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- Title
Addition of cladribine to daunorubicin and cytarabine increases complete remission rate after a single course of induction treatment in acute myeloid leukemia. Multicenter, phase III study.
- Authors
Holowiecki, J; Grosicki, S; Robak, T; Kyrcz-Krzemien, S; Giebel, S; Hellmann, A; Skotnicki, A; Jedrzejczak, W W; Konopka, L; Kuliczkowski, K; Zdziarska, B; Dmoszynska, A; Marianska, B; Pluta, A; Zawilska, K; Komarnicki, M; Kloczko, J; Sulek, K; Haus, O; Stella-Holowiecka, B; Baran, W; Jakubas, B; Paluszewska, M; Wierzbowska, A; Kielbinski, M; Jagoda, K; Polish Adult Leukemia Group (PALG)
- Abstract
To assess the efficacy of an original DAC-7 regimen: daunorubicine (DNR) 60 mg/m2/day, days 1-3; cytarabine (AraC) 200 mg/m2/day, days 1-7; cladribine (2-CdA) 5 mg/m2/day, days 1-5, 400 untreated adult acute myeloid leukemia patients (including 63 with preceding myelodysplastic syndrome), aged 45 (16-60) years were randomized to either DAC-7 (n=200) or DA-7 (without 2-CdA, n=200). The overall CR rate equaled 72% for DAC-7 and 69% for DA-7 arm (P=NS). After a single course of DAC-7 induction, the CR rate equaled 64% and was significantly higher compared to 47% in the DA-7 arm (P=0.0009). Median hospitalization time during the induction was 7 days shorter for DAC-7 compared to the DA-7 group (33 vs 40 days, P=0.002). Toxicity was comparable in both groups. The probability of 3-year leukemia-free survival (LFS) for DAC-7 and DA-7 group equaled 43 and 34%, respectively (P=NS). There was a trend toward higher LFS rate for patients aged >40 years receiving DAC-7 compared with DA-7 regimen (44 vs 28%, P=0.05). This study proves that addition of 2-CdA increases antileukemic potency of DNR+AraC regimen, thus resulting in a higher CR rate after one induction cycle when compared to DA-7, without additional toxicity. It shortens hospitalization time and may improve long-term survival in patients aged >40 years.
- Publication
Leukemia, 2004, Vol 18, Issue 5, p989
- ISSN
0887-6924
- Publication type
Journal Article
- DOI
10.1038/sj.leu.2403336