Hôpital Avicenne, Assistance Publique-Hôpitaux de Paris and Paris 13 University, Bobigny, France.
Br J Haematol. 2010 Apr;149(2):244-9. doi: 10.1111/j.1365-2141.2010.08082.x. Epub 2010 Feb 5.
In the phase III AZA-001 trial, low-dose cytarabine (LDara-C), the most widely used low-dose chemotherapy in patients with higher-risk myelodysplastic syndrome (MDS) who are ineligible for intensive treatment, was found to be associated with poorer survival compared with azacitidine. This analysis further compared the efficacy and the toxicity of these two drug regimens. Before randomization, investigators preselected patients to receive a conventional care regimen, one of which was LDara-C. Of 94 patients preselected to LDara-C, 45 were randomized to azacitidine and 49 to LDara-C. Azacitidine patients had significantly more and longer haematological responses and increased red blood cell transfusion independence. Azacitidine prolonged overall survival versus LDara-C in patients with poor cytogenetic risk, presence of -7/del(7q), and French-American-British subtypes refractory anaemia with excess blasts (RAEB) and RAEB in transformation. When analyzed per patient year of drug exposure, azacitidine treatment was associated with fewer grade 3-4 cytopenias and shorter hospitalisation time than LDara-C in these higher-risk MDS patients.
在 III 期 AZA-001 试验中，与阿扎胞苷相比，低剂量阿糖胞苷（LDara-C）作为高危骨髓增生异常综合征（MDS）患者中最广泛使用的低剂量化疗药物，在不适合强化治疗的患者中与较差的生存相关。本分析进一步比较了这两种药物方案的疗效和毒性。在随机分组前，研究人员预选了接受常规治疗方案的患者，其中一种是 LDara-C。在预选接受 LDara-C 的 94 名患者中，45 名随机分配至阿扎胞苷组，49 名随机分配至 LDara-C 组。与 LDara-C 相比，阿扎胞苷组的血液学反应更多、时间更长，且红细胞输注独立性更高。阿扎胞苷与 LDara-C 相比，在细胞遗传学风险差、存在-7/del(7q)、法国-美国-英国（FAB）亚型难治性贫血伴原始细胞过多（RAEB）和 RAEB 转化的患者中，总体生存期更长。当按患者每年的药物暴露量进行分析时，与 LDara-C 相比，阿扎胞苷治疗在这些高危 MDS 患者中导致的 3-4 级血细胞减少症更少，住院时间更短。
