Analysis Of Clinical Outcome Of Different Regimens In Newly Diagnosed Acute Promyelocytic Leukemia

Objective: To evaluate the efficacy and safety of all-trans retinoic acid(ATRA)combined with arsenic trioxide(ATO)as compare to ATRA combined with chemotherapy for induction and maintenance therapy in acute promyelocytic leukemia.Methods: A total of 134 patients with newly diagnosed APL were enrolled in this study from March 2009 to March 2016.Among them,37 patients in the experimental group(Exp.G)/ observation group were received ATRA combined with ATO for induction treatment,followed by 3 courses of anthracycline based chemotherapy for consolidate therapy,and then followed by 6-9 courses of ATRA combined with ATO for maintenance treatment.In the control group 1(Ctrl1),57 patients were received ATRA combined with ATO for induction therapy,followed by three courses of anthracycline based chemotherapy for consolidate therapy,followed by 6 courses of 2years of ATRA combined with ATO plus MTX,6-MP for maintenance therapy.In the control group 2(Ctrl2),40 patients were received the induction therapy of ATRA combined with chemotherapy,followed by three courses of anthracycline based chemotherapy,followed by 6 courses of 2 years of ATRA combined with MTX,6-MP maintenance therapy.The endpoint is 4 years of probabilities of Relapse-free Survival(RFS).4 yesrs of probabilities of Overall Survival(OS),and 4-year probabilities of Disease-free Survival(DFS).And the side effect of regimens was also evaluated.Results: The median follow-up time were 56 month,47 and 50 in Exp.G,the Ctrl1 and the Ctrl2.The complete remission rates were 100%,94.7% and 90%(Exp vs Ctrl1,P=0.156;Exp vs Ctrl2,P=0.048;Ctrl1 vs Ctrl2,P=0.375),The remission rate of the Exp.G was higher than that of the Ctrl2,the difference was statistically significant(P= 0.048).Before entering maintenance therapy,the three groups molecule biologic remission rate of PML / RAR? fusion gene were 91.2%(34/37),89.5%(51/57)and85%(34/40)(P=0.036),The negative rate of PML / RAR? fusion gene was significantly higher in the Exp.G than Ctrl2(P <0.05).The median time to induce remission was 43 days,44 days and 48 days in three groups(Ex.G vs Ctrl1,P=0.733;Exp.G vs Ctrl2,P=0.026;Ctrl1 vs Ctrl2,P=0.035),The Exp.G and the Ctrl1 were significantly shorter than the Ctrl2(P <0.05).4-year RFS were 94.6% vs 91.2% vs65%(Exp.G vs Ctrl1,P=0.544;Exp.G vs Ctrl2,P<0.001;Ctrl1 vs Ctrl2,P=0.001),4-year of RFS in the Exp.G and Ctrl1 were significantly better than those in the Ctrl2(P<0.05).4-year OS were 100% vs 96.5% vs 90%(Ex.G vs Ctrl1,P=0.249;Exp.G vs Ctrl2,P=0.048;Ctrl1 vs Ctrl2,P=0.191),The 4-year OS of the Exp.G was significantly better than the Ctrl2(P = 0.048).4-year of DFS were 94.6% vs87.7%%vs 60 %(Exp.G vs Ctrl1,P=0.268;Exp.G vs Ctrl2,P=0.010;Ctrl1 vs Ctrl2,P=0.020),4-year DFS of Exp.G and Ctrl1 was significantly better than that of Ctrl2(P <0.05).During the entire course of treatment: no death,no recurrence of CNS and no second tumor in the Exp.G,2 patients were relapsed,two cases are still alive.Two patients died in the Ctrl1,One case died of severe infection after recurrence of the second tumor M5,5 patients relapsed,Of which 2 cases of CNS leukemia recurrence,five cases are still alive.In the Ctrl2,4 patients died,14 patients relapsed,Of which 2 cases of CNS leukemia recurrence,12 cases are still alive.Exp.G,Ctrl1 and Ctrl1 induced differentiation syndrome were 45.9% vs 28% vs 40%(P>0.05).Conclusion:1.All-trans retinoic acid and arsenious acid double-induced and maintenance therapy in newly diagnosed APL have a higher induced remission rate,a shorter induction time and a higher 4-years of RFS?EFS?OS than ATRA combined with chemotherapy regimen.2.The treatment regimen of the observation group was simple,no recurrence of CNS,no second tumor.3.The rates of adverse events of the ATRA combined with the ATO regimen were similar to ATRA plus chemotherapy regimen,patient compliance is good.