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[Analysis of outocome of pirarubicin-based combination chemotherapy regimen in the treatment of newly diagnosed acute myeloid leukemia-a prospective, open, randomized and multicenter clinical trial].

OBJECTIVE
To compare the effectiveness and side effects of two chemotherapy regimens [pirarubicin + cytarabine (TA) and daunorubicin + cytarabine (DA)] in patients with acute myeloid leukemia (AML).


METHODS
From Oct 2006 to Jul 2009, there were 207 newly diagnosed AML patients randomized into DA or TA group from 72 centers all over the country. The aim of this clinical trial is to observe and evaluate complete remission rate (CR), total remission rate (TRR), and side effect after one or two circles of therapy.


RESULTS
In 198 evaluable patients, 126 cases in TA group and 72 in DA group were evalvable, with a ratio of 1.75:1. CR was 69.8% and TRR (CR + PR) was 81.8% in TA group and 63.9%, 80.9% in DA group, correspondingly (P > 0.05). For patients with subtype M(2), CR (77.1%) in TA group was higher than that in DA (60%). There was no difference in side effect between the two groups.


CONCLUSION
There is no difference of the effect between TA and DA chemotherapy for newly diagnosed AML patients. But for subtype M(2), TA is more efficacy. And there is no difference in side effect between the two regimens.