A phase I study using bortezomib with weekly idarubicin for treatment of elderly patients with acute myeloid leukemia.
A phase I study using bortezomib with weekly idarubicin for treatment of elderly patients with acute myeloid leukemia.
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DOI：
10.1016/j.leukres.2013.09.003
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发表时间：
2013-11
影响因子：
2.7
通讯作者：
Guzman, Monica L.
中科院分区：
文献类型：
--
作者：
Howard, Dianna S.;Liesveld, Jane;Phillips, Gordon L., II;Hayslipa, John;Weiss, Heidi;Jordan, Craig T.;Guzman, Monica L.
我们报告了四个剂量水平的硼替佐米联合伊达比星的I期研究结果。符合条件的患者包括新诊断的60岁≥急性髓系白血病患者，或任何复发的成人急性髓细胞白血病患者。波特佐米以0.8、1.0或1.2 mg/m2每周两次给药，每周一次，伊达比星10 mg/m2，疗程4周。20名患者接受治疗：13名初诊患者(中位年龄68岁，范围61-83岁)和7名复发患者(中位年龄58岁，范围40-77岁)。有10/13(77%)的初诊患者和1/7(14%)复发的患者有既往骨髓增生异常综合征(MDS)的记录；3名新诊断的没有MDS的患者具有发育不良的形态。在初始剂量水平(硼替佐米0.8 mg/m2和伊达比星10 mg/m2)出现两种剂量限制毒性；伊达比星降至8 mg/m2，未观察到随后的剂量限制毒性。本研究的最大耐受量为博替佐米1.2 mg/m2和伊达比星8 mg/m2。常见的不良反应包括：中性粒细胞减少症、感染、体质症状和胃肠道症状。没有受试者经历神经毒性。大多数患者表现出血液学反应，表现为循环母细胞减少。4例(20%)患者完全缓解。有一例与治疗有关的死亡。在这个风险较低、年龄较大的急性髓系白血病患者中，硼替佐米和伊达比星的联合应用耐受性良好，并未导致高死亡率。这项试验在www.Clinicaltrials.gov上注册为#NCT00382954。
We report the results of a phase I study with four dose levels of bortezomib in combination with idarubicin. Eligible patients were newly diagnosed with acute myeloid leukemia (AML) age ≥60 years, or any adult with relapsed AML. Bortezomib was given twice weekly at 0.8, 1.0, or 1.2 mg/m2 with once weekly idarubicin 10 mg/m2 for four weeks. Twenty patients were treated: 13 newly diagnosed (median age 68, range 61-83) and 7 relapsed (median age 58, range 40-77). Prior myelodysplastic syndrome (MDS) was documented in 10/13 (77%) newly diagnosed and 1/7 (14%) relapsed patients; the three newly diagnosed patients without prior MDS had dyspoietic morphology. Two dose-limiting toxicities occurred at the initial dose level (bortezomib 0.8 mg/m2 and idarubicin 10 mg/m2); idarubicin was reduced to 8 mg/m2 without observing subsequent dose-limiting toxicities. The maximum tolerated dose in this study was bortezomib 1.2 mg/m2 and idarubicin 8 mg/m2. Common adverse events included: neutropenic fever, infections, constitutional symptoms, and gastrointestinal symptoms. No subjects experienced neurotoxicity. Most patients demonstrated hematologic response as evidenced by decreased circulating blasts. Four patients (20%) achieved complete remission. There was one treatment-related death. The combination of bortezomib and idarubicin in this mostly poor-risk, older AML group was well tolerated and did not result in high mortality. This trial was registered at www.clinicaltrials.gov as #NCT00382954.
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影响因子：
20.3
作者：
Guzman, ML;Neering, SJ;Jordan, CT
通讯作者：
Jordan, CT
影响因子：
20.3
作者：
Blair, A;Hogge, DE;Sutherland, HJ
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Sutherland, HJ
影响因子：
6.5
作者：
JOHNSON, PRE;YIN, AL
通讯作者：
YIN, AL
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11.4
作者：
Bouabdallah, R;Lefrère, F;Fenaux, P
通讯作者：
Fenaux, P
影响因子：
11.4
作者：
Jordan, CT;Upchurch, D;Phillips, GL
通讯作者：
Phillips, GL