The Clinical Study Of RIF In The Treatment Of Acute Promyelocytic Leukaemia As Maintenans Therapy

ObjectiveThis randomized, noninferiority trial was designed to test the efficacy and safety as well as FACT-G score of an oral tetra-arsenic tetra-sulfide (As4S4)-containing formula named the Realgar-Indigo natural is formula (RIF) compared with intravenous arsenic trioxide (ATO) as maintenance therapy for newly diagnosed Acute Promyelocytic leukemia (APL).MethodsThe study collected 25 patients with APL who have received consolidation treatment after achieving complete remission (CR).In all,25 Patients were randomly assigned to oral RIF group or ATO group, received maintenance treatment with sequential either RIF or ATO followed by ATRA for 5 circles. Relevant monitoring was done after each circle. Effecacy, safety, life quality and medical costs between each group were analysed and evaluated.Results1. During the maintenance therapy no reappearance of abnormal blast cells were found, nor reversion to PML-RAR α positivity confirmed on serial samples after a previous negative result occur in both groups. The RIF group has similar effecacy as the ATO group.2. The rates of adverse events were similar in the two groups. The RIF group has similar safety as the ATO group.3. At the end of maintenance therapy the estimate of the FACT-G showed that the total score of the RIF group is higher than the ATO group with a statistically significant overall difference. We conclude that oral RIF based therapy significantly improved patients’s quality of life4. The estimated medical costs were 15870.23 yuan for each patient in the RIF group compared with 49484.42 yuan for each patient in the ATO group (p<0.05). We conclude that oral RIF based therapy significantly reduced the medical costs compared with ATO based therapy in APL patients.ConclusionWe conclude that oral RIF based therapy is not inferior to intravenous ATO based therapy, and it significantly reduced the medical costs and improved patients’s life quality during maintenance treatment compared with ATO based therapy in APL patients, providing supporting evidence of the potential advantages of this newer overal oral treatment over ATO based therapy.