Title
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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)
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Author
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Abstract
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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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Language
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English
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Source (journal)
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Leukemia. - Baltimore, Md, 1987, currens
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Source (book)
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Workshop on the Clinical Results with Decitabine, (5-aza-2'-deoxycytidine) in Hematologic Malignancies, MAY 30, 1996, PARIS, FRANCE
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Publication
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Baltimore, Md
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1997
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ISSN
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0887-6924
[print]
1476-5551
[online]
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Volume/pages
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11
:s:[1]
(1997)
, p. S24-S27
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ISI
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A1997WY97700006
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