AAML0523: a report from the Children's Oncology Group on the efficacy of clofarabine in combination with cytarabine in pediatric patients with recurrent acute myeloid leukemia.
AAML0523: a report from the Children's Oncology Group on the efficacy of clofarabine in combination with cytarabine in pediatric patients with recurrent acute myeloid leukemia.
复制标题
DOI：
10.1002/cncr.28674
复制
发表时间：
2014-08-15
期刊：
影响因子：
6.2
通讯作者：
Razzouk, Bassem I.
中科院分区：
文献类型：
--
作者：
Cooper, Todd M.;Alonzo, Todd A.;Gerbing, Robert B.;Perentesis, John P.;Whitlock, James A.;Taub, Jeffrey W.;Horton, Terzah M.;Gamis, Alan S.;Meshinchi, Soheil;Loken, Michael R.;Razzouk, Bassem I.
The discovery of new, effective non-anthracycline-based re-induction regimens for children with relapsed acute myeloid leukemia (AML) is critical. In this Phase I/II study, we investigated the tolerability and overall response rate of clofarabine in combination with cytarabine in children with relapsed/refractory acute myeloid leukemia (AML). AAML0523 enrolled 49 children with AML in first relapse or refractory to induction therapy. The study consisted of a dose finding phase (N=9) and an efficacy phase (N=40). Two children received clofarabine at 40 mg/m2/day and 47 at 52 mg/m2/day. Toxicities typical for intensive chemotherapy regimens were observed at all doses of clofarabine. The recommended pediatric phase II dose (RP2D) of clofarabine in combination with cytarabine was 52 mg/m2/day for 5 days. Of 48 evaluable patients, the overall response rate (ORR) (CR + CRp) was 48%. Four patients met conventional criteria for complete remission with incomplete count recovery (CRi). Twenty-one of 23 responders subsequently received hematopoietic stem cell transplantation (HSCT). Overall survival at 3 years was 46 % for responders compared to 16% for non-responders (p value <0.001). Patients with no minimal residual disease at end of first cycle by flow cytometric analysis had superior overall survival after 1 year (100% vs. 38%, p=0.01). The combination of clofarabine and cytarabine yielded an acceptable response rate without excess toxicity in children with relapsed AML. The nearly 50% survival rate in responders is highly encouraging in these high risk patients and suggests that this combination is an effective bridge to HSCT.
登录
查看更多内容
影响因子：
51.1
作者：
Rubnitz, Jeffrey E.;Inaba, Hiroto;Dahl, Gary;Ribeiro, Raul C.;Bowman, W. Paul;Taub, Jeffrey;Pounds, Stanley;Razzouk, Bassem I.;Lacayo, Norman J.;Cao, Xueyuan;Meshinchi, Soheil;Degar, Barbara;Airewele, Gladstone;Raimondi, Susana C.;Onciu, Mihaela;Coustan-Smith, Elaine;Downing, James R.;Leung, Wing;Pui, Ching-Hon;Campana, Dario
通讯作者：
Campana, Dario
影响因子：
5.8
作者：
Månsson, E;Flordal, E;Albertioni, F
通讯作者：
Albertioni, F
影响因子：
20.3
作者：
Faderl, S;Gandhi, V;Kantarjian, H
通讯作者：
Kantarjian, H
影响因子：
45.3
作者：
Faderl, Stefan;Wetzler, Meir;Kantarjian, Hagop M.
通讯作者：
Kantarjian, Hagop M.
影响因子：
3.2
作者：
Orgel, Etan;Zung, Laura;Freyer, David R.
通讯作者：
Freyer, David R.