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Rebecca Olin, MD, MS


Sorafenib Maintenance After Stem Cell Transplantation in FLT3-ITD AML

By: Sarah Campen, PharmD
Posted: Friday, October 2, 2020

For patients with FLT3-ITD acute myeloid leukemia (AML) who undergo allogeneic hematopoietic stem cell transplantation (HSCT), maintenance with sorafenib after transplantation seems to prevent relapse and improve survival compared with no maintenance therapy, according to a Chinese study published in The Lancet Oncology. “Sorafenib maintenance post-transplantation was associated with a significant improvement in the cumulative incidence of relapse, leukemia-free survival, and overall survival and is well tolerated for this population,” stated Qifa Liu, MD, of Southern Medical University, Guangzhou, China.

The open-label trial enrolled 202 patients with FLT3-ITD AML who underwent allogeneic HSCT. Eligible patients must have had composite complete remission before and after transplantation and hematopoietic recovery within 60 days post-transplantation. Patients were randomly assigned to receive sorafenib maintenance at 400 mg twice daily (n = 100) or nonmaintenance (n = 102) at 30 to 60 days post-transplantation. The median follow-up post-transplantation was 21.3 months.

The 1-year cumulative incidence of relapse was significantly lower in the sorafenib group (7.0%) compared with the control group (24.5%). Additionally, the median time to relapse was longer in the sorafenib group than in the control group: 11.6 months post-transplantation versus 5.7 months, respectively.

The rate of adverse events was similar among both groups. The most common grade 3 and 4 adverse events in the sorafenib and control cohorts, respectively, were infection (25% vs. 24%), acute graft-versus-host-disease (23% vs. 21%), chronic graft-versus-host-disease (18% vs. 17%), and hematologic toxicity (15% vs. 7%). No treatment-related deaths were reported.

Disclosure: The authors reported no conflicts of interest.

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