Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011
Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011
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DOI：
10.1182/blood-2004-03-0796
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发表时间：
2005-01-01
期刊：
影响因子：
20.3
通讯作者：
Larson, RA
中科院分区：
文献类型：
--
作者：
Byrd, JC;Rai, K;Larson, RA
氟达拉滨和利妥昔单抗联合治疗慢性淋巴细胞白血病（CLL）已产生了有希望的早期结果，但没有相对于标准氟达拉滨治疗方案的比较疗效数据。为了评估在氟达拉滨治疗中添加利妥昔单抗的效果，我们回顾性比较了癌症和白血病组B和美国Intergroup进行的2项多中心临床试验中招募的具有相似临床特征的患者的治疗结局，这些临床试验使用氟达拉滨和利妥昔单抗（CALGB 9712，n = 104）或氟达拉滨（CALGB 9011，n = 178）。在控制治疗前特征的多变量分析中，接受氟达拉滨和利妥昔单抗治疗的患者的无进展生存期（PFS; P <0.0001）和总生存期（OS; P = 0.0006）明显优于接受氟达拉滨治疗的患者。2年PFS概率为0.67 vs 0.45，2年OS概率为0.93 vs 0.81。两种治疗方法的感染毒性相似。这些比较数据是回顾性的，可能会受到支持性治疗差异或每项试验中不同基因亚群入组的混淆。这些发现的证实需要一项前瞻性随机试验，比较氟达拉滨和利妥昔单抗与氟达拉滨。
Fludarabine and rituximab combination therapies in chronic lymphocytic leukemia (CLL) have yielded promising early results, but no comparative efficacy data relative to standard fludarabine treatment regimens have been reported. To assess the effect of the addition of rituximab to fludarabine therapy, we retrospectively compared the treatment outcome of patients with similar clinical characteristics enrolled on 2 multicenter clinical trials performed by the Cancer and Leukemia Group B and the US Intergroup that used fludarabine and rituximab (CALGB 9712, n = 104) or fludarabine (CALGB 9011, n = 178). In multivariate analyses controlling for pretreatment characteristics, the patients receiving fludarabine and rituximab had a significantly better progression-free survival (PFS; P < .0001) and overall survival (OS; P = .0006) than patients receiving fludarabine therapy. Two-year PFS probabilities were 0.67 versus 0.45, and 2-year OS probabilities were 0.93 versus 0.81. Infectious toxicity was similar between the 2 treatment approaches. These comparative data are retrospective and could be confounded by differences in supportive care or dissimilar enrollment of genetic subsets on each trial. Confirmation of these findings will require a prospective randomized trial comparing fludarabine and rituximab to fludarabine.