Clinical Research Papers:
Efficacy and safety of decitabine in combination with G-CSF, low-dose cytarabine and aclarubicin in newly diagnosed elderly patients with acute myeloid leukemia
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Abstract
Jianyong Li1,2,*, Yaoyu Chen1,2,*, Yu Zhu1,2, Jianfeng Zhou3, Yanli Xu4, Yan Li5, Kang Yu6, Ling Pan7, Jianmin Wang8, Jiahua Ding9, Jian Gu10, Shanhua Zhou11, Jinning Shi12, Ming Hong1,2, Ji Xu1,2, Liangqin Pan1,2, Limin Duan1,2, Run Zhang1,2, Sujiang Zhang1,2, Huayuan Zhu1,2, Hua Lu1,2, Peng Liu1,2, Hongxia Qiu1,2, Hanxin Wu1,2 and Sixuan Qian1,2
1 First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China
2 Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China
3 Tongji Hospital affiliated to Tongji medical college of Huazhong University of Science and Technology, Wuhan, China
4 Nanjing Hospital Affiliated to Nanjing Medical University, Nanjing, China
5 First Affiliated Hospital of China Medical University, Shenyang, China
6 First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China
7 West China Hospital of Sichuan University, Chengdu, China
8 Changhai Hospital, Secondary Military Medical University, Shanghai, China
9 Zhongda Hospital, Southeast University, Nanjing, China
10 Clinic Medical College of Yangzhou University, Yangzhou, China
11 Zhongshan Hospital, Fudan University, Shanghai, China
12 Jiangning Hospital, Nanjing, China
* The authors contributed equally to this work
Correspondence:
Sixuan Qian, email:
Keywords: D-CAG, elderly patients, AML
Received: December 01, 2014 Accepted: January 13, 2015 Published: January 31, 2015
Abstract
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/m2 for 5 days and G-CSF for priming, in combination with cytarabine of 10-mg/m2 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).
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