Background

Cytarabine based therapy has been the standard consolidation regimen for AML (acute myeloid leukemia) for decades. However, the optimal dose, regimen and schedule is not known. HIDAC (high dose cytarabine at 18 g/m²) has been the conventional standard, however, recent studies have shown that intermediate doses of cytarabine (IDAC) have equal efficacy and lesser toxicities.

Methods

We retrospectively analysed 75 AML patients who entered consolidation out of 167 patients who underwent induction therapy between 2014 and 2018. HIDAC (at 18 g/m²) was given to 39 patients and 36 patients received IDAC at 9 g/m².

Results

Median age was 28 years (range 2–60). Male: female ratio was 1.02. More courses were administered in out-patient setting in IDAC group 61% (n = 58/95 courses) than in HIDAC 29% (n = 29/101 courses); p < 0.001. Incidence of clinically documented infection (CDI) was higher in HIDAC group (23.7%) compared to IDAC (8.4%), p = 0.004, and diarrhea showed a higher trend in the HIDAC group (9.9% vs. 3.1%; p = 0.052). Other toxicities were similar in both groups. There were 4 consolidation deaths in HIDAC whereas 3 deaths in IDAC group (p = 0.775). Median OS was 19.7 vs. 16.2 months and 3 years OS was 49.1% vs. 34.7% in HIDAC and IDAC groups respectively (p = 0.570). Median LFS was 12.6 versus 11.8 months; 3 years LFS was 46.4% versus 31% in HIDAC and IDAC groups respectively (p = 0.278).

Conclusion

For AML consolidation IDAC had lesser toxicity when compared with HIDAC though comparable efficacy needs to be confirmed with longer follow up and with prospective studies.

中文翻译：

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HIDAC 18 g 与 IDAC 9 g 在急性髓性白血病巩固治疗中的疗效：一项回顾性研究

背景

几十年来，基于阿糖胞苷的疗法一直是 AML（急性髓性白血病）的标准巩固方案。然而，最佳剂量、方案和时间表尚不清楚。HIDAC（18 g/m ²的高剂量阿糖胞苷）一直是常规标准，然而，最近的研究表明，中等剂量的阿糖胞苷 (IDAC) 具有相同的疗效和较低的毒性。

方法

我们回顾性分析了 2014 年至 2018 年间接受诱导治疗的 167 名患者中的 75 名进入巩固治疗的 AML 患者。39 名患者接受了 HIDAC（18 g/m ²），36 名患者接受了 9 g/m ²的 IDAC 。

结果

中位年龄为 28 岁（范围 2-60）。男女之比为1.02。IDAC 组 61%（n = 58/95 个课程）在门诊设置的课程比 HIDAC 29%（n = 29/101 个课程）多；p  < 0.001。与 IDAC (8.4%) 相比，HIDAC 组 (23.7%) 的临床记录感染 (CDI) 发生率更高，p  = 0.004，HIDAC 组的腹泻趋势更高（9.9% 对 3.1%；p  = 0.052 ). 两组的其他毒性相似。HIDAC 中有 4 例合并死亡，而 IDAC 组中有 3 例死亡 ( p  = 0.775)。HIDAC 和 IDAC 组的中位 OS 分别为 19.7 个月和 16.2 个月，3 年 OS 分别为 49.1% 和 34.7%（p = 0.570）。中位 LFS 为 12.6 个月和 11.8 个月；HIDAC 和 IDAC 组的 3 年 LFS 分别为 46.4% 和 31% ( p  = 0.278)。

结论

对于 AML 巩固，与 HIDAC 相比，IDAC 的毒性较小，但需要通过更长时间的随访和前瞻性研究来证实类似的疗效。