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

// Jianyong Li 1,2,* , Yaoyu Chen 1,2,* , Yu Zhu 1,2 , Jianfeng Zhou 3 , Yanli Xu 4 , Yan Li 5 , Kang Yu 6 , Ling Pan 7 , Jianmin Wang 8 , Jiahua Ding 9 , Jian Gu 10 , Shanhua Zhou 11 , Jinning Shi 12 , Ming Hong 1,2 , Ji Xu 1,2 , Liangqin Pan 1,2 , Limin Duan 1,2 , Run Zhang 1,2 , Sujiang Zhang 1,2 , Huayuan Zhu 1,2 , Hua Lu 1,2 , Peng Liu 1,2 , Hongxia Qiu 1,2 , Hanxin Wu 1,2 and Sixuan Qian 1,2 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/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).