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3 × 14 mg/m2 Idarubicin during induction: results of a pilot study in children with AML

Leukemia volume 14, pages 340–342 (2000)Cite this article

Idarubicin (IDR) is one of the most effective, but also toxic drugs in the treatment of AML. A finding, which was supported by several trials in adults, comparing induction regimens with daunorubicin (DNR) vs IDR which resulted in higher complete remission (CR) rates in the IDR group.1 The standard dose applied in children and adults is 8–12 mg/m2 during induction. To further improve results we increased the IDR dose from 12 mg/m2 as given in study AML-BFM 93 during induction (AIE = Ara-C, idarubicin, etoposide) to 14 mg/m2 in a pilot study. Seventeen children and adolescents (16 with de novo AML, one with secondary AML) from 11 hospitals (Düsseldorf, Freiburg, Hamburg, Hannover, Homburg/Saar, Münster, Ulm, Tübingen, München, Wien, Jena) were included (pilot group A). Informed consent from the children or parents was obtained. Outcome and toxicities were compared with the other 447 patients of study AML-BFM 93, enrolled until April 1998, who were treated with 12 mg/m2/day × 3 days IDR (group B) or 2 × 30 mg/m2/day × 3 days DNR (group C) during induction. Further treatment consisted of a 6-week consolidation therapy with seven different drugs in standard risk patients (M1/M2 with Auer rods and M4eo and a blast cell reduction on day 15⩽5%, M3 all patients),2 whereas high risk patients (all others) received an additional block high-dose Ara-C plus mitoxantrone (HAM). Then, all patients were treated with one block of high-dose Ara-C plus VP-16, cranial irradiation with 18 Gy (standard dose in children ⩾3 years) and maintenance therapy for a total duration of 18 months.3

Our analysis focused on the evaluation of therapy-induced toxicities, including those occurring after the second and third therapy block in order to gain more knowledge about the influence of induction treatment on later treatment complications. Documentation of toxicity data according to the NCI common toxicity criteria was extended in the patients of the pilot group and in a subset of protocol patients (control group B1 = 32 patients treated with 3 × 12 mg/m2 IDR) and control group C1 (33 patients treated with 6 × 30 mg/m2 DNR).

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Acknowledgements

Study AML-BFM 93 was carried out in Germany (57 hospitals), Austria (11 hospitals) and in eight hospitals in Switzerland. The coordinators of studies AML-BFM 93 were: J Ritter, U Creutzig, J Hermann, H Gadner, Universitäts-Kinderklinik, Münster, Jena and St Anna Kinderspital, Wien.

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Authors and Affiliations

  1. Münster

    U Creutzig, J Ritter & M Zimmermann

  2. Leipzig

    D Körholz

  3. Freiburg

    CM Niemeyer

  4. Hamburg

    K Kabisch

  5. Homburg-Saar

    N Graf

  6. Giessen

    A Reiter

  7. Tübingen

    H Scheel-Walter

  8. München

    Ch Bender-Götze

  9. Ulm

    W Behnisch

  10. Jena

    J Hermann

  11. Wien

    G Mann

Authors
  1. U Creutzig
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  2. D Körholz
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  3. CM Niemeyer
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  4. K Kabisch
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  5. N Graf
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  6. A Reiter
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  7. H Scheel-Walter
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  9. W Behnisch
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  11. G Mann
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  12. J Ritter
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  13. M Zimmermann
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Creutzig, U., Körholz, D., Niemeyer, C. et al. 3 × 14 mg/m2 Idarubicin during induction: results of a pilot study in children with AML. Leukemia 14, 340–342 (2000). https://doi.org/10.1038/sj.leu.2401670

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  • DOI: https://doi.org/10.1038/sj.leu.2401670

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