Analysis Of High-dose Cytarabine Consolidation Therapy For Acute Myeloid Leukemia

Aims: To compare idarubicin with daunorubicin as induction remission for acutemyeloid leukemia (AML), to assess the toxic effects and efficacy of high-dosecytarabine as consolidation chemotherapy in AML, to investigate the safety andapplication prospects of high-dose cytarabine.Methods: Between July of2007and December of2012211patients of AML wereenrolled in this study. All patients were diagnosed by MICM.197cases were newlydiagnosed, and14cases were relapsed.102cases were male, and109cases werefemale. The median age was42years (ranged from8to77years).211cases weregiven standard idarubicin with cytosine arabinoside (IA) or daunorubicin withcytosine arabinoside (DA) as induction remission therapy, compare the completeremission rate and overall response rate between the two groups of patients; Afterachieved remission by induction therapy,67cases received HD-AraC （1.5~3g·m-2per12hours by three-hour infusion day1、3、5）as post-remission treatment for1~4cycles. Assess the toxic effects of high-dose cytarabine, and analysis the survival of51cases who did not undergo the hematopoietic stem cell transplantation.Results:211patients of AML were enrolled in this study, after two induction cycles,the CR rate was73%, the ORR was75%.197cases were newly diagnosed，after oneinduction cycle,50of76patients (65%) achieved complete remission on IA armcompared with74of121patients (61%) on DA arm, the overall response rate was78%and76%respectively, there was no significant difference between two arms onCR rate and ORR (P=0.755、0.903);14cases were relapsed, there was7cases in IAand DA groups respectively, after one induction cycle,5of7patients (71%) achievedcomplete remission on IA arm compared with4of7patients (57%) on DA arm, theoverall response rate was85%and71%respectively. There was no significantdifference between two arms on CR rate and ORR (P=0.964、0.821); In summary,after one induction cycle, including patients diagnosed newly and relapsed,55of83patients (66%) achieved complete remission on IA arm compared with78of128patients (60%) on DA arm, the overall response rate was79%and76%respectively, there was no significant difference between two arms on CR rate and ORR (P=0.71、0.859). The toxicity of HD-AraC: regarding hematologic toxicity, allpatients expressed grade4myelosuppression, febrile neutropenia88.3%, infection41%, sepsis17.5%, bleeding9.35%, treatment-related mortality1.5%. Regardingnonhematologic toxicity, nausea/vomiting29.82%, liver function damage15.79%,skin rash7.60%, drug fever8.75%, there was no severe cardiac and nervous damage.The efficacy of HD-AraC: the median follow-up time was9(3~33) months,1yearover-all survival (OS) and relapse-free survival (RFS) were78%and74%respectively,2year over-all survival (OS) and relapse-free survival (RFS) were69%and62%respectively, relapse rate was21.56%, death rate was15.46%. Over-allsurvival (OS) and relapse-free survival (RFS) were significant different for differentprognosis group (P=0.024、0.009). The induction program was no significant forover-all survival (OS) and relapse-free survival (RFS).Conclusions: There was no significant difference between standard IA and DA asinduction remission therapy for AML patients. HD-AraC was well tolerated in AMLpatients as post-remission therapy, the treatment-related mortality was1.5%. Theover-all survival and relapse-free survival of low-risk group were better thanintermediate-risk and high-risk group, the difference was significant. The inductionprogram was no significant for over-all survival (OS) and relapse-free survival (RFS).