METHODS: Treosulfan was administered to 94 patients while 85 patients received busulfan. Our outcomes were RRT, chronic and acute GVHD, relapse related mortality (RRM), non-relapse mortality, and fungal infection. The clinical follow up data, regarding the primary and secondary endpoints of our study, of the patients who received treosulfan or busulfan based conditioning regimens were statistically analyzed.
RESULTS: The median follow-up was 14 months for the treosulfan group while it was 11 months for the busulfan group (p = 0.16). RRT was 11.7% and 7.1% for treosulfan and busulfan respectively. The incidence of extensive chronic GVHD was less frequent in the treosulfan group compared to the busulfan group (15.7% vs. 32.1%) (p < 0.001). The incidence of acute GVHD (Grade 3 or higher) was 32.2% in the treosulfan group while it was 31.6% in the busulfan group. The RRM was 17% in the treosulfan group while it was 34% in the busulfan group. The non-relapse mortality was 35.5% and 29.4% in the treosulfan group and in the busulfan group respectively (p = 0.962).
CONCLUSIONS: Treosulfan, with a lower RRM, lower chronic GVHD incidence and with a similar RRT profile appears to be a safe alternative to busulfan.
方法:对94例患者服用了曲硫丹,85例患者服用了白消安。我们的结果是RRT,慢性和急性GVHD,复发相关死亡率(RRM),非复发死亡率,和真菌感染。临床随访数据,关于我们研究的主要和次要终点,对接受以曲硫丹或白消安为基础的调理方案的患者进行统计学分析。
结果:曲硫安组的中位随访时间为14个月,白消安组的中位随访时间为11个月(p=0.16)。曲硫丹和白消安的RRT分别为11.7%和7.1%。与白消安组相比,曲硫安组广泛慢性GVHD的发生率较低(15.7%vs.32.1%)(p<0.001)。急性GVHD(3级或更高)的发生率在曲硫丹组为32.2%,而在白消安组为31.6%。曲硫丹组的RRM为17%,而白消安组的RRM为34%。曲硫安组和白消安组的非复发死亡率分别为35.5%和29.4%(p=0.962)。
结论:曲硫丹,较低的RRM,较低的慢性GVHD发病率和相似的RRT表现似乎是白消安的安全替代品.