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Efficacy and safety of decitabine in combination with G-CSF, low-dose cytarabine and aclarubicin in newly diagnosed elderly patients with acute myeloid leukemia

PURPOSE: This prospective phase II, open label, study was designed to assess the efficacy and safety of D-CAG induction treatment for elderly patients with newly diagnosed AML. EXPERIMENTAL DESIGN: All patients in this study were treated with decitabine of 15 mg/m(2) for 5 days and G-CSF for priming...

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Detalles Bibliográficos
Autores principales: Li, Jianyong, Chen, Yaoyu, Zhu, Yu, Zhou, Jianfeng, Xu, Yanli, Li, Yan, Yu, Kang, Pan, Ling, Wang, Jianmin, Ding, Jiahua, Gu, Jian, Zhou, Shanhua, Shi, Jinning, Hong, Ming, Xu, Ji, Pan, Liangqin, Duan, Limin, Zhang, Run, Zhang, Sujiang, Zhu, Huayuan, Lu, Hua, Liu, Peng, Qiu, Hongxia, Wu, Hanxin, Qian, Sixuan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Impact Journals LLC 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467448/
https://www.ncbi.nlm.nih.gov/pubmed/25749041
Descripción
Sumario:PURPOSE: This prospective phase II, open label, study was designed to assess the efficacy and safety of D-CAG induction treatment for elderly patients with newly diagnosed AML. EXPERIMENTAL DESIGN: All patients in this study were treated with decitabine of 15 mg/m(2) for 5 days and G-CSF for priming, in combination with cytarabine of 10-mg/m(2) q12h for 7 days and aclarubicin of 10 mg/day for 4 days (D-CAG). RESULTS: Among 85 evaluable patients, overall response rate (ORR) and complete remission (CR) were 82.4% and 64.7%, respectively, after 1 cycle of therapy. The ORR in patients aged <70 years was 83.0% and 81.6% in patients aged ≥70 years. There was a significantly longer median overall survival (OS) in patients with response (16 months) than in those without response (7 months, p< 0.0001). The OS for patients aged ≥70 years and 60-69 years was 10 months and 12 months, respectively (p=0.4994). The two-year OS probability was 19.2% and the twenty-month survival rate was 33.8%. Induction mortality of D-CAG treated elderly patients with AML is 4.4%. CONCLUSION: D-CAG regimen was well tolerated and showed a promising clinic efficacy in elderly patients with AML (≥70 years).