Objective: To evaluate the efficacy of chemotherapy regimen containing pirarubicin on the patients with high-risk, relapse and refractory acute leukemia.

Methods: 184 patients with high-risk, relapse and refractory acute leukemia were recruited and randomized to experiment group (111) and control group (73). The experiment group included 64 acute non-lymphocytic leukemia (ANLL) patients, 39 acute lymphocytic leukemia (ALL) patients and 8 mixed leukemia patients, and all received one of the following regimen: TA, VTP, VTLP or TAVP (T: pirarubicin, V: vincristine, P: prednisone, L: L-asparaginase). The patients in the control group received routine chemotherapy without pirarubicin.

Results: the complete remission rate (CR) was significantly higher in pirarubicin-treated group than in control group either for all the patients (64.4% vs 43.8%, p<0.05) or for ANLL patients (68.1% vs 36.2%, p<0.05). At the same time bone marrow suppression was severer in pirarubicin-treated group than in control group (p<0.05).

Conclusions: chemotherapy regimen containing pirarubicin is more effective than routine regimen without pirarubicin in the management of high-risk, relapse and refractory acute leukemia, especially in ANLL patients, although it induce severer but tolerable bone marrow suppression.

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