A phase II trial of induction and consolidation therapy of acute myeloid leukemia with weekly oral idarubicin alone in poor risk elderly patients
A phase II trial of induction and consolidation therapy of acute myeloid leukemia with weekly oral idarubicin alone in poor risk elderly patients
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DOI：
10.1038/sj.leu.2401522
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发表时间：
1999-10-01
期刊：
影响因子：
11.4
通讯作者：
Fenaux, P
中科院分区：
文献类型：
--
作者：
Bouabdallah, R;Lefrère, F;Fenaux, P
我们进行了一项II期门诊试验，测试每周口服依达柔比星（ZAVEDOS-ZVD）单独给药，以确定60岁以上低风险急性髓性白血病（AML）患者的客观反应率和毒性。处理分为三个阶段：诱导，在第1、8、15和22天使用20 mg/m(2)的ZVD；用20mg /m(2)的ZVD固结4周；维持6个周期，持续3个月，由口服巯基嘌呤2 mg/kg/天，每周4天，持续2个月；阿糖胞苷皮下注射1mg /kg，每周1次，连用2个月；第3个月第1天和第8天口服ZVD 20 mg/m(2)。诱导疗程失败时，患者接受补救性治疗，每周口服剂量40 mg/m(2) ZVD 4次。51例患者入组，中位年龄76岁，可接受入组课程。在这51例患者中，37例可以接受后续疗程，包括巩固或挽救。只有11例患者接受了维持治疗。63%的患者在诱导期间必须住院，平均持续时间为14.5天，87%的患者在抢救期间需要住院，平均持续时间为17.5天。只有5名患者（38%）在巩固期间需要住院。有3例中毒性死亡（6%），2例死于出血，1例死于肺栓塞。总缓解率为29%，完全缓解12例（25%），部分缓解2例（4%）。整个人群的中位总生存率为4个月，14例应答患者的中位DFS为9.6个月。本试验结果表明，这种新的每周口服ZVD化疗方案对于低风险老年AML患者是可行和有效的。这种方案可能有助于患者不能忍受强化静脉注射方案，是一个真正的替代姑息治疗。
We have conducted a phase II outpatient trial testing weekly oral administration of idarubicin (ZAVEDOS-ZVD) alone to determine the rate of objective response and toxicity in poor risk acute myeloid leukemia (AML) patients over 60 years of age. The treatment consisted of three phases: induction, with 20 mg/m(2) of ZVD on days 1, 8, 15 and 22; consolidation with 20 mg/m(2) of ZVD for 4 weeks; and maintenance with six cycles lasting 3 months and consisting of oral 6 mercapto-purine 2 mg/kg/day, 4 days a week for 2 months; subcutaneous cytarabine 1 mg/kg, once a week for 2 months; and oral ZVD 20 mg/m(2) on day 1 and day 8 of the third month. In case of failure after induction course, patients received salvage treatment with 4 weekly oral doses of 40 mg/m(2) ZVD. Fifty-one patients with a median age of 76 years were enrolled and could receive induction course. Of these 51 patients, 37 could receive subsequent courses, which consisted either of consolidation, or salvage. Only 11 patients underwent maintenance treatment. Sixty-three percent of patients had to be hospitalized during induction, for a median duration of 14.5 days, and 87% required hospitalization during salvage for a median duration of 17.5 days. Only five patients (38%) required hospitalization during consolidation. There were three toxic deaths (6%), two from hemorrhage and one from pulmonary embolism. The overall response rate was 29%, with 12 patients in complete response (25%) and two in partial response (4%). The median overall survival rate is 4 months for the whole population, and the median DFS is 9.6 months among the 14 responding patients. The results of this trial show that this new weekly schedule of oral ZVD chemotherapy is feasible and effective in poor risk elderly patients with AML. This regimen may be helpful for patients unable to tolerate intensive intravenous regimens, and is a real alternative to palliative treatments.