FLT3-ITD Negative Refractory/Relapsed or Geratic AML Patients Responded Well to Salvage Treatment with Low Dose Cytarabine and Sorafenib

Abstract

There are great needs to explore more efficient and low-cytotoxic treatment for refractory/relapsed (R/R) or old acute myeloid leukemia (AML) patients without FLT3-ITD mutation. We observed the procedures and outcomes of 13 such patients subsequently treated by sorafenib in our departments. Five of them used low-dose cytorabine concomitantly and 8 patients took sorafenib alone as induction therapy. Five patients achieved complete remission (CR) and the needed time ranged from 31 to 100 days. Four patients achieved CR by concomitantly using low-dose cytorabine and sorafenib, but only one patient achieved CR by taking sorafenib alone. The difference of CR induction rates between the two groups was significant. Sorafenib was then prescribed as the maintenance treatment to these AML patients achieving CR until adverse event happening or stem cell transplantation received. Only one patient developed adverse event of grade 3 during the maintenance with sorafenib and it was relieved by withdrawal of the drug. The event free survival with sorafenib ranged from 2 to 20 months. The median survival time of these CR patients was 520 days since the beginning of taking sorafenib. The median survival time of those not achieved CR with sorafenib was 344 days. But we found no significant differences of survival time between those achieving and not achieving CR. Our results of the observation suggested a group of R/R or geratic AML patients unfit for intensive chemotherapy induction and without FLT3-ITD mutation may well respond to single sorafenib treatment. The combination of low-dose cytarabine with sorafenib improved the response rate comparing with using sorafenib alone. This treatment is safe and the survival time is acceptable for such formidable patients.