Title
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) 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)
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Baltimore, Md ,
Subject
Human medicine
Source (journal)
Leukemia. - Baltimore, Md, 1987, currens
Source (book)
Workshop on the Clinical Results with Decitabine, (5-aza-2'-deoxycytidine) in Hematologic Malignancies, MAY 30, 1996, PARIS, FRANCE
Volume/pages
11(1997) :s:[1] , p. S24-S27
ISSN
0887-6924
1476-5551
ISI
A1997WY97700006
Carrier
E
Target language
English (eng)
Affiliation
University of Antwerp
Abstract
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/m(2) as a 6 h infusion every 12 h for 6 days in combination with either amsacrine 120 mg/m(2) as a 1 h infusion on days 6 and 7 (n = 30) or idarubicin 12 mg/m(2) as a 15 min 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 antileukemic agent with considerable toxicity. Current results merit further investigations in previously untreated leukemia.
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