Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia.
Fludarabine compared with chlorambucil as primary therapy for chronic lymphocytic leukemia.
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DOI：
10.1056/nejm200012143432402
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发表时间：
2000-12-14
影响因子：
158.5
通讯作者：
Schiffer, CA
中科院分区：
文献类型：
--
作者：
Rai, KR;Peterson, BL;Schiffer, CA
背景：氟达拉滨是治疗慢性淋巴细胞白血病的有效方法，但苯丁酸氮芥初始治疗对慢性淋巴细胞白血病没有反应。我们比较了氟达拉滨和苯丁酸氮芥在慢性淋巴细胞白血病主要治疗中的疗效。方法：1990年至1994年间，我们将509名既往未接受治疗的慢性淋巴细胞白血病患者随机分配至以下治疗之一：氟达拉滨（每平方米体表面积25毫克，每天静脉注射，每28天静脉注射一次，连续5天） 天）、苯丁酸氮芥（每平方米 40 毫克，每 28 天口服一次）或氟达拉滨（每天每平方米 20 毫克，每 28 天 5 天）加苯丁酸氮芥（每平方米 20 毫克，每 28 天）。在每月评估中获得额外缓解的患者继续接受最多 12 个周期的指定治疗。 结果：当计划的中期分析显示毒性过度且缓解率不优于单用氟达拉滨的缓解率时，停止将患者分配至氟达拉滨加苯丁酸氮芥组。在其他两组中，单独使用氟达拉滨的反应率显着高于单独使用苯丁酸氮芥。在接受氟达拉滨治疗的 170 名患者中，20% 的患者完全缓解，43% 的患者部分缓解。 181 名接受苯丁酸氮芥治疗的患者的相应值分别为 4% 和 33%（P
Background: Fludarabine is an effective treatment for chronic lymphocytic leukemia that does not respond to initial treatment with chlorambucil. We compared the efficacy of fludarabine with that of chlorambucil in the primary treatment of chronic lymphocytic leukemia.Methods: Between 1990 and 1994, we randomly assigned 509 previously untreated patients with chronic lymphocytic leukemia to one of the following treatments: fludarabine (25 mg per square meter of body-surface area, administered intravenously daily for 5 days every 28 days), chlorambucil (40 mg per square meter, given orally every 28 days), or fludarabine (20 mg per square meter per day for 5 days every 28 days) plus chlorambucil (20 mg per square meter every 28 days). Patients with an additional response at each monthly evaluation continued to receive the assigned treatment for a maximum of 12 cycles.Results: Assignment of patients to the fludarabine-plus-chlorambucil group was stopped when a planned interim analysis revealed excessive toxicity and a response rate that was not better than the rate with fludarabine alone. Among the other two groups, the response rate was significantly higher for fludarabine alone than for chlorambucil alone. Among 170 patients treated with fludarabine, 20 percent had a complete remission, and 43 percent had a partial remission. The corresponding values for 181 patients treated with chlorambucil were 4 percent and 33 percent (P