A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment
A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment
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DOI：
10.1002/cncr.22496
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发表时间：
2007-03-15
期刊：
影响因子：
6.2
通讯作者：
Wheatley, Keith
中科院分区：
文献类型：
--
作者：
Burnett, Alan K.;Milligan, Donald;Wheatley, Keith
背景老年急性髓细胞白血病患者的生存率没有提高。很少有临床试验可用于老年患者谁不被认为是适合的强化化疗方法。在1998年12月至2003年11月期间，作为国家癌症研究所急性髓性白血病14试验的一部分，217名被认为不适合强化化疗的患者被随机分配接受低剂量阿糖胞苷（Ara-C）（20 mg，每日两次，持续10天）或含或不含全反式维甲酸（ATRA）的羟基脲。小剂量阿糖胞苷缓解率较好（18% vs 1%;比值比[OR]，0.15; 95%置信区间[95% CI]，0.06-0.37; P =.00006）和更好的总生存期（OR，0.60; 95% CI，0.44-0.81; P =.0009），这是由达到完全缓解（CR）（CR持续时间：80周vs无CR患者10周）解释的。有不良细胞遗传学的患者没有受益。全反式维甲酸没有效果。治疗组之间的毒性评分或支持治疗需求没有差异。年龄较大、健康状况较差的患者预后较差，在这一患者群体中进行的试验很少。低剂量阿糖胞苷治疗上级优于最佳支持治疗和羟基脲，因为它在实现CR方面有更大的成功率，并且它可以代表标准治疗，在该患者组中可以与新治疗进行比较。[See第1007- 1009页，这个问题。Cancer 2007;109：1114-24. (c)2007年美国癌症协会。
BACKGROUND. The survival of older patients with acute myeloid leukemia has not improved. Few clinical trials have been available for older patients who are not considered fit for an intensive chemotherapy approach.METHODS. Between December 1998 and November 2003, as part of National Cancer Research Institute Acute Myeloid Leukemia 14 Trial, 217 patients, who were deemed unfit for intensive chemotherapy were randomized to receive low-dose cytarabine (Ara-C) (20 mg twice daily for 10 days) or hydroxyurea with or without all-trans retinoic acid (ATRA).RESULTS. Low-dose ara-C produced a better remission rate (18% vs 1%; odds ratio [OR], 0.15; 95% confidence interval [95% CI], 0.06-0.37; P =.00006) and better overall survival (OR, 0.60; 95% Cl, 0.44-0.81; P =.0009), which was accounted for by the achievement of complete remission (CR) (duration of CR: 80 weeks vs 10 weeks for patients with no CR). Patients who had adverse cytogenetics did not benefit. ATRA had no effect. Toxicity scores or supportive care requirements did not differ between the treatment arms.CONCLUSIONS. Older, less fit patients have a poor outcome, and few trials have been conducted in this patient group. Low-dose ara-C treatment was superior to best supportive care and hydroxyurea because it had greater success in achieving CR, and it could represent standard care against which new treatments may be compared in this patient group. [See editorial on pages 1007-10, this issue.] Cancer 2007;109:1114-24. (c) 2007 American Cancer Society.