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Both all-trans retinoic acid (ATRA) and arsenic trioxide (As 2O 3) have proven to be very effective in obtaining high clinical complete remission (CR) rates in acute promyelocytic leukemia (APL), but they had not been used jointly in an integrated treatment protocol for remission induction or maintenance among newly diagnosed APL patients. In this study, 61 newly diagnosed APL subjects were randomized into three treatment groups, namely by ATRA, As 2O 3, and the combination of the two drugs. CR was determined by hematological analysis, tumor burden was examined with real-time quantitative RT-PCR of the PML-RARα (promyelocytic leukemia -retinoic acid receptor α) fusion transcripts, and side effects were evaluated by means of clinical examinations.

Mechanisms possibly involved were also investigated with cellular and molecular biology methods. Although CR rates in three groups were all high (≥90%), the time to achieve CR differed significantly, with that of the combination group being the shortest one. Earlier recovery of platelet count was also found in this group. The disease burden as reflected by fold change of PML-RARα transcripts at CR decreased more significantly in combined therapy as compared with ATRA or As 2O 3 mono-therapy ( P. Microsoft software for students. Acute promyelocytic leukemia (APL) accounts for 10–15% of acute myeloid leukemia in which the maturation of granulocytic cells was blocked at the promyelocytic stage. It is also characterized by the t(15;17)(q22;q21) chromosome translocation generating the PML-RARα ( promyelocytic leukemia-retinoic acid receptor α) fusion gene, of which the leukemogenic role has been demonstrated by the transgenic mouse models (). Although conventional chemotherapy such as anthracyclines and cytosine arabinoside (ara-C) succeeded in two-thirds of APL patients in obtaining complete remission, high frequency of early death mainly due to exacerbation of bleeding syndrome and low 5-year disease-free survival (DFS) rates dwarf them to new drugs ().

Our group in the Shanghai Institute of Hematology (SIH) has long been interested in differentiation therapy of human cancers, as inspired by the Chinese philosophy that it is better to transform a bad element instead of simply getting rid of it. After the discovery in the 1970s to early 1980s showing that some leukemic cells could undergo phenotypic reversion under differentiation inducers (, ), we started to screen a large number of compounds and identified, in 1984, all- trans retinoic acid (ATRA) as a strong differentiation inducer for cell line and fresh cells of promyelocytic leukemia. Since 1986, ATRA has been applied to the treatment of APL at SIH, establishing a successful model of differentiation therapy (–). Unlike cytotoxic chemotherapy, ATRA induces terminal differentiation of leukemic cells along the granulocytic lineage (). Several prospective randomized trials demonstrated that ATRA-based differentiation therapy achieved clinical complete remission (CR) rates as high as 92–95% with rapid improvement of hemorrhage (–).