Multi-institutional randomized controlled clinical trial on China made 4-demethoxydaunokrubicin (IDA) in the treatment of acute leukemia.
- Author:
Yan LIU
1
;
Xiao-yan KE
;
Jun MA
;
Zhi-xiang SHEN
;
Xiao-hong ZHANG
;
Xin DU
;
Yi-ming ZHAO
;
Jing-qiao LÜ
;
Zhao-min ZHAN
;
Xiao-ying ZENG
;
Xiao-hua XU
;
Ze-sheng LU
Author Information
- Publication Type:Journal Article
- MeSH: Adolescent; Adult; Aged; Antibiotics, Antineoplastic; adverse effects; therapeutic use; China; Female; Humans; Idarubicin; adverse effects; therapeutic use; Leukemia, Myeloid, Acute; drug therapy; Male; Middle Aged; Precursor Cell Lymphoblastic Leukemia-Lymphoma; drug therapy; Single-Blind Method
- From: Chinese Journal of Oncology 2005;27(12):750-752
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVETo evaluate the efficacy and safety of IDA (Haizheng Parmacy, China) in the treatment of acute leukemia.
METHODSA multi-institutional single-blind randomized controlled clinical trial was carried out. A total of 155 newly diagnosed patients with AML and ALL were enrolled. The patients were randomly divided into two groups, one was given IDA (n = 77) and the other given zevodas (Pharnacia & Upjohn, n = 78) for comparison.
RESULTSAll the patients enrolled in this trial were eligible for assessment of side effects, and 129 patients for evaluation of overall response rate. In patients treated with IDA vs zevodas, the overall response rate (OR) was 78.1% vs 76.9%, CR was 68.8% vs 67.7%; in AML patients, OR was 82.4% vs 71.8%, and CR was 76.5% vs 64.1%; in ALL patients, OR was 80.0% vs 81.8%, and CR was 68.0% vs 68.2%. There was no sitatistically significant difference in hematologic and non-hematologic toxicities between the two groups.
CONCLUSIONThe efficacy of IDA in the treatment of acute leukemia is comparable to that of zevodas. Both have similar toxic side effects.
