Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997
Phase III trial of fludarabine plus cyclophosphamide compared with fludarabine for patients with previously untreated chronic lymphocytic leukemia: US Intergroup Trial E2997
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DOI：
10.1200/jco.2006.08.0762
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发表时间：
2007-03-01
影响因子：
45.3
通讯作者：
Tallman, Martin S.
中科院分区：
文献类型：
--
作者：
Flinn, Ian W.;Neuberg, Donna S.;Tallman, Martin S.
目的氟达拉滨联合环磷酰胺是治疗慢性淋巴细胞白血病(CLL)的有效方案。然而，与单独使用氟达拉滨相比，它可能伴随着更高的毒性。E2997是一项III期随机组间试验，比较了接受第一个化疗方案的CLL患者的氟达拉滨和环磷酰胺(FC ARM)与单独使用氟达拉滨(F ARM)的疗效。患者和方法有症状的CLL患者被随机分配到接受氟达拉滨25 mg/m(2)静脉注射(IV)第1至5天或环磷酰胺600 mg/m(2)IV第1至5天。这些周期每28天重复一次，最多6个周期。氟达拉滨联合环磷酰胺治疗完全缓解(CR)率显著高于对照组(23.4%vs4.6%，P
PurposeThe combination of fludarabine and cyclophosphamide is an effective regimen for patients with chronic lymphocytic leukemia (CLL). However, it may be accompanied by increased toxicity compared with fludarabine alone. E2997 is a phase III randomized Intergroup trial comparing fludarabine and cyclophosphamide (FC arm) versus fludarabine (F arm) alone in patients receiving their first chemotherapy regimen for CLL.Patients and MethodsSymptomatic, previously untreated patients with CLL were randomly assigned to receive either fludarabine 25 mg/m(2) intravenously (IV) days 1 through 5 or cyclophosphamide 600 mg/m(2) IV day 1 and fludarabine 20 mg/m(2) IV days 1 through 5. These cycles were repeated every 28 days for a maximum of six cycles.ResultsA total of 278 patients were randomly assigned in this Intergroup study. Treatment with fludarabine and cyclophosphamide was associated with a significantly higher complete response (CR) rate (23.4% v 4.6%, P