Safety and clinical activity of 5-aza-2'-deoxycytidine (decitabine) with or without Hyper-CVAD in relapsed/refractory acute lymphocytic leukaemia.
Safety and clinical activity of 5-aza-2'-deoxycytidine (decitabine) with or without Hyper-CVAD in relapsed/refractory acute lymphocytic leukaemia.
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在复发/难治性急性淋巴细胞性白血病中，有或没有超vad的5-aza-2'-脱氧胞苷（去替替啶）的安全性和临床活性。
DOI：
10.1111/bjh.13050
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发表时间：
2014-11
影响因子：
6.5
通讯作者：
Garcia-Manero G
中科院分区：
文献类型：
--
作者：
Benton CB;Thomas DA;Yang H;Ravandi F;Rytting M;O'Brien S;Franklin AR;Borthakur G;Dara S;Kwari M;Pierce SR;Jabbour E;Kantarjian H;Garcia-Manero G
为验证5-氮-2‘-脱氧胞苷(地西他滨)治疗复发性/难治性急性淋巴细胞白血病(ALL)的安全性和有效性，我们进行了一项为期两个阶段的研究：单用地西他滨或联合高CVAD(分次环磷酰胺、长春新碱、阿霉素、地塞米松与大剂量甲氨蝶呤和阿糖胞苷交替使用)。患者按顺序参与研究的任何一个部分或两个部分。起始期给予地西他滨10~120 mg/m2/d，隔周1次，共5天，28天为一周期。在联合部分，患者在Hyper-CVAD的前5天静脉滴注地西他滨5~60 mg/m2/d。共有39名患者在研究中接受治疗：14名患者仅接受第一部分治疗，16名患者连续接受两部分治疗，9名患者仅接受第二部分治疗。地西他滨在所有剂量下都是耐受的，3级或4级毒性反应包括非危及生命的肝毒性和高血糖。当地西他滨剂量达到80 mg/m2时，可以观察到DNA低甲基化的诱导。一些以前单独服用Hyper-CVAD的患者在加入地西他滨后完全缓解。地西他滨单独或与Hyper-CVAD联合使用是安全的，对晚期ALL患者具有临床活性。
To test the safety and activity of 5-aza-2’-deoxycytidine (decitabine) in patients with relapsed/refractory acute lymphocytic leukaemia (ALL), we conducted a phase 1 study with two parts: administering decitabine alone or in combination with Hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin and dexamethasone alternating with high-dose methotrexate and cytarabine). Patients participated in either part of the study or in both parts sequentially. In the initial part, decitabine was administered intravenously at doses of 10–120 mg/m2/day for 5 days every other week in cycles of 28 days. In the combination part, patients were treated on the first five days of Hyper-CVAD with intravenous decitabine at 5–60 mg/m2/day. A total of 39 patients received treatment in the study: 14 in the first part only, 16 sequentially in both parts and 9 in the second part only. Decitabine was tolerated at all doses administered, and grade 3 or 4 toxic effects included non-life-threatening hepatotoxicity and hyperglycaemia. Induction of DNA hypomethylation was observed at doses of decitabine up to 80 mg/m2. Some patients who had previously progressed on Hyper-CVAD alone achieved a complete response when decitabine was added. Decitabine alone or given with Hyper-CVAD is safe and has clinical activity in patients with advanced ALL.
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影响因子：
20.3
作者：
Kalac, Matko;Scotto, Luigi;O'Connor, Owen A.
通讯作者：
O'Connor, Owen A.
DOI：
10.1093/jnci/djp079
发表时间：
2009-05-20
期刊：
Journal of the National Cancer Institute
影响因子：
--
作者：
Le Tourneau C;Lee JJ;Siu LL
通讯作者：
Siu LL
影响因子：
3.6
作者：
Lübbert, M;Minden, M
通讯作者：
Minden, M
影响因子：
20.3
作者：
Garcia-Manero, Guillermo;Kantarjian, Hagop M.;Issa, Jean-Pierre
通讯作者：
Issa, Jean-Pierre
影响因子：
3.6
作者：
Momparler, RL
通讯作者：
Momparler, RL