The comparison between oral arsenic plus imatinib and imatinib alone for the treatment of newly diagnosed chronic myeloid leukemia

A recent study has shown that the use of imatinib combined with arsenic realgar-indigo naturalis formula (RIF) as a first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CP-CML) could potentially lead to a more effective achievement of a deeper molecular response when compared with imatinib as a standalone therapy. This study’s findings were published in the Journal of Cancer Research and Clinical Oncology. 
In this randomized, double-blind, multicentered phase III trial, 191 outpatients with newly diagnosed CP-CML were randomly assigned to receive oral RIF combined with imatinib (n = 96) or placebo combined with imatinib (n = 95). The primary end point of this study was the major molecular response (MMR) at six months. Secondary end points of this study included molecular response 4 (MR4), molecular response 4.5 (MR4.5), overall survival (OS), progression-free survival (PFS), and adverse events.

Baselines demographic data was well balanced between the two groups. The median duration of follow-up was 51 months. There was no significant difference in the rates of MMR between the combination and imatinib arms at 6 months (11.5% vs 12.6%; p = 0.828) or any other point throughout the trial. The 12-month cumulative rates of MR4.5 in the combination and imatinib arms were 20.8% and 10.5% (p = 0.043), respectively. In the core treatment with the two-year analysis, the frequency of MR4.5 was 55.6% in the combination arm compared to 38.6% (p = 0.063) in the imatinib arm. In both, combination arm and imatinib arm, the PFS (93.7% vs 95.8%; p = 0.546) and OS (92.3% vs 94.6%; p = 0.588) were similar at five years. Both groups exhibited similar safety profiles as well.

According to the above study, the combination of imatinib and RIF as a first-line therapy for CP-CML may potentially yield superior outcomes in terms of attaining a more profound molecular response, when compared to imatinib alone.