authors couldn't parse whether the high dose has a benefit for patients with higher residual disease burdens.

  • The study included patients from over 15 years ago.


  • No funding source was reported. One investigator has received research support from Novartis, BMS, Pfizer, and Incyte.

This is a summary of a preprint research study, "Intensified Cytarabine Dose During Consolidation in AML Patients Under 65 Years Is Not Associated With Survival Benefit: Real-world Data From the German SAL-AML Registry," led by Maher Hanoun of Essen University Hospital, Germany. The study has not been peer reviewed. The full text can be found at

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who has worked for several major news outlets before joining Medscape and also an MIT Knight Science Journalism fellow. Email:

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