1030P - Evaluation of dose intensification of cytarabine in postremission therapy in older AML patients within the prospective phase II AMLSG 06-04 study

Date 09 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Cancers in Adolescents and Young Adults (AYA)
Haematologic Malignancies
Presenter Lisa Häcker
Citation Annals of Oncology (2017) 28 (suppl_5): v355-v371. 10.1093/annonc/mdx373
Authors L. Häcker1, M. Tassara2, P. Brossart3, G. Held4, H.A. Horst5, M. Ringhoffer6, C. Köhne7, S. Kremers8, A. Raghavachar9, G. Wulf10, H. Kirchen11, D. Nachbaur12, M. Wattad13, A. Benner14, D. Weber1, V.I. Gaidzik1, P. Paschka1, K. Döhner1, H. Döhner1, R. Schlenk15
  • 1Internal Medicine, University Hospital Ulm, 89081 - ulm/DE
  • 2Medical Oncology, San Raffaele Hospital, 20132 - Milan/IT
  • 3Medical Oncology, University Hospital Bonn, 53127 - Bonn/DE
  • 4Medical Oncology, University Hospital Saarland, 66424 - Homburg/DE
  • 5Medical Oncology, University Hospital Kiel, 24105 - Kiel/DE
  • 6Medical Oncology, Klinikum Karlsruhe, 76133 - Karlsruhe/DE
  • 7Medical Oncology, Klinikum Oldenburg, 26133 - Oldenburg/DE
  • 8Medical Oncology, Krankenhaus Lebach, 66882 - Lebach/DE
  • 9Medical Oncology, Klinikum Wuppertal, 42283 - Wuppertal/DE
  • 10Medical Oncology, Universitätsmedizin Göttingen, 37075 - Göttingen/DE
  • 11Medical Oncology, Krankenhaus der Barmherzigen Brüder, 54292 - Trier/DE
  • 12Medical Oncology, University Hospital Innsbruck, 6020 - Innsbruck/AT
  • 13Medical Oncology, Klinikum Essen, 45239 - Essen/DE
  • 14Division Of Biostatistics, German Cancer Research Center, 69120 - Heidelberg/DE
  • 15Nct Trial Center, German Cancer Research Center, 69120 - Heidelberg/DE



Progress in the treatment of acute myeloid leukemia (AML) in older patients (pts) is still limited. In the randomized part of the AMLSG 06-04 trial, valproic acid (VPA) was evaluated in combination with intensive therapy plus all-trans retinoic acid (ATRA) in older pts (>60 years) with newly diagnosed AML. The randomized part of the study (cohort-1) was terminated due to excessive VPA-induced toxicity (Tassara et al, Blood 2014;123:4027-36.). The study was amended thereafter (cohort-2) to evaluate a cytarabine dose-intensifcation in first consolidation therapy. Here we report on the comparison of the two cohorts.


Between 2004 and 2008, patients were treated in cohort-1 (n = 186) and cohort-2 (n = 376). 2 cycles of induction therapy (ATRA, idarubicin, cytarabine, n = 93 with VPA) were followed by consolidation-1 (mitoxantrone, ATRA, cytarabine [cohort-1, 0.5g/m2; cohort-2, 1g/m2] bid, days 1-3) and consoldation-2 (idarubicin, etoposide, ATRA).


Median age was 68 (range, 60-84) years without difference between the cohorts (p = 0.49). Complete remission (CR) rates after induction therapy were 45% and 48% (p = 0.59) in cohort-1 and -2, respectively. There were no significant differences in the cumulative incidences of relapse (CIR, p = 0.26) and death (p = 0.51) between cohort-1 and -2 with CIR of 63% (SE, 4.8%) in cohort-1 compared to 51% (SE, 6.3%) in cohort-2. A Cox regression model on overall survival revealed older age (hazard ratio (HR) for a 10 years difference, 1.97, p 


Although evaluated in a cohort- rather than a randomized study, intensification of cytarabine dosage in consolidation therapy seems to improve survival.

Clinical trial identification


Legal entity responsible for the study

University Hospital Ulm


University Ulm, Pfizer


R. Schlenk: Research funding: Novartis, Pfizer, Amgen, AstraZeneca, PharmaMar; Speakers bureau: Novartis, Pfizer; Advisory board: Daiichi Sankyo, Novartis, Pfizer. All other authors have declared no conflicts of interest.