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Randomized Controlled Trial
. 2014 Jun 26;123(26):4027-36.
doi: 10.1182/blood-2013-12-546283. Epub 2014 May 5.

Valproic acid in combination with all-trans retinoic acid and intensive therapy for acute myeloid leukemia in older patients

Michela Tassara  1 , Konstanze Döhner  2 , Peter Brossart  3 , Gerhard Held  4 , Katharina Götze  5 , Heinz-A Horst  6 , Mark Ringhoffer  7 , Claus-Henning Köhne  8 , Stephan Kremers  9 , Aruna Raghavachar  10 , Gerald Wulf  11 , Heinz Kirchen  12 , David Nachbaur  13 , Hans Günter Derigs  14 , Mohammed Wattad  15 , Elisabeth Koller  16 , Wolfram Brugger  17 , Axel Matzdorff  18 , Richard Greil  19 , Gerhard Heil  20 , Peter Paschka  2 , Verena I Gaidzik  2 , Martin Göttlicher  21 , Hartmut Döhner  2 , Richard F Schlenk  2
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Free article
Randomized Controlled Trial

Valproic acid in combination with all-trans retinoic acid and intensive therapy for acute myeloid leukemia in older patients

Michela Tassara et al. Blood. .
Free article

Erratum in

  • Blood. 2015 May 7;125(19):3037

Abstract

The outcome of patients with acute myeloid leukemia who are older than 60 years has remained poor because of unfavorable disease characteristics and patient-related factors. The randomized German-Austrian AML Study Group 06-04 protocol was designed on the basis of in vitro synergistic effects of valproic acid (VPA) and all-trans retinoic acid with chemotherapy. Between 2004 and 2006, 186 patients were randomly assigned to receive 2 induction cycles with idarubicin, cytarabine, and all-trans retinoic acid either with VPA or without (STANDARD). In all patients, consolidation therapy was intended. Complete remission rates after induction tended to be lower in VPA compared with STANDARD (40% vs 52%; P = .14) as a result of a higher early death rate (26% vs 14%; P = .06). The main toxicities attributed to VPA were delayed hematologic recovery and grade 3/4 infections, observed predominantly during the second induction cycle. After restricting VPA to the first induction cycle and reducing the dose of idarubicin, these toxicities dropped to rates observed in STANDARD. After a median follow-up time of 84 months, event-free and overall survival were not different between the 2 groups (P = .95 and P = .57, respectively). However, relapse-free-survival was significantly superior in VPA compared with STANDARD (24.4% vs 6.4% at 5 years; P = .02). Explorative subset analyses revealed that AML with mutated Nucleophosmin 1 (NPM1) may particularly benefit from VPA. This trial was registered at www.clinicaltrials.gov as #NCT00151255.

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