【Objective】 To evaluate long-term efficacy and safety of arsenic trioxide (ATO) in combination with anthracycline-based chemotherapy as consolidation therapy for newly diagnosed acute promyelocytic leukemia (APL) patients. 【Methods】 From May 2003 to December 2009

ATO (10 mg/ d for 5d each wk for 4 week or for 20 d continuously) and anthracycline-cytosine arabinoside chemotherapy with “3+7” regimen was a consolidation protocol after complete remission (CR) for newly diagnosed APL patients.【Results】 54 new cases were treated with ATO and conventional chemotherapy after CR. There were 29 males and 25 females

with a 31 median age. Patients received median 4 (range: 2 to 8) courses of ATO and conventional chemotherapy postremission. Median cumulative dose of ATO was 15.1 mg/kg

ranged from 5.9 to 34.8 mg/kg. It commonly developed grade 3/4 neutropenia at the end of ATO course

which did not increase clinical bacterial infection. Other ATO-related toxicities were mild and reversible. No death in CR occurred. All patients after the completion of consolidation therapy had a confirmed molecular remission by real-time quantitative polymerase chain reaction (RT-PCR) or by fluorescent in-situ hybridization assay for PML-RARα transcripts. With a median follow-up of 39 months (range

12-91 months)

two patients experienced relapse at 25 and 46 months. Kaplan-Meier estimated of 3-year and 5-year leukemia-free survival (LFS) and cumulative incidence of relapse were (97.7±2.3)% and (93.4±4.7)%

(2.4±2.3)% and (6.8±4.7)%

respectively. Overall

17 and 29 patients had remained in CR for more than 5 and 3 years. No chronic accumulative toxicities and secondary tumors were observed. The following factors had no significant relationship with LFS: gender

age

initial WBC count

hemoglobin level

platelet count

LDH level

the percentage of APL blasts in peripheral blood and bone marrow at diagnosis

and induction therapy with or without ATO. 【Conclusions】 The combination ATO with chemotherapy as post remission therapy is highly effective and safe for newly diagnosed APL patients.