喷司他丁、环磷酰胺和利妥昔单抗方案用于老年慢性淋巴细胞白血病患者
Pentostatin, cyclophosphamide, and rituximab regimen in older patients with chronic lymphocytic leukemia.
作者信息
Shanafelt Tait D, Lin Thomas, Geyer Susan M, Zent Clive S, Leung Nelson, Kabat Brian, Bowen Deborah, Grever Michael R, Byrd John C, Kay Neil E
机构信息
Department of Internal Medicine, Division of Hematology, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA.
出版信息
Cancer. 2007 Jun 1;109(11):2291-8. doi: 10.1002/cncr.22662.
BACKGROUND
The prevalence of chronic lymphocytic leukemia (CLL) increases with age. Although chemoimmunotherapy (CIT) has dramatically improved response rates in patients with CLL, some CIT regimens are not well tolerated by many patients >or=70 years of age.
METHODS
Sixty-four previously untreated patients with CLL and serum creatinine <1.5 times the upper limit of normal who met National Cancer Institute (NCI) 96-WG criteria for treatment received pentostatin (2 mg/m(2)), cyclophosphamide (600 mg/m(2)), and rituximab (375 mg/m(2)). The authors measured performance status at study entry and used age, weight, and baseline creatinine to calculate creatinine clearance (CrCl).
RESULTS
Eighteen of 64 (28%) patients were ages >or=70 years. Although individuals ages >or=70 years were more likely to have delayed treatment cycles (28% vs 7%; P=.03), there were no significant differences in the number of cycles administered, need for dose reductions, or grade 3-4 hematologic, infectious, or other toxicities. No significant differences in overall response rate, complete response rate, or progression-free survival were observed by age. Twenty-five (39%) patients had a CrCl < 70 mL/min (range, 34-67). Although individuals with CrCl < 70 were more likely to require dose reduction (24% vs 5%; P=.05), there were no significant differences in the number of cycles administered or grade 3-4 hematologic, infectious, or other toxicities. No significant difference in overall response rate, complete response rate, or progression-free survival were observed between patients with CrCl >or= 70 mL/min and those with CrCl < 70 mL/min.
CONCLUSIONS
In this clinical trial, the PCR regimen was well tolerated by older patients and individuals with CrCl <or= 70. The efficacy of PCR was not significantly affected by age or renal function. These findings suggest PCR may be a good therapeutic option for older patients and those with modestly decreased renal function.
背景
慢性淋巴细胞白血病（CLL）的患病率随年龄增长而增加。尽管化学免疫疗法（CIT）显著提高了CLL患者的缓解率，但一些CIT方案对许多年龄≥70岁的患者耐受性不佳。
方法
64例既往未接受治疗的CLL患者，血清肌酐<正常上限的1.5倍，符合美国国立癌症研究所（NCI）96-WG治疗标准，接受喷司他丁（2mg/m²）、环磷酰胺（600mg/m²）和利妥昔单抗（375mg/m²）治疗。作者在研究开始时评估了患者的体能状态，并使用年龄、体重和基线肌酐来计算肌酐清除率（CrCl）。
结果
64例患者中有18例（28%）年龄≥70岁。尽管年龄≥70岁的个体更有可能出现治疗周期延迟（28%对7%；P=0.03），但在给药周期数、剂量减少需求或3-4级血液学、感染或其他毒性方面没有显著差异。按年龄观察，总体缓解率、完全缓解率或无进展生存期无显著差异。25例（39%）患者的CrCl<70mL/min（范围为34-67）。尽管CrCl<70的个体更有可能需要减少剂量（24%对5%；P=0.05），但在给药周期数或3-4级血液学、感染或其他毒性方面没有显著差异。CrCl≥70mL/min的患者与CrCl<70mL/min的患者在总体缓解率、完全缓解率或无进展生存期方面没有显著差异。
结论
在这项临床试验中，年龄较大的患者和CrCl≤70的个体对PCR方案耐受性良好。PCR的疗效不受年龄或肾功能的显著影响。这些发现表明，PCR可能是老年患者和肾功能轻度下降患者的良好治疗选择。
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