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


METHODS
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%.


CONCLUSIONS
D-CAG regimen was well tolerated and showed a promising clinic efficacy in elderly patients with AML (≥70 years).
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Jianyong
J
Li
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Yaoyu
Y
Chen
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Yu
Y
Zhu
Tongji Hospital affiliated to Tongji medical college of Huazhong University of Science and Technology, Wuhan, China.
Jianfeng
J
Zhou
Nanjing Hospital Affiliated to Nanjing Medical University, Nanjing, China.
Yanli
Y
Xu
First Affiliated Hospital of China Medical University, Shenyang, China.
Yan
Y
Li
First Affiliated Hospital of Wenzhou Medical College, Wenzhou, China.
Kang
K
Yu
West China Hospital of Sichuan University, Chengdu, China.
Ling
L
Pan
Changhai Hospital, Secondary Military Medical University, Shanghai, China.
Jianmin
J
Wang
Zhongda Hospital, Southeast University, Nanjing, China.
Jiahua
J
Ding
Clinic Medical College of Yangzhou University, Yangzhou, China.
Jian
J
Gu
Zhongshan Hospital, Fudan University, Shanghai, China.
Shanhua
S
Zhou
Jiangning Hospital, Nanjing, China.
Jinning
J
Shi
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Ming
M
Hong
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Ji
J
Xu
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Liangqin
L
Pan
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Limin
L
Duan
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Run
R
Zhang
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Sujiang
S
Zhang
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Huayuan
H
Zhu
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Hua
H
Lu
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Peng
P
Liu
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Hongxia
H
Qiu
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Hanxin
H
Wu
First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, China.|Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing Medical University, Nanjing, China.
Sixuan
S
Qian
D015250:Aclarubicin / Q000008:administration & dosage; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D003561:Cytarabine / Q000008:administration & dosage; D000077209:Decitabine; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome
D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D015250:Aclarubicin; D000077209:Decitabine; D001374:Azacitidine
AML; D-CAG; elderly patients