Department of Hematology University Hospital Center Rebro, Kispatic street 12 1000 Zagreb, Croatia.
Haematologica. 2010 Sep;95(9):1489-95. doi: 10.3324/haematol.2009.018580. Epub 2010 Apr 7.
Corticosteroids are a standard component of the treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma. Our aim was to determine whether dexamethasone results in a better outcome than prednisolone.
Adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma were randomized to receive, as part of their induction therapy on days 1-8 and 15-22, either dexamethasone 8 mg/m(2) or prednisolone 60 mg/m(2). Those who reached complete remission were given two courses of consolidation therapy with high-dose cytarabine and mitoxantrone and methotrexate and asparaginase. Subsequently patients younger than 50 years, with a suitable donor, were to undergo allogeneic stem cell transplantation, whereas the others were planned to receive either an autologous stem cell transplant or high-dose maintenance chemotherapy with prophylactic central nervous system irradiation. Randomization was done with a minimization technique. The primary endpoint was event-free survival and the analyses was conducted on an intention-to-treat basis.
Between August 1995 and October 2003, 325 patients between 15 to 72 years of age were randomized to receive either dexamethasone (163 patients) or prednisolone (162 patients). After induction and the course of first consolidation therapy, 131 (80.4%) patients in the dexamethasone group and 124 (76.5%) in the prednisolone group achieved complete remission. No significant difference was observed between the two treatment groups with regards to 6-year event-free survival rates (+/-SE) which were 25.9% (3.6%) and 28.7% (3.5%) in the dexamethasone and prednisolone groups, respectively (P=0.82, hazard ratio 0.97; 95% confidence interval, 0.75-1.25). Disease-free survival after complete remission was also similar in the dexamethasone and prednisolone groups, the 6-year rates being 32.3% and 37.5%, respectively (hazard ratio 1.03; 95% confidence interval 0.76-1.40). The 6-year cumulative incidences of relapse were 49.8% and 53.5% (Gray's test: P=0.30) while the 6-year cumulative incidences of death were 18% and 9% (Gray's test: P=0.07).
In the ALL-4 trial in adult patients with acute lymphoblastic leukemia or lymphoblastic lymphoma, treatment with dexamethasone did not show any advantage over treatment with prednisolone.
皮质类固醇是急性淋巴细胞白血病和淋巴母细胞淋巴瘤治疗的标准组成部分。我们的目的是确定地塞米松是否比泼尼松龙产生更好的结果。
接受诱导治疗的成年急性淋巴细胞白血病或淋巴母细胞淋巴瘤患者在第 1-8 天和第 15-22 天随机分为地塞米松 8mg/m(2)或泼尼松龙 60mg/m(2)。达到完全缓解的患者接受两次高剂量阿糖胞苷和米托蒽醌以及甲氨蝶呤和门冬酰胺酶巩固治疗。随后，年龄小于 50 岁且有合适供体的患者将接受异基因干细胞移植，而其他患者计划接受自体干细胞移植或预防性中枢神经系统照射的高剂量维持化疗。随机化采用最小化技术。主要终点是无事件生存，分析基于意向治疗。
1995 年 8 月至 2003 年 10 月，年龄在 15 至 72 岁之间的 325 名患者被随机分为接受地塞米松（163 名患者）或泼尼松龙（162 名患者）。在诱导和第一次巩固治疗后，地塞米松组有 131 名（80.4%）患者和泼尼松龙组有 124 名（76.5%）患者达到完全缓解。两组之间 6 年无事件生存率（±SE）无显著差异，地塞米松组为 25.9%（3.6%），泼尼松龙组为 28.7%（3.5%）（P=0.82，风险比 0.97；95%置信区间，0.75-1.25）。完全缓解后的无病生存也相似，地塞米松组和泼尼松龙组的 6 年率分别为 32.3%和 37.5%（风险比 1.03；95%置信区间 0.76-1.40）。6 年累积复发率分别为 49.8%和 53.5%（Gray 检验：P=0.30），6 年累积死亡率分别为 18%和 9%（Gray 检验：P=0.07）。
在 ALL-4 试验中，成人急性淋巴细胞白血病或淋巴母细胞淋巴瘤患者接受地塞米松治疗并未显示出优于泼尼松龙治疗的优势。
