Lee, Je-Hwan; Kim, Hawk; Joo, Young-Don; Lee, Won-Sik; Bae, Sung Hwa; Zang, Dae Young; Kwon, Jihyun; Kim, Min Kyoung; Lee, Junglim; Lee, Gyeong Won; Lee, Jung-Hee; Choi, Yunsuk; Kim, Dae-Young; Hur, Eun-Hye; Lim, Sung-Nam; Lee, Sang-Min; Ryoo, Hun Mo; Kim, Hyo Jung; Hyun, Myung Soo; Lee, Kyoo-Hyung
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
2017Jun ; 18 ( 6 ) :JCO2017728618.
PMID : 28632487
ÀúÀÚ »ó¼¼Á¤º¸
Lee, Je-Hwan -
Kim, Hawk -
Joo, Young-Don -
Lee, Won-Sik -
Bae, Sung Hwa -
Zang, Dae Young -
Kwon, Jihyun -
Kim, Min Kyoung -
Lee, Junglim -
Lee, Gyeong Won -
Lee, Jung-Hee -
Choi, Yunsuk -
Kim, Dae-Young -
Hur, Eun-Hye -
Lim, Sung-Nam -
Lee, Sang-Min -
Ryoo, Hun Mo -
Kim, Hyo Jung -
Hyun, Myung Soo -
Lee, Kyoo-Hyung -
ABSTRACT
Purpose We compared two induction regimens, idarubicin (12 mg/m(2)/d for 3 days) versus high-dose daunorubicin (90 mg/m(2)/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/m(2)/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.
na
¸µÅ©