Long-term results of children with acute myeloid leukemia: A report of three consecutive Phase III trials by the Children's Cancer Group: CCG 251, CCG 213 and CCG 2891
Long-term results of children with acute myeloid leukemia: A report of three consecutive Phase III trials by the Children's Cancer Group: CCG 251, CCG 213 and CCG 2891
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DOI：
10.1038/sj.leu.2403925
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发表时间：
2005-12-01
期刊：
影响因子：
11.4
通讯作者：
Arceci, R
中科院分区：
文献类型：
--
作者：
Smith, FO;Alonzo, T;Arceci, R
儿童癌症组 (CCG) 在 1979 年至 1995 年间对新发急性髓性白血病儿童进行了三项 III 期前瞻性临床试验。CCG 251 (n = 485)、CCG 213 (n = 532) 和 CCG 2891 (n = 886) 总共招募了 1903 名出生至 21 岁的符合条件的儿童。随访正在进行中，中位随访时间分别为 7.9 年、10.9 年和 8.6 年。这三项临床试验开发了基于高剂量阿糖胞苷和道诺霉素的剂量和时间密集型诱导方案，如果确定了 HLA 匹配的相关供体，则在第一次缓解时将患者随机分配至同种异体骨髓移植。尽管采用了剂量和时间密集的诱导方案，缓解诱导率仍然相对稳定在 77 - 78%。然而，无论缓解后治疗的类型如何，与接受标准定时诱导治疗的患者相比，接受强化定时诱导治疗的患者的总生存期、无事件生存期和无病生存期 (DFS) 有所增加。接受强化定时诱导、随后进行相匹配的相关供体同种异体移植的患者的结果最好，6 年时的 DFS 为 65 +/- 9%。这三项临床试验为未来研究的发展奠定了坚实的基础，重点关注进一步的风险群体分层和新型分子靶向疗法的开发。
The Children's Cancer Group (CCG) conducted three Phase III prospective clinical trials for children with de novo acute myeloid leukemia between the years 1979 and 1995. A total of 1903 eligible children ages birth to 21 years of age were enrolled on CCG 251 (n = 485), CCG 213 (n = 532) and CCG 2891 (n = 886). Follow-up is ongoing, with medians of 7.9, 10.9 and 8.6 years, respectively. These three clinical trials developed dose- and time-intensive induction regimens based upon high-dose cytarabine and daunomycin and randomly assigned patients to allogeneic bone marrow transplantation in first remission if an HLA-matched related donor was identified. Despite dose- and time-intensive induction regimens, remission induction rates remained relatively stable at 77 - 78%. However, overall survival, event-free survival and disease-free survival (DFS) increased for patients receiving intensive-timing induction therapy in comparison to patients who received standard-timing induction, regardless of the type of postremission therapy. Outcomes were best for patients receiving intensive-timing induction followed by matched related donor allogeneic transplantation with DFS of 65 +/- 9% at 6 years. These three clinical trials have established a strong foundation for the development of future studies focusing on further risk group stratification and the development of novel, molecularly-targeted therapies.