1. Prospective Randomized Comparison of Idarubicin and High-Dose Daunorubicin in Induction Chemotherapy for Newly Diagnosed Acute Myeloid Leukemia
- Author
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Hun Mo Ryoo, Yunsuk Choi, Won-Sik Lee, Eun-Hye Hur, Gyeong Won Lee, Myung Soo Hyun, Jung Lim Lee, Jihyun Kwon, Hyo Jung Kim, Sang Min Lee, Sung-Nam Lim, Je-Hwan Lee, Kyoo-Hyung Lee, Young-Don Joo, Jung-Hee Lee, Hawk Kim, Dae Young Zang, Dae-Young Kim, Sung Hwa Bae, and Min Kyoung Kim
- Subjects
Adult ,Male ,0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,Daunorubicin ,Pharmacology ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Idarubicin ,Cumulative incidence ,Prospective Studies ,Survival rate ,Dose-Response Relationship, Drug ,business.industry ,Cytarabine ,Induction chemotherapy ,Myeloid leukemia ,Induction Chemotherapy ,Middle Aged ,Prognosis ,medicine.disease ,Survival Rate ,Leukemia, Myeloid, Acute ,Leukemia ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Female ,business ,medicine.drug - Abstract
Purpose We compared two induction regimens, idarubicin (12 mg/m2/d for 3 days) versus high-dose daunorubicin (90 mg/m2/d for 3 days), in young adults with newly diagnosed acute myeloid leukemia (AML). Patients and Methods A total of 299 patients (149 randomly assigned to cytarabine plus idarubicin [AI] and 150 assigned to cytarabine plus high-dose daunorubicin [AD]) were analyzed. All patients received cytarabine (200 mg/m2/d for 7 days). Results Complete remission (CR) was induced in 232 patients (77.6%), with no difference in CR rates between the AI and AD arms (80.5% v 74.7%, respectively; P = .224). At a median follow-up time of 34.9 months, survival and relapse rates did not differ between the AI and AD arms (4-year overall survival, 51.1% v 54.7%, respectively; P = .756; cumulative incidence of relapse, 35.2% v 25.1%, respectively; P = .194; event-free survival, 45.5% v 50.8%, respectively; P = .772). Toxicity profiles were also similar in the two arms. Interestingly, overall and event-free survival times of patients with FLT3 internal tandem duplication (ITD) mutation were significantly different (AI v AD: median overall survival, 15.5 months v not reached, respectively; P = .030; event-free survival, 11.9 months v not reached, respectively; P = .028). Conclusion This phase III trial comparing idarubicin with high-dose daunorubicin did not find significant differences in CR rates, relapse, and survival. Significant interaction between the treatment arm and the FLT3-ITD mutation was found, and high-dose daunorubicin was more effective than idarubicin in patients with FLT3-ITD mutation.
- Published
- 2017