A randomized phase II study on the effects of 5-Aza-2'-deoxycytidine combined with either amsacrine or idarubicin in patients with relapsed acute leukemia: an EORTC Leukemia Cooperative Group phase II study (06893)

5-Aza-2′-deoxycytidine combined with either amsacrine or idarubicin has been applied in a treatment protocol for patients with a relapse of acute myeloid or lymphocytic leukemia. Sixty-three patients received 5-Aza-2′-deoxycytidine 125 mg/m² as a 6 h infusion every 12 h for 6 days in combination wit...

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Main Authors: Willemzen, Rein (Author) , Suciu, S. (Author) , Archimbaud, E. (Author) , Muus, P. (Author) , Stryckmans, P. (Author) , Louwagie, E. A. (Author) , Berneman, Z. (Author) , Tjean, M. (Author) , Wijermans, P. (Author) , Döhner, Hartmut (Author) , Jehn, U. (Author) , Labar, B. (Author) , Jaksic, B. (Author) , Dardenne, M. (Author) , Zittoun, R. (Author)
Format: Article (Journal)
Language:English
Published: 1997
In: Leukemia
Year: 1997, Volume: 11, Pages: S24-S27
ISSN:1476-5551
Online Access:Verlag, lizenzpflichtig, Volltext: http://www.redi-bw.de/db/ebsco.php/search.ebscohost.com/login.aspx%3fdirect%3dtrue%26db%3da9h%26AN%3d23255536%26site%3dehost-live
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Author Notes:R. Willemze, S. Suciu, E. Archimbaud, P. Muus, P. Stryckmans, E.A. Louwagie, Z. Berneman, M. Tjean, P. Wijermans, H. Dohner, U. Jehn, B. Labar, B. Jaksic, M. Dardenne, R. Zittoun

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520 |a 5-Aza-2′-deoxycytidine combined with either amsacrine or idarubicin has been applied in a treatment protocol for patients with a relapse of acute myeloid or lymphocytic leukemia. Sixty-three patients received 5-Aza-2′-deoxycytidine 125 mg/m² as a 6 h infusion every 12 h for 6 days in combination with either amsacrine 120 mg/m² as a 1 h infusion on days 6 and 7 (n = 30) or idarubicin 12 mg/m² as a 15 mm infusion on days 5, 6 and 7 (n = 33). Twenty-three patients (36.5%) obtained a complete remission (CR); eight of 30 patients treated with amsacrine and 15 of 33 treated with idarubicin. Patients with an interval of more than 1 year between initial diagnosis and start of the protocol achieved CR in 51.4%, compared to 15.4% for patients with an interval of less than 1 year. Patients with normal cytogenetics had a higher CR rate (61%) than those with abnormal cytogenetic findings (15.8%). Digestive tract and hematologic toxicity was prolonged, compared to standard induction schedules. Median disease-free survival was approximately 8 months, with only 20% of patients staying in remission for more than 1 year. 5-Aza-2′-deoxycytidine is a good antileukernic agent with considerable toxicity. Current results merit further investigations in previously untreated leukemia. 
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