Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia
Results of the Dana-Farber Cancer Institute ALL Consortium Protocol 95-01 for children with acute lymphoblastic leukemia
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DOI：
10.1182/blood-2006-06-027714
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发表时间：
2007-02-01
期刊：
影响因子：
20.3
通讯作者：
Silverman, Lewis B.
中科院分区：
文献类型：
--
作者：
Moghrabi, Albert;Levy, Donna E.;Silverman, Lewis B.
丹娜-法伯癌症研究所（DFCI）儿童ALL联合方案95-01旨在最大限度地减少新诊断ALL儿童的治疗相关发病率，同时不影响疗效。患者参与随机比较(1)阿霉素联合或不联合心脏保护剂dexrazoxane（高危患者），(2)强化鞘内化疗和颅放射（标准高危患者），(3)Erwinia和Escherichia coli天冬酰胺酶（所有患者）。1996年至2000年间，491名患者（0-18岁）入组（272名标准风险患者和219名高风险患者）。中位随访5.7年，所有患者的5年无事件生存率（EFS）估计为82% +/- 2%。Dexrazoxane对高危患者5年EFS无显著影响（P = 0.99），标准危患者中枢神经系统（CNS）治疗类型的预后无显著差异（P = 0.26）。与大肠杆菌天冬酰胺酶相比，Erwinia天冬酰胺酶的毒性发生率较低（10%对24%），但5年EFS也较差（78% +/- 4%对89% +/- 3%，P = 0.01）。我们得出的结论是：(1)右唑嗪不会干扰阿霉素的抗白血病作用；(2)在预防标准风险患者中枢神经系统复发方面，强化鞘内化疗与颅脑放疗一样有效；(3)每周一次的Erwinia比大肠杆菌天冬酰胺酶毒性更小，但效果也更差。
The Dana-Farber Cancer Institute (DFCI) Childhood ALL Consortium Protocol 95-01 was designed to minimize therapy-related morbidity for children with newly diagnosed ALL without compromising efficacy. Patients participated in randomized comparisons of (1) doxorubicin given with or without dexrazoxane, a cardioprotectant (high-risk patients), (2) intensive intrathecal chemotherapy and cranial radiation (standard-risk patients), and (3) Erwinia and Escherichia coli asparaginase (all patients). Between 1996 and 2000, 491 patients (aged 0-18 years) were enrolled (272 standard risk and 219 high risk). With a median of 5.7 years of followup, the estimated 5-year event-free survival (EFS) for all patients was 82% +/- 2%. Dexrazoxane did not have a significant impact on the 5-year EFS of high-risk patients (P =.99), and there was no significant difference in outcome of standard-risk patients based on type of central nervous system (CNS) treatment (P =.26). Compared with E coli asparaginase, Erwinia asparaginase was associated with a lower incidence of toxicity (10% versus 24%), but also an inferior 5-year EFS (78% +/- 4% versus 89% +/- 3%, P =.01). We conclude that (1) dexrazoxane does not interfere with the antileukemic effect of doxorubicin, (2) intensive intrathecal chemotherapy is as effective as cranial radiation in preventing CNS relapse in standard-risk patients, and (3) once-weekly Erwinia is less toxic than E coli asparaginase, but also less efficacious.